RU2625296C1 - Polyfunctional wave radiator - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: wave radiator contains a body with a diaphragm, which limits the internal cavity of the body and is installed with the possibility of contact interaction with the bio object. The case contains an electromagnetic inductor, a membrane and a flat-concave acoustic lens. The membrane is attached to the electromagnetic inductor by one side, and the other side to the flat surface of the acoustic lens. Through-holes are made in the lens. The piezo-emitter of sound waves is placed on the diaphragm. The membrane is made in the form of a ring.

EFFECT: increased efficiency of treatment.

2 cl, 1 dwg

Description

The invention relates to the field of medical technology, in particular to devices that generate sound and shock waves, and can be used as part of devices for shock wave and sound effects on biological objects, in particular, to stimulate metabolic processes, cell proliferation, revascularization, stimulation blood flow, reduce inflammation, as well as to relax smooth muscle elements of the walls of internal organs and activate peristalsis.

At present, in the practice of treating chronic degenerative-dystrophic diseases with an inflammatory component, shock-wave devices are successfully used. The confirmed effect of low-intensity shock-wave action on the stimulation of metabolic processes, revascularization, cell proliferation and other positive effects is known. However, it should be noted that the effect of the shock wave on the relaxation of smooth muscle elements of the walls of internal organs and the activation of peristalsis is unknown.

It is known about the use of shock wave therapy, for example, in vertebrology, in the treatment of hernia of intervertebral discs (RF patent for the invention No. 2417800 "Method for the non-invasive treatment of morphological and anatomical pathologies of intervertebral discs", IPC A61N 1/18, A61N 7/00, date publ. 05/10/2011), which, due to the precise action of the focused low-frequency shock wave on the target area, improves local blood circulation, loosens calcium deposits and fibrous lesions, which cause inflammation and pain, one of the most important of its effects is the stimulation of the development of a new microvascular bed in the problem area.

It is known about the application of exposure to defocused shock waves:

in traumatology and orthopedics - shock-wave therapy devices from Dornier MedTech:

“Dornier Aries” (information on the presentation of the product in October 2010, web page: http: //xn--b1a6ab3b.xn--p1ai/files/Dornier/Aries%20ProdPres_e_1010%20v0%20short_rus.pdf),

“Dornier EPOS Ultra” (web page: http://vgsgroup.ru/index.php/ru/2011-07-25-23-11-17/-dornier-medtech/item/15-uwu/55-epos );

in the treatment of the musculoskeletal system, in case of fractures and osteoporosis to ensure revascularization, increased circulation (US patent No. US 7985189 B1 "Method for using acoustic shock waves in the treatment of medical conditions", IPC A61N 7/00, A61B 17/225, date of publication July 26, 2011);

for effects aimed at stimulating the release of tissue growth factors (US patent No. US 7841995 B2 "Pressure pulse / shock wave therapy methods and an apparatus for conducting the therapeutic methods", IPC A61N 7/00, A61B 17/225, date publ. 30.11 .2010);

to stimulate metabolic processes in tissues in order to accelerate the healing of postoperative wounds, trophic ulcers, stimulation of renal activity (RF patent for the invention No. 2076641, IPC A61B 17/225, publication date 10.04.1997);

in physiotherapy to stimulate metabolic processes in diseases of the genitourinary system (RF patent for the invention No. 2482806, IPC A61B 17/225, A61N 5/00, date of publication. 05.27.2013);

for the correction of microcirculation in chronic catarrhal gingivitis in humans (RF patent for the invention No. 250000365, IPC A61N 7/00, A61B 17/24, date of publication. 10.12.2013);

in the treatment of chronic prostatitis (RF patent for the invention No. 2400269, IPC A61N 7/00, A61K 31/47, published on September 27, 2010).

In the treatment of one of the most common diseases today - urolithiasis (ICD), in which stones are formed in the urinary system, different in composition and size, various types of treatment are used. The crushing stones with contact and non-contact methods is considered the gold standard in the treatment of ICD. However, crushing is accompanied by inflammatory processes, vascular damage, hematomas, edema, etc. The elimination of these negative effects allows the use of low-intensity shock wave therapy. However, in practice, crushing stones does not guarantee their complete removal.

As noted above, the shock-wave effect does not lead to relaxation of smooth muscle elements and activation of peristalsis, which requires the use of additional methods of treatment, since the remaining stone fragments after crushing increase the risk of relapse of the ICD.

