RU2407429C2 - Antenna-applicator and device for determining temperature changes of internal tissues of biological object and methods of determining temperature changes and cancer risk detection - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to field of medicine, namely to devices and methods for determining temperature changes in internal tissues of biological object and can be used for non-invasive early detection of cancer risk. Antenna-applicator contains segment of wave guide, partly or completely filled with dielectric, which has one closed end and opposite open end, contacting with biological object, system of electromagnetic waves excitation, located in wave guide between closed end of wave guide and dielectric, connected with inlet part of microwave radiothermometre and sensor of skin temperature, located near open end of wave guide, made with possibility to transmit information to computing device. Device for determining temperature changes in addition to antenna-applicator includes microwave radiothermometre, measuring intensity of signal, coming from antenna outlet, proportional to brightness temperature of biological object tissues, and computing device, made with possibility to receive information from sensor of skin temperature and from microwave radiothermometre and to detect changes in temperature of internal tissues. Also claimed are method of determining changes of internal tissues and method of determining changes of internal tissues in time, by simultaneous measurement of brightness temperature and skin temperature in the first and the second points, at the first and at the second moments of time, taking into account coefficient of skin temperature contribution to brightness temperature. Also claimed are methods of detecting high risk of cancer in biological object, in particular of breast cancer, by simultaneous measurement of brightness temperature and skin temperature in the reference and specified points of biological object, determination of tissue thermal activity level, on the basis of which parametre W, characterising cancer risk, is determined, and determination of cancer risk by comparison of parametre W with threshold level of cancer risk.

EFFECT: application of invention allows to detect temperature changes in internal tissues, simplifies measurement process and increases method sensitivity in detection of cancer risk.

22 cl, 20 dwg, 1 tbl, 3 ex

Description

Technical field

The invention relates to the field of medicine and medical technology, in particular to a radiothermography method based on non-invasive detection of temperature changes and thermal anomalies of the internal tissues of biological objects by measuring the intensity of their own electromagnetic radiation.

The invention can be used in medical equipment for non-invasive measurement of the temperature of internal tissues, monitoring its condition, detecting temperature changes and thermal abnormalities of internal tissues, in diagnostic complexes for early diagnosis of cancer and other pathologies of internal organs to detect a high risk of cancer, in particular for early diagnosis of breast cancer.

State of the art

One of the important tasks of modern medicine is the development of methods and devices for non-invasive detection of temperature anomalies of internal tissues and early diagnosis of diseases of internal organs.

Currently, for these purposes, the method of radiothermometry is used, which allows, non-invasively, measuring the brightness temperature of human tissues by measuring the intensity of their own electromagnetic radiation. It is known that if you lean the microwave antenna against the surface of the body, then the power of the microwave signal at the output of the antenna will be directly proportional to the average temperature in the volume under the antenna. This averaged temperature is usually called the luminance temperature, or radiometric temperature. Thus, by measuring the signal intensity at the antenna output, anomalies in brightness temperature can be detected non-invasively. Since the brightness temperature is the average temperature under the antenna, then, based on the data on the nature of the change in brightness temperature, we can judge the nature of the change in temperature of internal tissues. This approach has been widely used for non-invasive detection of thermal anomalies of internal tissues using a single-frequency microwave radiothermometer.

An obvious drawback of this approach is that the brightness temperature is determined not only by the temperature of the internal tissues, but also by the temperature of the skin. Moreover, skin temperature makes a huge contribution to the brightness temperature. In particular, in the 10-centimeter range, the contribution of skin temperature to the brightness temperature is 30-50 percent, depending on the antenna design, frequency range and tissue properties. Thus, revealing the brightness temperature anomalies, one cannot be sure that they are associated precisely with a change in the temperature of internal tissues, and in many applications it is necessary to determine the nature of a change in the internal temperature.

This drawback is most clearly seen when assessing changes in the temperature of internal tissues by measuring brightness temperature when temperature monitoring of internal tissues is performed using a single-frequency radiometer. The contact antenna applicator, which is used in the microwave radiometer to receive the microwave signal, has a strong effect on the skin temperature at the point under study, which, of course, affects the brightness temperature, and it begins to change significantly, although the actual temperature of the internal tissues practically does not change.

In order to evaluate the nature of the temperature change in depth, multifrequency microwave radio thermometers are usually used. If we measure the brightness temperature at several frequencies, then based on these results, we can evaluate the nature of the change in depth. In J.W. Hand, G. M. J. Van Leeuwen, S. Mizushina, J.B. Van de Kamer, K. Maruyama, T.Sugiura, D.V. Azzopardi, A.D. Edwards, "Monitoring of deep brain temperature in infants using multi-frequency microwave radiometry and thermal modeling", Phys Med. Biol. (2001), pp. 1885-1903 describes a microwave radio thermometer, which consists of 5 single-frequency microwave radiometers receiving a signal in the 500 MHz band. The center frequency of the highest channel was 8 GHz, and the lower channel - 1.3 GHz. Further, analyzing 5 values of brightness temperature at 5 frequencies, an algorithm for restoring the temperature inside the brain is proposed in the work. The disadvantage of this approach is, on the one hand, the complexity of the equipment, since one five-channel radiometer consists of 5 single-frequency radiometers. The second disadvantage of a multi-frequency device is its low noise immunity. To work in the 1.3 GHz band, special shielding of the premises is necessary, which in the vast majority of medical institutions does not exist.

At the same time, if at one point, the brightness temperature and skin temperature are simultaneously measured, then subtracting the contribution of the skin layers from the brightness temperature, the temperature of the internal tissues can be determined. But for this it is necessary at the same point to simultaneously measure the skin temperature. In many cases, in addition to detecting temperature abnormalities of internal tissues, it is also necessary to measure skin temperature at the same points.

In A.H. Barrett & Ph. C. Myers, "Subcutaneous Temperature: A method of Noninvasive Sensing", Science, Nov. 14, 1975, vol. 190, pp. 669-671, describes a method for non-invasively detecting a cancer risk in a biological subject and shows that using a single-frequency radiometer breast cancer diagnostic sensitivity is 74%. Thus, the number of false positive results is 26%.

If, in addition to measuring the internal temperature using a microwave radiometer, measuring the skin temperature using a temperature sensor, it is possible to reduce the number of false-negative results by several times, bringing them to 10%, which is comparable with the results of mammography.

It is known to use for diagnosis of breast cancer a computer-equipped diagnostic complex RTM-01-RES (Burdina L.M. et al., Radiometry in the algorithm for a comprehensive examination of the mammary glands, Modern Oncology, Volume 6, No. 1, 2005), which includes it includes an internal temperature sensor and a skin temperature sensor made as a separate unit, a means of visualization, processing and evaluation of the information received.

