RU2479301C2 - Apparatus for treating lymphedema in breast cancer patients - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medical equipment, particularly to apparatuses for treating upper extremity lymphedema. The apparatus comprises a movable carrier, an instrument box with a control unit, a two-side open polymeric heat chamber with two sealers coupled with a shape-generating perforated polymer frame connected with a bearing polymer perforated lodgement, a waste ozone/NO air mixture deactivator, a temperature sensor, a coolant generator, an ozone/NO air mixture generator, a low-frequency ultrasonic vibration generator with acoustic assemblies and instrument waveguides. The heat chamber is equipped with an outlet branch; one end of the chamber is fixed by an elastic sealer on an output flange of the instrument box installed on a tray of the movable carrier and pivotally connected with the lodgement. A bearing transverse bar with a massage instrument in the form of a freely rotating roller from a massage ring set is height-movable and locked, and console-connected to a holder mounted on one side of the movable carrier. A thermally and photochrome-ultrasound applicator is connected to a power supply of the instrument box one output of which is connected to a board of a semiconductor polychromatic LED array, and the other one is connected to a vibro-pulse massage unit. Additionally, the apparatus is equipped with an open-side polymer sleeve that matches the size of the affected extremity.

EFFECT: use of the invention improves the clinical effectiveness in upper extremity lymphedema due to the use of the complex of physical factors combined with the high-activity drug substances for activating lymphatic drainage.

24 dwg, 1 tbl

Description

The invention relates to medical equipment, in particular to devices used to treat lymphedema of the upper limb in patients with breast cancer, and can be used in the treatment and rehabilitation of patients with lymphedema of another etiology, in diabetology, dermatology and cosmetology, in sporting, etc.

There is evidence that, with early detection and adequate treatment of breast cancer (hereinafter referred to as breast cancer) in most women, almost complete cure is possible (J. Jassen, 1998). Depending on the degree of development of the tumor process, women with diagnosed breast cancer undergo: surgical treatment, radiation therapy, chemotherapy, hormonal or combined (combined) treatment. After combined treatment of breast cancer in 56% of cases, a complication occurs - postmastectomy edema of the limb or postmastectomy syndrome (Figure 1). It is accompanied by a limitation of the function of the shoulder joint, damage to the peripheral nerve trunks, a decrease in the strength of the muscles of the shoulder girdle and arm of the operated side, a violation of the statics of the trunk, manifestation of radiation injuries (post-radiation soft tissue fibrosis, post-radiation ulcer, osteitis, etc.) in the area of radiation fields, the development of edema the upper limb of the operated side - up to 20% after surgery, and with the addition of chemotherapy and radiation therapy - up to 72%, severe pain, erysipelas, scars, contractures and etc., dramatically reducing the quality of life of the operated patients. Moreover, one of the main reasons - lymphatic edema (lymphedema) of varying degrees of development is noted in 30-50% of operated patients (K.A. Mika, 2008). The mechanism of development of lymphedema is impaired lymphatic drainage resulting from surgery and radiation therapy. The adverse effects of combined treatment of breast cancer are an indication for physical, psychological and social rehabilitation.

Effective treatment of lymphedema of various etiologies, arising primarily after the combined treatment of breast tumors, i.e. at the stage of their rehabilitation, it can be achieved through exposure to the area of lymphedema with a complex of physical factors in combination with highly active medicinal substances while optimizing the technological schemes of energy, material and informational impacts on areas with impaired lymph outflow to activate lymphatic drainage. The above serves as the basis for the development of modern medical technologies for the rehabilitation treatment and rehabilitation of breast cancer patients with lymphedema of the upper limb, as well as the technical means for their implementation, ensuring their multifunctional use in the process of medical and rehabilitation measures, i.e. providing both separate and complex, in a single treatment cycle, effect on the region of lymphatic edema of the upper limb with physical and physico-chemical factors, for example, thermal contrast, photochromic and ultrasonic radiation, mechano-dynamic effects, as well as highly active groups of drugs (Fig. 2).

Known devices for implementing methods of treating lymphedema of the upper limb in patients with breast cancer, used in the postoperative period at the stage of physical rehabilitation, including kinesiotherapy, combined, if necessary, with physiotherapeutic procedures: various types of massage, including lymphatic drainage according to Vodder (W. Vodder) and rhythmic air massage aimed at moving the lymph by “squeezing” it, as well as an underwater shower, circular baths, galvanization, electrical stimulation, etc., enhancing the dynamic work of muscles, their rhythmic contractions, activating blood and lymph vessels, which facilitates the outflow of venous blood and lymph, improves overall microcirculation [1].

However, these devices that implement the appropriate methods of kinesiotherapy and physiotherapeutic procedures do not provide complex physical and physico-chemical effects on lymphatic edema of the upper limb of the operated side to activate lymphatic drainage in conditions of severe pain syndrome characteristic of lymphedema. Moreover, the period of rehabilitation treatment is long and often does not provide a sufficient increase in the quality of life of patients with lymphedema.

A device is known for implementing the method of autokinesiotherapy in the treatment of diseases of the spine [2, 3], which is a therapeutic massage and gymnastic table containing a frame, a tabletop with an opening, a traverse with a tool in the form of a freely rotating roller, consisting of a set of massage rings of various configurations, having the possibility of controlled vertical movement relative to the opening of the countertop, carried out by the patient himself in the process of conducting medical or massage-gymnastic procedures.

However, the design of this device, intended for mechanodynamic effects on the muscular corset of the spine and the spine itself, cannot be used in patients with lymphedema for complex physical and physico-chemical effects on lymphatic edema of the upper limb of the operated side to activate lymphatic drainage in conditions of severe pain syndrome, characteristic for lymphedema resulting from complications after combined treatment of breast cancer.

The closest in technical essence and the achieved result is a device designed to implement a method of treating a diabetic foot syndrome [4], comprising: a mobile stand, an instrument unit with a control unit, a polymer pressure chamber with a sealant for placement in it of an extremity affected by the pathological process, waste ozone / NO-containing air deactivator, temperature sensor, heat carrier generator generating warm or cold air flows and ozone / NO-soda generator a rusting air mixture in communication with a polymer pressure chamber, a generator of low-frequency ultrasonic vibrations with acoustic units and waveguides-instruments, a capillary-porous pad with ozone // NO-containing medicinal substance.

However, this device used to treat altered pathological processes of biological tissues in patients with diabetes mellitus with the syndrome of "diabetic foot" is not intended for the treatment of lymphedema of the upper limb in patients with breast cancer, where it is necessary to provide a multifunctional effect on the area of liphedema, which has a pronounced violation of lymphatic drainage, with a complex of physical and physical -chemical factors in combination with highly active medicinal substances, allowing to activate lymphatic drainage in conditions of pronounced of pain. The above does not allow the device to be used in therapeutic measures aimed at reducing the time of rehabilitation treatment in patients with lymphedema and improving their quality of life.

The objective of the invention is to increase the effectiveness of treatment of patients with lymphedema of the upper extremities through the use of a complex of physical factors in combination with highly active medicinal substances to activate lymphatic drainage.

