RU2372116C2 - Local uhf-hyperthermia apparatus - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medical equipment, namely to devices for local hyperthermia apparatuses for malignant tumours. An apparatus comprises an UHF-field generator and at least two electrodes connected thereto, each supplied with a sylphon bellows applicator containing an elastic working wall and filled with a liquid dielectric, an electrode alignment and liquid dielectric supply system, UHF-field generator control system, needle temperature-sensitive elements with 8-channel temperature indicator, information display and documentation system. The apparatus is also provided with a scanning electromechanical drive, a thermostat automatically controllling temperature, a mobile hyperthermic table for the patient and an elastic catheter with a flexible temperature-sensitive element, a thermostat. The catheter is filled with a conductive liquid.

EFFECT: invention allows reducing risk of thermal injury of healthy tissues and probability of "hot points" under electrodes applicators.

2 cl, 1 dwg

Description

Technical field

The invention relates to medicine, and more

precisely to the device for high-frequency therapy.

The device can be successfully used for local hyperthermia of malignant tumors: osteosarcoma, larynx cancer, thyroid cancer, melanoma, breast cancer, Ewing's sarcoma, skin cancer, hypernephroid cancer of the kidney, lung cancer, tumors of the gastrointestinal tract, as well as in the treatment of chronic diseases: late radiation damage to tissues, prostatitis, adenoma and prostate cancer, hepatitis, endometritis, non-specific inflammatory diseases of the lungs and other organs, neurodermatitis, psoriasis, eczema, pp eptoderma, infectious allergic asthma, cystitis, adnexitis.

State of the art

Currently, methods for treating chronic diseases and malignant tumors by overheating (hyperthermia) of the corresponding pathological focus inside the patient’s body (human or animal) to 43-45 ° C by penetrating electromagnetic waves of ultrahigh frequency (UHF), magnetic and electric fields of ultrahigh and high are developing rapidly. frequencies.

A device for hyperthermia is known, containing a microwave energy generator and an antenna connected to this generator, which emits electromagnetic waves into a given area of the patient’s body. Such a device uses the microwave range of electromagnetic waves 2450 MHz (wavelength 12 cm), 915 MHz, (33 cm) and 433 MHz (65 cm) [1].

However, the device operating in the microwave range, allows you to overheat only shallow (1-2 cm) located tissue due to the low penetration of electromagnetic radiation in this range. For example, microwave radiation with a wavelength of 12 cm penetrates into muscle tissue to a depth of 1 cm, and from a wavelength of 65 cm to a depth of 2 cm [2].

In addition, microwave radiation penetrates relatively freely into tissues with high electrical resistance (cartilage of the larynx, tendon, fascia, bone) and since the heat generated in them is difficult to remove due to the low volumetric flow rate, these tissues can overheat and damage even before of how the hyperthermic temperature is reached in the tumor - 41-45 ° С. Therefore, with microwave hyperthermia, for example, cancer of the larynx, the risk of thermal damage to the cartilage of the larynx is significantly higher than tissues with low electrical resistance (muscles, malignant tumors) [3, 4, 5, 8].

In any case, the small depth of penetration of microwave radiation into tissues and the uncertainty of combinations of electrical parameters of tissues does not allow for precise localization of heat in the patient’s body during microwave hyperthermia.

More promising is the method of local hyperthermic exposure to malignant tumors by the electric field of the UHF band - 300-30 MHz.

The UHF field penetrates living tissue 10 or more times deeper, and the distribution of heat in depth and volume is more uniform than with microwave hyperthermia.

The specified method is implemented by a device containing an electric UHF field generator, the output circuit of which is loaded on a capacitor consisting of electrodes, between which is located the area of the patient’s body in which the malignant tumor is located - the object of therapeutic exposure to the electric UHF field. Such electric field heating is called the capacitive method of hyperthermia.

The well-known "Method and device for hyperthermic treatment of tumors", which uses the heating of tumors with an electric field of UHF (40.68 MHz) through a layer of liquid dielectric (Lopatin V.F. et al. Patent No. 1132389 from 01.09.81) [6]. To implement this method, a domestic UHF-hyperthermic complex EXTRATERM was created.

