RU2320381C2 - Photo-ultrasonic device - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: device for effecting biological object by optical radiation and ultrasound intends for treatment of vast infected wounds as well as for treatment of soft and hard biological tissues at different pathologies, including, tumors, anomaly of vessels, dermatological diseases. Device has optical unit made of matching optical system and optical radiation source connected with power supply, ultrasonic unit made of ultrasonic converter connected with power supply, unit for bringing items in coincidence providing spatial disposition of ultrasonic converter and matching optical system in relation one to other in such a way that directional pattern of optical source would be oriented onto distal end of ultrasonic converter. Device also has control unit connected with ultrasonic and optical units providing synchronized operation of ultrasonic and optical units, and feedback unit connected with control unit. Device also has solution supply unit which provides delivery of photo-sensitizer, antibiotic and contrast components in to area of effect.

EFFECT: improved efficiency of treatment of infected wounds.

20 cl, 22 dwg, 21 ex

Description

Technical field

The invention relates to medicine, in particular to therapy and surgery, and can be used to treat extensive infected wounds, as well as to treat soft and hard biological tissues in various pathologies, including tumors, vascular abnormalities, dermatological diseases, etc.

State of the art

Known methods and devices for ultrasonic (ultrasound) exposure to biological tissues [1]. In these methods, ultrasonic vibrations in the frequency range of 20-300 kHz are superimposed on the tip, which is in mechanical contact with the biological object directly or indirectly through an additional intermediate medium in the form of a liquid, ointment, etc. The amplitude of the periodic displacement of the tip, which can have a different configuration (scalpel, rod with a flat end, spherical, etc.) reaches about 200 microns. Ultrasound medical device includes, as a rule, an electronic generator of electrical oscillations, which are converted into ultrasonic converters of various types (magnetostrictive, piezoelectric, etc.) into ultrasonic vibrations. Then, the ultrasonic vibrations are amplified and transmitted through an acoustic waveguide-hub, which usually has a complex profile tapering towards the end, to the indicated tip. Currently, this technology is successfully used in many fields of medicine, including oncology, dentistry, general surgery, etc. [2]. Its advantages include high cutting performance, minimal injuries, the possibility of selective exposure to fabrics with various acoustic properties, etc. Ultrasound devices for therapy with frequencies up to several MHz are also known, in which a relatively large diameter ultrasonic transducer is in contact with the surface of the bio-volume directly without an additional waveguide-hub.

On the other hand, it is known to treat purulent-infected wounds using antibiotics and / or antiseptic drugs in the form of solutions, powders, emulsions, ointments, applications, etc. These drugs were aimed at destroying many bacteria that are usually present in the wound. In particular, in the purulent wound, 5 main types of bacteria can be distinguished, which make up 97% of the wound microflora (each of the remaining species does not exceed 1%): Staphylococcus aureus (can reach 60% of the microflora) and Streptococcus purulent - gram-positive, Pseudomonas aeruginosa, Escherichia coli and Proteus - gram-negative. However, the systematic use of broad-spectrum antibiotics has led to the emergence of ever newer resistant strains of microorganisms, including unknown etiologies. In addition, the application of dressings does not provide contact of the entire surface of these dressings soaked in the preparation with the infection located deep in the wound tissue, and also causes a large consumption of drugs.

About 30 years ago, the method of using low-frequency ultrasound for the treatment of infected wounds became known [3, 4]. This method consists in introducing an ultrasound tip into a solution with antibiotics or antiseptics pre-poured into the wound. These components, in particular at the required concentrations, can be diluted in normal saline. A whole series of phenomena arising from ultrasound exposure, including cavitation, acoustic flows and sound pressure, ensures the cleaning of the wound from necrotic deposits, mixing of drugs and enhancing their impregnation into the wound walls, activation of phagocytosis, direct bactericidal effect due to the formation of radicals in the cavitation zone, etc. P. In general, these phenomena contribute to the acceleration of wound healing. The disadvantages include the relatively low efficiency of treatment of extensive deep wounds due to the locality of exposure and the difficulty of defeating antibiotic-resistant strains of microorganisms.

Also known is the method of photodynamic therapy (PDT), which consists of introducing intravenously or locally into the body photosensitizers that selectively accumulate in pathological cells, in particular in tumor cells [5]. Subsequent irradiation of the cells with light with a wavelength that coincides with the absorption band of the photosensitizer used allows the selective destruction of cells due to the photochemical formation of toxic radicals, in particular singlet oxygen. Initially, this method was used mainly in oncology, but later it was used in dermatology and other areas of medicine. Attempts are also known to use PDT to kill antibiotic-resistant bacteria by local or local administration of a photosensitizer to the area of the infected area [6]. The use of PDT for bacteriological tasks, primarily for the treatment of purulent-infected wounds, showed good results, because to date, the appearance of photoresistant strains has not been identified. PDT has been shown to be highly effective primarily for aerobic gram-positive bacteria. In gram-negative, the accumulation of photosensitizers inside the microorganism was not very effective due to the presence of a thick membrane consisting of two strong lipid layers that prevent the photosensitizer from penetrating into the bacteria. In one of the solutions for such medical problems, it was proposed to use a bactericidal photoplastic by applying a thin pad soaked in a photosensitizer solution to the wound, followed by irradiation from an autonomous compact matrix of LEDs or an extended chemoluminescent source [7, 8]. The disadvantage of this method is the difficulty of penetrating light into the deep layers of the wound due to their low optical transparency, as well as the relatively long time required for the photosensitizer to penetrate deeper into the infected wound surface, followed by accumulation in microorganisms (from several hours to a day).

The ability to overcome these shortcomings appeared after combining the optical and ultrasound methods, as well as the creation of the corresponding photo (laser) ultrasound (FUS) devices [9-15]. In particular, in one of the proposed options, ultrasound is used first for cutting tissue, and then the laser provides thermal coagulation of areas with bleeding. Or vice versa, at first the laser is used for thermal destruction of the tissue, and then these products are removed using ultrasound aspiration. However, consistent use over time does not fully achieve a synergistic effect. This disadvantage was eliminated in the combined effect of both ultrasound and optical radiation on a biological object [9-10]. In one of the technical solutions, an optical waveguide serves simultaneously to transmit ultrasound and laser radiation to a biological object [9, 12-15]. This made it possible to significantly accelerate the cutting speed while coagulating the fabric and cleaning the end of the fiber from laser ablation products. However, it did not contain a description of the targeted use of the FUS method and device for treating infected wounds. In addition, in this method, local exposure is carried out mainly in the area of the distal end of the fiber with a diameter of about 100-800 microns, which is not suitable for treating extensive wounds with a transverse size of several centimeters or more.

The method of joint use of ultrasound and laser radiation for the treatment of infected wounds was first proposed in 1986, including the use of a laser for additional heat treatment of the wound and the application of the PDT method [16-18]. A review of various modifications of these methods, indicating the role of enhancing the impregnation of photosensitizers in tissues and the formation of radicals under ultrasound exposure, is presented in [19]. However, in these works there is no technical description of devices allowing to realize a combined effect on the wound. A similar method of using ultrasound together with PDT in oncology with a focus on the non-optical initiation of singlet oxygen due to ultrasound excitation of intermediate chemical compounds was proposed in [20]. However, in this patent there is no proposal for the use of this method for the treatment of infected wounds, and it does not provide a device that implements the method of combined exposure of ultrasound and light to a real object. The closest in technical solutions is the method of treatment of infected wounds, proposed in [19, 22]. It consists in preliminary ultrasound scoring of a solution containing antibiotics and a photosensitizer delivered to the wound area. Then, after the end of the ultrasound with a time delay, light is irradiated. The disadvantage of this method is the time-dependent (i.e. alternating) exposure to the wound of ultrasound and light, as well as the independent use of known standard ultrasound and light devices.

The aim of the present invention is to remedy these shortcomings, that is, the creation of a combined FUZ device that allows for the effective treatment of extensive and deep infected wounds by simultaneously exposing them to light and ultrasound in an optimal combination using one device.

This goal is achieved in that the device for simultaneous exposure of a biological object of optical radiation and ultrasonic vibrations contains an optical unit consisting of an optical radiation source connected to a power supply and a matching optical system. The device also contains an ultrasonic unit, consisting of an electronic generator connected to an ultrasonic converter. The fundamental difference of this invention is that it contains a combining unit that provides spatial orientation of the matching system and the ultrasonic transducer, necessary for the combined action of optical radiation and ultrasonic vibrations on the same bio-volume zone. An additional control unit is also introduced, connected to the ultrasound and optical units, which provides sequential or simultaneous time-synchronized operation of both units according to a given program. The device provides a block for supplying the solution to the zone of the combined FUZ exposure, also connected to the control unit. The block may contain a main container for the preparation and storage of the final solution with the necessary components, as well as additional containers containing a photosensitizer, antibiotics, antiseptics and other components entering the solution in the required proportions. Also, the unit for supplying the required solution to the zone of the combined FUZ exposure may include a pump for supplying the solution through the hollow tube to the wound zone.