This object is achieved in that in a device for a comprehensive physiotherapeutic effect on limb biotissues, containing a supporting mobile rack, an instrument unit with a control unit, a polymer pressure chamber with a sealant, a decontaminated ozone / NO-containing air mixture decontaminator, a temperature sensor, and a flow-generating heat carrier generator warm or cold air and an ozone / NO-containing air mixture generator communicating with a polymer pressure chamber, a low-frequency ultrasonic generator baths with acoustic units and waveguides-instruments, a capillary-porous gasket with ozone / NO-containing medicinal substance, characterized in that it is equipped with a bilaterally open polymer pressure chamber with two sealants, paired with a forming polymer perforated frame connected to a supporting polymer perforated bed, placed in its cavity, while it is equipped with a branch pipe connected to a decontaminator of spent ozone / NO-containing air mixture, which discharges this mixture through it l and flows of warm or cold air into the environment, also of one of its terminal parts, the polymer pressure chamber is paired and fixed with an elastic sealant on the output flange of the instrument unit mounted on the pallet of the supporting mobile rack pivotally connected to the lodgment of the polymer pressure chamber; supporting traverse with a massage tool in the form of a freely rotating roller, consisting of a set of alternating massage rings of the same thickness but different diameter, while the forming ring of small diameter is made circular, and the forming ring of large diameter is made wavy, in addition, a traverse with a massage tool of the massage block has the ability to move in height with a fixed position and is cantilever connected to a holder mounted on one of the sides of the supporting mobile rack; thermo- and photochromic-ultrasonic applicator connected to the power supply unit of the instrument unit, one of the outputs of which is connected to the matrix board of the semiconductor polychrome LEDs, and the other output is connected to a vibro-pulse massage module, in addition, the thermo- and photochromic-ultrasonic applicator is connected to the output generating a generator of low-frequency ultrasonic vibrations, the second output of the generation of which is connected to an acoustic unit coupled to a waveguide-tool; in addition, the device is equipped with a polymer one-sided open sleeve corresponding to the size of the affected limb.

As of the filing date of the application for the invention, there are no known devices for treating lymphedema in breast cancer patients with the indicated distinctive features, which allow providing a non-invasive effect on the skin and tissue structures of the region of lipidema with impaired lymphatic drainage by a complex of physical factors in combination with highly active medicinal substances to activate lymphatic drainage.

The proposed device realizes the possibility of its multifunctional use for the treatment of lymphedema in patients with breast cancer with the possibility of activating lymphatic drainage and stopping other manifestations of the postmastectomy syndrome by affecting the skin and tissue structures of the area of the liphedema with impaired lymphatic drainage by a complex of physical and physico-chemical factors in combination with highly active medicinal substances , namely: thermal contrast exposure to the coolant in the form of replaceable flows of warm and x fresh air; surface contact high-amplitude ultrasonic exposure and the heat generated by it, ozone / NO-containing air mixture and ozone / NO-containing medicinal substance, photochromic radiation of polychrome semiconductor LEDs emitting in the visible part of the spectrum, for example, red, yellow, green, blue, etc. , as well as mechanodynamic effects, including vibroimpulse exposure. Each of the aforementioned influencing factors implements properties and indicators that are significant for the successful solution of the problem of the invention:

1) Thermal contrast exposure (V.V. Pedder et al., 1992, 1998) implements a non-invasive method of introducing drugs into the body, at the level of the prelimphatic link - the method of thermocontrast absorption of a drug substance by biological tissue (hereinafter - TKAB drug method), carried out by hyper and hypothermic effects on the surface of the skin, which improves skin permeability for highly active ozone / NO-containing medicinal substances, along with the active involvement in the mass transfer process along with the circulatory system and lymphatic systems as one of the most important sanogenic-potent functional systems of the body (Yu.I. Borodin, 1986). The TKAB drug method is based on the non-invasive administration of a medicinal substance to a great depth through the skin of the body due to the effect of increasing the permeability of the skin barrier with sequential excitation and inhibition of sweating. This is achieved by exposing the skin to contrasting temperatures, which realize the cyclic heating-cooling process. The aforementioned contributes to an increase in skin permeability due to the intensification of rheological and diffusion processes at the interfaces: “drug solution - skin surface”, “drug solution - excretory duct of the sweat gland”, “drug solution - wall of the greasy hair follicle”, “drug solution - interstitium of the lymphoregion - intercellular matrix - loose connective tissue - tissue channels "," drug solution - lymphatic capillaries - lymphatic and blood microvessels ", etc. At the same time, lymph and blood the venous vascular systems turn out to be “entangled” with layers of drug molecules, which contributes to a high penetration rate through semipermeable membranes, which are the walls of the lymphatic and venous capillaries, and “absorption” of the drug from the subcutaneous tissue, interstitial space into the microvasculature and the sanogenic region of the lymphatic and the circulatory systems of the body, acting directly or indirectly on tissue altered by the process. In addition, thermal contrast temperatures have a reflexogenic effect on the thermoreceptors of the skin and the body's immune system;

2) Surface contact high-amplitude ultrasonic and heat treatment of biological tissues (V.V. Pedder, 1980) is realized by using the low-frequency range of ultrasound (26.5-44 kHz), which provides a “multifunctional” effect on the focus of pathologically altered tania for surrounding tissues. It contributes to the active repair of biological tissues in the lesion and surrounding tissues with surface contact high-amplitude sounding both in continuous and intermittent modes, both directly and through a capillary-porous technological element (hereinafter referred to as capillary-porous lining) with a drug solution . In this case, a complex of physical, physicochemical and biological processes is initiated in the ultrasound field: cavitation, acoustic flows, alternating pressure, sound-capillary, sound-chemical, thermal (heating of the voiced medium) and other effects, in turn, affecting the processes occurring at the interfaces “Waveguide - instrument - drug solution - biological tissue”, leading to high-quality sanitation of the surface of voiced tissues, inactivation of pathogenic microflora, extraction of pathological contents from the focus of ism immersed in the tissue process, impregnation deep into the tissues of medicinal substances, axisymmetric heating of the voiced tissues, vibration microwave massage at the cellular and tissue levels, accelerating the regeneration of biological tissues, etc., which reduces the time of treatment of diseases when using available drugs, and also reduces their use. Axisymmetric heating resulting from the dissipation of ultrasound energy in the acoustic system at the “waveguide-instrument-biological tissue” interface due to the difference in their acoustic impedances, as well as in voiced biological tissues due to the dissipation of ultrasound energy that has passed the “waveguide-instrument-biological tissue” interface increases the temperature in the zone of contact scoring to 40-45 ° C for 1-2 minutes, which contributes to hyperemia of the skin, increased microcirculation (lymph and blood flow), activation of the immune system, as well as e processes of exchange and regeneration, intensification of diffusion processes with the removal of toxins from the deep layers of biological tissues of the lesion focus, analgesia, thermo-and vibro-microwave anti-inflammatory action on densified and sclerotic tissue, which reduces the likelihood of hypertrophic and keloid scars, contractures;