Thus, with ICD, the effects obtained as a result of shock wave therapy are a necessary but not sufficient condition for removing stones from the urinary tract. To remove stones and fragments remaining after crushing, it is necessary to achieve the effect of relaxation of the smooth muscle elements of the urinary tract and enhance their peristalsis.

The confirmed effect of sound exposure on the relaxation of smooth muscle elements is known, as well as on the activation of peristalsis (including the ureters). In medical practice, in particular in urology, in the treatment of urolithiasis, sound stimulants have been used for a long time, acting on a biological object with a sound wave.

The well-known "Method for the treatment of urolithiasis" (RF patent for the invention No. 2360679, IPC A61K 31/505, A61P 13/04, A61B 17/225, published on July 10, 2009), which provides an increase in the effectiveness of stone therapy using sound stimulation. When implementing the known method, the complex effect of alpha-adrenergic blocking and sound stimulation on the projection of the kidney by sound waves is performed, as a result of which there is an effective passage of stones and their fragments after lithotripsy.

A device is known that produces sound wave radiation intended for influencing a biological object: a sound wave therapy apparatus according to German patent application No. DE 102007014245 A1 ("Sound wave apparatus for medical treatment has changeable part of delay block capable of influencing angle of radiation produced", IPC A61N 7/00, A61B 17/225, date of publication September 25, 2008).

It is known to use a sound stimulator in physiotherapy - the Intrafon-1 apparatus to restore or improve urodynamics in the presence of a stone in the ureter. In the presence of small stones (with a transverse size of up to 6 mm), as well as crushing residues (stone fragments), exposure to sound waves using the Intrafon-1 apparatus helps restore active contractions of the ureters, as a result of which small stones or fragments are usually excreted, remaining after crushing (web page: http://ilab.xmedtest.net/?q=node/5243, publ. 21.01.2013). The design of the sound stimulator was protected by RF patent for the invention No. 201461 “Sound stimulator”, IPC A61H 23/00, date publ. 06/15/1994. A sound stimulator intended for physiotherapeutic treatment comprises a sound vibration emitter (sound wave emitter), a control pulse generation unit, a conversion unit, a sound vibration parameter setting unit and a parameter display unit connected to the control pulse generation unit. As the emitter of sound waves in the known device, it is proposed to use one of the most common types of emitter - electrodynamic sound emitter.

The known device, which includes an emitter that generates sound waves, is designed to effect only sound waves and has a limited scope (since it does not affect the stimulation of metabolic processes, cell proliferation, revascularization).

It is known "Device for stimulating tissue metabolism by shock-wave pulses" (RF patent for the invention No. 2151559, IPC A61B 17/225, published date 06/27/2000), which includes an emitter of focused acoustic shock-wave pulses. The emitter is made in the form of an electromagnetic generator of shock-wave pulses, including an electromagnetic inductor containing coaxial coils. The inductor is equipped with a metal membrane. The emitter also includes a focusing system, at the output of which a diaphragm with an adjustable hole is installed. During the operation of the device, in each pulse, the current flowing in the inductor coil shockly accelerates the metal membrane in contact with the liquid, which is preliminarily filled with the internal cavity of the generator. In this case, a shock-wave acoustic pulse is formed in the liquid, which is focused by the focusing system into the impact zone.

However, the known emitter is intended only for the formation of shock wave pulses, which limits the scope of its application (since it does not generate radiation that affects the relaxation of smooth muscle elements and activation of peristalsis).

As a technical solution (prototype), the closest in combination of essential features to the claimed invention, it is proposed to choose an electromagnetic shock wave emitter, which is part of the well-known "Device for shock wave therapy" (RF patent for the invention No. 2420241, IPC A61B 17/225 , B06B 1/02, published on 06/10/2011), which relates to physiotherapeutic shock wave devices and is intended for treatment by the shock wave method, in order to rehabilitate patients with chronic diseases in morning organs (kidneys, liver, gall bladder, prostate and others.) as well as in orthopedic practice.

An electromagnetic emitter of shock waves (or a generator of shock waves) contains a housing inside which there is an electromagnetic inductor, a diaphragm (also called a membrane) adjacent to the inductor and used to create a shock wave pulse during the passage of current in the inductor coil, and a telephoto focusing system. The focusing system is a collecting acoustic lens mounted in the housing after the membrane. The cover, which performs the function of an elastic diaphragm, limits the internal cavity of the emitter body, ensuring tightness, and is also designed to ensure tight contact with the patient’s body (with the surface of the biological object) during shock wave transmission. The housing is equipped with a fitting for supplying water to the working cavity of the housing. The acoustic lens is made of polymeric material and mounted with the possibility of movement in the axial direction. In a known technical solution, the impact on the object is carried out in the peripheral region of the shock wave.