The optical source can be made in the form of a substrate of bright LEDs with the desired wavelength. It is also possible to use a therapeutic lamp with a fiber or several fibers, as compact as possible and, if necessary, with filters that provide the required spectral region that matches the absorption band of the photosensitizer used. It is possible to use a laser that provides the highest radiation power among the listed sources. The matching optical system can be made in the form of a separate fiber or multiple fibers connected to separate optical sources. Optical sources with corresponding matching systems or many similar sources, made in the form of an optical matrix, are placed on one side and / or evenly on all sides around the ultrasound transducer and / or inside it. The matrix substrate may have a different shape, for example flat, conical, semi-cylindrical or hemispherical. It is possible to use separate matrix modules, for example, plane geometry, which can change their spatial orientation on one side or around the ultrasound transducer depending on the geometry of the wound.

The combining unit can be made in the form of a bracket attached mechanically to the fixed part of the ultrasonic transducer and fixing each source or specified substrate so that the radiation patterns of individual optical sources are oriented to a specific pathology zone and / or to the distal end of the acoustic transducer.

The ultrasonic transducer can be made with a through cylindrical channel having optical reflective cylindrical walls, contributing to a better distribution of radiation from an optical source through the channel to the biological object. An optical source together with a matching optical system or only a matching system in the form of a lens system or an optical fiber are fixed in the upper (proximal) fixed part of the ultrasound transducer using a matching unit, the implementation of which depends on the type of transducer - magnetostrictive or piezoelectric. The advantages of magnetostrictive converters, usually presented in the form of a package of nickel plates, are high mechanical strength, low voltage and good temporary stability. This allows you to use them with a relatively large mechanical resistance of biological tissue (for example, in the form of bone, blood vessels, etc.). At lower mechanical loads, for example, when treating wounds in soft tissues, it is possible to use piezoelectric transducers, the advantages of which include high efficiency, relatively small dimensions and weight. Due to the design features in magnetostrictive transducers it is very difficult to carry out the through channel, while in the piezoelectric transducers the through channel can be realized through the use of ring piezoelectric packs.

An ultrasonic transducer with a through cylindrical axial channel can be made with a thread in the distal tail. In this case, the matching system is made in the form of an optical fiber fixed in the movable distal part of the ultrasonic transducer using the alignment unit. The latter is made in the form of a clamping nut with a sealing sleeve inserted into it, then the nut is screwed onto the threads of the distal part of the transducer. The light guide is placed in the through hole of the sealing tube. The ultrasonic transducer may contain an axial channel of cylindrical shape, at least only in the distal part, with the difficulty of performing a completely through channel. This will add a lateral cylindrical channel connecting the outer surface of the transducer with the axial channel. In this case, the matching system is in the form of an optical fiber, which is located inside the side and axial channels. The alignment block is made both in the form of the nut with the sleeve indicated above, and in the form of a crustein attached to an external fixed surface and also having a sleeve. The latter is made of sufficiently elastic material so as not to damage the optical fiber (for example, Teflon), in the opening of which an optical fiber is freely placed.

The matching optical system can consist of two parts, for example, an optical flexible fiber fixed in the fixed proximal part of the ultrasonic transducer and a rigid cylindrical fiber fixed in the movable distal part of the ultrasonic transducer. The diameter of such a fiber can be relatively large, up to 10 mm or more, and the length can reach, if necessary, 10-20 cm or more. The distal tail of the ultrasonic transducer can be made detachable completely from optical material with a threaded connection, as a result of which it can be screwed onto the main part of the ultrasonic transducer. The specified optical element in addition to the delivery of optical radiation will also play the role of an acoustic waveguide-hub. If necessary, a mirror coating may be applied to the outer surface of this shank. The distal part may have a different shape, for example, end, rounded or in the form of a scalpel.

In addition to the above-described performance of the ultrasound block in the present invention, it is possible to use focused ultrasound, which allows you to concentrate ultrasound or acoustic energy in the deeper layers of the biological tissue, where the presence of infected areas, for example in the form of abscesses, or suppuration due to penetrating stabbing and gunshot wounds, is possible. At the same time, the ultrasonic block is made in the form of a focusing acoustic antenna with various types of ultrasonic transducers, both traditional and new. As an example, we can mention such known types of transducers as magnetostrictive, piezoelectric, or electric discharge. In the latter case, a powerful acoustic wave is generated in water due to a powerful electric discharge between two electrodes placed in the focus of the acoustic antenna. Between these transducers and the skin surface, a medium such as a liquid or ointment is introduced, having the acoustic properties necessary to ensure acoustic matching of the acoustic antenna and the bioobject. The antenna is oriented in space so that its focus coincides with the pathology area, and the axis of the optical source intersects the focus area of the acoustic antenna. An acoustic antenna may have an axial hole for receiving an optical source with a matching matching optical system. Optical sources can also be fixed evenly along the edges of the acoustic antenna.

The ultrasound block can also be made in the form of a source of pulsed or modulated magnetic field located on the outside of the biological object. In this case, metal particles of small diameter are introduced into the solution in the pathology zone. In this case, the vibrations of these particles under the influence of a magnetic field lead to a corresponding displacement of their environment. This in turn leads to the formation of pulsed acoustic waves or ultrasound with a high degree of repetition of magnetic field pulses. At a lower frequency, for example, in the region of units or several tens of Hz, it is possible to create vibrations or acoustic disturbances that ensure efficient mixing of the solution.

The solution supply unit is made in the form of a container containing a solution with the necessary components, including contrast agents, for example, in the form of metallic and nonmetallic particles of small diameter, or a medium with air bubbles of small diameter, as well as a tube through which the solution enters the pathology area. The control unit contains various programs for introducing the solution, for example, single before combined exposure, cyclic or continuous with a choice of feed rate. The tube for introducing the solution can be connected to the hollow channel of the ultrasonic transducer, and the flow rate is chosen so as to provide a continuous flow of the solution, on which ultrasonic vibrations are superimposed. It is also possible the formation of an aerosol stream modulated by ultrasonic vibrations. In this case, the optical source will be oriented so as to provide irradiation of the zone to which these streams are directed. Also, the optical source can be integrated into the ultrasonic transducer so that the optical axis of the source coincides with the flow direction. One of the technical solutions is to make the distal part of the tube transparent and having an outlet of small diameter. In this case, the axis of the optical matching system will be spatially oriented so that the radiation is directed to the distal end of the tube. It is also possible to ensure the supply of individual components in the form of powder and solution into the wound area through separate channels. For example, it is possible to supply an antibiotic separately in one channel (in the form of a powder or solution), in the 2nd - an antiseptic (in the form of a powder or solution), in the 3rd - a photosensitizer solution, in the 4th - metal particles of small diameter used in an embodiment of a device with a magnetic field source, and the like.

The ultrasound transducer can include a laser source of pulsed or modulated radiation and a matching optical system, the wavelength being selected in the optical absorption range of the solution used or the additional absorbing components used in the solution. To enhance acoustic vibrations, an absorbing optical liquid or / and a thin film or / and a radiation-transparent plate can be placed on the surface of a biological object.

The device includes a feedback unit connected to the synchronization unit, and sensors that provide information about the parameters of ultrasound (power, frequency, amplitude of movement of the distal end, etc.), optical radiation (intensity, wavelength, etc.) , bioobject (temperature, biological indicators of a wound, etc.) and the processed medium (current composition of the solution, temperature, etc.). Further, the recorded information is used to control the exposure mode and to adjust the processing parameters accordingly. All this allows you to optimize and control the control process of the combined FUZ exposure and, if necessary, change the exposure parameters themselves.

Thus, due to a number of new distinctive features, the present invention differs significantly from existing devices and can significantly increase the efficiency of the treatment of infected wounds. This is achieved through the following effects. The impact of ultrasound is accompanied by such phenomena as cavitation, sound pressure, acoustic flows, the formation of radicals during cavitation, etc. Thanks to these phenomena, ultrasound primarily provides effective mixing of the solution in the wound and promotes the forced impregnation of antibiotics and / or antiseptics and / or photosensitizers into the wound walls, bacteria and infected layers in the wound. All this allows you to significantly accelerate the accumulation of the photosensitizer in bacteria. Initially, the selectivity of photosensitizer accumulation in bacteria is due to the relatively high rate of reproduction of bacterial microorganisms in wound conditions compared to healthy cultures. When using ultrasonic vibrations, they allow you to clean the wound from necrotic deposits and deposits (wound detritus, etc.). Mixing the solution with its simultaneous light irradiation makes it possible to effectively irradiate the entire volume of the solution due to the periodic entry of the deep layers on the upper surface of the solution into the zone of the most effective irradiation. This was previously impossible due to the relatively low transparency of the solution, primarily due to the presence of suppuration products. In addition to PDT, the cavitation effect leads to the additional formation of radicals both in solution and inside bacterial microorganisms due to the sonodynamic effect, which increases the efficiency of bacteriological treatment of the wound surface. This makes it possible to exclude the development of bacterial flora resistance to photodynamic action, as is the case with antibiotics. The addition of an antibiotic (for example, gentamicin) to a solution with a photosensitizer is aimed primarily at combating gram-negative microorganisms, although it provides suppression of gram-positive microorganisms. The use of ultrasound also allows you to further enhance the diffusion of photosensitizers primarily in gram-negative bacteria. The combined combined effect also allows reducing doses of both light and ultrasound, as well as drugs and a photosensitizer, as compared to the option of their separate use.

Joint exposure also leads to more efficient activation of the immune system by stimulating the work of its individual components, in particular antibodies. As a result, in the present invention, it becomes possible to obtain a significant synergistic effect from the simultaneous exposure to several physical and physico-chemical factors, which cannot be achieved using each factor or phenomenon separately. As a result of the manifestation of all these effects, the presented device allows to accelerate the course of regenerative processes, normalize microcirculation, maturation and differentiation of granulation tissue and significantly reduce the healing time of purulent-infected wound areas.