3) Mechanodynamic treatment of biological tissues (M.M. Klimenko, 1997; V.V. Pedder, M.M. Klimenko, 2003) implements the mechanisms of mechanotherapeutic therapeutic effect on the tissue-changed areas of lymphedema and surrounding tissues during their “running-in” or “ rolling ”under slight pressure during the reciprocating movement of the affected area of the upper limb relative to the surface of the rings of a freely rotating roller. The indicated causes hyperemia and heating of the skin-muscle layers of the affected upper limb, intensifies mass transfer in the blood, lymph and interstitial circulation and microcirculation systems, and also promotes the impregnation of drugs applied to the skin surface deep into the affected tissues in the area of lymphedema;

4) Vibroimpulse treatment (vibroimpulse massage) of biological tissues (V.V. Pedder, 1999) implements the therapeutic effects of the pseudo-boiling effect created by the polyamplitude and multifrequency chaotic movement of the balls acting on the elastic membrane of the vibromodule, the surface of which is equipped with hemispherical protrusions that act in their own on the patient’s body surface, both directly and through a capillary-porous pad with a medicinal solution. The vibroimpulse shock effects created by the random movement of the balls cause multidirectional tangential and normal displacements of the skin, ultimately leading to an increase in temperature and hyperemia of the skin, increased microcirculation, blood and lymph circulation, diffusion and impregnation of drugs deep into the area of tissues changed by the pathological process;

5) Ozone / NO-containing medicinal substances (V.V. Pedder et al. 1985-2010; S. Rilling, R. Viban, 1985; S.P. Peretyagin, 1992; A.F. Vanin, 1998; A. B. Shekhter, 1998; K.V. Lipatov, 2001, etc.) implement the therapeutic effects of ozone and exogenous nitric oxide II (NO) both in the form of ozone / NO-containing air mixture, and in its complex with medicinal solutions, for example, ozone / NO-containing saline, ozonide / NO-containing oil-in-water emulsion, ozonide / NO-containing vegetable oil, which are azeotropic to the body, i.e. behaving as biologically pure and compatible with the body substances that simultaneously affect many pathogenetic links of diseases (circulatory and lymphatic circulation disorders, diffuse hypoxia, anaerobic glycolysis, accumulation of active radicals, etc.), which are:

- initiation of bactericidal, fungicidal and virucidal effects;

- activation of oxygen-dependent processes, normalization of lipid peroxidation, the acid-base state and potential of the antioxidant system, in increasing the deformability of red blood cells and the oxygen-transporting function of the blood;

- improving the rheological properties of blood and lymph, vascular trophism and tissue metabolism, normalizing microcirculatory disorders in the circulatory and lymphatic systems;

- stimulation of vasodilating, detoxifying, immunocorrecting, oxygenating, antihypoxic, analgesic effects, etc .;

6) Processing of biological tissues with photochromic radiation (V.V. Pedder, 1979-2010; A.B. Veselovsky et al., 2001; O.I. Efanov, 2002 and others), using polychrome semiconductor LEDs emitting in narrow-band regions of the visible spectrum, for example, red, yellow, green, blue, etc. The main target of exposure is skin. In the area of the skin surface of 1 cm ² there are approximately 6500 capillaries, 200-300 pain points, 140-330 sweat glands, up to 380 capillary glands, up to 500 hair follicles, up to 70,000 white process epidermal cells, as well as BAP, causing a variety of local and systemic reactions to radiation. The therapeutic effect is primarily due to biochemical and biophysical changes in the affected area at the cellular level (Capa, 1981, etc.). Visible light is absorbed by the chromatophore groups of protein molecules and oxygen with the participation of melanin, hemoglobin, enzymes, etc. Photochemical reactions are initiated by the excitation of vibrational processes in the molecules of a substance and the activation of excitation of atomic electrons by external energy equal to or greater than the energy of molecular bonds and atomic processes. All types of excitation of biological molecules arise at a quantum energy of 0.1-5.0 eV. At the same time, it is known that the energy of photons, for example, laser infrared radiation is 1.0-1.5 eV, the radiation of the visible range of the spectrum is 2.0-3.1 eV, the radiation of the UV range is 3.2- 12.4 eV. The established identity of the effects of laser and LED irradiation of the body (with comparable energy and dose characteristics) makes it possible to use photochromic radiation in color light therapy (photochromotherapy). The selectivity of biological processes depending on the wavelength (color) of the locally acting low-energy radiation generated by semiconductor LEDs has been shown and it has been established that radiation of different wavelengths has a different but systemic effect on the course of pathological processes (N.V. Serov, 1993; E. F. Levitsky, 1998). Each component of light in this technical solution is narrow-band LED radiation of red (λ = 0.75-0.62 μm), yellow (λ = 0.58-0.576 μm), green (λ = 0.57-0.51 μm ) and blue (λ = 0.47-0.45 μm) spectral regions, has a specific effect and can be used in the treatment of lymphedema in patients with breast cancer. Data on the role of the main radiation wavelengths that could be used in photochromotherapy of the above disease are given below (N.V. Serov, 1993; A.B.Veselovsky et al., 2001; O.I. Efanov, 2002).

Red radiation (λ = 0.75-0.62 μm) has good penetration through the skin. It is absorbed by the molecules of the respiratory chain enzymes (cytochrome oxidase, cytochrome C), the antioxidant system (superoxide dismutase), and reparative regeneration inducers (alkaline phosphatase). It activates catabolytic processes and connective tissue fibroblasts, stimulating reparative regeneration reduces the likelihood of the formation of densified and sclerotic tissue, the likelihood of hypertrophic and keloid scars, contractures. Reduces the impulse activity of the nerve conductors of the skin and the area of the pathological focus, provides an analgesic effect. By acting on BAP, it stimulates cellular and humoral immunity, etc.

Yellow radiation (λ = 0.58-0.576 μm) is well absorbed by the skin and adsorbed by the cells, interacting with the receptors and the lipid layer of the cell membranes of red blood cells, white blood cells, lymphocytes, etc., normalizes the distribution of electric charge over their surface with the restoration of the energy potential of damaged cell membranes and cell metabolism. It increases the oxygen binding capacity of red blood cells, their deformability, improves blood microcirculation and the formation of collaterals with the restoration of blood supply to tissues. Normalizes the number of leukocytes, enhances phagocytosis, increases local and general immunity. It has anti-inflammatory, detoxification and analgesic effects, etc.

Green radiation (λ = 0.57-0.51 μm) is absorbed by the flavoproteins of the respiratory chain, protein complexes of calcium ions with a change in cellular respiration in the irradiated tissues. It restores the activity of the sympathoadrenal system inhibited by the pathological process, weakens the intensity of inflammation and autoimmune defects, reduces the pulse rate and blood pressure, reduces the release of histamine from neutrophils, etc.

Blue radiation (λ = 0.47-0.45 μm) is absorbed by the molecules of heme toporphyrin pyridine nucleotides with activation of the respiratory chain, enhances glycolysis and lipolysis in cells and will accelerate the photodestruction of bilirubin to substances that are easily excreted from the body and do not have a neurotoxic effect. It activates venous circulation, promotes lymphatic elimination, and reduces the excitability of nerve conduits of the skin. Reduces tactile and pain sensitivity (analgesic effect).

The foregoing will ensure a non-invasive effect on the skin and tissue structures of the area of lifidema with impaired lymphatic drainage by exchanging in a single technological cycle rehabilitation treatment and rehabilitation of patients with lymphedema of the upper extremity (after combined treatment of breast cancer) with a combination of physical factors in combination with highly active medicinal substances that contribute to the activation of lymphatic drainage , the elimination of complications and relapse of the disease, as well as improving their quality of life.

