RU2622362C2 - Method for semi-automatic diagnosis of breast pathologies - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: stationary gradient field of mammary glands skin temperature is scanned by a contact temperature sensor of the "Volumetric Thermal Diagraph" device (VTD) through the holes in an elastic mask. The obtained results are processed by comparing the data obtained during scanning with the data obtained as a result of statistical processing of control groups of patients with normal state, fibrocystic mastopathy of the left and right mammary glands, and right and left mammary glands cancer. The comparison data are output to the computer screen in the form of an epicrisis. The following parameters are taken into account in the diagnosis: the distance from the isothermal poles to the tumour center in percent relative to the mammary gland radius, the angle of isothermal poles deviation from the horizontal line, the depth of isothermal poles along the normal line to the mammary gland skin surface, the temperature in the tumor center, the ratio of tumour projection are to the mammary gland area on thermograms.

EFFECT: method provides diagnostics of benign and malignant mammary gland formations.

3 cl, 7 dwg

Description

The present invention relates to medicine and is intended for semi-automatic diagnosis of a number of pathologies of the mammary glands.

Known methods for diagnosing pathologies in the mammary glands. They, as a rule, are aimed at identifying pathologies of various types inside them and are based on the use of: X-ray, ultrasound, thermal imaging, as well as thermal contact diagnostic methods. These known methods have a number of significant drawbacks: X-ray and ultrasound methods are associated with the harmful effects of radiation on the mammary glands and at the same time do not give information about the nature of the detected pathology (see, for example, LM Klyukin. Device for the clinical diagnosis of a biological object. RF patent № 2267982 dated January 20, 2006 with priority dated September 15, 2003). In addition, they discriminate against women by age of examination, starting at age 40, although breast pathologies also occur at an earlier age.

A safe thermal imaging method for examining the mammary glands is also known, but it provides the diagnosis of pathologies in them only if they are close to the surface of the skin and has too much error of the cover. In addition, due to the large error reaching more than 2 degrees C, there is no possibility of early recognition of a pathology that does not allow their early recognition (see, for example, Klyukin L.M. Screening and monitoring of tumor neoplasms using the diagnostic method contact thermography. Medical equipment, No. 3, 2010, p. 7-12).

There is also a method for diagnosing mammary glands, by forming a network of points on the mammary glands where the skin temperature is measured by the contact dynamic method through holes in an elastic mask, the numbers of which specify the scanning sequence (see, Klukin L. M. Method and device for temperature diagnostics of bioobject pathologies. US Pat. US 7, 214, 194 B2 dated May 8, 2007 with priority dated January 8, 2002). This method has a much greater sensitivity - up to 0.01 degrees C. This patent can be considered as a prototype of this application.

The disadvantages of this method are:

1. The limitation of the method for diagnosing only breast cancer.

2. The inability to diagnose benign diseases that are the precursors of oncology.

This patent is the closest analogue (prototype) of the proposed method.

The illustrations necessary to describe the proposed method for the semi-automatic diagnosis of pathologies of diseases in the mammary glands that implements the proposed method are shown in figures 1-7.

In FIG. 1. The numbers indicate: 1 - patient; 2 - the central screed of elastic masks; 3 - the location of the Central hole for the nipple of the breast; 4 - numbered holes on the mask; 5 - elastic removable mask, 6 - frame; 7 - back tie for attaching the frame.

In FIG. 2. shows a sample thermogram obtained for one of the three most significant and verified breast nosologies (left or right). The numbers denote: the poles of the selected zones sequentially from the left and right mammary glands, indicated by cross marks and numbers. 7, 8, 10 — centers of the poles of the isotherms of the right mammary gland; 13, 14, 15 - poles of the isotherms of the left breast; 9 is a table of the two-dimensional coordinates indicated in FIG. 2 centers of the poles of both mammary glands; 11 - an indication of the dislocation of the detected tumor on the corresponding gland; 12 - number of coordinates on the same iron; 16 - temperature in the tumor.

In FIG. 3. The table is shown in more detail (9th position in Fig. 2.), obtained as a result of processing the survey data and given in the same thermogram, on which the four-coordinate parameters of the selected zones are marked. The numbers indicate: 17 - numbering in order of poles; 18 - for the left gland; 19 - for the right gland; 20 - distance from the pole to the center of the tumor relative to the radius of the mammary gland (in%), 21 - angle of deviation from the horizontal of the isotherms corresponding to the poles (counterclockwise); 22 - isotherm pole depth normal to the surface of the skin of the chest; 23 - temperature in the center of the tumor; 24 is the ratio of the area of the projection of the tumor relative to the area of the mammary gland in the thermogram (in%).

In FIG. Figure 4 shows typical forms that provide an assessment of the risk of cancer of the breast cancer, verified on a large statistical material. The numbers indicate: 25 - "wedge"; 26 - "rose"; 27 - the ellipse.

In FIG. Figure 5 shows the verified results obtained in the clinic by computer processing of data (according to parameters 18-24 in Fig. 3) for 5 basic epicrisis for the most important nosologies for both mammary glands, including the norm, benign tumors and breast cancer. The numbers denote: 28 - the mammary glands are normal; 29 - fibrocystic mastopathy of the left breast; 30 - fibrocystic mastopathy of the right breast; 31 - cancer of the right breast; 32 - cancer of the left breast.

