RU2332954C1 - Nf leonov's method for treating oncologic diseases by method of local hyperthermia - Google Patents

Abstract

FIELD: medicine; oncology.

SUBSTANCE: extending thermoapplicator is input in the target affected organ. A distal part of a thermoapplicator is made from two soft elastic tubes of different length. The ends of tubes are punched by apertures for incoming and outgoing water. Tubes are rigidly and tightly bridged to a cavity of a thin elastic stretched cover wherein tubes are placed. The gate or a clamp for adjustment of pressure of water in an organ is placed on the end of an outgoing tube. An aerotonometer or the pressure gauge are connected in front of the gate or a clamp to a tube. The hot water is supplied under pressure to one tube, the temperature being smoothly raised. The cooling water is deduced through the second tube. A working surface of a distal part of a thermoapplicator is placed in a zone of a lesion of an organ. Then, the temperature is smoothly raised and pressure of water is submitted to an elastic cover. Simultaneously, deducing stream of water is partially blocked till the moment of expansion of elastic cover of a thermoapplicator and acceptance of the internal form of the target affected organ. Then a stream of leaving water is opened performing continuous circulation of water through a cover with warming of the target affected organ to 42-45°C.

EFFECT: increased efficiency of treatment due to maintenance of a necessary constant of temperature in the affected organ in the course of treatment and full coverage of all organ from inside during the warming process.

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Description

Application area

The invention relates to a method for treating cancer with local hyperthermia by introducing an expanding heater into human organs.

The invention can be used in oncology in the treatment of malignant neoplasms of various localization by applying hyperthermia in the treatment of cancer of the oral cavity, esophagus, stomach, duodenum, colon, rectosigmoid compound, rectum, anus, bladder, uterine body, cervix.

State of the art

Hyperthermia is widely known in the art. This is the heating of the tumor to a temperature of 42-45 degrees, at which the death of cancer cells and tumor decay are observed. This method of treatment has been known for a long time: it was described in the ancient Indian Mahabharat, and Hippocrates used it to treat breast tumors in the 4th century BC.

In recent years, numerous methods of hyperthermia in the treatment of malignant neoplasms have spread in cancer clinics. They are based on the fact that when overheated, the sensitivity of a cancer cell to the damaging effects of radiation and chemotherapeutic effects used to destroy it increases significantly. The effectiveness of the antitumor effect of hyperthermia has been repeatedly confirmed at international conferences (USA, Italy, Germany, Italy, etc.), numerous thematic national conferences, symposia, and scientific publications.

Malignant tissue is less resistant to heat than healthy tissue for a number of reasons. Firstly, it initially has a higher temperature, since the metabolism in malignant cells is much more intense. Secondly, the blood supply to the tumors is much worse than that of healthy tissues, so when heated, they are not able to be effectively cooled by an increase in blood flow, like healthy ones. In addition, the oxygen delivered by such vessels is beginning to be insufficient to supply the tumor with energy. Thirdly, the vessels in the tumors have an abnormal structure, therefore, with an increase in 1 temperature, they are easily embolized - clogged. As a result, with increasing temperature in the tumor tissue, hypoxia and acidosis develop - acidification, which leads to impaired function and, ultimately, cell death. Thus, hyperthermia has an independent destructive effect on cancer cells.

Existing methods of treatment are based on a session of hyperthermia, in which the patient is heated in a special water bath until the body temperature reaches 43-43.5 ° C. It is clear that without additional help in such conditions one cannot survive. The whole procedure is performed under general anesthesia. And it is equated to surgical operations of the 6th (one of the highest) categories of complexity. The two main dangers awaiting the patient are heat shock and heat denaturation (protein coagulation). The procedure is carried out on the verge of a foul: a person will survive - he will not survive.

The disadvantages of the known methods is the high complexity, the injury rate of the patient, the riskiness and saturation of rare specific expensive medical equipment.

More simple and gentle methods are procedures based on local hyperthermia of the affected organ.

Various devices are known for local and general hyperthermia (heating to 42-45 ° С) to selectively increase the antitumor effect of ionizing radiation and chemicals: bathtubs (for general and local hyperthermia), local thermal applications, "Yacht", "Plot" installations , "Luch-52" and others.