The invention is illustrated by drawings, where:

- figure 1 shows a diagram of the pathogenesis of postmastectomy syndrome;

- figure 2 shows a diagram of possible ways of inhibiting postmastectomy syndrome of the upper limb in the process of rehabilitation treatment and rehabilitation of patients with lymphedema of the upper limb after combined treatment of breast cancer;

- figure 3 shows a diagram of a General view of a device for the treatment of lymphedema in patients with breast cancer (rear view);

- figure 4 shows a diagram of a General view of a device for the treatment of lymphedema in patients with breast cancer (type A, front view);

- figure 5 shows a diagram of a General view of a supporting mobile rack (lodgement pivotally connected to the pallet, in the working fixed position);

- figure 6 shows a diagram of a General view of a supporting mobile rack (lodgement pivotally connected to the pallet, in an idle fixed position);

- Fig.7 shows a diagram of a General view of the instrument unit and the associated polymer pressure chamber (section BB, rotated, Figure 3);

- Fig. 8 shows a diagram of a polymer pressure chamber (section B-B, Fig. 7);

- figure 9 shows a General view of an acoustic unit (f ₁ = 26.5 kHz) with a waveguide tool having a developed emitting end;

- figure 10 shows a General view of the thermo- and photochromic-ultrasonic applicator (f ₂ = 44 kHz);

- figure 11 shows the thermo- and photochromic-ultrasonic applicator (type G);

- Fig.12 shows a vibro-pulse massage module;

- Fig.13 shows a diagram of a General view of the massage block (in cross section);

- Fig.14 shows a massage block (top view);

- Fig.15 shows a massage block (view D, Fig.13);

- Fig.16 shows a massage block (section EE, Fig.13);

- Fig.17 shows a diagram of a polymer sleeve;

- Fig. 18 shows an exemplary sequence diagram of the implementation of the stages of the treatment of lymphedema in breast cancer patients by a complex physiotherapeutic effect of physical factors and target medicinal substances on the area of lymphedema, including a cyclogram of the heating-cooling effect thermocontrast effect, which implements the effect of enhancing the permeability of the upper limb skin barrier;

- Fig.19 shows a block diagram of the management of the complex effects of physical factors and highly active medicinal substances on the upper limb affected by lymphedema using electromechanical units of the device;

- Fig. 20 shows a diagram of the stage of non-invasive introduction of ozone / NO-containing air mixture into the tissue of the upper extremity by the method of thermocontrast absorption, affected by lymphedema when it is placed in a polymer pressure chamber (the TKAB LV method is used, using heated air as a hyperthermic coolant, and in as a hypothermic coolant - ozone / NO-containing air mixture + ambient air flow);

- Fig.21 shows a diagram of a stage of vibro-pulse processing of tissues of the upper limb affected by lymphedema;

- Fig. 22 shows a diagram of the stage of mechanodynamic processing of tissues of the upper limb affected by lymphedema placed in a polymer sleeve by "rolling" or "rolling" (at an angle of 20-30 ° and a slight pressure) during reciprocating movements of the limb;

- Fig.23 shows a diagram of the stage of thermo- and photochromic-ultrasonic treatment of tissues of the upper limb affected by lymphedema, including surface contact high-amplitude low-frequency ultrasonic exposure (f ₂ = 44 kHz) and the heat generated by it, as well as photochromic radiation of semiconductor LEDs emitting in narrow-band regions of the visible spectrum: red, yellow, green, blue both in continuous and intermittent modes, and both directly and through a capillary-porous pad with a solution of ozone / NO-s holding the drug;

- Fig.24 shows a diagram of a stage of surface contact high-amplitude low-frequency ultrasonic exposure (f ₁ = 26.5 kHz), in "continuous" or "intermittent" modes, on the biological tissue of the upper limb affected by lymphedema as through a capillary-porous pad soaked with ozone / NO-containing medicinal substance, and without it.

When implementing the method of treating lymphedema in breast cancer patients using the proposed device, along with the well-known drugs used for this disease, it is justified to use, first of all, ozone / NO-containing medicinal substances, for example, in the form of:

- ozone / NO-containing air mixture generated by the apparatus for gas ozone therapy "Ozotron" (Fig.19);

- ozone / NO-containing physiological saline, ozonide / NO-containing oil emulsion of the oil-in-water type, ozonide / NO-containing vegetable oil (for example, olive, sunflower, linseed, etc.) obtained by barbating in the original containers solutions of highly active ozone / NO-containing air mixture generated by the apparatus for gas ozone therapy "Ozotron" (Fig.19).

A device for the complex physiotherapeutic effect on limb biological tissues used in the treatment of lymphedema in breast cancer patients contains the following main blocks and elements (Figs. 3–24): a mobile stand, 1 instrument unit, massage block 3, a polymer pressure chamber 4, a polymer sleeve 5 .

Bearing mobile rack 1 (Fig 3 - 8) is multi-tiered and consists of a mobile support platform 1.1 with four wheels 1.2, two of which have position locks. The supporting platform 1.1 is interfaced by means of tubular posts 1.3 with a pallet 1.4, which is connected by means of hinges 1.5 to the cradle 1.6. In this case, the pallet 1.4 serves to place the instrument unit 2 on it, and the lodgement 1.6 to place the polymer pressure chamber 4 on it. In addition, the supporting mobile stand 1 is equipped with a tool tray 1.7 for placing devices and tools acting on the biological tissues of the lymphedema area on it, tubular a handrail 1.8 for its movement and a supporting tubular element 1.9, between which a holder 1.10 is fixed in the form of a plate with a groove 1.10.1 for moving the yoke 3.1 with the massage tool of the massage block 3 in height relative to the supporting Lathforma 1.1 and its fixation in the selected position, as well as the tool container 1.11.