The device contains a table and electrodes connected to a UHF generator, it is equipped with a frame mounted on the table with the possibility of changing the angle of inclination and longitudinal movement, and chambers for liquid dielectric connected to the dielectric supply means, one side of which is made elastic, and the electrodes are connected to frame and are located in the bottom of the chamber, while the table and frame are made of material with a dielectric constant not exceeding 5.

The main disadvantage of this method is the overheating of subcutaneous fat (TFA), which has a high electrical resistance, which leads to a high risk of thermal damage to healthy surface tissues in patients with a pronounced layer of TFA (> 1.5-2 cm) and, accordingly, makes selective heating of tumors of the internal hollow organs and tissues to hyperthermic temperatures.

Note that at an electric field frequency of 40 MHz, which is used in the domestic EXTRATERM UHF hyperthermic complex, subcutaneous fat is heated much less than at a frequency of 8 MHz (THERMOTRON RF-8, Japan) and 13 MHz (ONCOCARE, France) [ 2, 3, 9].

The prototype of the invention is "Device for high-frequency therapy and an orientation system for it" [10].

A device for high-frequency therapy, contains an electric UHF field generator, electrodes with applicators in the form of a bellows with a liquid dielectric, an electrode orientation system (dielectric bracket, rods with electrodes), a linear mechanism for moving the brackets along the X Y and Z axes, a bed with wheels for electrode installation in any position relative to the table for the patient. The disadvantages of the prototype:

1. With local UHF-HT tumors, the temperature of the liquid dielectric in the applicator electrodes is not regulated in the required temperature range - +2 - + 45 ° С.

2. There is a high probability of occurrence of "hot spots", signaling the risk of thermal damage to healthy tissues until the tumor reaches hyperthermic temperature - 41-45 ° C, and it is difficult to heat tumors of the internal hollow organs to hyperthermic temperatures.

3. There is no possibility of moving the patient on the hyperthermic table to the X-ray room for the controlled introduction of temperature sensors into tissues and hollow organs and the subsequent movement of the patient on this table to the electrode orientation system to place the area of the body with the tumor in the interelectrode space.

The clinical experience of using local UHF hyperthermia in the complex and combined treatment of malignant tumors of various localizations and histogenesis showed the following:

1. With local UHF-HT tumors in patients with a pronounced layer of subcutaneous fat (PUFA), it was not always possible to achieve hyperthermic temperatures in the tumors (41-45 ° C) due to the appearance of “hot spots” under the applicator electrodes in surface healthy tissues signaling the risk of thermal damage to healthy tissues, while the selective heating of tumors of the internal hollow organs was especially difficult.

2. For controlled introduction of temperature sensors (TD) into tissues and hollow organs, the patient had to be transferred from a stationary hyperthermic table to a gurney and taken to an X-ray or ultrasound cabinet and then transferred to a hyperthermic table again. The procedure for transferring the patient was accompanied by tissue displacement and TD, as well as microdamage of tissues by needle TD. In addition, it was difficult to lay the patient between the applicator electrodes.

3. The control of the liquid dielectric supply means and the electrode orientation means was difficult. There was no software computer display and documentation of information from the AP and the generator, which significantly impeded the conduct of UHF hyperthermia sessions.

The essence of the invention

The novelty of the invention lies in the introduction into the known device of a thermostat, an elastic catheter filled with electrically conductive liquid, a mobile table for a patient, a computer-controlled system for controlling an UHF generator, means for supplying a liquid dielectric and means for orienting electrodes, means for displaying and documenting information.

Previously, with UHF hyperthermia, the temperature of the liquid dielectric was manually controlled from +10 to + 45 ° C, then in the proposed device with a thermostat, the temperature is automatically controlled in the specified mode in the range from +2 to + 45 ° C. A lower temperature (+2 versus + 10 ° С) of a liquid dielectric allows to increase the cooling depth of healthy surface tissues and reduce the likelihood of “hot spots” under the applicator electrodes.

If selective heating of tumors of the internal hollow organs was previously difficult, an elastic flexible catheter inserted into the hollow organ at the level of the location of the tumor and filled with electrically conductive fluid can increase the temperature in the tumor by 1-3 ° C compared with the temperature achieved without a catheter . This reduces the likelihood of the appearance of "hot spots" under the applicator electrodes until hyperthermic temperature in the tumor is reached.