Brief Description of the Figures

Figure 1 is a General diagram of a combined photo-ultrasonic (FUS) device. 1 - infected wound; 2 - the surface of the skin; 3 - solution; 4 - waveguide-hub; 5 - ultrasonic (ultrasound) transducer; 6 - power supply of the ultrasonic converter; 7 - optical sources; 8 - block alignment; 9 - power supply unit of an optical source; 10 - control unit; 11 - block supply solution; 12 - solution delivery element (tube); 13 - feedback block; 14 - sensors.

Figure 2 - diagram of the FUZ device based on a matrix optical feed. 1 - infected wound; 2 - the surface of the skin; 3 - solution; 4 - waveguide-hub; 5 - ultrasonic transducer; 7 - matrix optical irradiator; 8 - bracket; 15 - superbright LEDs.

Figure 3 - diagram of the FUZ device based on optical fibers. 1 - infected wound; 2 - the surface of the skin; 3 - solution; 4 - waveguide-hub; 5 - ultrasonic transducer; 8 - bracket; 16 - optical fibers.

Figure 4 - diagram of the FUZ device based on optical fibers. 1 - infected wound; 2 - the surface of the skin; 3 - solution; 4 - waveguide-hub; 8 - combining unit (elastic rings or glue); 16 - optical fibers.

5 is a diagram of the FUZ device with an axial cylindrical channel. 1 - infected wound; 2 - the surface of the skin; 3 - solution; 4 - waveguide-hub; 5 - ultrasonic transducer; 7 - optical source; 8 - bracket; 17 - a cylindrical channel; 18 - wall of the cylindrical channel.

6 is a diagram of the FUZ device with an axial cylindrical channel based on a flexible optical fiber. 1 - infected wound in the deep cavity; 2 - the surface of the skin; 3 - solution; 4 - waveguide-hub; 5 - ultrasonic transducer; 16 - optical fiber; 17 - a cylindrical channel; 19 - clamping nut; 20 - elastic gasket.

7 is a diagram of the FUZ device with axial and lateral cylindrical channels based on a flexible optical fiber. 1 - infected wound in the deep cavity; 2 - the surface of the skin; 3 - solution; 4 - waveguide-hub; 5 - ultrasonic transducer; 8 - bracket; 16 - optical fiber; 17 - axial cylindrical channel; 19 - clamping nut; 20 - elastic gasket; 21 is a lateral cylindrical channel.

Fig. 8 is a diagram of the FUZ device based on a combination of flexible and hard optical fibers. 1 - infected wound; 2 - the surface of the skin; 3 - solution; 4 - waveguide-hub; 5 - ultrasonic transducer; 16 - flexible fiber; 17 - axial cylindrical channel; 19 - clamping nut; 20 - elastic gasket; 22 - hard fiber.

Figure 9 - diagram of the FUZ device for processing internal cavities. 1 - infected wound; 2 - the surface of the skin; 3 - solution; 5 - ultrasonic transducer; 8 - flexible articulation; 16 - optical fiber; 23 - the internal cavity.

Figure 10 is a diagram of the FUZ device based on focused ultrasound for processing internal cavities. 1 - infected wound; 2 - the surface of the skin; 3 - solution; 8 - bracket; 16 - optical fiber; 23 - internal cavity; 24 - acoustic antenna; 25 - the inner surface of the acoustic antenna.

11 is a diagram of the FUZ device based on focused ultrasound for the treatment of superficial deep wounds. 1 - infected wound; 2 - the surface of the skin; 3 - solution; 7 - optical sources; 24 - acoustic antenna; 25 - the inner surface of the acoustic antenna.

12 is a diagram of the FUZ device based on an additional laser source. 1 - infected wound; 2 - the surface of the skin; 3 - solution; 7 - optical sources; 24 - acoustic antenna; 25 - the inner surface of the acoustic antenna; 26 is an additional laser source.

Fig. 13 is a diagram of the FUZ device based on an additional laser source using an absorbing film. 1 - infected wound; 2 - the surface of the skin; 3 - solution; 26 - an additional laser source; 27 - absorbing film.

Fig - scheme FUZ device for spray-aerosol treatment of wounds. 1 - infected wound; 2 - the surface of the skin; 5 - ultrasonic transducer; 7 - optical sources; 8 - bracket; 11 - block supply solution; 12 - solution delivery element (tube); 17 - a cylindrical channel; 28 - particles of the solution.

Fig is a diagram of the FUZ device based on a pulsed magnetic field. 1 - infected wound; 2 - the surface of the skin; 3 - solution; 7 - optical sources; 29 - block pulsed magnetic field; 30 - metal particles.

Fig. 16 is a diagram of the FUZ device with an additional protective mesh. 1 - infected wound; 2 - the surface of the skin; 3 - solution; 4 - waveguide-hub; 5 - ultrasonic transducer; 7 - optical sources; 31 - a protective grid.

Fig is a diagram of the FUZ device with an additional cylinder container. 1 - infected wound; 2 - the surface of the skin; 3 - solution; 4 - waveguide-hub; 16 - optical fiber; 31 - a protective grid; 32 is a cylindrical container; 33 - hollow volume; 34 - vacuum unit; 35 - block supply or suction of liquid.

Fig. 18 is a diagram of the FUZ device with localization of the solution in the wound. 1 - infected wound; 2 - the surface of the skin; 3 - solution; 4 - waveguide-hub; 5 - ultrasonic transducer; 7 - matrix optical irradiator; 8 - bracket; 15 - superbright LEDs; 36 is a plastic surface.

Fig is a diagram of the FUZ device using an additional bath. 1 - infected wound; 2 - the surface of the skin (limb); 3 - solution; 4 - waveguide-hub; 7 - matrix optical irradiator; 8 - bracket; 15 - superbright LEDs; 37 - bath; 38 - matrix of additional ultrasonic sources; 39 - additional optical sources.

Fig - temporary modes of operation of the FUZ device during the treatment of infected wounds.

Fig - the effectiveness of reducing the degree of bacterial contamination of microorganisms of infected wounds for various treatment modes.

Fig - dynamics of the healing of infected wounds in laboratory animals (rabbits).

Figure 1 shows a generalized scheme of a combined photo-ultrasound (FUS) device designed to treat extensive infected wounds 1 located on the surface of the skin 2. A solution 3 is poured into the wound, which may contain antibiotics, antiseptics, a photosensitizer, various contrast agents, etc. items that enhance both the effect of optical radiation by enhancing its absorption in solution 3, and ultrasonic vibrations by lowering the cavitation threshold, improving the propagation of vibrations, acoustic agreement Bani, ultrasound exposure, etc. The distal end 4 of the ultrasound transducer 5 connected to the power supply unit 6 is placed in the solution. The distal end 4, also called the waveguide-concentrator, has a usually complex shape tapering towards the end and is designed to amplify ultrasonic vibrations generated in the upper stationary proximal part of the ultrasonic transducer 5. Depending on the type of transducer 5, it can be either a magnetostrictor or a package of piezoelectric plates. Simultaneously, the wound 1 is affected by radiation from optical sources 7 attached to the ultrasound transducer 5 using the combining unit 8. One of the variants of the combining unit 8 is shown in Fig. 1 in the form of a mechanical bracket. The radiation sources 7 are connected to the power supply 9. To control the combined exposure to ultrasound and light, the system contains a control unit 10. Its functions include ensuring the work on a specific program through power supplies 6 and / or 9 ultrasound and / or optical exposure to the object, setting the required the parameters of the combined effect and programming the time sequence for treating the wound 1. The solution supply unit 11 is designed to supply the solution 3 required in composition to the wound 1 using the delivery element (feed tube) 12 in sponds with the treatment regimen used. This can be a single, continuous or cyclic feed at different points in time. The solution supply unit 11 is connected to the control unit 10 and may include containers for storing the solution and its individual components, a pump for forcing the solution in the form of a jet or aerosol, etc. The system also includes a feedback unit 13 connected to the control unit 10. The function of this unit is to process signals received in this case from 4 feedback sensors 14 and containing information about the parameters of the influence of ultrasound and optical radiation, as well as the state the biological object itself and the parameters of the processed medium. Further, this information is used at least to control the process of exposure and maximum for its control and optimization.

Figure 2 shows an application of the scheme considered in figure 1 for the treatment of wounds 1, where a photomatrix source 7 is used as an irradiation source, which can be made in the form of a flat, conical, semi-cylindrical or hemispherical substrate on which superbright LEDs 15 are placed. LEDs are arranged on a substrate in a specific spatial sequence, creating a matrix structure. The electrical circuit for their inclusion can be serial, parallel or series-parallel, with the latter option being more preferable. Each of the LEDs or a group of superbright LEDs 15 can have a modular design, including an independent matching optical microsystem for each LED or group of LEDs for concentration of radiation in the wound 1 near the distal end of the waveguide 4.