The instrument unit 2 (FIGS. 3-19) comprises: a supporting body 2.1; control unit (BU) 2.2; touch control panel 2.3; an ozone generator / NO-containing air mixture 2.4, for example, an Ozotron gas ozone therapy apparatus (NPP Metromed, Omsk) in communication with a polymer pressure chamber 4 through a supply pipe 2.4.1, an electrovalve 2.4.2, a chamber 2.5 and associated her nozzle nozzle 2.5.1 and the output flange 2.5.2, which, in turn, is mated to one of the end parts of the sleeve 4.1 of the polymer pressure chamber 4, fixed on it with an elastic sealant 4.2, while the second elastic sealant 4.3 is placed on the opposite end of the sleeve 4.1 polymer pressure chamber four; heat carrier generator 2.6, generating flows of warm or cold air, which is a source of heating or cooling the internal volume of the medium in the cavity of the polymer pressure chamber 4, for example, an electric heat heater ETV, which includes a heater (N) and a fan (B) of cold air (not shown in the diagram) providing for 3-10 minutes (technologically feasible period of time) heating the skin surface of the upper limb 6 (hereinafter - the limb 6) to a temperature of 45-50 ° C, causing hyperemia and sweating. Other types of heating devices, for example, different types of infrared emitters, the infrared radiation of which penetrates through the skin relatively quickly to a depth of 40 mm and causes hyperemia and sweating, can be used as a heat source 2.6 of the coolant generator 2.6, for example, while in conventional convection heating with an air coolant, the body surface warms up only by 3-4 mm, which, nevertheless, is sufficient to initiate the effect of thermocontrast absorption of the skin drug substance cover and the underlying capillary and vascular blood and lymph systems of the body. The coolant generator 2.6, as well as the generator of ozone / NO-containing air mixture 2.4, communicates with the polymer pressure chamber 4 through the supply pipe 2.6.1, the electrovalve 2.6.2, the chamber 2.5, and the nozzle pipe 2.5.1 and the outlet flange 2.5 connected to it .2. The instrument unit 2 also contains: a generator of low-frequency ultrasonic vibrations 2.7 (hereinafter referred to as an ultrasonic generator (UZG) 2.7), for example, from an apparatus of ultrasonic low-frequency “Caviton” (NPP “Metromed”, Omsk) having two outputs for generating low-frequency ultrasonic vibrations (f ₁ = 26.5 kHz and f ₂ = 44 kHz), one of which is connected to the acoustic node 2.8 (f ₁ = 26.5 kHz), coupled to a waveguide-tool 2.9, with a developed emitting end (d = 25 mm) and designed for contact ultrasonic processing of biological tissues changed by the process in loviyah small surgical fields and as the surface roughness through the capillary-porous pad 2.10 impregnated ozone / NO-containing drug substance, and without it; thermo- and photochromic-ultrasonic applicator 2.11 (hereinafter referred to as TIFKh-U applicator 2.11), for example, from the physiotherapy apparatus “Rossonik-MM” (NPP “Metromed”, Omsk), which includes one of the two outputs of the ultrasonic generator (UZG ) 2.7 acoustic node 2.11.1 (f ₂ = 44 kHz) having a waveguide tool 2.11.2 with a developed disk-shaped radiating end (d = 75 mm), designed for contact ultrasonic processing of biological tissues changed by the process in a large operating field with a minimum surface roughness as through Pillar-porous gasket 2.10, and without it. The acoustic unit 2.11.1, along with mechanical ultrasonic vibrations emitted by the developed end face of the waveguide-tool 2.11.2, allows you to generate heat generated by the dissipation of the emitted ultrasound at the "waveguide-tool - biological tissue - layers of biological tissues of different density" interfaces. In addition, the TIFC-U applicator 2.11 is equipped with an annular matrix 2.11.3 with semiconductor LEDs 2.11.4 fixed on it, installed flush with the end of the bearing housing 2.11.5 and outside the disk-shaped radiating end of the waveguide-tool 2.11.2 and emitting in the visible spectral regions: red (λ = 0.75-0.62 μm), yellow (λ = 0.58-0.576 μm), green (λ = 0.57-0.51 μm) and blue (λ = 0.47 -0.45 microns) colors that can emit both continuous and intermittent modes. In this case, the board of the ring matrix 2.11.3 of semiconductor polychrome LEDs 2.11.4 TiFH-U of the applicator 2.11 is connected to one of the outputs of the power supply unit (PSU) 2.12 of the instrument unit 2, and the other output of the power supply unit (PSU) 2.12 is connected to the vibro-pulse massage module 2.13 (Figure 10, Figure 12). The vibro-pulse massage module 2.13 of the instrument unit 2 is a device [5], comprising: a housing 2.13.1, an electric motor 2.13.2, a wave-like disk 2.13.3, balls 2.13.4 placed in an active zone filled with damping powder of fluoroplastic 2.13.5, between the wave-like disk 3.13.3 and the elastic membrane 2.13.6 with hemispherical protrusions 3.13.7 on its outer surface. When the disk 2.13.3 rotates, large kinetic energy is transmitted to the balls 2.13.4 and their multifrequency and polyamplitude chaotic movement is initiated in the direction of the elastic membrane 2.13.6 with the generated heat and creating the effect of pseudo-boiling on its working surface. This leads to the occurrence of multidirectional tangential displacements of the skin surface, for example, in the lymphedema region, interacting with randomly oscillating hemispherical protrusions 2.13.7 of the elastic membrane 2.13.6, which is protected from destruction by active drug substances by the polymer film 2.13.8. For the preparation of ozone / NO-containing medicinal substances (ozone / NO-containing physiological solution, ozonide / NO-containing oil emulsion of the oil-in-water type, ozonide / NO-containing vegetable oil), in the pneumatic system of an ozone / NO-containing air generator mixture 2.4 provides a branch pipe 2.4.3 (Fig.7), attached to the appropriate capacity (Fig.19).

The control unit (BU) 2.2, located in the instrument block 2, controls the cyclogram of the “heating-cooling” process, which implements the effect of enhancing the permeability of the skin barrier with non-invasive introduction of ozone / NO-medicinal substances into the body, as well as ensuring its multi-stage approach to the surface of the affected skin limphedema of limb 6 contains (Fig. 19): power supply (PI) 2.2.1; software unit (BOP) 2.2.2; a set of control keys - (KO ₃ / NO) 2.2.3 and (KN / V) 2.2.4; switching device (KU) 2.2.5. At the same time (KO ₃ / NO) 2.2.3 - controls the ozone / NO-containing air mixture generator 2.4, the key (K-H / B) 2.2.4 - controls the electric fan heater (ETV) of the coolant generator 2.6. Keys: (KO ₃ / NO) 2.2.3 and (KH / B) 2.2.4 implement non-invasive injection of ozone / NO-containing medicinal substance into the skin of limb 6 by means of a switching device (KU) 2.2.5, paired with software unit (PB) 2.2.2. The electrovalve 2.4.2 and the electrovalve 2.6.2 - are designed to direct the flows of cold medicinal substance in the form of ozone / NO-containing air mixture and hot air, created respectively by the ozone / NO-containing air mixture generator 2.4 and coolant generator 2.6, in accordance with the sequence diagram (Fig. 18), through the corresponding nozzles 2.4.1, 2.6.1, the chamber 2.5, the nozzle nozzle 2.5.1 and the output flange 2.5.2 into the polymer pressure chamber 4.

Massage block 3 (Figs. 3-6, Figs. 13-16, Fig. 18, Fig. 22) consists of a traverse 3.1 with a massage tool in the form of a freely rotating roller 3.2, consisting of a set of massage rings of large diameter 3.3 and a set of massage rings small diameter 3.4, mounted on a sliding fit on a hollow axis 3.5, mounted through bearings 3.6 on a traverse 3.1. The generators of the massage rings 3.3 are made in the form of wavy protrusions, and the generators of the massage rings 3.4 are circular. This creates a variable relief of the diametric and linear dimensions of the massage rings assembly (in the form of a roller 3.2). When a limb 6 moved under its own weight comes into contact with respect to a variable relief of a set of massage rings 3.3 and 3.4 of a rotating roller 3.2 formed by alternately installing massage rings 3.3 and 3.4, a multidirectional contact mechanodynamic effect on the lymphedema regions and surrounding tissues during the “running-in” is provided "Or" rolling. " In this case, the reciprocating movements of the affected area of the limb 6 are performed at an angle of 20-30 ° relative to the freely rotating roller 3.2 along the course of the blood flow in the veins, and lymph to the lymph nodes, including skin over the groups of lymph nodes. The specified causes hyperemia and heating of the skin-muscle layers of the affected limb 6, intensifies mass transfer in the blood, lymph and interstitial circulation and microcirculation systems, and also promotes the impregnation of drugs applied to the skin surface deep into the affected tissues in the area of lymphedema. The massage unit 3 through the cross-shaped vertical support 3.7 of the yoke 3.1 by means of bolt connections 3.8 is connected to the plate holder 1.10 of the supporting mobile rack 1 having a groove 1.10.1, which allows the vertical movement of the massage unit 3 (up or down) relative to the plate holder 1.10.