The method, which is implemented in the diagnostic complex RTM-01-RES and which can be considered as the closest analogue of the methods according to the claimed invention, involves first measuring the brightness temperature at 22 points of the mammary gland using a single-frequency microwave radio thermometer, and then measuring the skin temperature in those the same 22 points of the mammary gland using a separate infrared temperature sensor. Based on these measurements, then an analysis of the results is performed, on the basis of which a conclusion is made about pathological deviations.

This method has several disadvantages. Firstly, the sequential measurement of the brightness temperature, and then the measurement of the skin temperature, made in the form of a separate sensor unit, is quite laborious and requires significantly more time than just one measurement. Secondly, without special marking it is very difficult to ensure that the brightness temperature and skin temperature are measured at the same points. Labeling of the mammary gland with coloring matter is not always welcomed by patients. Thirdly, measuring the brightness temperature at 22 points of the mammary gland takes about 10 minutes, during which time the skin of the mammary gland cools, i.e. brightness temperature and skin temperature are measured at different times.

Obviously, it is desirable to simultaneously measure the brightness temperature and skin temperature at the same point. But to measure the brightness temperature, the applicator antenna must be in close contact with the skin surface, while it is known that no additional elements can be arbitrarily placed in the antenna aperture, since an element placed in the antenna aperture and absorbing electromagnetic waves will affect the measured temperature, the reflectance of the antenna and the radiation pattern.

The most widely used in radiothermometry are contact waveguide applicators in the form of a rectangular waveguide open at one end in contact with the patient. For example, in the method of detecting breast tumors according to US patent No. 5779635 (K. Carr), a matrix of several antennas is used, including an electromagnetic radiation receiving system, located in a rectangular waveguide partially filled with a dielectric, having one closed end and the other open facing the patient, end.

In multi-frequency radiothermometry, an applicator antenna is used that has a rectangular waveguide open at one end, filled with a dielectric, and an electromagnetic wave excitation system located in the waveguide and connected to the input of the radiothermometer (JWHand, GMJVan Leeuwen, S. Mizushina, JBVan de Kamer, K. Maruyama, T. Sugiura, DVAzzopardi, ADEdwards, "Monitoring of deep brain temperature in infants using multi-frequency microwave radiometry and thermal modeling", PhysMed. Biol. 2001), pp. 1885-1903).

The closest analogue of the claimed antenna applicator is the antenna applicator developed by the author of the present invention for non-invasively measuring the temperature of the internal tissues of a biological object according to RF patent 2306099, publ. September 20, 2007, containing a segment of the waveguide closed at one end, partially or completely filled with a dielectric, a dielectric plate located at the opposite end of the waveguide segment in contact with a biological object, and there is a gap filled with air between the dielectric plate and the dielectric filling the waveguide or other dielectric material with low thermal conductivity and low dielectric constant, an electromagnetic wave excitation system located in the waveguide between rytym end of the dielectric waveguide and connected to the inlet portion radiometer. This antenna has very good parameters, but it also does not allow to simultaneously measure the brightness temperature and skin temperature.

SUMMARY OF THE INVENTION

The objective of the invention is to provide an antenna applicator that provides simultaneous measurement of brightness temperature and skin temperature at the same point in a biological object, and a device for determining temperature changes in internal tissues, as well as methods for determining temperature changes in internal tissues and methods for identifying patients at risk cancer, in particular the risk of breast cancer, using the proposed devices.

The solution of this problem provides the ability to detect temperature changes in internal tissues, the ability to monitor temperature changes in internal tissues, increases the sensitivity of the method when a high risk of cancer is detected, simplifies the measurement process, reduces the number of false negative results and reduces the time of diagnosis. The design of the proposed antenna applicator also provides increased noise immunity.

One object of the claimed invention is an antenna applicator for determining temperature changes in the internal tissues of a biological object by simultaneously non-invasively measuring the brightness temperature and skin temperature of a biological object, containing:

a waveguide segment partially or completely filled with a dielectric having one closed end and an opposite open end in contact with a biological object,

an electromagnetic wave excitation system located in the waveguide between the closed end of the waveguide and the dielectric, connected to the input part of the microwave radiometer,

a skin temperature sensor located at the open end of the waveguide, configured to transmit information to a computing device.

The skin temperature sensor of the antenna applicator can be connected to the computing device by conductors located orthogonal to the electric field vector of the antenna applicator.

As a temperature sensor, the applicator antenna may include a contact shielded temperature sensor located at the open end of the waveguide in contact with the biological object, or an infrared shielded skin temperature sensor located inside the length of the waveguide at a distance from the open end of the waveguide with a gap between the infrared temperature sensor and the biological object.

The applicator antenna may further comprise a low pass filter at the output of the skin temperature sensor.

The applicator antenna may be further provided with a metallized flange located at a distance from the open end of the waveguide.

The applicator antenna may comprise a dielectric plate partially or completely made of a material transmitting near infrared waves located at the open end of a waveguide segment, and there is a gap between the dielectric plate and the dielectric filling the waveguide filled with air or other dielectric material with low thermal conductivity , low dielectric constant and infrared transmitting waves.

The applicator antenna may be equipped with a heating system.

The antenna applicator can be made in the form of one or more series-connected segments of the waveguide, for example a circular waveguide having a different cross section.

In addition, the applicator antenna may contain one or more series-connected segments of the internal waveguide and located outside of the internal waveguide of one or more segments of the external waveguide, the gap between the segments of the internal and external waveguides partially or completely filled with a dielectric.

A matching element can be applied to the dielectric from the open end of the waveguide by metallization, which ensures the use of an antenna applicator for tissues with different dielectric constants.

The applicator antenna may be further provided with a temperature sensor measuring the temperature of the applicator antenna and transmitting information to the computing device and / or a sensor for measuring the temperature of the skin temperature sensor located on the skin temperature sensor body, measuring the temperature of the sensor body and transmitting information to the computing device.

Another object of this invention is a device for determining temperature changes in the internal tissues of a biological object, including:

an applicator antenna comprising:

a waveguide segment partially or completely filled with a dielectric having one closed end and an opposite open end in contact with a biological object,

an electromagnetic wave excitation system located in the waveguide between the closed end of the waveguide and the dielectric, connected to the input part of the microwave radiometer,

a skin temperature sensor located at the open end of the waveguide, configured to transmit information to a computing device;

microwave radio thermometer, measuring the intensity of the signal coming from the output of the antenna, which is proportional to the brightness temperature of the tissues of the biological object; and

a computing device configured to receive information from a skin temperature sensor and from a microwave radio thermometer and detect changes in the temperature of internal tissues.

The device may use any of the above embodiments of the antenna applicator.

The device may include a means of visualization and display.