The devices are equipped with emitters, a tissue heating control system, and a cooling system. They use microwave, high-frequency, ultra-high-frequency devices, air, artificially created microclimate, ferromagnetic fluids, electromagnets.

A device for electromagnetic hyperthermia (ed. St. No. 711913, MKI A61N 1/06). The device has a pump connected to a working tank, which contains a membrane mounted on the electrode, the main and auxiliary heat exchangers with a block of thermoelectric batteries, pipelines. To improve the protection of healthy tissues in the heating zone, the device is equipped with a temperature sensor; there is an air bubble trap, solenoid valves, a working tank with inlet and outlet, a pump, a pressure switch, thermoelectric batteries.

The device is bulky, complicated in technical design and operation, not convenient for the patient and staff.

For the treatment of colorectal cancer, intracavitary antenna emitters operating at a frequency of 915 MHz are used in combination with telegamma irradiation of a tumor from 3-4 fields with a single focal dose of 5 Gy (Local hyperthermia in combination with radiation in the complex treatment of some forms of malignant tumors. Methodical recommendations. Minsk, 1986, p.31). A cylindrical antenna emitter with a plexiglass casing is inserted into the rectum.

The main disadvantage of the device is the uneven heating of the tumor and the inability to maintain the given modes.

Known intracavitary local hyperthermia in combination with radiation exposure (A.A. Kochegarov et al. / In the book. The use of hyperthermia in hyperglycemia in the complex treatment of malignant neoplasms, Minsk, 1981, S. 60-68).

According to the recommendations of the author, under the control of the x-ray unit, a heat exchanger is introduced into the esophagus at the tumor level, in which water with a temperature of up to 44.5 ° C is used as a heat carrier. In this case, the heat exchanger blocks the tumor by 3-4 cm, the duration of the procedure is 1 hour. The disadvantage, as the authors themselves note, is that histological sections retain tumor elements in the deep layers of tissues.

For contact hyperthermia in the treatment of hollow organs, the UT-15 ultra-thermostat is known, equipped with a heat exchanger and a double-lumen catheter (A.G. Konoplyannikov et al. Local hyperthermia in radiation therapy of malignant neoplasms, Moscow, 1983). The device can be used to treat bladder tumors. The coolant (liquid) with a temperature of 42 ° C is served for 2 hours through a catheter into the bladder. At the same time, healthy tissues are also heated, at the same time, tumor cells in the deep layers, the walls of the bladder remain intact.

Tubes of various sizes and shapes are known for the treatment of superficially located tumors (Svetitsky P.V. Local hyperthermia in the treatment of malignant tumors of the head and neck. / Med. Journal of Uzbekistan, 1980, No. 10, pp. 63-64). Hot air is supplied through the tube to the affected area, performing local hyperthermia. However, heating is only superficial, 7 minutes after the start of the procedure, due to blood flow in all layers of soft tissues, the temperature stabilizes despite further warming. A serious drawback of the described devices is the poor coverage of the heating zone, and with tumors greater than 5 cm and the endophytic nature of growth, there may be a danger of underheating of the tumor, especially its periphery, which can contribute to the stimulation of tumor growth. Heat dissipation cannot ensure its strict dosing in the tumor zone. This leads to the fact that, along with alternative changes - massive necrosis, foci of necrobiosis, expressed by dystrophic changes, massive areas of viable cancer cells remain.

For local hyperthermia of the rectum, organic glass rectostat is known, in which water circulates at a temperature of 44-45 ° C, supplied from the UT-15 ultra-thermostat. The rectostat is inserted into the rectum, the coolant is connected and the procedure is performed in a certain mode (Actual problems of oncology and medical radiology. / Sat. Scientific works, Issue X, Minsk, 1981, p.143). This device is similar to the following for its purpose in the treatment of colorectal cancer.

The disadvantages of the device are: the mismatch of the working surface of the rectostat and the pathological focus; insufficient heating of the pathological focus due to the use of organic glass, which is a heat insulator, for manufacturing a rectostat.

The closest analogue is a device for thermotherapy (WO 00/35391 A1, 06/22/2000), made in the form of a thermal applicator containing a cylindrical casing with a rounded distal end and graduation at the proximal end, a heat exchanger, to which heat transfer and inlet pipes are connected , and mounting sleeve.