The polymer pressure chamber 4 (Fig. 3, Fig. 4, Fig. 7, Fig. 8, Fig. 19) consists of a bilaterally open sleeve 4.1 made of an elastic polymer film, for example, polyethylene with elastic sealants 4.2 and 4.3 at its ends. The polymer pressure chamber 4 is equipped with a discharge pipe 4.4 connected to a decontaminator 4.5 of spent ozone / NO-containing air mixture, which leads the mixture through it and flows of warm or cold air into the environment. The polymer pressure chamber 4 is connected with a spacer forming polymer perforated skeleton 4.6 connected to an internal supporting polymer perforated lodgement 4.7 having a limiter 4.8 placed in its cavity. The presence of perforations is necessary for better heat transfer between the limb 6, placed in the cavity of the sleeve 4.1 and the warm / hot or cold streams of air and ozone / NO-containing air mixture, created respectively by the coolant generator 2.6 and the ozone / NO-containing air mixture generator 2.4. In the upper middle part of the perforated frame 4.6, a temperature sensor 4.9 is fixed (a thermoregulating element for monitoring and limiting the dynamics of heating and cooling the environment of the cavity of the polymer pressure chamber 4).

The polymer sleeve 5 (Fig. 17, Fig. 22) consists of a one-sided open sleeve 5.1 made of an elastic polymer film, for example, polyethylene with an elastic sealant 5.2 on its terminal open part. It is intended to exclude direct contact of the skin surface of the limb 6 with the medicinal substance applied to it with the working parts: waveguide-instrument 2.8 of the acoustic unit 2.7, waveguide-instrument 2.11.2, TIH-U of the applicator 2.11, vibration-pulse massage module 3.13, massage rings 3.3 and 3.4 rotating roller 3.2 massage block 3.

The treatment of lymphedema in patients with breast cancer is carried out using the proposed device in stages, mainly in the following sequence of cyclic exposure to a limb 6 affected by lymphedema by a complex of physical factors with highly active medicinal substances (Fig. 7, Fig. 18-24), namely:

- non-invasive thermocontrast action on the tissues in the “heating-cooling” mode with a hyperthermal coolant (heated air) and a hypothermic coolant (ozone / NO-containing air mixture) according to the cyclogram;

- non-invasive vibroimpulse effects on tissues;

- non-invasive mechanodynamic effects on the tissue "rolling" during reciprocating movements of the limb;

- non-invasive thermo- and photochromic-ultrasonic exposure, namely surface contact high-amplitude low-frequency ultrasound (f ₂ = 44 kHz), heat generated by it, as well as photochromic radiation of semiconductor LEDs emitting in the narrow-band regions of the visible spectrum: red, yellow, green, blue ;

- non-invasive surface contact high-amplitude low-frequency ultrasonic exposure (f ₁ = 26.5 kHz) in the "continuous" or "intermittent" modes of biological tissues of the upper limb affected by lymphedema, both through a capillary-porous pad with ozone / NO-containing medicinal substance, and without her;

- ozone / NO-containing medicinal substances.

According to the doctor’s prescription, depending on the dynamics of the therapeutic effect, it is possible to change the sequence and time of exposure to physical factors and medicinal substances during the treatment of lymphedema in patients with breast cancer.

Preparing the patient for treatment using the proposed device is carried out according to the generally accepted method of examining patients with breast cancer with lymphedema of the upper limb. After analyzing the data of clinical, laboratory and instrumental studies and confirming the diagnosis, treatment tactics are chosen, drugs are selected taking into account the severity of the disease, the number of treatment procedures is planned taking into account the degree of tissue damage by the pathological process and the duration of the disease.

The treatment of lymphedema in a patient with breast cancer begins with the implementation of the procedure that implements the first stage of treatment (Fig. 7, Fig. 18, Fig. 19, Fig. 20), namely, they carry out a cyclogram of the heating-cooling-thermocontrast process, which implements the effect of increasing skin permeability limbs of the surface of the limb 6 for exogenous administration of ozone / NO-containing drug substance deep into the tissues of the limb 6 due to the intensification of rheological processes at the interface “drug substance - skin surface - walls of excretory the shafts of sweat and sebaceous glands - the walls of the root vaginas of the hair follicles, hair bags, etc. ”, saturating the indicated capillary-porous system with the subsequent interaction of the ozone / NO-containing drug with blood and lymph systems and stimulating interstitial mass transfer.

The patient is placed on a swivel and height-adjustable chair, so that the polymer pressure chamber 4 and massage block 3 are located on the side of the upper limb 6, affected by lymphedema and in a position convenient for the implementation of appropriate treatment procedures. One of the open ends of the sleeve 4.1 is put on the output flange 2.5.2 and fixed with an elastic sealant 4.2. Through another open (working) end, an expansion form-forming polymer perforated frame 4.6, a support polymer perforated lodgement 4.7 are introduced. The temperature sensor cable 4.9 is connected to the switching device (KU) 2.2.5. The extremity 6 is introduced into the cavity of the polymer pressure chamber 4 to the limiter 4.8, and the end of the sleeve 4.1 is fixed with an elastic sealant 4.3 in the shoulder region of the patient to ensure sealing.

To implement the stage of "heating" - stage 1 of the sequence diagram (Fig.7, Fig.18-20), turn on the power source 2.2.1 of the control unit (BU) 2.2 of the instrument unit 2. The program unit (PB) 2.2.2 includes a key (K -N / V) 2.2.4, which through a switching device (KU) 2.2.5 includes a heater (N) of an electric fan heater (EHF) of a coolant generator 2.6, a temperature control element (temperature sensor) 4.9 and an electric valve 2.6.2. Warm or hot air from the air heater (N) of the electric fan heater (HEF) of the heat carrier 2.6 through the pipe 2.6.1, the electrovalve 2.6.2, the chamber 2.5, the nozzle pipe 2.5.1 and the outlet flange 2.5.2 is fed into the polymer pressure chamber 4 with preliminary introduced into it and sealed limb 6. Excessive volume of warm or hot air through the outlet pipe 4.4 and drainage, the function of which is performed by deactivator 4.5 is discharged into the external environment. This provides a gradual heating of the skin of the limb 6 to a temperature of 45-50 ° C for 6-10 minutes. The specific heating temperature is determined by the attending physician. After holding the heating temperature of limb 6 in the air volume of the polymer pressure chamber 4, accompanied by severe hyperemia or sweating, a discrete time limiter of the temperature sensor 4.9 is triggered and the heater (ETV) heater coil 2.6 is switched off.