Figure 3 shows another option for supplying radiation using optical fibers 16, which are fixed in space using the combining unit 8. The latter is a few special brackets that are attached externally to the ultrasonic transducer 5. In this case, the radiation source may be a laser wavelengths. Such a scheme makes it easy to change the spatial orientation of the optical fibers. In particular, they can be parallel to the distal end of the waveguide 4 or located at some distance from it, and also tilt at different angles relative to the Central axis of the waveguide. In this case, the fibers themselves when treating wounds can either be located above the surface of the solution, or be lowered into the solution (indicated by a dotted line). The first option will be preferable to use in the treatment of superficial wounds, and the second can be used to deliver radiation to the deep layers of the wounds. Optical fibers can also be embedded in through holes in the wall of a hollow cylindrical tube, which is fixed by the proximal end in the fixed part of the ultrasonic transducer. It should be noted that such a system is also suitable for placing the previously described optical fibers in the end distal part of the specified tube or additional ring, through the central part of which passes the ultrasonic waveguide.

Figure 4 shows a further development of the circuit shown in figure 3. Here, the optical fibers 16 are attached using a special alignment unit 8 directly to the distal end 4. These can be, in particular, elastic rings that draw the fibers to the surface of the waveguide, or a special adhesive connection. Such a scheme makes it possible to bring the optical fibers 16 closer to the wound 1 treatment region and place them around the waveguide, which ultimately provides a more concentrated effect of optical radiation along with ultrasonic vibrations on solution 3 in the wound 1.

Figure 5 shows a variant of the placement of the optical source 7 in the upper part of the transducer 5. For delivery of radiation to the treated area in the transducer 5 and its distal part 4 there is an axial cylindrical channel 17, in which the cylindrical walls 18 are made mirror-like, for example, with using special additional coating or by polishing them. The optical source 7 is fixed using the combining unit 8 in the upper part of the Converter 5.

Figure 6 shows an option for fixing the optical fiber 16 in the lower distal part of the waveguide 4 having an additional thread on the outer surface. A clamping nut 19 is screwed onto this thread, sealing the elastic gasket 20, which is made, for example, of Teflon. The gasket evenly compresses the fiber 16, providing the necessary fixation rigidity and at the same time preventing the fiber itself located in the axial cylindrical channel 17 from being destroyed. This design allows you to quickly replace fibers, for example, in the treatment of various patients. Thus, in such a scheme, the optical fiber 16 is used to simultaneously supply light and ultrasound energies. Due to the mechanical flexibility of the fiber, it can be delivered to hard-to-reach curvilinear channels of a biological object, for example, to various internal cavities such as the nasal, auricular or oral, to the inner surface of the larynx, to the urethra, to the rectum, to the stomach, etc., in which pus can flow -inflammatory processes. The supply of solution 3 can be carried out using an additional tube of small diameter parallel to the fiber and in contact with it.

7 shows a diagram of the input of the fiber 16 through the side channel 21 in the wall of the waveguide 4. The fiber is fixed using a matching unit 8 made in the form of a special bracket attached to the ultrasonic transducer 5 from the outside. This design is convenient in cases where it is difficult to implement a through axial cylindrical channel 17 in the Converter 5, as, for example, as shown in Fig.6. Due to the mechanical flexibility of the fiber, it can be brought into various inaccessible purulent cavities (see the previous section), in particular for ear inflammations, especially in children. One way is that the fiber is inserted through the hole drilled by the laser in the bone tissue in the ear, where the solution with the photosensitizer and antibiotic is poured, and then the fiber is used to conduct ultrasound and light. In the second, the light guide brings light to the ear membrane, which passes part of the radiation inward into the focus of inflammation, while ultrasonic vibrations (inaudible by the ear) are applied using a conventional transducer applied to the outside of the ear.

On Fig shows a diagram of the fixation of the rigid fiber 22 of a relatively large diameter. A clamping nut 19 is screwed onto the thread of the distal part of the waveguide 4, which seals the elastic gasket 20. The gasket uniformly compresses the rigid fiber 22, providing the necessary fixation and at the same time preventing the destruction of the rigid fiber 22. The radiation is delivered using a flexible optical fiber 16 located in an axial cylindrical channel 17. This scheme allows you to increase the size of the zone of both optical and ultrasound exposure to the wound being treated.

Figure 9 shows a variant of the treatment of the internal cavity 23 with the wound 1. Ultrasound irradiation is carried out using the ultrasound transducer 5, pressed to the skin 2 from the outside. Ultrasonic transducer 5 may be conventional without a waveguide 4 in the distal part. The delivery of radiation is carried out using an optical fiber 16, placed directly in the cavity 23. The spatial fixation of the fiber 16 relative to the Converter 5 is carried out, for example, using a flexible swivel connection 8.

Figure 10 shows the use of focused ultrasound using a special ultrasound transducer 24, called an acoustic antenna with an internal curved (spherical or parabolic) surface 25, emitting either one acoustic pulse repeating at a certain frequency, or continuous ultrasonic vibrations.

Figure 11 shows the use of focused ultrasound for irradiation of superficial deep wounds 1 using optical sources 7 located in the center of the acoustic antenna 24 or along its edges. This scheme allows the treatment of deep surface infected wounds. For example, the concentration of ultrasound energy on the deeper layers of the wound will allow more efficient mixing of the solution, which will also increase the effective time of optical irradiation of the solution throughout its volume.

On Fig presents a variant of the formation of ultrasonic vibrations as a result of absorption of optical radiation from an additional laser source 26 both on the inner absorbing surface 25 due to the coating, the acoustic lens 24, and directly in the liquid of the solution 3 in contact with this surface. In this case, the liquid will provide both the generation of acoustic pulses and the necessary acoustic matching. Acoustic antenna 24 may be made optically transparent to laser radiation. In the case of relative transparency of the coating of the inner surface 25, this radiation can also be used to irradiate the solution 3, however, it is more convenient to use independent sources 7, as shown in Fig. 11. It is also possible to place the absorbing film on the surface of the solution 3.

On Fig shows a variant of the optical generation of ultrasonic waves due to direct absorption of radiation from an additional laser source 26 in the solution 3. To enhance ultrasonic vibrations, it is possible to place a thin and light absorbing film 27 in the solution, as in Fig. 12. The placement of the absorbing film 27 also eliminates the penetration of powerful radiation into the wound 1. The formation of ultrasonic vibrations due to absorption of radiation from a laser source 26 leads to the appearance of many phenomena already described, such as, for example, in the case of using a classical source of ultrasonic vibrations.

On Fig shows a variant of the jet-aerosol treatment of wounds 1, which can have any spatial arrangement, including vertical. For example, purulent wounds, as well as infected tumors in the neck, should be attributed to such wounds. In the center of the ultrasound transducer 5, a cylindrical channel 17 is made through which a drug solution is supplied. The initial acceleration to the particles of the solution 28 is reported by the acoustic system through friction between the walls of the channel 17 and the supplied fluid. Depending on the feed rate, either jet or aerosol-jet treatment of wounds is carried out 1. The solution can also be supplied using the solution delivery element - a tube, to which, in turn, a feed pump can be connected. There may be special containers for storing both the solution itself and its components. In this embodiment of the device, it is more convenient to use independent radiation sources 7, which can be made in the form of a therapeutic lamp with optical fibers and light filters, photomatrix systems or LEDs connected to laser sources. Another option is to place the fiber in the cylindrical channel 17 of the ultrasonic transducer 5 and supply a solution in the space between the fiber and the channel walls. In this case, the following options are possible: the optical fiber is stationary, and the ultrasonic converter 5 is operating, i.e. continuously irradiated with light as a liquid exiting the channel 17 in the form of a jet or aerosol, on which ultrasonic vibrations are superimposed, and the wound itself; repeating laser pulses arrive through the stationary fiber, which, due to absorption, form hydrodynamic disturbances, which in turn eject the liquid in the form of a jet or aerosol, and irradiation can be carried out both by the pulses themselves and by using external optical sources 7; Ultrasonic vibrations are superimposed only on the optical fiber, which is mounted at the beginning of the channel 17 (for example, using a nut) and is located inside the fixed tube through which the fluid enters, while the tube can taper towards the end and as a result of ultrasonic vibrations, the liquid is ejected from the tube in the form of a jet or aerosol, and radiation, in turn, is delivered through the light guide, as a result of which a liquid transparent to radiation and a wound are irradiated. For all the options considered, it is possible to use both a flexible fiber and a rigid cylindrical tip.

On Fig shows a variant of the generation of ultrasound in the wound 1 through the use of a pulsed magnetic field block 29, generating powerful magnetic pulses. The latter, in turn, cause metallic particles of small diameter 30 to be placed in a periodic oscillatory motion, which are placed in solution 3. As a result, pulsed acoustic waves or ultrasound are generated at a high pulse repetition rate of the magnetic field. The flow diagram of the solution and the options for using optical sources may be similar to those described in the previous section.

On Fig presents a variant of the combined FUZ device, in which a protective mesh 31 is screwed onto the upper stationary proximal part of the ultrasound transducer 5 using a standard threaded connection. This mesh, which is a hollow cylinder with a perforated bottom surface, is inserted to prevent possible contact of the movable distal part 4 with the surface of the wound 1. This design is important, first of all, when treating large infected areas, such as peritonitis. The solution flow pattern and use cases for optical sources may be similar to those described in the previous two sections. In this case, the optical sources 7 can be attached to the cylinder with the grid 31. In the cylinder itself, wide vertical slots can be made to ensure irradiation of the solution 3 in the space between the bottom surface of the protective grid 31 and the movable distal part 4. Also, the cylinder with the grid can be made optically transparent for light radiation from an appropriate material.