Regarding the well-known technical solution, as well as for the above analogues, the following should be noted. A well-known emitter containing only an electromagnetic inductor, ensures the formation of only a shock wave that does not provide relaxation of smooth muscle elements of internal organs and activation of peristalsis, which reduces the effectiveness of treatment using a known technical solution, in particular, with urolithiasis.

It should also be noted that the gap between the acoustic lens and the membrane determines the presence of two media interfaces, each passing through which leads to energy loss and distortion of the structure of the shock wave, which reduces the stimulating effect when exposed to the shock wave and the effectiveness of the treatment when using the emitter.

In addition, there is the possibility of overheating of the membrane due to the fact that, although there is a liquid layer between the membrane and the acoustic lens (a gap filled with liquid), the circulation of the liquid in the gap seems insufficient to ensure effective cooling of the membrane. As a result of heating, the membrane surface can be deformed (up to mechanical damage), and with intensive heating, the lens can also be deformed, which can enhance changes in the structure of the shock wave: distortion of the wave propagation, decrease in its power, and the appearance of uneven energy density at the wave front, which will lead to reduce the stimulating effect when exposed to a shock wave, and therefore, reduce the effectiveness of treatment when using the emitter.

When developing new medical devices and devices, important factors affecting the increase in treatment efficiency are, in particular, the expansion of the therapeutic effect of the device (i.e., the increase in the body systems that the device has an effect on), and the increase (enhancement) of effects due to the effect apparatus (for example, stimulation of metabolic processes, cell proliferation, revascularization, relaxation of smooth muscle elements, activation of peristalsis).

The technical result, the achievement of which the claimed invention is directed, is to increase the effectiveness of treatment by providing the possibility for the emitter to generate both shock and sound waves, as well as enhancing the effects of the device.

To achieve the above technical result, a wave emitter is proposed comprising a housing with a diaphragm bounding the internal cavity of the housing and installed with the possibility of contact interaction with a biological object. An electromagnetic inductor, a membrane and a flat-concave acoustic lens are installed in the housing. The membrane is installed between the electromagnetic inductor and the acoustic lens. One side of the membrane is adjacent to the electromagnetic inductor. Moreover, according to the claimed technical solution, the other side of the membrane is adjacent to the flat surface of the acoustic lens. Through holes are made in the acoustic lens. A piezo-emitter of sound waves is placed on the diaphragm.

The inclusion in the composition of the claimed device of a piezoelectric emitter of sound waves placed on the diaphragm, makes it possible for the emitter to form a sound stimulating wave, which has the effect of relaxing smooth muscle elements and activating peristalsis. This embodiment allows you to expand the spectrum of effects on the biological object during operation of the apparatus, which includes the inventive emitter, which, in comparison with the prototype, provides increased treatment efficiency, in particular in the treatment of ICD, when a low-intensity shock-wave effect stimulates metabolic processes, revascularization, proliferation, etc., and sound stimulation provides relaxation of smooth muscle elements and activation of peristalsis of the ureters, which ensures the elimination of Olsha stones and fragments after crushing.

The implementation of through holes in the acoustic lens provides, in comparison with the prototype, more efficient cooling of the membrane due to more intensive circulation of fluid through the holes in the lens, which allows you to get a shock wave with a uniform distribution of energy density at the front of the wave, this improves the efficiency of the stimulating effect of the shock wave and increases the effectiveness of treatment when using the inventive device.

The absence of a gap between the membrane and the acoustic lens in the claimed technical solution, in contrast to the prototype, provides one interface between the transmission of the shock wave pulse from the membrane to the acoustic lens, which reduces the energy loss of the pulse and distortion of the structure of the shock wave, and therefore, strengthen the effectiveness of the stimulating effect of the shock wave and increase the effectiveness of the treatment when using the inventive device.

In order to further reduce the heating of the membrane during operation of the emitter, it is proposed that the membrane be made in the form of a ring (i.e., with a central hole), because when eddy currents are induced in the annular zone, less heating occurs.

Graphic materials contain an example of a specific implementation of the claimed technical solution.

The drawing shows a multifunctional wave emitter, the main view, section.

The multifunctional wave emitter comprises a housing 1 made of metal, for example, of duralumin.