After this, "cooling" is carried out - the continuation of stage 1 of the cyclogram (Fig. 7, Fig. 18-20) associated with a sharp cooling of the skin of the limb 6, placed in a polymer pressure chamber 4, from 45-50 ° C to a temperature of 25-30 ° With and exposure at this temperature for about 3 minutes. To do this, at the command of the software block (PB) 2.2.2, the key (K-N / V) 2.2.4 is turned on, which turns off the heater (H) through the switching device (KU) 2.2.5 and turns on the fan (C) of the electric fan heater (B) the coolant generator 2.6, and also turns on the key (KO ₃ / NO) 2.2.3, which through the switching device (KU) 2.2.5 turns on the ozone generator / NO-containing air mixture 2.4 for the period of time from the start of the process of “cooling” the skin limb cover 6 before its end and in the next 5-6 minutes after turning off the air heater (H) switching devices ohm (KU) 2.2.5 electric fan heater (EHF) of the coolant generator 2.6. The flow of cold ozone / NO-containing air mixture (about 20 ° C) generated by the fan (B) of the electric fan heater (ECE) of the heat-transfer agent 2.6 and the ozone / NO-containing air mixture generator 2.4 is supplied through the pipe 2.4.1, the electric valve 2.4.2, the chamber 2.5, nozzle nozzle 2.5.1 and outlet flange 2.5.2 into the polymer pressure chamber 4 with the upper limb placed in it 6. Excess ozone in the spent ozone / NO-containing air mixture through the discharge nozzle 4.4 and the drain, the function of which is performed by deactivator 4.5 deactivir etsya and is discharged into the environment. The above causes a sharp cooling of the internal environment of the elastic polymer pressure chamber 4 to a set temperature of 25-30 ° C and, accordingly, the surface of the skin of the limb 6, previously heated to the stage of developed hyperemia and thermal sweating with the formation of ozone / NO-containing condensate on the skin surface with properties medicinal substance. At the same time, mass transfer is intensified at the “ozone / NO-containing medicinal substance - skin surface” interface with a transglandular (rheological) pathway for its penetration into the body’s internal environment through the excretory ducts of sweat and sebaceous glands, root vaginas of hair follicles and hair bags, etc. ., with the subsequent implementation of the formed ozone / NO-containing medicinal substance of its direct bactericidal, fungicidal, virucidal, detoxifying, immunocorrecting, oxygenating th, NO-oxidizing, vazodilyatiruyuschego and other influences that contribute to strengthening of microcirculation in the blood and lymphatic system, normalization of blood oxygen transport function, relief of acidosis and ischaemia of the upper limb and the surrounding tissue to her. After “cooling” the limb 6 by aeration with a stream of ozone / NO-containing air mixture to a temperature of 25-30 ° C, according to the signal from the temperature sensor 4.9, the fan (B) of the electric fan heater (EHF) of the heat-transfer generator 2.6 is turned off by the key (K-N / B ) 2.2.4 through the switching device (KU) 2.2.5. After naturally heating the skin of limb 6 to a temperature of about 36.5 ° C (on average after 5-6 minutes), by a signal from a temperature sensor 4.9, the program unit (PB) 2.2.2 disables the key (KO ₃ / NO) 2.2 .3, a switching device (KU) 2.2.5 and, accordingly, an ozone / NO-containing air mixture generator 2.4, as well as an electrovalve 2.4.1. Then the limb 6 is released from the sealant 4.3 of the end part of the sleeve 4.1 of the polymer pressure chamber 4.

At the second stage of treatment of lymphedema (Fig. 12, Fig. 18, Fig. 19, Fig. 21), a procedure is implemented that implements step 2 of the cyclogram — the process of vibroimpulse action on the surface sections of the limb 6 changed by the pathological process. For this, ozone is applied to it / An NO-containing medicinal solution (for example, ozonide / NO-containing vegetable oil (it is possible to apply a capillary-porous pad 2.10 soaked in the indicated medicinal solution). Then, turn on the power supply unit (PSU) 2.12, set the vibration meter vertically under its own weight ice massage module 2.13 on the surface of limb 6 and they exist for 2-3 minutes reciprocating or circular movements relative to the treated areas, including along the course of blood flow in the veins, and lymph to the lymph nodes, including areas of their accumulation, avoiding their injury .. Then the vibro-pulse massage module 2.13 is turned off.

In the third stage of treatment of lymphedema (Fig. 3, Fig. 4, Fig. 13-6, Fig. 17-19, Fig. 22), a procedure is carried out that implements step 3 of the cyclogram — the process of mechanodynamic action on the limb 6 changed by the pathological process. For of this, it is drained, fresh ozone / NO-containing drug solution is again applied to it, it is introduced into a one-sided open sleeve 5.1 of the polymer arm 5, which is fixed with an elastic sealant 5.2 in the shoulder region and the limb 6 affected by lymphedema at an angle of 20-30 ° is laid massage rings 3.3 and 3.4 free bp the moving roller 3.2 of the massage block 3. Then, the reciprocating movements of the limb 6 are performed relative to the roller 3.2 of the massage block 3, with a slight pressure during its movement by pushing “forward” from the hand to the shoulder. The movement of the limb 6, relative to the roller 3.2 of the massage block 3, during its movement "backward" from the hand to the shoulder is carried out mainly without pressure. In the process of movements of limb 6 relative to the rotating roller 3.2 of the massage block 3, consisting of massage rings 3.3 and 3.4, having different diameters and configurations of their generators, volumetric deformation of the tissues of the limb 6 is carried out, accompanied by increased blood and lymph flow, and mass transfer in the interstitial space of soft tissues, and ultimately a sharp increase in lymphatic drainage. The procedure takes 5-6 minutes.

At the fourth stage of treatment of lymphedema (Fig. 9, Fig. 10, Fig. 18, Fig. 19, Fig. 23, Fig. 24), a procedure is carried out that implements step 4 of the cyclogram — the process of thermo- and photochromic-ultrasonic exposure to an altered pathological parts of the surface of the limb 6. The process is drained, fresh ozone / NO-containing medicinal solution is applied again, for example, ozone / NO-containing physiological solution, ozonide / NO-containing oil emulsion of the oil-in-water type, ozonide / NO- containing vegetable oil (capillary-porous 2.10 LadKom impregnated with said drug solution). They include a power supply unit (PSU) 2.12 and TiFH-U applicator 2.11, which are mounted vertically and under their own weight on the surface of limb 6 and they perform reciprocal or circular movements relative to the treated sections for 4-5 minutes, including along the course of the course blood in the veins, lymph to the lymph nodes, including areas of their accumulation with the exception of their trauma. In the first 2 minutes, the disk-shaped radiating end (d = 75 mm) of the waveguide-tool 2.11.2 TiFH-U of the applicator 2.11 carry out, in the "continuous" or "intermittent" mode, the contact exposure to low-frequency ultrasound (f ₂ = 44 kHz) on underlying tissues of the lymphedema region, accompanied by heating of the surface of the skin of the limb 6 and heating of the tissues to a temperature of about 40-45 ° C. In the next 2-3 minutes, by turning on the ring matrix 2.11.3 with the TiFH-U semiconductor LEDs, the applicator 2.11 is exposed in the “continuous” or “intermittent” modes to the surface of the limb 6 with narrow-band LED radiation. In the first 5-6 procedures: red (λ = 0.75-0.62 μm) and yellow (λ = 0.58-0.576 μm), green (λ = 0.57-0.51 μm) and blue (λ = 0.47-0.45 μm) by the regions of the radiation spectrum, and in the next 5-6 procedures, by the green (λ = 0.57-0.51 μm) and blue (λ = 0.47-0.45 μm) areas emission spectrum. According to the indications and as prescribed by the doctor, a joint action on the limb with 6 heat energies, low-frequency ultrasound and narrow-band LED radiation in both “continuous” and “intermittent” modes is possible. After the end of the TiFH-U procedure, the applicator 2.11 is disconnected from the ultrasonic generator (UZG) 2.7 and the power supply unit (PSU) 2.12. According to the indications and the prescription of the doctor, in a small operative field (Fig.24) having a surface unevenness, it is possible to carry out only contact high-amplitude low-frequency ultrasonic treatment (f ₁ = 26.5 kHz), in “continuous” or “intermittent” modes, changed the process of biological tissues of limb 6 affected by lymphedema, both through a capillary-porous pad 2.10, impregnated with ozone / NO-containing medicinal substance, and without it.