On Fig shows a variant of the combined FUZ device, which uses an additional cylindrical container in the form of a glass 32. In the walls of this glass there are free cavities 33 in which a vacuum is created using the vacuum unit 34. This ensures tight contact of the glass 32 with the skin surface cover 2, part of which is drawn into the hollow volume 33 due to rarefaction. The solution 3 can be delivered or removed using the fluid supply or suction unit 35, which is a hollow tube placed inside the canister 32. Also, the distal part of the waveguide 4 and the light guide 16 are located inside the canister 32. Such a combined FUS device also provides an inclined method of attachment to the skin surface cover 2 and, accordingly, wounds 1. In particular, it can be used to treat tonsils. Another variant of the device is possible when the optical fibers 16 are mounted on the outside of the glass 32. In this case, wide vertical slots can be made in the glass itself to ensure irradiation of the solution 3. Also, the cylindrical glass 32 can be made optically transparent for light radiation from the corresponding material.

On Fig shows a variant of the combined FUZ device, which uses an additional protective plastic surface 36. It is necessary in cases where the infected wound 1 is localized on a flat or sloping surface (eg limb) of the biological object 2, i.e. when there is no obvious recess for pouring the solution 3. In this case, an additional shell made of plastic 36 prevents the outflow (spreading) of the solution 3. The patient, when treating wounds, takes such a position that the wound area is oriented horizontally. Ultrasonic vibrations of the movable distal part 4 are superimposed on the plastic surface 36 with full contact. The plastic itself can be made optically transparent to conduct optical radiation from the source 7. It can also be attached to the surface of the skin 2 using, for example, medical glue or a patch. It is also possible to use an additional gauze napkin impregnated with solution 3 and placed under the plastic when pressed tightly against the surface of the wound 1, for example using the same plastic surface. Another variant of the considered FUZ device is possible when the plastic 36 has an elongated hole through which the ultrasonic waveguide-hub 4 passes.

On Fig shows a variant of the combined FUZ device, in which an additional bath is used for processing. It is necessary in those cases when an extensive infected wound 1 is localized, for example, on the foot of a foot or hand, i.e. when limb 2 can be placed in a special bath 37 of appropriate sizes. The supply of ultrasound and optical radiation is possible in two ways. In the first case, the FUS device (for example, as in FIG. 2) is immersed in a solution 3 poured into the bath 37, then the wound 1 is treated. In the second case, individual ultrasound transducers or an array of ultrasonic sources 38 based on piezoelectric elements with a frequency of 0.1- 2 MHz dock to the walls of the bath. Sources of optical radiation 39 or a matrix of sources also dock to the walls of the bath or is located above the bath with solution 3. In this case, the bath 37 itself can be made optically transparent or metallic. In the latter case, optical windows are provided. Such a FUZ device can be used, for example, for the treatment of extensive and extended wounds formed, for example, after burns. In principle, it is possible to place the whole body in an appropriate sized bath.

On Fig shows the temporal modes of treatment of the wound with various programs for supplying the solution, the moments of the inclusion of ultrasound and light. For example, it can be a single injection of the solution before the subsequent combined exposure, a cyclic or continuous jet or jet-aerosol with different jet speeds. The choice of a particular mode is determined by the medical task and the features of the wounds being treated, including their location, size, etc.

On Fig.18 shows the mode of single introduction of the photosensitizer (F) with a constantly operating ultrasound, after which the light (C) is turned on in a constant mode, and then they are simultaneously turned off. The main advantage of this mode is its high speed when processing wounds, which is very important when treating wounds in the field or in a hospital with a large number of patients in the department. However, due to the lack of preliminary exposure to Ф in the wound, its effectiveness is not the maximum possible, although the use of ultrasound can significantly accelerate the process of diffusion of Ф in the wound and accumulation in bacteria.

On Fig.28 shows the cyclic introduction of F with a constantly working ultrasound, after which the light (C) is turned on in a constant mode, and then they are simultaneously turned off. The advantage is a deeper impregnation of Ф into bacteria and wound walls, and more Ф is impregnated than in the first case. As a result, wound cleaning will be bacteriologically better than in the first case.

On Fig. 20.3 shows the cyclic introduction of F and the cyclic effect of ultrasound, which coincides with the period of introduction of F. Advantage - pauses in the operation of the ultrasound are used to cool the ultrasonic converter. The need for this is associated with the heating of many converters during operation, which prevents their continuous use. With this method, the operation of the ultrasonic transducer in time will be maximum, therefore, a larger amount of Ф is impregnated in bacteria. Thus, with this method, the maximum bactericidal effect is possible, but the time expenditure is large.

20.4 shows a method in which ultrasound is first turned on for a short time to pre-clean necrotic deposits that impede the penetration of Ф, then Ф is introduced and its short-term ultrasound mixing is performed, and after a certain time delay, ultrasound and C are simultaneously turned on. Such preliminary cleaning shown primarily with significant necrotic plaque on the walls of wounds of several millimeters. In general, this mode is the most effective, although it is more time-consuming and time-consuming.

On Fig.5.5 shows a method in which a solution with f is fed into the wound area continuously. After a certain time, ultrasound and C. are simultaneously turned on. This mode is necessary when treating extensive wounds, such as with peritonitis. At the same time or periodically, the solution is pumped out of the wound along with disintegrated necrotic products.

It should be noted that in many cases the necessary antibiotics and antiseptics are also introduced into the solution.

On Fig presents the effectiveness of reducing the degree of bacterial contamination of microorganisms of infected wounds for various treatment modes (see details in example 1). The graph data indicate a clear synergistic effect in bacteriological monitoring of the state of microflora of wounds in the case of the combined use of several influencing factors.

On Fig presents the dynamics of healing of infected wounds in laboratory animals (rabbits) (see details in example 3). Experimental data indicate the acceleration of reparative processes when using the FUZ device in comparison with the use of all other treatment methods. The histogram shows the average time in days based on the three main stages of the wound healing process for all seven groups. These histograms indicate a clear synergistic effect in wound healing in the case of the combined use of several influencing factors.

Practical examples

Example 1. FUZ device and its application for the treatment of purulent-infected postoperative wounds. As an optical source, a therapeutic LED matrix is used, the main module of which in accordance with the patent of V. P. Zharov [7] was developed at MSTU. N.E.Bauman (Moscow) and manufactured at the FSUE Research Institute "Polyus" (Moscow). This matrix includes 336 superbright LEDs located on the inner surface of the cylinder. The main parameters of this matrix: wavelength of the LEDs 660 ± 10 nm; power density (intensity) along the central axis of 1-2 mW / cm ² ; the total area of uniform exposure - 1500 cm ² ; cylinder diameter and length 22 cm 18 cm, respectively; LEDs are connected in series-parallel circuitry. The photomatrix is powered from a network with a voltage of 220 V and a frequency of 50 Hz. As the ultrasonic module of the source, the ultrasonic transducer is a low-frequency ultrasonic device URSK-7N-22 (developed by MSTU named after N.E. Bauman) with the following parameters: frequency of ultrasonic vibrations - 26.5 kHz; the amplitude of movement of the distal end of the waveguide-hub 40 ± 20 microns; type of waveguide-hub - single-wave cylindrical rod; the waveguide is made of a titanium alloy with an end diameter of 6 mm at the distal end. The working ends of the waveguides can have a different shape: flat, providing a supply of ultrasonic flow in the direction of the axis of the waveguide; hemispherical, providing tight contact between the gauze pad impregnated with the solution and the treated biological tissues (the patient, when treating wounds, takes such a position that the wound area is oriented horizontally, and then ultrasonic vibrations are superimposed on the surface of the napkin when the moving distal part of the transducer with gauze is in tight contact, also tightly applied to the wound); beveled at an angle of 30 ° to create directional ultrasonic flow, etc. Type of transducer - magnetostrictive, limitation of the continuous operation of the magnetostrictor due to thermal effects - 5 min; the resonance of the oscillatory system is provided by an automatic frequency control system. The ultrasonic apparatus URSK-7N-22 is also powered from a network with a voltage of 220 V and a frequency of 50 Hz. Used photosensitizer: phthalocyanine with an aluminum metal complex (Russian name - “photosens”, developer and manufacturer - SSC NIOPIK, Moscow), having a maximum absorption band in the range of 660-676 nm and diluted in physiological solution at concentrations of 1-10 mg / l . The antibiotic used is gentamicin sulfate 0.08 g, diluted in normal saline in a volume of 1-2 ml. In order to adapt to the treatment of extensive wounds in accordance with the invention, the photomatrix is unscrewed into two half-cylinders, one of which is fixed above the wound (with a long wound, it is possible to fix two cylinders at once on both sides of the ultrasound source). The method of application of this device is to guide the solution into the wound, followed by periodic superposition of ultrasonic vibrations on the solution lasting 20-40 seconds and pauses between individual ultrasound exposures for about 3 minutes. After exposure of the photosensitizer necessary for its impregnation into bacterial microorganisms (on average it takes 10-30 minutes), continuous optical irradiation of the wound area is performed for about 20-30 minutes. At the same time, a simultaneous ultrasound effect is performed with the same duration and pauses as before the photomatrix was turned on. The optical dose for 20 minutes of exposure is 1.2 J / cm ² , for 30 minutes - 1.8 J / cm ² , for 40 minutes - 2.4 J / cm ² . A similar device was preliminarily tested at Moscow City Clinical Hospital No. 7 in the treatment of surgical purulent-infected wounds in the gastrointestinal tract. Studies were carried out with 5 main groups: control, according to standard treatment methods using solutions of antibiotics, antiseptics, ointment dressings, etc .; Ultrasound + antibiotic; PDT; Ultrasound + PDT; Ultrasound + PDT + antibiotic; control was carried out according to the degree of bacterial contamination of wounds in all groups. The research results (Fig.21) showed the greatest degree of decrease in bacterial seeding in the 5th group (up to 10 on average), which indicates the highest efficiency of the proposed FUZ device in the treatment of infected wounds. It should be noted that various contrast agents such as polystyrene microspheres, metal balls, albumin bubbles, usually used to enhance the contrast of ultrasound images (diameter 3-5 μm, concentration up to 10 ⁹ / ml), introduced into the blood or wound, etc., can be used in such applications. d. All of them are designed to enhance the action of ultrasound due to lowering the cavitation threshold, which also allows to reduce the requirements for the power of ultrasound. The adhesion of marked bubbles to necrotic products allows more effective destruction of the latter due to cavitation effects. There is every reason to believe that bacteria can also accumulate on the surface of the bubbles, which will allow their selective mechanical destruction. It should be noted that, if necessary, it is possible to simultaneously use the standard aspiration procedure necessary to remove suppuration products, replace unsuitable for further use solution, etc.