A method for determining temperature changes in internal tissues according to the invention includes:

simultaneous measurement of brightness temperature and skin temperature at the first point of a biological object,

determination of the temperature of internal tissues at the first point according to the following formula:

, где

where

T _int1 is the temperature of the internal tissues at the first point,

T _br1 - brightness temperature at the first point,

T _sk1 - skin temperature at the first point,

κ is a dimensionless coefficient characterizing the contribution of skin temperature to brightness temperature,

simultaneous measurement of brightness temperature and skin temperature at the second point of a biological object,

determination of the temperature of internal tissues at the second point according to the following formula:

, где

where

T _int2 is the temperature of the internal tissues at the second point,

T _br1 - brightness temperature at the second point,

T _sk2 is the skin temperature at the second point,

κ is a dimensionless coefficient characterizing the contribution of skin temperature to brightness temperature,

assessment of changes in the temperature of internal tissues by the formula:

.

.

Moreover, according to the invention, a method for determining temperature changes in internal tissues over time can also be implemented, including:

simultaneous measurement of brightness temperature and skin temperature at a given point of a biological object at the first moment of time,

determination of the temperature of internal tissues at the first moment of time according to the following formula:

, где

where

T _{int t1} is the temperature of the internal tissues at the first time,

T _{br t1} - brightness temperature at the first moment of time,

T _skt1 - skin temperature at the first moment of time,

κ is a dimensionless coefficient characterizing the contribution of skin temperature to brightness temperature,

simultaneous measurement of brightness temperature and skin temperature at the same point of a biological object in the subsequent second moment of time,

determination of the temperature of internal tissues at the second point in time according to the following formula:

, где

where

T _intt2 is the temperature of the internal tissues at the second instant of time,

T _brt2 - brightness temperature at the second moment of time,

T _skt2 - skin temperature at the second point in time,

κ is a dimensionless coefficient characterizing the contribution of skin temperature to brightness temperature,

an estimate of the temperature change of internal tissues over time using the following formula:

.

.

The invention can be used in a method for identifying a high risk of cancer in a biological subject, including:

simultaneous measurement of the brightness temperature of the biological object and the skin temperature of the biological object in at least one reference point,

simultaneous measurement of the brightness temperature of a biological object and the skin temperature of a biological object at specified points,

determination of the temperature of internal tissues at reference and given points according to the following formula:

, где

where

T _int - the temperature of the internal tissues at the reference point T _on int or at a given point T _i int, respectively,

T _br - brightness temperature at the reference or set point,

T _sk - skin temperature at a reference or a given point,

κ is a dimensionless coefficient characterizing the contribution of skin temperature to brightness temperature,

determination of the level of thermal activity of tissues D, characterizing thermal changes in the tissues of a biological object, according to the expression:

, где

where

D is the level of thermal activity of tissues,

C1 is the weight coefficient, which is a dimensionless constant factor. In practice, C1 is often equal to 1, and the formula will have the following form:

, где ΔT_i - повышение температуры внутренних тканей в заданных точках измерения по сравнению с температурой внутренних тканей в опорной точке, определяемое по следующей формуле:

where ΔT _i is the increase in the temperature of internal tissues at given measurement points compared to the temperature of internal tissues at a reference point, determined by the following formula:

, где

where

T _i int - the temperature of the internal tissues at the i-th given point,

T _on int is the temperature of the internal tissues at the reference point,

T _i sk - skin temperature at the i-th given point,

T _on sk - skin temperature at the reference point,

CC2 is a weight coefficient that characterizes the weight of skin temperature compared to the temperature of internal tissues. In most cases, this coefficient is taken equal to 1, and with CC2 equal to 1, the mathematical formula for calculating ΔTi will have the following form:

,

,

determination of the parameter W, which characterizes the risk of cancer based on the level of thermal activity of tissues D and the relationship between the temperature of internal tissues and skin temperature, according to the expression

, где

where

W is a parameter characterizing the risk of cancer,

D is the level of thermal activity of tissues,

LL is a parameter characterizing the difference between the temperature of internal tissues and the skin temperature of a biological object, equal to

and LD is a parameter characterizing the variance of the difference between the temperature of internal tissues and the skin temperature of a biological object, equal to

where U and UB are dimensionless coefficients determined experimentally, for the given examples, the numerical value of the parameter U is selected in the range from 0.5 to 0.7, and the numerical value of the parameter UB is selected in the range from 0.2 to 0.3,

and determining a cancer risk by comparing a cancer risk parameter W with a threshold cancer risk level. For the given examples, the threshold level of cancer risk is in the range from 0.7 to 1, a more accurate value can be chosen so that in the “training sample” all patients with cancer have a W value higher than the threshold level, and patients who do not have cancer are lower than the threshold level.

For paired organs of a biological object, when determining the level of thermal activity of tissues D, the value of the temperature difference at the measurement points of the right and left paired organ, determined by the following formula, is additionally taken into account:

, где

where

Tint _iprav - internal tissue temperature in i-right of the given point pair body,

Tint _ilev - the temperature of the internal tissues at the i-th given point of the left paired organ,

Tsk _irav - skin temperature at the i-th given point of the right paired organ,

Tsk _ilev - skin temperature at the i-th given point of the left paired organ,

CC3 is a dimensionless weight coefficient that characterizes the weight of the skin temperature T _i sk compared to the internal temperature and is usually assumed to be 1. If it is 1, then the formula will take the following form:

and the level of thermal activity of tissues D is defined as

, где

where

C1, C2 - weighting coefficients that determine the contribution of these components, which are also equal to 1 in practice, as a result of which the formula will have the following form:

.

.

In particular, the invention can be used in a method for detecting a high risk of breast cancer in a biological object, including:

simultaneous measurement of the brightness temperature of the biological object and the skin temperature of the biological object in at least one reference point,

simultaneous measurement of the brightness temperature of the breast of a biological object and the skin temperature of the breast of a biological object at specified points,

determination of the temperature of internal tissues in the reference and given points of the mammary gland according to the following formula:

, где

where

T _int - the temperature of the internal tissues in the reference or given point of the mammary gland,

T _br is the brightness temperature at the reference or predetermined point of the mammary gland,

T _sk - skin temperature at the reference or given point of the mammary gland,

κ is a dimensionless coefficient characterizing the contribution of skin temperature to brightness temperature,

determination of the level of thermal activity of tissues D, characterizing thermal changes in breast tissue, according to the expression:

, где

where

D is the level of thermal activity of breast tissue,

C1, C2 - weighting factors that determine the contribution of these components, which are also equal to 1 in practice, as a result of which the formula will have the following form:

,

,

ΔT _i is the increase in temperature of internal tissues at predetermined points of the mammary gland compared to the temperature at the reference point, determined by the following formula:

, где

where

T _i int is the temperature of the internal tissues at the i-th given point of the mammary gland,

T _on int - the temperature of the internal tissues at the reference point of the mammary gland,

T _i sk - skin temperature at the i-th given point of the mammary gland,

T _on sk - skin temperature at the reference point of the mammary gland,

CC2 is a dimensionless weight coefficient that characterizes the contribution of the difference in skin temperature at a given and reference point, in practice it is often equal to 1, and the formula will have the following form:

, и

, and

DT _i is the value of the temperature difference between the right and left mammary glands at given points, determined by the following formula:

, где

where

Tint _iprav - internal tissue temperature in i-one predetermined point of the right breast,

Tint _ilev - the temperature of the internal tissues at the i-th given point of the left breast,

CC3 is a dimensionless weight coefficient that characterizes the weight of the temperature difference of the skin at a given point of the right and left mammary gland, with its equality in practice 1, the formula will take the following form:

Tsk _irav - skin temperature at the i-th given point of the right mammary gland,

Tsk _ilev - skin temperature at the i-th given point of the left mammary gland,

determination of the parameter W, characterizing the risk of cancer based on the level of thermal activity of tissues D and the relationship between the temperature of the internal tissues and the temperature of the skin of the breast, according to the expression

, где

where

W is a parameter characterizing the risk of cancer,

D is the level of thermal activity of breast tissue,

LL is a parameter characterizing the difference between the temperature of internal tissues and the temperature of the skin of the breast, equal to

and LD is a parameter characterizing the variance of the difference between the temperature of the internal tissues and the temperature of the skin of the breast, equal to

where U and UD are the experimental coefficients, while the numerical value of the parameter U is experimentally selected in the range from 0.5 to 0.7, and the numerical value of the parameter UB is selected in the range from 0.2 to 0.3,

and determining a cancer risk by comparing a cancer risk parameter W with a threshold cancer risk level.

Brief Description of the Drawings

Figure 1 presents the antenna applicator, known from the prior art.

Figure 2 shows a variant of the applicator antenna with a contact shielded skin temperature sensor.

On Fig.3 presents a variant of the antenna applicator with an infrared shielded skin temperature sensor.

Figure 4 presents the antenna applicator with an infrared shielded skin temperature sensor and with a beveled dielectric filling the waveguide.

Figure 5 presents a variant of the antenna applicator, with a low pass filter, to increase the noise immunity.

Figure 6 presents the antenna applicator, which at the open end of a segment of the waveguide contains a dielectric plate, partially or completely made of material that transmits waves of the near infrared and microwave ranges.

Figure 7 presents the antenna applicator, equipped with a flange, to increase the noise immunity.

On Fig presents the antenna applicator, which contains a heating system for the antenna applicator.

Figure 9 presents a variant of the antenna, which contains several series-connected segments of the waveguide having different cross-sections.

Figure 10 shows a variant of the applicator antenna, in which a segment of the external waveguide is located outside the internal waveguide, and the gap between the segments of the internal and external waveguides is partially filled with a dielectric.

11 shows a variant of the applicator antenna and its cross-section along line AA, in which a metallized matching element is connected between the excitation system and the infrared sensor.

On Fig presents a variant of the antenna applicator, which is additionally equipped with a temperature sensor that measures the temperature of the antenna applicator and transmitting information to the computing device.

On Fig presents a variant of the antenna applicator, which is additionally equipped with a temperature sensor located on the housing of the skin temperature sensor, measuring the temperature of the sensor housing and transmitting information to the computing device.

On Fig presents a schematic representation of a device for determining temperature changes in the internal tissues of a biological object containing an applicator antenna, a microwave radiothermometer and a computing device.

On Fig presents another variant of the device for determining the temperature changes of internal tissues, containing an antenna applicator, microwave radiometer, a computing device and additionally containing a low pass filter at the output of the skin temperature sensor.

On Fig presents a variant of the device for determining the temperature changes of internal tissues, comprising an antenna applicator with a heating system.

On Fig presents a variant of the device for determining temperature changes in internal tissues, containing a touch sensor.

On Fig shows the result of the expert system for Example 1 clinical use.

On Fig shows the result of the expert system for Example 2 clinical use.

On Fig shows the result of the expert system for Example 3 clinical use.

DETAILED DESCRIPTION OF THE INVENTION

Figure 1 presents the antenna applicator, known from the prior art (according to the patent of the Russian Federation 2306099), not containing a skin temperature sensor. Figure 2-13 presents embodiments of the antenna applicator according to the invention. The electromagnetic energy of the microwave range from the biological object (7) through the open end of the waveguide (1) enters the waveguide, partially filled with a dielectric (8), and then the electromagnetic radiation enters the excitation system (2) of the antenna-applicator and through the coaxial cable to the input of the radiometer.

Figure 2 shows a General schematic representation of the claimed antenna applicator containing a segment of the waveguide (1), partially filled with a dielectric (8), having one closed end and opposite open end in contact with the biological object (7), electromagnetic excitation system (2) waves, located in the waveguide between the closed end of the waveguide and the dielectric, connected by conductors (5) to the inlet part of the microwave radiometer, and a skin temperature sensor (3) located at the open end of the waveguide.

Information from the temperature sensor (3) via wires (6) enters the computing device. Information about the brightness temperature measured by a microwave radio thermometer is also received there. In this embodiment, a shielded contact temperature sensor of the skin located on the surface of the dielectric and in direct contact with the skin is used as a temperature sensor.

Figure 3 presents a variant of the antenna applicator with an infrared shielded skin temperature sensor. There is a gap (9) between the infrared temperature sensor (3) and the skin surface. The infrared signal from the surface of the biological object (7) through the open end of the waveguide (1), through the air gap (9), enters the infrared temperature sensor (3).

It is known that in the aperture of the antenna it is impossible to place any additional elements arbitrarily, since an element placed in the aperture of the antenna and absorbing electromagnetic waves will affect the measured temperature. In addition, elements located in the aperture affect the reflection coefficient of the antenna and the radiation pattern.

At the same time, if a metallized screen (10) is placed between the excitation system and the open end of the waveguide, having only one open surface directed towards the bioobject, then the dimensions of the metal screen can be selected so that its effect on the measured brightness temperature is on the radiation pattern and its reflection coefficient was minimal. The effect of the metallized screen on the measured brightness temperature will also be minimal, since the conductivity of the metal is very high.

An infrared temperature sensor (3) located in the screen, through the open surface of the screen and the air gap (9), can measure remotely and non-invasively the temperature of the skin of the biological object (7). The calculated and experimental data show that in a ten-centimeter wavelength range a screen with a diameter of 10 mm located between the excitation system and the open end of the waveguide filled with a dielectric does not adversely affect the antenna parameters, and by optimizing the size of the screen and the excitation system, a low reflection coefficient can be obtained antennas in a wide range of frequencies.

To reduce the influence of the temperature of the dielectric (8) filling the waveguide (1) on the results of measuring the skin temperature of a biological object, it can be cut at an angle (11), as shown in Fig. 4, so that a smaller part of the dielectric falls into the field of view of the infrared sensor. The viewing angle of the infrared sensor must be chosen so that the dielectric filling the waveguide does not fall into the field of view of the infrared sensor.