If earlier the medical staff was forced to transfer the patient from a stationary hyperthermic table to a gurney and vice versa, then a mobile hyperthermic table allows you to immediately transport the patient to the X-ray room and then, without any problems, place the patient between the electrodes.

If earlier it was difficult to control the liquid dielectric supply means and the electrode orientation means and there was no computer software for displaying and documenting information from the TD and the generator, then the system for controlling, displaying and documenting information simplifies and speeds up the UHF hyperthermia sessions.

The list of drawings:

The functional diagram of the device for local UHF hyperthermia is shown in the drawing:

1. UHF field generator (40.68 MHz).

2. The electrode plate.

3. An elastic applicator made in the form of a bellows and filled with a liquid dielectric (ID).

4. The electric pump of the liquid dielectric circulation system.

5. Tank with liquid dielectric.

6. Thermostat for regulating the temperature of a liquid dielectric from +2 to + 45 ° С.

7. Electromechanical drive for scanning electrode applicators.

8. Bracket with electrode holders.

9. An eight-channel temperature measuring device with needle and flexible fiber-optic three-element temperature sensors (TD).

10. The tumor.

11. Light, cross section of the chest.

12. A catheter with an electrically conductive fluid, equipped with a fiber optic flexible TD.

13. The system of management, display and documentation of information (SUODI).

14. The arrows indicate the ability of the applicator electrodes to perform forward-backward movements.

15. Mobile hyperthermic table on wheels.

Device description

The generator (1) of the UHF field with the matching unit and the electrode plates (2) make up the generator system (SG), which has a direct and feedback connection with the SUODI (13), and is also connected by an electric field to the tumor located in the lungs (11) (10) with a needle TD from an eight-channel thermometric device (9), and with an elastic catheter (12) filled with an electrically conductive fluid and connected to a thermometric device (9) with a flexible fiber-optic TD.

Applicators (3), electric pumps (4), tanks (5) with railway, thermostats (6) make up a dual-circuit system of circulation (SC) of a liquid dielectric, which is controlled by the SUODI (13) and transmits information to it.

The electromechanical drive (7), the bracket (8) with the electrode holders make up the electrode orientation system (ESR), which is controlled by the SUODI (9) and moves the electrodes back and forth (14), up and down.

A mobile hyperthermic table (15) is designed to place the patient and move him to the X-ray room for the controlled administration of TD into tissues (including the tumor) and hollow organs and subsequent patient movement on this table to the ESR to place the area of the body with the tumor in the interelectrode space and move the body patient up and down.

Device operation

The patient is placed on a mobile table (15); one of the needle temperature sensors (TD) of the heat measuring device (9) is inserted into the tumor (10), one flexible TD is mounted in a flexible elastic catheter (12), the catheter is installed in a hollow organ, for example, in the bronchus of the lung (11), at the level of the tumor and is filled a liquid dielectric (HD) with high electrical conductivity, while the force lines of the electric UHF field (with the generator running) are concentrated around the catheter and the temperature in the tumor of the hollow organ rises, as a rule, by 1-3 ° C compared with the temperature that is reached in op catheter-free aches; electrodes (2) with applicators (3) without iron are installed on the patient’s body in the tumor area (10) and are filled with an electric pump (4) from the container (5) through a thermostat (6) with a liquid dielectric with a given temperature so that under liquid pressure the elastic wall of the applicator (3) repeated the uneven surface of the patient's body; from the generator (1) to the electrode plates (2) an alternating voltage of 40.68 MHz is applied, and the output power of the generator rises until hyperthermic temperatures of 41–45 ° C are reached in the tumor; the electromechanical drive (7) is switched on for scanning tissue heating by the UHF electric field, which is created between a mobile pair of electrode plates (2) that perform translational movements (back and forth) at the operator's command; SUODI (13) remembers these movements and repeats them at the command of the operator during the UHF hyperthermia session. Information about the temperature from the points of thermometry and the output power of the generator is supplied to the SUODI (13), which controls the output power of the generator (1), a scanning electromechanical drive (7) with a bracket (8), the temperature of the liquid using a thermostat (11) and the pressure of the liquid dielectric in the applicators (3) using an electric pump (4).