Example 2. A device for FUS treatment of purulent-infected surgical wounds in oncological surgery. As an optical source, the optical module of the ATO-1-150 therapeutic lamp is used (designer and manufacturer - FSUE NII Polyus, Moscow). Parameters and type of matching system: multi-core flexible fiber with an external diameter of 1 cm; fiber length - 30 cm; the type of light filter pressed to one of the ends of the light guide using the fixing element-nut is interchangeable and interference. In particular, to work in conjunction with photosensitivity (see Example 1), a light filter with a maximum passband in the region of 670 ± 20 nm is used. The radiation power density (intensity) with a light spot covering the entire wound area about 30 cm long is 10 mW / cm ² . As an ultrasonic module, an ultrasonic transducer is used - a low-frequency ultrasonic device URSK-7N-22 (see example 1). The light guide is spatially fixed in the region of the distal part using an additional bracket. A similar device passed preliminary testing at the Central Clinical Hospital of the Ministry of Railways No. 4 of Moscow in the treatment of purulent-infected wounds in cancer patients after radical treatment (removal) of the oncological region or organs. The photosensitizer and antibiotic used are the same (see example 1). Studies of the dynamics and nature of the course of wound processes have shown that the combined use of several physicochemical factors, as proposed in this invention, causes a clearly reproducible synergistic effect and leads to a noticeable activation of reparative processes. In particular, the data of morphological and histological studies have shown that in the first days after the start of wound treatment, significant reductions in purulent-necrotic masses occur, microcirculation parameters improve: reduction of thrombosis, absence of hemorrhage, significant reduction of edema. Further observations showed that mature granulations appear in the wounds, the layer of horizontal fibroblasts is actively fibrosing, there are no microcirculatory disorders, active epithelization is occurring along the edges of the wound. All this leads to complete epithelialization of wounds without complications at any stages of the wound process.

Example 3. The use of the device according to example 1 for FUZ treatment of purulent-infected wounds in animals. The experiments were conducted at the SIC MGMSU. ON. Semashko. In laboratory animals, rabbits of male chinchilla, weighing 3.5 kg, 9 months of age, under local anesthesia with 2% lidocaine solution 10.0 ml, with a scalpel in the back, wounds 6 cm long and 1.5 cm deep with dissection were applied skin, subcutaneous fat, muscle fascia and muscle notching. Wound infection was carried out by introducing colonies of museum strains of microorganisms (staphylococcus, streptococcus, E. coli, Pseudomonas aeruginosa and Proteus). Animals were kept under standard vivarium conditions in separate cages for 30 days. Laboratory animals were divided into 7 groups: 1st group (control), in which no treatment was carried out; 2nd group: the traditional method of treatment using ointment dressings (levomekol, sintomycin emulsion, Vishnevsky ointment) and antiseptic solutions (furatsilin, dioxidin) with dressings 1 time per day; 3rd group: exposure to light only was carried out 1 time per day for 20-30 minutes; 4th group: ultrasound treatment of wounds with a solution of the antibiotic gentamicin for 5 minutes 1 time per day; 5th group: PDT with a photosensitivity solution (preliminary exposure for 6 hours) and light exposure for 20-30 minutes once a day; 6th group: PDT, as in the 5th group, but together with continuous ultrasound exposure for 5 minutes 1 time per day; 7th group: PDT with ultrasound, as in the 6th group, but with a solution of gentamicin 1 time per day. The research results (Fig. 22) of the course of the wound process involving clinical, pathomorphological and histochemical data, including capillaroscopy of the wound edges and thermometry, showed that the use of the FUS device (7th group) provides the highest treatment efficiency for purulent surgical wounds in animals. Compared with the control (healing time - 24.6), FUZ technology (healing time - 12.2) reduces wound healing (stage of complete epithelization) by 12.4 days, that is, two times. These data indicate a clear synergistic effect with a combination of several influencing factors.

Example 4. The use of FUS devices to activate the immune system for purulent-infected diseases. As an optical source, optical modules of a therapeutic LED matrix (see example 1) and a therapeutic lamp (see example 2) are used. As an ultrasound module, an ultrasound transducer is used - a low-frequency ultrasonic device “Tonsillor-2” with the following parameters: frequency of ultrasonic vibrations - 26.5 kHz; the amplitude of movement of the distal end of the waveguide-hub 40 ± 20 microns; type of waveguide-hub - single-wave cylindrical rod; the waveguide is made of a titanium alloy with an end diameter at the distal end of 3 mm; the type of converter is magnetostrictive with automatic tuning of the resonant frequency. Power is also supplied from a network with a voltage of 220 V and a frequency of 50 Hz. In IBCh them. Studies by M.M.Shemyakin and Yu.A. Ovchinnikov of the Russian Academy of Sciences were conducted to evaluate the effectiveness of the described system on blood serum obtained from patients with reduced immunity. Assessment of the state of the immune system was carried out using a new method for measuring the ratio of high-grade and low-grade G class antibodies in blood serum developed by B.C. Ghevondyan and N.M. Ghevondyan. It was shown that the temporary dose of optical exposure at the specified parameters should be at least 10-20 minutes, while for ultrasonic exposure there is an optimum in exposure time for 1-3 minutes with continuous and direct contact of the ultrasonic waveguide with serum, above which with a further increase in exposure, antibody activation gradually decreases and even changes to inhibition.

Example 5. FUZ device for the treatment of purulent-infected wounds in hard-to-reach cavities. As the ultrasound source, the ultrasonic converter module of the URSK-7N-22 apparatus (see example 1) or Tonsillor-2 (see example 4) is used. The source of optical radiation is HeNe laser radiation with a power of 50 mW and a wavelength of 632.8 nm. Derivatives of hematoporphyrin (the Russian name "photogem") are used as a photosensitizer. Laser radiation is delivered using a single-core fiber with a diameter of 600 microns with an external polymer sheath. This fiber is fixed in the distal part of the ultrasonic waveguide using a compression nut, as shown in Fig.6. In such a device, a light guide is used to simultaneously supply light and ultrasound energies. Due to the mechanical flexibility of the fiber, it can be inserted into narrow, inaccessible curvilinear channels, for example, into the ear or nasal cavities. As radiation sources, many well-known lasers for medical applications can be used, for example, gas gas lasers using neutral gas (HeNe, etc.); semiconductor lasers (GaAs, triple compounds, etc.); ion lasers (Ar +, Kr +); dye lasers; solid-state Nd: YAG laser (first and second harmonics with wavelengths of 1064 and 532 nm), etc.

Example 6. FUZ device for processing extensive purulent-infected surfaces. A feature of this device compared to that described in example 1 is the introduction between the distal part of the ultrasonic waveguide and the wound surface of an additional protective mesh. The purpose of this grid is to eliminate the possible contact of the moving distal part of the waveguide with the wound surface, which is a hollow cylinder with a perforated bottom surface. The diameter of the mesh cylinder is 2 cm, the diameter of one mesh hole is 2 mm. This cylinder is not screwed onto the upper fixed part of the ultrasonic transducer (magnetostrictor) using a standard threaded connection. Optical sources are a matrix of superbright LEDs on a hemispherical substrate with a central axial hole, which is attached to the cylinder with a grid so that the cylinder passes through the central hole of the substrate. The optical axis of each LED is directed to the end of the distal part of the waveguide. The radiation wavelength of superbright LEDs is 660 ± 10 nm. The photosensitizer and antibiotic used are the same as in Example 1. This design is important, first of all, when treating large infected areas, in particular purulent-infected wounds in the gastrointestinal tract and with purulent peritonitis.

Example 7. FUZ device for the treatment of surface wounds of complex (not horizontal) spatial configuration. For the possibility of processing such surfaces, including their vertical position, the device is based on the apparatus URSK-7N-22 (see example 1) using a piezoelectric ultrasonic transducer with a through axial cylindrical channel. A solution liquid is continuously fed into this channel with a flow rate of up to 3.3 ml / s. The design of the ultrasonic transducer allows you to vary the inner diameter of the through cylindrical channel from 3.6 to 6 mm, and the hole itself is tapered tapering to the channel outlet at an angle of 35 °. This makes it possible to form a jet-aerosol treatment regime at an ultrasonic frequency of 26.5 kHz due to the arising friction force between the surface of the cylindrical channel and the feed solution. As optical sources, all the elements described above can be used, including arrays of superbright LEDs (see examples 1,6); therapeutic lamps with a multicore optical fiber (see example 2); and mono-fiber lasers. Optical sources are attached on the outside of the piezoelectric transducer using special brackets. A similar device has been pre-tested in MMA them. I.M.Sechenova in the treatment of purulent wounds associated with head and neck tumors.