The disadvantage of the prototype is the inconvenience and complexity when holding the device into the organ cavity, and when introduced into the organs of complex shape: the uterus or stomach, the focal area of the affected organ covered by the thermal applicator is limited. This does not allow the treatment of tumors of the late stages of a large area of organ damage.

Also the closest analogue is the patent RU 2232563 for a thermo-applicator for exposure to biological tissue. The device comprises a casing, cylindrical at the proximal end, and a heat exchanger with input and output of the coolant. The distal part of the casing is made in the form of a hollow hemisphere of ellipsoid shape, separated from the heat exchanger body and connected by a conductor to a negative pressure device, and the heat exchanger body is equipped with channels for air suction on its working surface. In the second embodiment, the thermal applicator comprises a cylindrical casing with a rounded distal end, graduation at the proximal end and a mounting sleeve on the outer surface, and a heat exchanger with heat carrier inlet and outlet. The mounting sleeve is made with the possibility of installing a removable perforated nozzle, to the channels of which tubes for suction of air are connected.

The disadvantage of the prototype is also the inconvenience and complexity when conducting the device into the organ cavity, and when introduced into the organs of complex shape: the uterus or stomach, the focal area of the affected organ covered by the thermal applicator is limited. This does not allow the treatment of tumors of the late stages of a large area of organ damage.

The technical result of the invention is the simplicity of the treatment method, wide and complete coverage of the entire organ from the inside during the heating process, accessibility to use in conventional clinics.

Brief Description of the Drawings

Figure 1 shows the constructive device of the thermal applicator with manual control, where 1 is an elastic (stretchable) sheath, 2 is an inlet tube, 3 is an outlet tube, 4 is a pressure water supply device, 5 is a pressure gauge or pressure sensor, 6 is a thermometer, 7 - valve or clamp.

Figure 2 shows the constructive device of the thermal applicator with automatic control and the cyclical flow of water, where 8 is the control panel.

Figure 3 shows the principle of introducing the distal part of the thermal applicator into the affected organ (in this example, into the stomach), where 9 is the organ (stomach), 10 is the area of organ damage by malignant tumors; type - a - before the start of the hyperthermia procedure and after its completion before removing the thermal applicator; view - b - at the time of the procedure of hyperthermia.

SUMMARY OF THE INVENTION

The claimed technical result is achieved due to the fact that the treatment is carried out by introducing into the affected organ a special expanding thermal applicator that accepts the internal volume of the affected organ. The thermal applicator is a heat exchanger with input and output coolant. Water is used as a heat carrier. Treatment is carried out by heating the affected organ to 42-45 ° C. The distal part of the thermal applicator consists of two soft elastic tubes rigidly and hermetically connected to the cavity with a thin elastic shell. Heated water is supplied into one tube under pressure, and cooling water is discharged through another tube, thus maintaining a constant temperature inside the affected organ necessary for its treatment. The temperature of the outgoing water is controlled by a thermometer and automatically regulate it with the help of a thermal relay, and using the pressure gauge set the required water pressure in the thermal applicator.

For treatment, the distal part of the thermal applicator is inserted into the affected organ and its working surface is placed in the affected area of the organ. Heated water is then supplied under pressure and at the same time, the water outlet stream is partially blocked. From the moment the envelope of the thermal applicator expands and takes on the internal forms of the affected organ, the flow of escaping water is fully opened. Next, continuous water circulation through the shell is carried out and thereby the heating of the affected organ is maintained until the end of the procedure. At the end of the procedure, the circulation of water in the shell is stopped. The water remaining in the shell is drained, after which the thermal applicator is removed from the organ.

At the end of the output tube, a valve or clamp is placed to regulate the water pressure inside the organ, and before the valve or clamp, a pressure gauge or pressure sensor is connected to the tube.

The method is based on the introduction of a special water expanding heater (thermal applicator) into the affected organ, which receives the internal volume of the affected organ and heats the affected organ to 42-45 ° C.

The thermal applicator (see Fig. 1, 2) consists of two soft elastic tubes (2, 3) located in a thin elastic stretch shell (1). Heated water is supplied through a single tube (2) under pressure from a pressurized water supply device (4). As such a device, even the usual output of a hot and cold water tap faucet can be used. Cooling water is discharged through another tube (3).