It is obvious that the conductors (6) coming from the temperature sensors (Figs. 2-4) are located in the aperture of the antenna and, in the general case, have a strong influence on the antenna pattern and on the error in measuring the brightness temperature. But the authors of the present invention found that it is preferable to arrange the conductors orthogonally to the electric field vector in the waveguide, in which case their influence will be insignificant, and they will not affect the results of measuring the brightness temperature.

When shielding contact sensors of skin temperature (figure 2) they also do not affect the measured brightness temperature and can be used to measure skin temperature.

In order for the conductors not to impair the noise immunity of the antenna, it is possible to put low-pass separation filters (12) at the output of the conductor from the waveguide, as shown in Fig. 5, which do not allow microwave oscillations to penetrate into the waveguide.

As an infrared sensor, it is possible to choose, for example, PerkinElmer Inc. sensors having a diameter of 8 mm and a height of 5 to 10 mm. The viewing angles of these sensors range from 7 to 100 degrees. Information about the measured temperature comes from the sensor in the form of a potential difference at the sensor contacts.

As a contact sensor, you can use a temperature sensor, for example, Honeywell International Inc.

6 shows an applicator antenna, which at the open end of a waveguide segment contains a dielectric plate partially or completely made of material that transmits near-infrared and microwave waves, which protects the skin temperature sensor and the inside of the antenna from moisture and dirt, and simplifies disinfection of the antenna before measurement.

Another way to increase the noise immunity of the antenna is shown in Fig. 7, which shows the applicator antenna having a metallized flange (15) located at a distance (16) from the open end of the waveguide. To ensure high noise immunity, the distance from the flange to the skin surface should be from 1.5 to 2.5 mm. Figure 8. presents the antenna applicator, which contains a system (17) for heating the antenna applicator, which allows you to reduce the influence of the temperature of the antenna on the error of measurement of skin temperature. In the absence of heating, the antenna temperature is close to ambient temperature. During the measurement of the brightness temperature, the applicator antenna contacts the skin and has a strong effect on the measured temperature. It should be noted that the antenna temperature also affects the error in measuring the brightness temperature. To minimize this effect, the applicator antenna is heated to a temperature close to skin temperature (approximately 33 ° C), and is maintained at this level during measurement. This allows you to reduce the influence of the antenna temperature on the error in measuring skin temperature and brightness temperature.

Figure 9 presents the antenna applicator, which contains several series-connected segments of the waveguide having different cross-sections, allowing for good coordination in a wide frequency range.

Figure 10 shows the antenna applicator containing the internal waveguide (and located outside the inner waveguide segment of the external waveguide (18), and the gap between the segments of the internal and external waveguides is partially filled with a dielectric (19). The presence of additional external waveguides (19) allows to increase noise immunity of the antenna.

11 shows a variant of the applicator antenna and its cross-section along line AA, in which a metallized matching element (20) is connected between the excitation system and the infrared sensor. It allows you to adjust the reflection coefficient of the antenna in a wide range of frequencies to use the antenna applicator for tissues with different dielectric constants.

The error in measuring skin temperature, as a rule, depends on the temperature of the sensors used to measure it. At the same time, the temperature of the sensors changes when measuring the ambient temperature, in the process of heating the sensor, the energy dissipated in the equipment, and the energy received from the patient. But if you measure the temperature of sensors that measure skin temperature, and the temperature of the antenna, then you can compensate for errors that occur during the measurement.

Therefore, the antenna in FIG. 12 is further provided with a temperature sensor (21) measuring the temperature of the applicator antenna and transmitting information to the computing device.

The antenna can also be equipped with an additional sensor (22) for measuring the temperature of the skin temperature sensor, which is located on the body of the skin temperature sensor, as shown in Fig. 13. This sensor (22) measures the temperature of the skin temperature sensor housing and transmits temperature information of an infrared or contact skin temperature sensor to a computing device. This information can be used in a computing device in order to reduce the influence of ambient temperature on the measurement results. Infrared sensors, for example, PerkinElmer Inc., in addition to information about the measured temperature provide information about the temperature of the case, which allows you to use this information to reduce the error in measuring skin temperature.

On Fig presents a schematic representation of a device for determining temperature changes in the internal tissues of a biological object containing an antenna applicator (1), a microwave radiothermometer (23) and a computing device (24).

On Fig presents another variant of the device for determining the temperature changes of internal tissues, containing the antenna applicator (1), microwave radiothermometer (23), a computing device (24) and further comprising a low-pass filter (25) at the output of the skin temperature sensor. Each conductor coming from the skin temperature sensor must pass through a low-pass filter, which prevents microwave oscillations from entering the antenna aperture through conductors going to the skin temperature sensor. The filter should be located as close as possible to the point of entry of the conductors (6) into the waveguide.

On Fig presents a variant of the device for determining the temperature changes of internal tissues, comprising an antenna applicator (1) with a heating system (17), which reduces the influence of the antenna temperature on the error of measurement of skin temperature. To heat the antenna, you can use either resistors mounted on the antenna body or Peltier elements. The latter allow not only heating the antenna, but also cooling it. But the operation of the Peltier element requires the organization of a heat sink. When using resistors, a heat sink is not required, and cooling occurs due to the natural cooling of the antenna.

On Fig presents a variant of the device for determining temperature changes in internal tissues, containing a touch sensor (27), which is triggered if the applicator antenna touches the skin of the patient and transmits information about the touch to the computing device. The computing device processes information from all touch sensors (27) and, if there is a touch, allows the program to save the measurement results in the computer's memory. This allows the doctor to be sure that the antenna is in contact with the skin. It is known that to ensure reliable measurement results of brightness temperature, the antenna applicator should fit snugly against the skin. To do this, use a touch sensor located near the aperture of the antenna or in the aperture of the antenna. Using touch sensors also allows you to stop measuring brightness temperature when the antenna is torn from the skin. In this case, the touch sensors are triggered and give a signal to the computing device about the lack of contact. In this case, the ambient temperature is displayed on the meter indicator. The touch sensor can be implemented in various ways: a mechanical touch sensor, measurement of capacitance between the sensor and the skin, measurement of electrical potentials, etc. This design uses an optical touch sensor. An optical fiber and an ambient light sensor are installed near the aperture of the antenna. At the moment of touch, the light does not enter the light sensor and a trip occurs.

Next, methods of determining temperature changes in which the applicator antenna according to the invention can be used are described in more detail using an example of a method for detecting a high risk of cancer in a biological object.

Measurement Method

Attach the working surface of the applicator to the first (reference) point and simultaneously measure the skin temperature and brightness temperature at the reference point and specified points according to the measurement scheme. The pressure of the antenna applicator on the skin should not be excessively strong, but at the same time, the applicator should rest on the skin with the entire working surface. This must be monitored visually. The use of substances that improve the contact of the sensor with the skin, as it is used in ultrasound studies, is not necessary. The axis of the antenna applicator should be perpendicular to the skin surface, as the result of the study depends on the angle of the antenna applicator. Measurement data is stored in a computer.