Example 8. The use of FUS treatment of infected surfaces with simultaneous combined surgical operation on the example of the connection (FUS welding) of bone tissue. The latter is achieved by ultrasonic polymerization of filler material, consisting of liquid monomer of cyacrine with bone chips and various additional components, in particular, based on albumin. The monomer polymerized by ultrasound diffuses into the bone tissue and interacts with its components, in particular with collagen, forming a solid bone conglomerate. The latter in the process of tissue regeneration is saturated with new living bone structures. A certain problem in this case is the instability of the tissue regeneration rate and poor blood supply through the junction area. To eliminate this drawback, FUZ technology is used, while laser radiation is intended to provide additional selective photopolymerization of biological additives. The use of the FUS method is realized by simultaneous exposure of ultrasound and light to the area of bone fracture with the simultaneous supply of optical additives (bone chips, bioadditives, etc., including photosensitizers and albumin) to the treated area. This can significantly reduce the risk of infection of the treated area. In this case, it is possible to use thermal effects under the action of laser radiation to accelerate the polymerization and diffusion of additives. To do this, you can use near and mid-IR lasers: neodymium, erbium, holmium, carbon dioxide, etc. Thermal destruction of photosensitizers, as well as direct thermal effects on bacteria, can also enhance the bactericidal effect. This technology is promising in the treatment of bone tissue in relation to the tasks of oncology, plastic thermal deformation of cartilage in otolaryngology, orthopedics and cosmetology.

Example 9. FUZ device for the treatment of purulent-infected wounds using high-frequency ultrasound. As the ultrasound module, high-frequency ultrasound piezoelectric transducers from ultrasound therapeutic devices with frequencies of 0.88, 1.7 or 2.7 MHz are used. It is possible to use several sources of ultrasonic frequencies at the same time (matrix ultrasound system), as well as several different frequencies at the same time, for example, 0.88 and 2.7 MHz. The power density of the ultrasound (intensity of the ultrasound field) can be used in the range from 0.4 to 1 W / cm ² . Another option is to scan the frequency of the ultrasonic converter, which allows you to tune sequentially to the resonant frequencies of the biological object. Photosensitizer is used as a photosensitizer (see Example 1), which has pronounced photodynamic properties, and teosphthalicum at a concentration of 0.05-0.5 mg / ml as a sonosensitizer (designer and manufacturer - SSC NIOPIK, Moscow). The latter has sonodynamic properties, that is, under the influence of ultrasonic vibrations, it falls apart into radicals, in particular H ₂ O ₂ , which have bactericidal properties. The concentration of H ₂ O ₂ can reach 10 ^-6 mol / L, that is, slightly more than in the case of photosensitizers. Therefore, the possible use of two sensitizers (photo and sono) simultaneously enhances the bactericidal effect. As optical sources, matrices of superbright LEDs are used (see examples 1, 6); therapeutic lamps with optical fibers (see example 2); lasers with optical fibers and fibers. At the same time, optical sources are mounted on ultrasonic sources using special brackets, as described in previous examples. Such a FUZ device that works simultaneously with a photosensitizer and a sonosensitizer, as well as with various ultrasonic frequencies, can be successfully used to treat not only infected wounds, but also surface-accessible purulent tumors.

Example 10. FUZ device based on the use of focused ultrasound. As an acoustic antenna, a line of piezoelectric transducers with a frequency of about 1 MHz, which are focused, for example, in the region of the stomach, is used. Parameters of the focused antenna: frequency 0.7-1.5 MHz, antenna diameter 5-15 cm, power 0.1-100 W / cm ² , pulse duration 0.01-100 ms. Thus, many hard-to-reach zones for conventional ultrasound can be processed. It should be noted that contrast agents, a photosensitizer, metal particles can be selectively delivered to a wound or tumor using various carriers such as liposomes, antibodies, etc. It is also possible the introduction of small bubbles with a diameter of 3-5 microns, as noted earlier, to enhance the action of ultrasound. Also, the use of such a FUZ device is promising in cases of ulcers, including diabetic, burns, suppuration around transplants, prostheses, incl. in orthopedics and dentistry, for the treatment of inflammation of the periosteum, etc.

Example 11. FUZ device based on the generation of ultrasound or acoustic vibrations using the energy of a pulsed magnetic field. The source of the magnetic field is a solenoid inductor with a diameter of 10 cm, which creates a pulsed magnetic field with a voltage of up to 2 T with a pulse duration of 1-10 ms. The inductor is located close to the wound. The magnitude of the effective action of the magnetic field reaches 3-5 cm. Metal particles that are inert to the biological object with a size of 0.1-50 microns (iron in the shells, etc.) are introduced into the wound. Periodic exposure to a magnetic field leads to a periodic displacement of these particles, which in turn leads to the generation of acoustic vibrations and to the mixing of the solution in which they are located. The optical effect in this device is carried out according to the schemes described above.

Example 12. FUZ device for treating purulent-infected wounds using a gauze wipe. As the ultrasound source, the ultrasonic converter module of the URSK-7N-22 apparatus (see example 1) or Tonsillor-2 (see example 4) is used. Doubled frequency solid-state yttrium aluminate laser radiation is used as a source of optical radiation. Power - 200 mW, wavelength 670 nm, “photosens” is used as a photosensitizer. After the toilet of the wound (including the use of antiseptics and antibiotics, as well as ointments), a gauze napkin impregnated with an isotonic solution with photosens and antibiotic is applied to its surface. The use of a tissue is necessary in cases where the infected wound is localized on a flat or sloping surface (for example, a limb), i.e. when there is no obvious recess for pouring the solution, and thus the gauze napkin prevents the outflow (spreading) of the solution. When treating wounds, the patient takes such a position that the wound area is oriented horizontally. Further, ultrasonic vibrations are superimposed on the surface of the napkin when the moving distal part of the ultrasonic transducer is in tight contact with gauze, also tightly applied to the wound. Through ultrasound, a significant acceleration of the impregnation of the photosensitizer and antibiotic into bacteria and purulent wound surfaces is achieved. After this, the tissue is removed and the wound area is irradiated with a laser. It is possible to use a partially transparent dressing, and it is also possible to use a dressing with an increased grid spacing of a gauze napkin to ensure the simultaneous presence of a napkin and subsequent optical irradiation. It is also possible to use such a napkin with simultaneous superposition of ultrasonic vibrations and laser radiation. It is also possible to use additional transparent plastic (Fig. 18) applied over a napkin, which can be attached to the skin with medical glue. This option helps to completely eliminate the flow of the solution, while the ultrasound will be applied to the surface of the plastic, and the laser radiation will be delivered through the plastic, which can be made transparent. It is also possible to periodically remove the gauze cloth when replacing the plastic, or it is possible to remove through a small hole in its surface, which is then sealed.

13. Other examples

The presented examples do not exhaust all possible potential circuits, designs, and applications of the new combined device. The most promising of them are briefly listed below, including various types of ultrasound modules, optical sources, and photosensitizers.

13.1. Along with an increase in the number of optical sources and their combination into matrices, it is also possible to increase the number of ultrasonic sources, for example, it can be a matrix of conventional ultrasonic converters. An ultrasonic transducer with several distal tips is also possible. Ultrasonic vibrations are transmitted to them from one waveguide-hub. This scheme can be realized either using a rigid waveguide with many tips, or by screwing a round nozzle on the end of the waveguide containing many steps for the simultaneous action of ultrasonic vibrations on the solution with a sufficiently large wound area. In this case, the light can be supplied using optical sources by analogy with the previous schemes. A variant of the optical waveguide supply of optical radiation to each individual tip is also possible.

13.2. The generation of ultrasound or acoustic vibrations due to the photoacoustic effect during pulsed or periodic absorption of laser radiation in a solution or a thin absorbing film deposited on it. Erbium and carbon dioxide lasers with the maximum absorption in water are the most promising sources. For optical excitation of ultrasonic vibrations in aqueous solutions, it is also possible to use continuous intensity-modulated (for example, using electro-optical modulators, as well as by changing the curvature of a flexible intracavity metal mirror, etc.) or pulse-periodic lasers.

13.3. Blood processing during collection and storage to exclude or at least inactivate infections in it, including HIV, AIDS viruses in various modes, parasites such as P. falciparum and T. crusi (in vivo, extracorporeal, in special containers, etc.) . In this case, it is possible to introduce a fiber with an ultrasonic tip directly into the vessels and thus destroy the infection in the blood or on the walls of the vessels.