If the water supply and drain cycle is not closed (see Figure 1), then a valve (7) or a clamp for regulating the water pressure inside the organ is placed at the end of the outlet tube, and a pressure gauge (5) or pressure sensor is connected to the tube in front of the valve or clamp as well as a thermometer (6). If the water supply and discharge cycle is closed, the water inlet and outlet pipes are connected (see Figure 2) to the device for heating and water supply under pressure (4). The flow and temperature of the water in the heating device is regulated either automatically or manually from the control panel (8) by taking readings from a pressure gauge (5) or pressure sensor, as well as a thermometer (6) installed on the output stream. A shell with lead-in tubes is a distal part of the thermal applicator device.

Before starting the heating process, the elastic shell is empty; it corresponds in volume and thickness to the two tubes to which it is connected. For the convenience of introducing the device into the organ, the tubes themselves can be made in the form of a single tube with a longitudinal partition. The longitudinal partition creates two tubes approximately two times smaller in size inside the thick tube. Due to this, the distal part of the thermal applicator becomes thinner and is easily inserted into any organ: stomach, esophagus, duodenum, rectum, bladder, uterus.

The elastic shell when heated water is supplied to the tube under water pressure expands (see Figure 3 (b)) and takes the volume of the organ into the cavity of which the thermal applicator is inserted. This allows you to completely warm the entire organ from the inside.

The simplicity of the method, which is available for use in conventional clinics, is ensured by the fact that the device can operate by connecting a tube that introduces water into the shell to the mixer from a domestic tap with hot and cold water. The water-discharging tube can be discharged to the drainage system.

After thermal exposure of the affected organ with a temperature of 42-45 ° C for 60 minutes, the cancer cells die.

The method is implemented as follows. After endoscopic examination (for example, rectoscopy), in which the presence and depth of the upper and lower edges of the tumor in the organ, as well as the boundaries of the circular localization of the tumor (front, back, left, right wall), are determined, the distal part of the thermal applicator is inserted and its working surface is placed in the area (10) of organ damage (see Figure 3 (a)). Due to the supply of water pressure through the tube (2) and at the same time partially shut off the tap (7) of the water outlet flow, the sheath (1) of the thermal applicator expands and takes on the internal forms (9) of the organ (see Figure 3 (b)), creating a dense the contact of the tumor surfaces of the entire organ and the thermal applicator.

When the pressure readings on the device (5) indicate (see Figure 1) that the organ is completely filled with the shell, the valve (7) is almost completely opened or this happens automatically (see Figure 2) if a circulation water heater is used.

After that, water begins to continuously circulate through the shell (1) and heat the affected organ (9). The temperature of the outlet water is controlled by a thermometer (6), and the pressure is also monitored by a manometer (5) or a pressure sensor. Depending on the readings of these devices, the flow rate and temperature of the water, as well as the pressure in the shell, are regulated. Regulation is carried out either manually using the valve (7), or automatically.

At the end of the procedure, the circulation of water in the shell is stopped, the valve (7) is opened and the water remaining in the shell (1) is drained. The shell (1) is again compressed to its previous forms (see Fig. 3 (a)) and then carefully removed from the organ by the tubes.

Claims (1)

A method of treating cancer with local hyperthermia, characterized by introducing into the affected organ a special expanding thermal applicator, which is a heat exchanger, with the input and output of a heat carrier and heating the affected organ to 42-45 ° C, characterized in that the distal part of the thermal applicator is made of two soft elastic tubes of different lengths, the ends of which are perforated with holes for the inlet and outlet water, the tubes are rigidly and hermetically connected to the cavity of thin elas a stretch shell in which the tubes are placed, with a valve or clamp placed on the end of the outlet tube to regulate the water pressure inside the organ, and before the valve or clamp, a pressure gauge or pressure sensor is connected to the tube, and in one tube, gradually raising the temperature, serves under heated water by pressure, and cooling water is discharged through another tube, while the working surface of the distal part of the thermal applicator is located in the affected area of the organ, then, gradually raising the temperature, water pressure is applied to the elast the primary membrane and at the same time partially block the outflowing water flow until the elastic cover of the thermal applicator expands and takes on the internal forms of the affected organ, then the flow of the emerging water is opened and the water circulates continuously through the membrane with heating of the affected organ, and at the end of the procedure, the water circulation the shell, drain the water remaining in the shell, after which the distal part of the thermal applicator is removed from the body.

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