The internal cavity of the housing 1 is closed by the diaphragm 2. The connection of the diaphragm and the housing along the edge of the housing is sealed. The diaphragm is made elastic - to provide more tight contact with the surface of the biological object; from acoustically transparent material - to ensure the transfer of wave action in the tissue of a biological object during operation of the device. Silicone diaphragms are commonly used.

On the diaphragm 2 there is a piezoelectric emitter of sound waves 3, which can be located both on the outer and inner surfaces of the diaphragm. In the example of a concrete embodiment shown in the drawing, the piezo-emitter 3 in contact with the diaphragm is attached to the inner surface of the diaphragm 2 (conventionally shown in the drawing), namely, it is glued. As a piezoelectric transducer of sound waves, for example, a piezoelectric transducer SPS-2220-03 can be used.

To the piezoelectric emitter of sound waves 3 summed up the conductor 4, providing power during operation of the device.

An insulating insert 5 is provided inside the housing, which insulates the inner surface of the housing 1. The inner insulating insert can be made, for example, of PCB.

In the presented example, a snug fit of the edge of the diaphragm 2 to the inner surface of the flange flange 6 of the housing 1 is provided by pressing the upper end part of the liner 5.

In the housing 1 is installed an electromagnetic inductor 7, made in the form of an electromagnetic coil, the turns of which are laid in the grooves of the insulator. A current lead is connected to the inductor coil 8. The electromagnetic inductor, when the device is in operation, provides the creation of an electromagnetic pulse, due to which the membrane forms a shock wave pulse (shock wave).

A membrane 9 adjacent to the electromagnetic inductor 7 is installed in the internal cavity of the housing through the sealing ring 10. As a membrane, for example, a plate of a single-sided foil textolite can be applied, which is placed on the electromagnetic inductor, having the plate having a dielectric surface to the inductor.

Above the membrane 9, a plane-concave acoustic lens 11 is installed in the inner cavity of the housing, which collects and forms a low-intensity wave during operation. The flat surface of the lens 11 is adjacent to the membrane 9. The contact of the surface of the membrane and the flat surface of the lens can be achieved, for example, by installing the acoustic lens 11 against the support surface of the protrusion made in the insulating insert 5 by fixing the membrane against the lens by elements installed after the membrane (as is done in the example shown in the drawing) or, for example, the lens with its flat surface can be fixed on the membrane with glue. Through the lens 11, through holes 12 are made with a diameter of 1.5 to 3 mm located along three concentric circles (holes are made with an increasing diameter from the center to the periphery). When the device is operating, the openings 12 provide the possibility of cooling the membrane 9 adjacent to the flat surface of the acoustic lens 11 due to the circulation of the liquid filling the cavity between the membrane 9 and the diaphragm 2 (working cavity). The membrane 9 is made in the form of a ring (i.e., with a central through hole), which reduces the heating of the membrane upon excitation of Foucault currents during operation of the device.

The conductor 4 passes through an insulating fitting 13 installed in the Central through holes of the membrane 9 and the acoustic lens 11.

The clamp of the electromagnetic inductor 7 to the membrane 9, the clamp of the membrane 9 to the acoustic lens 11, as well as the tight fit of the edge of the diaphragm 2 to the shoulder 6 of the housing 1 are provided when installing the housing element - holder 14 (connected to the housing 1 by means of a threaded connection) and ring 15 (installed in the housing between the holder 14 and the inductor 7), followed by fixing their position with a threaded clamping ring 16.

The conductors 4 and 8 pass through the through holes made in the holder 14, the ring 15, the inductor 7, the membrane 9, the lens 11.

During the operation of the device, the working cavity must be filled with liquid in which the shock wave propagates. A valve for supplying liquid is installed in the housing (not shown in the drawing). Thanks to the valve, it is also possible to replace the liquid during operation of the device.

The tightness of the working cavity is ensured by the installation of the sealing ring 10 and the tight connection of the diaphragm 2 with the housing 1 along the flange shoulder 6, as well as by the insulating fitting 13 (ensuring tightness at the passage of the current lead through the membrane and lens).

The functioning of the inventive multifunctional wave emitter is carried out as part of the apparatus of wave therapy.

The apparatus comprises a power supply unit and a control unit connected to an external connecting cable. A multifunctional wave emitter (located outside the device) is also connected to the cable.

For the apparatus to work, the working cavity of the emitter must be filled with liquid, for example, distilled water.

The power supply unit provides energy for the operation of the electromagnetic inductor 7, as well as for the operation of the piezoelectric emitter of sound waves 3.