13.4. In addition to the use for the treatment of infected wounds, the presented combined technology is very promising for other medical applications, including the treatment of dermatological diseases, abscesses of the localization, sinusitis, frontontitis, treatment of purulent foci in the roots of the teeth and other inflammatory processes in dentistry, in the treatment of inflammation of the ear, especially children, etc. Oncology should be singled out separately when ultrasound is used both to enhance diffusion of the photosensitizer in the tumor and to form additional radicals that are toxic to tumor cells due to the sonodynamic effect. At the same time, it is promising to use photosensitizers and sonosensitizers at the same time. The introduction of contrast agents, in particular bubbles or microspheres, will provide additional selective damage to tumor cells due to the effects of lowering cavitation thresholds. In this case, the simultaneous use of light for the implementation of PDT is assumed. Various combinations of PDT and ultrasound are also possible when they are used and with some temporary overlap among themselves. Since ultrasound penetrates deeper into the tissue than laser radiation (at least several times), we should expect the destruction of deeper superficial tumors during combined treatment. The most optimal mode is the use of ultrasound for transporting photo- and sonosensitizers, followed by a mild ultrasound effect on the tumor in order to more evenly distribute it in the tumor volume, then PDT is implemented, followed by the inclusion of ultrasound at the final stage. It is also possible to use first sonodynamic therapy, and then connect PDT, but this depends on the degree of sensitivity of the sensitizers used to ultrasound and light. For ultrasonic impregnation of solutions, it is possible to use the above-described options for fixing the solution on the surface using glasses, a protective film, etc. In tumors of internal localization, it is possible to use focused ultrasound in combination with optical fiber delivery of optical radiation to the tumor. As an example, as a radiation source, you can use a continuous dye laser with a wavelength of 630 nm and a power of up to several watts, as a photosensitizer photogam, using an ultrasonic transducer with a frequency of about 1 MHz. For the formation of optical radiation, it is also possible to use chemical reactions with a significant yield of fluorescence in the products of these reactions, enhanced by ultrasound (the formation of intermediate products, radicals, etc.).

13.5. Ultrasound devices. As ultrasound modules, ultrasonic converters of domestic and foreign ultrasonic devices can be used. In particular, domestic: URSK-7N, URSK-8N, URSK-18, URSK-7N-18, URSK-7N-20, URSK-7N-21, URSK-7N-22 and their modifications designed for general surgery tasks, and also ultrasonic welding, cutting and sanitation of biological objects; “Tonsillor” -1.2 for otolaryngology, “Gineton” -1.2 for gynecology, “Stomaton” for dentistry, “Procton” for proctology, “Onkoton” for oncological surgery; in all of the listed ultrasound devices the frequency of 26.5 kHz. Foreign ultrasound devices: CUSA (USA), 23kHz; SUS-101 (Japan), 23kHz; SONOTEC (Japan), 24 kHz; AMDENT (Sweden), 25 kHz; PIEZON (Switzerland), 28 kHz, etc. Modification of ultrasonic modules with changing the frequency of ultrasonic vibrations according to a given program from the control unit in the range from 20 kHz to several MHz, as well as modulation of ultrasonic vibrations of the low-frequency component in the range of 10 Hz-12 kHz are also possible.

13.6. Photosensitizers. Almost all currently known compounds can be used as photosensitizers, including hematoporphyrin derivatives (Photogem in Russia, Photofrin-2, Photosan-3 in the USA and Canada); Alossens; all types of chlorins, for example "Radachlorin"; phthalocyanines, for example, based on Zn, Al, Ga, Co (in Russia, on the basis of aluminum - “Photosense”); naphthalocyanines, for example based on Zn, Al, Si, etc.

13.7. Glass, quartz, sapphire, diamond, etc. can be used as the material of optical hard tips.

13.8. To further increase the processing efficiency, it is possible to use several photosensitizers and optical sources, for example, LEDs with different wavelengths that coincide with the absorption bands of the corresponding photosensitizers.

13.9. The present invention can also be used in combination with other physiotherapeutic influences, in particular with continuous and pulsed magnetic or electric fields, etc.

Literature

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Claims (20)

1. A device for influencing a biological object with optical radiation and ultrasound (US), comprising an optical unit consisting of a matching optical system and an optical radiation source connected to a power supply, an ultrasound unit consisting of an ultrasonic transducer connected to a power supply, an alignment unit, providing a spatial arrangement of the ultrasonic transducer and the matching optical system relative to each other so that the radiation pattern of the optical source is oriented towards the distal nets of the ultrasound transducer, the device contains a control unit connected to the ultrasound and optical units, which ensures the time-synchronized operation of the ultrasound and optical units, the device also has a feedback unit associated with the control unit, and a solution supply unit connected to the control unit and providing delivery photosensitizer, antibiotic and contrasting components in the exposure zone. 2. The device according to claim 1, characterized in that the optical source is made in the form of an LED or therapeutic lamp with a light filter or a compact laser or many similar sources in the form of an optical matrix placed on one side or evenly around the ultrasonic transducer on a flat, conical, semi-cylindrical or hemispherical substrate, and the alignment unit is made in the form of a bracket attached mechanically to the fixed part of the ultrasonic transducer and fixing the spatial position of the source or specified odlozhku. 3. The device according to claim 1, characterized in that the matching optical system is made in the form of a separate optical fiber or a plurality of optical fibers fixed with one or evenly around the ultrasonic transducer using an alignment unit made in the form of one or more brackets mounted on the fixed part of the ultrasound the transducer and / or in the form of ring washers, pressing the optical fibers to the surface of the distal part of the ultrasonic transducer. 4. The device according to claim 1, characterized in that the ultrasonic transducer is made with a through cylindrical axial channel having a special coating on the channel walls that reflects radiation, and the optical source together with a matching optical system or only a matching system in the form of a lens system or optical the optical fiber is fixed in the upper proximal fixed part of the ultrasound transducer using the alignment unit, made in the form of a bracket. 5. The device according to claim 1, characterized in that the ultrasonic transducer is made with a through cylindrical axial channel and a thread only on the distal movable part of the ultrasonic transducer, and the matching system is made in the form of optical fiber fixed in the movable distal part of the ultrasonic transducer using a matching unit made in the form of a clamping nut with a sealing sleeve inserted into it, screwed onto the threads of the distal part of the converter, the light guide is placed in the hole of the sealing elastic sleeve. 6. The device according to claims 1-5, characterized in that the ultrasonic transducer comprises, on the distal side, a non-through axial cylindrical channel and an additional lateral cylindrical channel connected to the axial channel, the matching system being made in the form of an optical fiber, which is located inside the lateral and axial channels, and the combining unit is made in the form of a bracket attached to the external stationary surface of the transducer. 7. The device according to claims 1, 5 and 6, characterized in that the matching optical system consists of two parts, an optical flexible fiber, and an alignment block fixing this fiber in the fixed proximal part of the ultrasonic transducer, as well as a rigid cylindrical fiber. 8. The device according to claims 1, 4, 5 and 6, characterized in that the distal part of the ultrasonic transducer is made detachable from optical material with a threaded shank screwed onto the main part of the ultrasonic transducer, while the outer surface of the shank is coated with a mirror, and the distal the part has a shape, for example end, rounded or in the form of a scalpel. 9. The device according to claim 1, characterized in that the ultrasound unit is made in the form of a focused acoustic antenna, while the antenna and the optical source are fixed using the combining unit so that the focus of the acoustic antenna coincides with the pathology area, and the axis of the optical source intersects the focus area acoustic antenna. 10. The device according to claims 1 and 9, characterized in that the acoustic antenna has a hole in the center to accommodate the optical source or the optical source is fixed using the alignment unit with the edge of the acoustic antenna. 11. The device according to claims 1 and 9, characterized in that the matching system is made in the form of an optical fiber whose axis is aligned with the focus of the acoustic antenna. 12. The device according to claim 1, characterized in that it further comprises a source of a pulsed or modulated magnetic field located on the outside of the biological object, while the solution contains metal particles. 13. The device according to claims 1 to 3, characterized in that the solution injection tube is connected to the hollow cylindrical axial channel of the ultrasonic transducer in order to provide jet and / or aerosol-jet treatment of the wound, in addition, the feed pump is connected to the tube, and The device itself contains containers for storing both the solution and its components. 14. The device according to claims 1, 2, 3 and 13, characterized in that the distal part of the tube is transparent and has an outlet, and the axis of the optical matching system is spatially oriented so that it intersects the distal end of the tube. 15. The device according to claim 1, characterized in that the ultrasonic unit is made in the form of a focused acoustic antenna, and a coating that absorbs radiation is applied to the inner surface of the antenna, or this surface is in contact with a liquid that absorbs radiation. 16. The device according to claim 1, characterized in that it contains sensors of ultrasonic parameters (power, frequency, amplitude of movement of the distal end of the ultrasonic transducer), and / or optical radiation (intensity, wavelength), and / or state of the biological object (temperature, state wounds) and / or solution in the wound (current composition of the solution, temperature), which are connected to the feedback unit to control the effects. 17. The device according to claim 1, characterized in that it further comprises a container with walls transparent for optical radiation and ultrasonic vibrations, connected to the solution supply tube, while the container itself is pressed against the edges of the wound so as to ensure tightness that prevents leakage of the inside its solution. 18. The device according to claim 1, characterized in that it further comprises a solution suction unit in contact with the solution using an additional tube, while it is connected to the control unit, and the tube can be placed inside the tube used to supply the solution and place the fiber. 19. The device according to claim 1, characterized in that it further comprises an infrared laser unit connected to a control unit, designed both for additional thermal decomposition of the photosensitizer in solution and for evaporation of part of the solution from the wound. 20. The device according to claim 1, characterized in that it contains a protective mesh in the form of a cylinder to exclude possible contact of the moving distal part of the waveguide with the wound surface, the closed base of which is made with many holes, and the cylinder itself is fixed in the upper stationary proximal part of the ultrasound transducer with threaded connection.

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