Next, determine the temperature of the internal tissues at the reference and given points according to the following formula:

, где

where

T _int is the temperature of the internal tissues at the reference or given point,

T _br - brightness temperature at the reference or set point,

T _sk - skin temperature at a reference or a given point,

κ is a dimensionless coefficient characterizing the contribution of skin temperature to brightness temperature,

and determine the level of thermal activity of tissues D, characterizing thermal changes in the tissues of a biological object, according to the expression:

, где

where

D is the level of thermal activity of tissues,

C1 - weight coefficient

ΔT _i - increase in the temperature of internal tissues at given measurement points compared to the temperature of internal tissues at a reference point, determined by the following formula:

, где

where

T _i int - the temperature of the internal tissues at the i-th given point,

T _on int is the temperature of the internal tissues at the reference point,

T _i sk - skin temperature at the i-th given point,

T _on sk - skin temperature at the reference point,

CC2 - weight coefficient.

The parameter W, characterizing the risk of cancer, is determined on the basis of the level of thermal activity D and the ratio between the temperature of the internal tissues and the temperature of the skin, according to the expression:

, где

where

W is a parameter characterizing the risk of cancer,

D is the level of thermal activity of tissues,

LL is a parameter characterizing the difference between the temperature of internal tissues and the skin temperature of a biological object, equal to

and LD is a parameter characterizing the variance of the difference between the temperature of internal tissues and the skin temperature of a biological object, equal to

where U and UB are the experimental coefficients,

and determining a cancer risk by comparing a cancer risk parameter W with a threshold cancer risk level.

The experimental coefficients U and UB are chosen so that in patients with verified cancer the value of the parameter W is higher than the threshold level, and for patients who do not have cancer, the value of the parameter W is below the threshold level.

For paired organs of a biological object, when determining the level of thermal activity of tissues D, the value of the temperature difference at the measurement points of the right and left paired organ, determined by the following formula, is additionally taken into account:

где

Where

Tint _iprav - internal tissue temperature in i-right of the given point pair body,

Tint _ilev - the temperature of the internal tissues at the i-th given point of the left paired organ,

Tsk _irav - skin temperature at the i-th given point of the right paired organ,

Tsk _ilev - skin temperature at the i-th given point of the left paired organ,

CC3 - weight coefficient,

and the level of thermal activity of tissues D is defined as

, где

where

C1, C2 - weighting factors.

In the diagnosis of breast cancer, the examination is carried out from 6 to 12 days of the menstrual cycle. The temperature in the room where measurements are taken should be in the range of 20-25 ° C. Before starting the examination, the patient’s mammary glands should adapt to the ambient temperature within 7-10 minutes. The examination should be carried out before a palpation examination, mammography or ultrasound, since the latter have a strong influence on the temperature distribution of the mammary glands. During the examination, the patient lies on his back with his hands behind his head.

The working points in the examination of the mammary gland are the midpoints of the quadrants, the boundaries between the quadrants, the nipple region and the axillary regions (lymph nodes), and the reference point. The reference point is located in the center of the chest, 5 centimeters above the epigastric point. In total, measurements are usually taken at 21 points.

The brightness temperature, skin temperature and internal temperature are displayed in the form of thermograms and in the form of a temperature field.

On the thermogram, the temperature is displayed on the vertical axis, along the horizontal number of points. The temperature of the mammary gland can be displayed using various symbols, for example, the circle displays the temperature of the right breast, and the cross - the left. On the field, the internal temperature and skin temperature can be displayed using a color palette, for example, high temperatures are displayed in red, low temperatures in blue, and average breast temperature in yellow and green.

The value of the parameter of thermal activity of the tissue D, the parameter W and the boundary of the risk area are conveniently displayed on the graph separately for the right and separately for the left mammary glands.

The doctor, looking at this graph, sees how much the patient being examined is above or below the border of the risk area for each of the mammary glands.

The threshold risk level for cancer can be set experimentally. In one embodiment of the method of the invention, the threshold level of cancer risk, for example, is determined by calculating the threshold level G based on empirical data using the following formula:

, где

where

AA, b, CC - coefficients that depend on the diameter of the mammary gland and are presented in the table,

AA 0.7 0.6 0.7 b one 0.8 1.3 SS 1.45 1.35 1,1

.and X is a parameter that characterizes the increase in internal temperature compared with the "norm", which can be calculated by the following formula

.

The difference Δ = W-G characterizes the risk of malignancy. Positive values correspond to a high risk, negative values correspond to a low risk, and if the value of W for the examined patient is higher than the threshold, then the examined patient is at risk for breast cancer.

Clinical Examples

Example 1. Patient S. Age: 38 years.

ACTION COMPLAINTS: presence of compaction in the right mammary gland.

ANAMNESIS OF DISEASE: A seal in the right mammary gland was discovered independently in October this year. was examined in the outpatient clinic of the RSCR and with a diagnosis of fibrosclerosis of the right breast was hospitalized for surgical treatment.

CONDITION OF THE PATIENT: The position is active. General condition is satisfactory. The physique is correct. The food is satisfactory. The skin and visible mucous membranes are clean, normal in color. Lymph nodes of normal size. Musculoskeletal system without pathology. The thyroid gland is not enlarged. The mammary glands against the background of moderate mastopathy, on the right in the upper-outer quadrant, a seal with uneven, fuzzy contours, rounded in size up to 2.0 cm is determined. Peripheral l / nodes are not enlarged.

IN MAMMOGRAPHIES: against the background of moderate mastopathy, distinct nodules are not defined in the upper-outer quadrant on the right, however, ultrasound reveals a hypoechogenic formation of a heterogeneous structure, 13 * 11 mm in size, with anechogenic inclusions.

Clinical diagnosis: FIBROSCLERO3 RIGHT BREAST.

CYTOLOGICAL STUDY: cubic epithelium with proliferation and atypical hyperplasia of the D-3 type.

The patient is planned to undergo surgical treatment in the scope of sectoral resection of the right breast with an urgent histological examination.

The result of the expert system for Example 1 clinical use is shown in Fig. 18.

According to the clinical and radiological examination, the patient has a benign breast formation.

At the same time, the expert system showed that in the right mammary gland, the parameter W is higher than the threshold level, which indicates a high risk of breast cancer.

An urgent histological examination revealed the presence of infiltrative ductal carcinoma.

Conclusions: a histological examination confirmed the correctness of the radiothermometric conclusion about the high risk of breast cancer.

Example 2. Patient A. Age: 51 years.

COMPLAINTS ON ACCESS: formation of the right mammary gland.

Anamnesis of the disease: Seal noticed itself about 2 months ago. Turned for examination at the RSCR, where a clinical and radiological examination revealed fibrosclerosis of the right breast.