Positive effect

The device allows to achieve hyperthermic temperatures in tumors of internal internal hollow organs, as well as in tumors of other organs and tissues - 41 - 45 ° C and higher. These temperatures, combined with exposure to ionizing radiation, can significantly reduce the total focal dose of radiation therapy, significantly increase the survival of patients and improve the quality of life of treated patients by reducing the frequency of crippling surgical interventions.

For example, after thermo-radiation therapy using UHF-HT, the five-year survival rate for patients with cancer of the oral cavity and oropharynx was 2 times higher than in the radiation therapy group without UHF-HT (51% versus 22%, p <0.05) [10 ]. During thermo-radiation therapy using UHF-GT in patients with laryngeal cancer (stage III disease), the overall five-year survival rate was 95%. In the group of patients where radiation therapy was carried out in combination with microwave-HT, the overall five-year survival rate was 50% and was almost the same as in the control group - 47% [11]. When thermo-chemoradiotherapy of osteosarcoma using UHF-GT, the five-year survival of patients whose tumors reached hyperthermic temperatures of 41-45 ° C and above was 75%, and in the control group (chemo-radiation therapy), the five-year survival was 21% (P <0.01 )

Subhyperthermic temperatures in tumors - 39 - 41 ° С did not improve the results of treatment of patients with osteosarcoma. It is important that among the treated patients, in the tumors of which hyperthermic temperatures were reached, 25% of the patients survived without surgical intervention, and the subgroup in the tumors of which only hyperthermic temperatures were reached, 7% survived without surgery, and 7% in the control group [ 12].

LITERATURE

1. Devyatkov N.D. Gelvich E.A. Mazokhin V.N. A set of equipment for electromagnetic hyperthermia of malignant neoplasms // Honey. radiology. - 1987, N 1. - S. 73-76.

2. Liventsev N.M., Livenson A.R. Electromedical equipment. - M., 1974. - 524 p.

3. Shtemler V. M., Kolesnikov S. V. Features of the interaction of electromagnetic fields with biological objects. Human and animal physiology. - M .: Medicine, 1978. - T. 22. - S. 9-67.

4. Savin B.M., Stepansky G.A. Human and animal physiology. The biological effect of electromagnetic radiation. M., 1978. S.12-64.

5. Shteinshleger VB, Misezhnikov G.S., Selsky A.G. // Success fiziol. sciences. - 1981. -T.134, No. 1. - C.158-163.

6. Lopatin V.F., Dedenkov A.N., Klyuch V.E. Method and device for hyperthermic treatment of tumors. Patent No. 1132389 from 09/01/84.

7. Lopatin V.F., Mardynsky Yu.S., Vtyurin B.M. Local UHF hyperthermia in radiation therapy of cancer of the organs of the oral cavity and oropharynx // Ros.onkol. Journal. - 2001. - No. 4. - S.30-35.

8. Mardinsky Yu.S., Andreev V.G., Lopatin V.F., Thermoradiotherapy of larynx cancer // Oncology Issues. - 2000. - T. 46, No. 6. - S.708-712.

9. Mardinsky Yu.S., Lopatin V.F., Bizer V.A. Local UHF hyperthermia during radiation treatment of osteogenic sarcoma of long tubular bones in children and adolescents // Questions of Oncology. - 2007. - T.53, No. 5 - S.584-588.

10. Lopatin V.F. and Shvedenko I.M. Device for high-frequency therapy and an orientation system for it. Utility Model Certificate. RU 26004 from 05.29.2002.

Claims (2)

1. Device for local UHF hyperthermia, containing a UHF field generator and at least two electrodes connected to it, each of which is equipped with an applicator made in the form of a bellows, containing an elastic working wall and filled with a liquid dielectric, means for orienting the electrodes and feeding a liquid dielectric, a control system for a UHF field generator, needle temperature sensors with an 8-channel thermometric device, a system for displaying and documenting information, characterized in that it is equipped with scanning m electromechanical drive, thermostat with automatic temperature control, a mobile hyperthermic table for the patient and an elastic catheter with a flexible temperature sensor, thermostat, while the catheter is filled with an electrically conductive fluid. 2. The device according to claim 1, characterized in that the temperature is controlled in the range from 2 to 45 ° C.

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