RU64899U1 - THERMOAPPLICATOR LEONOV FOR THERMAL TREATMENT OF ONCOLOGICAL DISEASES - Google Patents

Abstract

The utility model 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, uterus, cervix. The technical result of the utility model is the simplicity of introducing a device for heating inside the organ, the wide and complete coverage of the entire organ from the inside during the heating process, the simplicity of treatment with the device of oncological diseases, and the availability for use in conventional clinics. 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, rigidly and hermetically connected to the cavity with a thin elastic stretch shell in which the tubes are placed. In one tube, gradually raising the temperature, heated water is supplied under pressure, and cooling water is discharged through the other tube, a pressure gauge or pressure sensor is installed at the end of the outlet tube, as well as a thermometer, in addition, there is a valve or clamp at the end of the outlet tube to adjust the pressure water inside the affected organ.

Description

Application area

The utility model 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, uterus, 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, therefore, when heated, they are unable 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, when the temperature rises, they are easily embolized - clogged. As a result, with an increase in 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 are the high complexity, the injury rate of the patient, the riskiness, and the saturation of the rare specific expensive medical equipment.

More simple and gentle ways - local hyperthermia. 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 performance and operation, inconvenient 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 telegram radiation of a tumor from 3-4 fields with a single focal dose of 5 g. (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 an 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. A coolant (liquid) with a temperature of 42C is supplied 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 rectal hyperthermia, an organic glass rectostat is known in which water circulates at a temperature of 44-45 ° C, supplied from a UT-15 ultra-thermostat. The rectostat is inserted into the rectum, the coolant is connected and the procedure is carried out 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 the heat carrier inlet and outlet tubes 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 patent RU2232563 for a thermal 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 purpose of the utility model is to develop a simple device for the treatment of cancer, available for use in conventional clinics.

The technical result of the utility model is the simplicity of introducing a device for heating inside the organ, the wide and complete coverage of the entire organ from the inside during the heating process, the simplicity of treatment with the device of oncological diseases, and the availability for 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) shell, 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.

Device essence

The claimed technical result is achieved due to the fact that the thermal applicator is an expanding heater, which is a heat exchanger. Heated water is introduced and removed into the heat exchanger, and due to this, the affected organ warms up to 42 - 45 ° С.

The difference is that the distal part of the thermal applicator is made of two soft elastic tubes of different lengths. The ends of the tubes are perforated with holes for the inlet and outlet water. The tubes are rigidly and hermetically connected to the cavity with a thin elastic stretch shell, into which the tubes are placed. In one tube, gradually raising the temperature, heated water is supplied under pressure, and cooling water is discharged through the other tube.

Treatment is carried out by introducing into the affected organ a special expanding thermal applicator that takes the internal volume of the affected organ. The thermal applicator is a heat exchanger with inlet and outlet of the heat carrier water is used as the 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 circulation of water 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. The principle of using the device is based on the introduction of a special expanding water heater (thermal applicator) into the affected organ that receives the internal volume of the affected organ, and heats the affected organ to 42-45 ° C. The thermal applicator (see Figure 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 based on the readings of the thermometer (6), as well as the pressure gauge (5) or pressure sensor, either automatically or manually, from the control panel (8). A shell with inlet - outlet tubes is the distal part of the thermal applicator device. Before starting the heating process, the elastic shell is empty, it corresponds to the volume and thickness of 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: the oral cavity, esophagus, stomach, duodenum, colon, rectosigmoid joint, rectum, anus, bladder, uterine body, cervix. The elastic shell when the heated water is fed into 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 device, available for use in conventional clinics, is ensured by the fact that the device can work 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 a cancer-affected organ at a temperature of 42-45 ° C for 60 minutes, the cancer cells die.

The device operates 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 position is placed the surface 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 tight contact of the surfaces of the tumor of the entire organ and 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 thermal applicator for the thermal treatment of cancer, which is an expanding heater, which is a heat exchanger into which heated water is introduced and removed, and due to this, the affected organ is heated 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 inlet and outlet water, rigidly and hermetically connected to the cavity with a thin elastic stretch shell in which BCI, whose function is to feed and water withdrawal.