CONDITION OF THE PATIENT: The position is active. General condition is satisfactory. The physique is correct. The food is satisfactory. The skin and visible mucous membranes are clean, normal in color. Lymph nodes of normal size. Musculoskeletal system without pathology. The thyroid gland is not enlarged. The mammary glands are changed: on the right at the border of the upper quadrants, a tuberous formation of 3 * 4 cm is palpated.

When mammography on the right against the background of fat involution, the negative dynamics from 2003 in the form of the appearance on the border of the upper quadrants of the site of severity with the accumulation of microcalcifications.

With repeated punctures, including under the control of the Cytogight, cytological examination: cubic epithelium.

The result of the expert system for Example 2 clinical use is shown in Fig.19.

According to the cytology of cancer cells not detected.

The results of the expert system showed that in the right mammary gland, the parameter W is higher than the threshold level, which indicates a high risk of breast cancer.

With a preliminary diagnosis of fibrosclerosis of the right breast, the patient underwent surgical treatment - sectoral resection of the right breast. In an urgent histological examination, intraductal cancer.

Next, a wide sectoral resection of the right breast with axillary lymphadenectomy was performed.

Histological examination:

MICROSCOPIC DESCRIPTION: In the mammary gland (without a sector) in the area of operation, the foci of intraductal cancer have no signs of invasive growth. In the lymph nodes, moderate histiocytosis of the sinuses, lipomatosis, and cancer metastases were not detected.

The postoperative period without features. In a satisfactory condition, it is discharged under the supervision of a district oncologist. RT is recommended after complete healing of the wound, the solution of the issue of hormonal therapy after consultation with an oculist at the place of residence.

Conclusion: the results of a histological examination confirmed the conclusion of a radiothermometric study on the high risk of breast cancer.

Example 3. Patient G. Age: 61 years.

ACTION COMPLAINTS: on the presence of a seal in the left mammary gland.

Anamnesis of the disease: m / f has been observed since 2002 regarding mastopathy. Sent to the RSCD for consultation. An examination in the RSCR revealed a nodal component with a local accumulation of microcalcifications. Hospitalized for surgical treatment.

Clinical diagnosis: FIBROSCLERO3 LEFT BREAST.

CONDITION OF THE PATIENT: General condition is satisfactory. The skin and visible mucous membranes are clean, normal in color. Lymph nodes of normal size. In the upper-outer quadrant of the left mammary gland, a seal with fuzzy contours of up to 3 cm is palpated. Nodules are not palpated on the right.

With mammography: against the background of fibrotic mastopathy, on the right at the border of the upper quadrants, a section of the restructuring of the structure with an accumulation of microcalcifications is determined. Result of targeted biopsy: Fibrous adipose tissue.

OPERATION: sectoral resection of the left breast.

The postoperative period without features.

Histological examination: fibrosis, simple ductal hyperplasia, papillomatosis.

In satisfactory condition, the patient is discharged from the surgical clinic under the supervision of a surgeon at the place of residence.

The result of the expert system for Example 3 clinical use is shown in Fig.20.

The results of the expert system showed that the parameter W is below the threshold, which indicates a low risk of breast cancer. This was confirmed by a histological conclusion.

Conclusions: The results of the histological conclusion confirmed the conclusions of the radiothermometric conclusion about the benign nature of education.

The practical implementation of the other claimed methods is similar to that described above.

Thus, the use of the applicator antenna according to the invention and various methods using it, such as a method for determining temperature changes in internal tissues, a method for determining temperature changes in internal tissues over time, a method for detecting a high risk of a cancer in a biological object, in particular a high risk of breast cancer , can be effectively used for monitoring and non-invasive diagnostics for early detection of cancer and other pathologies of internal organs, in particular for the early diagnosis of breast cancer.

Claims (22)

1. An antenna applicator for determining temperature changes in the internal tissues of a biological object, comprising: a waveguide segment partially or completely filled with a dielectric, having one closed end and an opposite open end in contact with the biological object,
an electromagnetic wave excitation system located in the waveguide between the closed end of the waveguide and the dielectric, connected to the input part of the microwave radio thermometer, a shielded skin temperature sensor located at the open end of the waveguide, configured to transmit information to a computing device. 2. The antenna applicator according to claim 1, characterized in that the skin temperature sensor is connected to the computing device by conductors located orthogonal to the electric field vector of the antenna applicator. 3. The antenna applicator according to claim 1, characterized in that it comprises a contact shielded temperature sensor located at the open end of the waveguide in contact with the biological object. 4. The antenna applicator according to claim 1, characterized in that it contains an infrared shielded skin temperature sensor located inside the length of the waveguide at a distance from the open end of the waveguide with a gap between the infrared temperature sensor and the biological object. 5. The antenna applicator according to claim 1, characterized in that it further comprises a low pass filter at the output of the skin temperature sensor. 6. The antenna applicator according to claim 1, characterized in that it further comprises a metallized flange located at a distance from the open end of the waveguide. 7. The antenna applicator according to claim 1, characterized in that it further comprises a dielectric plate partially or completely made of material that transmits near-infrared waves located at the open end of the waveguide segment, and between the dielectric plate and the dielectric filling the waveguide, there is a gap filled with air or other dielectric material with low thermal conductivity, low dielectric constant and transmitting infrared waves. 8. The antenna applicator according to claim 1, characterized in that it further comprises a heating system. 9. The antenna applicator according to claim 1, characterized in that it contains one or more series-connected segments of the waveguide having a different cross section. 10. The antenna applicator according to claim 1, characterized in that it contains one or more series-connected segments of a circular waveguide having different cross-sections. 11. The applicator antenna according to claim 1, characterized in that it contains one or more series-connected segments of the internal waveguide and located outside the internal waveguide of one or more segments of the external waveguide, the gap between the segments of the internal and external waveguides partially or completely filled with a dielectric . 12. The applicator antenna according to any one of claims 1 to 11, characterized in that a matching element is applied to the dielectric from the open end of the waveguide by metallization, which enables the use of an applicator antenna for fabrics with different dielectric constants. 13. The antenna applicator according to any one of claims 1 to 11, characterized in that it is additionally equipped with a temperature sensor that measures the temperature of the antenna applicator and transmits information to the computing device. 14. The antenna applicator according to any one of claims 1 to 11, characterized in that it further comprises a sensor for measuring the temperature of the skin temperature sensor located on the body of the skin temperature sensor, measuring the temperature of the sensor body and transmitting information to the computing device. 15. A device for determining temperature changes in the internal tissues of a biological object, including:
an applicator antenna comprising:
a waveguide segment partially or completely filled with a dielectric having one closed end and an opposite open end in contact with a biological object,
an electromagnetic wave excitation system located in the waveguide between the closed end of the waveguide and the dielectric, connected to the input part of the microwave radiometer,
a shielded skin temperature sensor located at the open end of the waveguide, configured to transmit information to a computing device;
microwave radio thermometer, measuring the intensity of the signal coming from the output of the antenna, which is proportional to the brightness temperature of the tissues of the biological object; and
a computing device configured to receive information from a skin temperature sensor and from a microwave radio thermometer and detect changes in the temperature of internal tissues. 16. The device according to p. 15, characterized in that it contains an antenna applicator, made according to any one of claims 2-14. 17. The device according to p. 15, characterized in that it further comprises a display means. 18. A method for determining temperature changes in internal tissues, including:
simultaneous measurement of brightness temperature and skin temperature at the first point of a biological object,
determination of the temperature of internal tissues at the first point according to the following formula:

where T _intt1 is the temperature of the internal tissues at the first point,
T _br1 - brightness temperature at the first point,
T _sk1 - skin temperature at the first point,
K is a dimensionless coefficient characterizing the contribution of skin temperature to brightness temperature,
simultaneous measurement of brightness temperature and skin temperature at the second point of a biological object,
determination of the temperature of internal tissues at the second point according to the following formula:

where T _intt2 is the temperature of the internal tissues at the second point,
T _br2 - brightness temperature at the second point,
T _sk2 - skin temperature at the second point,
K is a dimensionless coefficient characterizing the contribution of skin temperature to brightness temperature,
assessment of changes in the temperature of internal tissues by the formula:

19. A method for determining temperature changes in internal tissues over time, including:
simultaneous measurement of brightness temperature and skin temperature at a given point of a biological object at the first moment of time,
determination of the temperature of internal tissues at the first moment of time according to the following formula:

where T _intt1 is the temperature of the internal tissues at the first moment of time,
T _brt1 - brightness temperature at the first moment of time,
T _skt1 - skin temperature at the first moment of time,
κ is a dimensionless coefficient characterizing the contribution of skin temperature to brightness temperature,
simultaneous measurement of brightness temperature and skin temperature at the same point of a biological object in the subsequent second moment of time,
determination of the temperature of internal tissues at the second point in time according to the following formula:

where T _intt2 is the temperature of the internal tissues at the second instant of time,
T _brt2 - brightness temperature at the second moment of time,
T _skt2 - skin temperature at the second point in time,
κ is a dimensionless coefficient characterizing the contribution of skin temperature to brightness temperature,
an estimate of the temperature change of internal tissues over time using the following formula:

20. A method for detecting a cancer risk in a biological object, comprising: simultaneously measuring the brightness temperature of the biological object and the skin temperature of the biological object in at least one reference point,
simultaneous measurement of the brightness temperature of a biological object and the skin temperature of a biological object at specified points,
determination of the temperature of internal tissues at reference and given points according to the following formula:

where T _intt is the temperature of the internal tissues at the reference or given point,
T _br - brightness temperature at the reference or set point,
T _sk - skin temperature at a reference or a given point,
κ is a dimensionless coefficient characterizing the contribution of skin temperature to brightness temperature,
determination of the level of thermal activity of tissues D, characterizing thermal changes in the tissues of a biological object, according to the expression:

,
where D is the level of thermal activity of tissues,
ΔT _i - increase in the temperature of internal tissues at given measurement points compared to the temperature of internal tissues at a reference point, determined by the following formula:

where T _i int is the temperature of the internal tissues at the i-th given point,
T _on int is the temperature of the internal tissues at the reference point,
T _i sk - skin temperature at the i-th given point,
T _on sk - skin temperature at the reference point,
determination of the parameter W, which characterizes the risk of cancer based on the level of thermal activity of tissues D and the relationship between the temperature of internal tissues and skin temperature, according to the expression

,
where W is the parameter characterizing the risk of cancer,
D is the level of thermal activity of tissues,
LL is a parameter characterizing the difference between the temperature of internal tissues and the skin temperature of a biological object, equal to

and LD is a parameter characterizing the variance of the difference between the temperature of internal tissues and the skin temperature of a biological object, equal to

where U and UB are the experimental coefficients,
and determining a cancer risk by comparing a cancer risk parameter W with a threshold cancer risk level. 21. The method according to claim 20, characterized in that for the paired organs of a biological object, when determining the level of thermal activity of tissues D, the value DT _{i of the} temperature difference at the measurement points of the right and left paired organ is additionally taken into account, determined by the following formula:

where Tint is _right - the temperature of the internal tissues at the i-th given point of the right paired organ,
Tint _ilev - the temperature of the internal tissues at the i-th given point of the left paired organ,
Tsk _irav - skin temperature at the i-th given point of the right paired organ,
Tsk _ilev - skin temperature at the i-th given point of the left paired organ, and the level of thermal activity of tissues D is determined as

,
where ΔT _i is the increase in the temperature of internal tissues at given measurement points compared to the temperature of internal tissues at a reference point,
DT _i is the temperature difference at the measurement points of the right and left paired organ. 22. A method for identifying a risk of breast cancer in a biological subject, comprising
simultaneous measurement of the brightness temperature of the biological object and the skin temperature of the biological object in at least one reference point,
simultaneous measurement of the brightness temperature of the breast of a biological object and the skin temperature of the breast of a biological object at specified points,
determination of the temperature of internal tissues in the reference and given points of the mammary gland according to the following formula:

where T _int is the temperature of the internal tissues in the reference or given point of the mammary gland,
T _br is the brightness temperature at the reference or predetermined point of the mammary gland,
T _sk - skin temperature at the reference or given point of the mammary gland,
κ is a dimensionless coefficient characterizing the contribution of skin temperature to brightness temperature,
determination of the level of thermal activity of tissues D, characterizing thermal changes in breast tissue, according to the expression:

where D is the level of thermal activity of breast tissue,
ΔT _i is the increase in temperature of internal tissues at predetermined points of the mammary gland compared to the temperature at the reference point, determined by the following formula:

where T _i int is the temperature of the internal tissues at the i-th given point of the mammary gland,
T _on int - the temperature of the internal tissues at the reference point of the mammary gland,
T _i sk - skin temperature at the i-th given point of the mammary gland,
T _on sk - skin temperature at the reference point of the mammary gland,
DT _i is the value of the temperature difference between the right and left mammary glands at given points, determined by the following formula:

where Tint is _right - the temperature of the internal tissues at the i-th given point of the right breast,
Tint _ilev - temperature of internal tissues at the i-th given point of the left breast,
Tsk _irav - skin temperature at the i-th given point of the right breast,
Tsk _ilev - skin temperature at the ith given point of the left breast, determining the parameter W, which characterizes the risk of cancer based on the level of thermal activity of tissues D and the relationship between the temperature of internal tissues and the temperature of the skin of the breast, according to the expression

,
where W is the parameter characterizing the risk of cancer,
D is the level of thermal activity of breast tissue,
LL is a parameter characterizing the difference between the temperature of internal tissues and the temperature of the skin of the breast, equal to

and LD is a parameter characterizing the variance of the difference between the temperature of the internal tissues and the temperature of the skin of the breast, equal to

where U and UD are the experimental coefficients,
and determining a cancer risk by comparing a cancer risk parameter W with a threshold cancer risk level.

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