The treatment of lymphedema in breast cancer patients using the proposed device is combined with the proposed ozone / NO-containing drugs with the prescription of the traditionally used target drugs or can be used as an independent method of physical therapy.

After turning off the device as a whole, all further manipulations associated with the completion of the treatment session are carried out in the prescribed manner. Depending on the stage of the disease and the degree of activity of the pathological process. The number of procedures performed in one treatment session may vary by the attending physician. On average, the duration of the course of treatment using the proposed device is from 10 to 12 procedures carried out both daily and every other day, and depends on the clinical form and stage of the disease. A second course of treatment can be carried out no earlier than 3 months after the previous one. The proposed device was used in the implementation of medical technologies for the treatment of lymphedema in breast cancer patients in the clinic of the Oncology Department of the Omsk State Medical Academy on the basis of the Omsk Regional Clinical Oncology Center in 20 patients with lymphedema of the upper extremity aged 44 to 57 years. Of these, 10 women with lymphedema

Table 1 No. p / p Indicators The proposed technical solution for the treatment of lymphedema of the upper limb (group 1) Traditional methods and devices for the treatment of lymphedema of the upper limb (2nd group) one Pain relief, 24 hours 5-6 16-18 2 Reduction of edema, cm 2-3 0-1 3 Relapses of erysipelas, number 0-1 2-3 four The number of treatment days, days 10-12 16-20 5 Relapse of the disease up to a month, count 0-1 5-6 6 Restriction of movement in the shoulder joint, degrees from the vertical axis 85-90 40-45

my upper limb of the 1-11 degree, making up the main - the 1st group, was treated according to the proposed technical solution. The 2nd group of 10 women with lymphedema of the upper limb, I-II degree, was treated with traditional methods (manual massage, rhythmic air massage, underwater shower, circular baths, heparin and troxevasin ointments, elastic compression underwear, etc.). All patients had pronounced symptoms of edema, manifestations of erysipelas, intoxication, restriction of movement in the shoulder joint, etc.

Comparative data on the advantages of the proposed device for the treatment of patients with lymphedema of the upper limb in comparison with the traditional method of treating this patient population are presented in Table 1. It is shown that the proposed technical solution allows the highly effective medical technology for the treatment of lymphedema in breast cancer patients to increase the efficiency of treatment of patients for by reducing the time of rehabilitation treatment, reducing the likelihood of a relapse of the disease and improving the quality of their life and that points to the possibility of achieving high levels of employment and social adaptation.

This technical solution is implemented by the Metromed Research and Production Enterprise (Omsk), together with the specialists of the Oncology Department of the Omsk State Medical Academy, physiotherapy complex Lymphaton-MM, which includes: working components from the Ozotron gas ozone therapy unit, and the apparatus ultrasonic low-frequency "Caviton", the physiotherapeutic apparatus "Rossonic-MM", a prototype of which in 2008-11 successfully tested in clinical oncology. To date, guidelines have been prepared on the application of the proposed technical solution in clinical practice for the treatment of upper limb lymphedema in patients with breast cancer and other diseases associated with it. In accordance with the established procedure, technical measures are being taken to put into serial production in 2011-12. hardware physiotherapeutic complex "Lymphaton-MM". The hardware physiotherapeutic complex Lymphaton-MM also has indications and can be used in the treatment of the diabetic foot syndrome in patients with diabetes mellitus.

Information sources

1. Mika K. Rehabilitation after removal of the mammary gland: trans. from polish / K.Mika. - M.: Medical lit., 2008 .-- 144 p.

2. RF patent No. 2026084, MKI A47B 9/00, A61G 12/00, BI No. 17, 1997.

3. Klimenko M.M. Methods of treatment of diseases of the spine by the massage and gymnastic method (autokinesiotherapy). - Kemerovo, 1998 .-- 50 p.

4. RF patent No. 2277002, MKI A61N 7/00, A61M 37/00, BI No. 15, 2006.

Claims (1)

A device for the complex physiotherapeutic effect on limb biological tissues, comprising a mobile stand, an instrument unit with a control unit, a polymer pressure chamber with a sealant, a decontaminated ozone / NO-containing air mixture decontaminator, a temperature sensor, a heat carrier generator that generates flows of warm or cold air, and a generator ozone / NO-containing air mixture in communication with a polymer pressure chamber, a generator of low-frequency ultrasonic vibrations with acoustic nodes and waveguides tools, a capillary-porous pad with ozone / NO-containing medicinal substance, characterized in that it is equipped with a bilaterally open polymer pressure chamber with two sealants, paired with a forming polymer perforated frame connected to a supporting polymer perforated lodgement placed in its cavity, In this case, it is equipped with a branch pipe connected to a decontaminator of spent ozone / NO-containing air mixture, discharging this mixture through it and flows of warm or cold air into the environment, also of one of its terminal parts, the polymer pressure chamber is paired and fixed with an elastic sealant on the output flange of the instrument unit mounted on the pallet of the supporting mobile rack pivotally connected to the lodgment of the polymer pressure chamber; supporting traverse with a massage tool in the form of a freely rotating roller, consisting of a set of alternating massage rings of the same thickness but different diameter, while the generatrix of the rings of small diameter is made circular, and the generatrix of the rings of large diameter is made wavy, in addition, the traverse with the massage tool of the massage block has the ability to move in height with a fixed position and is cantilever connected to a holder mounted on one of the sides of the supporting mobile rack; thermo- and photochromic-ultrasonic applicator connected to the power supply unit of the instrument unit, one of the outputs of which is connected to the matrix board of the semiconductor polychrome LEDs, and the other output is connected to a vibro-pulse massage module, in addition, the thermo- and photochromic-ultrasonic applicator is connected to the output generating a generator of low-frequency ultrasonic vibrations, the second output of the generation of which is connected to an acoustic unit coupled to a waveguide-tool; in addition, the device is equipped with a polymer one-sided open sleeve corresponding to the size of the affected limb.

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