Using the control unit, the operating parameters for the operation of the electromagnetic inductor 7 and the piezoelectric emitter of sound waves 3 are set depending on the type of procedures: voltage, frequency of pulses and the number of pulses (exposure time) for the electromagnetic inductor 7, as well as the duration of exposure to the sound wave of the piezo emitter 3. V the control unit also has an emergency stop function.

Using the control unit, certain modes of operation of the wave action apparatus are set:

- simultaneous (joint) impact of shock and sound waves,

- alternating effects of shock and sound waves,

- isolated exposure (exposure to only shock waves or exposure to only sound waves).

The power supply from the power supply unit through the current lead 8 is transferred to the electromagnetic inductor 7. When electric current flows through the turns of the electromagnetic coil of the inductor 7, the Foucault eddy currents are excited in the metal membrane 9 and the pulse oscillation of the membrane 9 is sharp, resulting in a shock wave pulse transmitted to an acoustic lens adjacent to the membrane 11. Lens 11 forms a converging low-intensity shock-wave beam, which then propagates in the liquid medium to the diaphragm 2. Running in the lens through holes 12 ensures intensive access of water to the membrane, thereby allowing its effective cooling. In addition, an additional contribution to reducing the heating of the membrane during operation is made by its implementation in the form of a ring (as a result of the peculiarities of eddy currents arising in the annular zone). The elastic acoustically transparent diaphragm 2 is tightly attached to the surface of the bioobject and transmits a shock-wave effect to the tissue of the bioobject (for a better wave passage between the outer surface of the diaphragm and the bioobject, a layer of sound-conducting gel should be applied). The shock wave passes through the tissue of the biological object to the target (targeted) area, which is the impact zone. The impact on the targeted area occurs along the entire front of a low-intensity shock wave. As a result of exposure in the targeted area, effects occur: stimulation of metabolic processes, cell proliferation, revascularization, stimulation of blood flow, reduction of inflammatory phenomena, etc.

During operation of the piezoelectric emitter of sound waves 3, it is supplied with power from the power supply unit through the current lead 4. The piezoelectric emitter of sound waves operates with constant voltage and frequency values. The control unit controls the duration of exposure to the sound wave. The piezoelectric emitter 3 generates a sound wave that passes through the diaphragm 2, a layer of a conductive gel deposited between the diaphragm and the surface of the bioobject, and penetrates the tissue of the bioobject, causing relaxation of smooth muscle elements of internal organs and increased peristalsis.

The inclusion in the composition of the claimed technical solution of the piezo-emitter of sound waves placed on the diaphragm, in comparison with the prototype, allows the emitter to generate not only shock waves, but also sound waves, which expands the spectrum of the device. During the operation of the device, stimulation of metabolic processes, cell proliferation, revascularization, stimulation of blood flow, reduction of inflammatory phenomena and other effects due to shock-wave action, as well as relaxation of smooth muscle elements and activation of peristalsis due to sound exposure are provided. The use of the claimed device allows you to expand the spectrum of effects on the biological object during operation of the apparatus, which includes the inventive emitter, which improves the effectiveness of treatment.

The contact of the membrane and the flat surface of the lens (when there is one interface between the media) compared with the implementation in the prototype of the membrane and the lens separated by a layer of liquid (when there are two interfaces between the media), reduces energy losses during the transmission of a shock wave pulse and reduces distortion of the structure shock wave, which positively affects the effectiveness of the stimulating effect of the shock wave and, therefore, increases the effectiveness of the treatment when using the inventive device.

The implementation, in contrast to the prototype, through holes in the lens, as well as the implementation of the membrane in the form of a ring provide a decrease in the heating of the membrane (compared with the prototype), which allows to obtain a shock wave with a uniform distribution of energy density at the wave front, which reduces distortion of the structure of the shock wave and also has a positive effect on the effectiveness of the stimulating effect of the shock wave when exposed to the targeted area of the biological object and increases the effectiveness of treatment when using th device.

Claims (2)

1. A wave emitter, characterized in that it contains a housing with a diaphragm, limiting the internal cavity of the housing and installed with the possibility of contact interaction with a biological object, an electromagnetic inductor, a membrane and a flat-concave acoustic lens installed in the housing, the membrane being installed between the electromagnetic inductor and the acoustic lens and one side adjacent to the electromagnetic inductor, and the other to the flat surface of the acoustic lens, while in the acoustic lens are made oznye holes, and the diaphragm disposed piezo sound waves. 2. The wave emitter according to claim 1, characterized in that the membrane is made in the form of a ring.

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