In FIG. Figure 6 shows the first recently discovered by the author effect, consisting in the presence of a periodic (about 20 minutes) thermal field in the mammary glands (L. Klyukin. The influence of spatially dynamic processes of blood supply to the female mammary glands on preclinical cancer diagnosis by scanning contact thermography. Science and Technological Developments of Russia, 2014, vol. 93, No. 4, pp. 3-16; LMKlukin, VANamiot, Regular Thermal Waves in Mammary Gland Tissues, Biophysics, 2015, Vol.60, No.l, pp.138-139) . Numbers 33-37 in FIG. 6, respectively, the phases of dynamic processes are shown.

In FIG. 7 shows a sample thermogram on which, after computer processing of the data 21-24 of the table, FIG. 3 received the coordinates of the tumor. The numbers in FIG. 7 shows: 38 - the area of the tumor, 39 - the right mammary gland, 40 - the left mammary gland.

The technical result of the proposed method is achieved by the fact that, as the first step, information is entered into the computer from the head of the DOT device (L. M. Klyukin. Screening and monitoring of tumor neoplasms using the method of diagnostic contact thermography. Medical equipment, No. 3, pp. 7-12 , 2010). After standard treatment of the skin of the mammary glands, the patient 1 is dressed, with the help of screeds 2-6 replaceable masks 5, on the mammary glands, in which there are regular holes 4 through which the temperature of the breast and the holes 3 for the nipple of the breast are diagnosed. After examining the skin temperature in the holes 4 and conducting it in both mammary glands, if they do not have skin diseases or the absence of one of them (as a result of a mastectomy), the data obtained by the DOT head are entered into the computer, where the examination results processing program is installed in advance . As a result of the implementation of the computer program, a corresponding thermogram of one or both mammary glands is observed on the computer monitor, as shown in FIG. 2. On this thermogram, the coordinates of the poles of the isotherm families and the regions in which these centers are located are highlighted. They are highlighted in red or blue on the thermogram, the saturation of which depends on the gradient values of temperature in the region. The temperature values in the centers are given relative to the average temperature of the mammary gland, taken as the zero level at which there is no color. These poles are indicated on the thermogram by the numbers 7, 8, 10, 13, 14 and 15.

On the same thermogram, figure 9 indicates a table in which there are two-dimensional coordinates of the poles and the values of a number of parameters obtained during the examination, in addition to the coordinates (temperature and area). In addition, under the number 11 is given the observed form characteristic of a cancer tumor, under the number 12 is given the name of this form and under the number 16 is the temperature in the center of the tumor.

In more detail, table 9 shown in FIG. 2 for a given thermogram is shown in FIG. 3. The numbers 17 indicate the numbers of the mentioned isotherm poles, the numbers 18 indicate the locations on which mammary gland these poles are located (left breast). The number 19 indicates the same thing, but on the right chest, the numbers 20 indicate the distance of the poles from the center of the thermogram along the radius of the thermogram in%. The numbers 21 give the angular coordinates of the poles, relative to the horizontal, which is the line connecting the two nipples of the mammary glands or, if one of them is missing, taking into account the bilaterality of the nipples. The number 22 gives the values of the third coordinate - the depth of the location of the tumor centers, taken normal to the skin of the mammary gland. The number 23 indicates the gradient values in the centers of tumor formations. The number 24 indicates the ratio of the area of the projection of the tumor relative to the area of the skin of the mammary gland (in%).

In FIG. 4. The forms characteristic of tumor neoplasms such as breast cancer (BC) are shown. (According to the User Manual of DOT, the presence of these forms implies the inclusion of patients in the risk zone for breast cancer, followed by monitoring, since DOT provides complete safety with frequent examination. In the case of uncontrolled growth, a biopsy is taken on the malignancy of tumors).

In FIG. 5, according to the table obtained from FIG. 3, the three-dimensional coordinates of the tumor centers and the temperatures in them are plotted along the ordinate axis for each of the examined group of patients with verified nosology and the values on parameters coordinate 20-24 are marked on the coordinate axis. On the abscissa axis, the numbers of patients in each group are 28-31.

However, as can be seen from FIG. 6, changes are possible in thermograms associated with a cyclic change in the thermal field (a new discovered factor associated with a periodic change in blood supply in the mammary glands). Accordingly, the exemplary paintings in FIG. 4 for breast cancer and benign tumors can be masked by changing blood supply.

In FIG. 5 shows the difference in types of nosology obtained on the basis of statistical data processing for the indicated nosologies of differences. The numbers indicate: normal - 28, fibrocystic mastopathy (FCM) of the left breast - 29, FCM of the right breast - 30, breast cancer of the left breast - 31 and breast cancer of the right breast - 32.

Statistical data 28-32 (Fig. 5) was obtained as a result of processing groups of patients with verified nosology 28-32. Moreover, we chose FCM nosology due to the fact that in practice it prevails as a precursor of breast cancer (S. M. Demidov, D. A. Demidov, S. V. Sazonov, “Diagnosis and treatment of precancerous diseases of the breast”, 2014 , LAP; 220 pp .; GP Korzhenkova “Improving the diagnosis of breast cancer in the context of a mass mammographic examination of the female population.” Abstract for the degree of doctor of medical sciences, 08.07.2013).

The proposed method is implemented as follows.

The well-known procedures for preparing a patient for examination, mentioned above, are implemented on it using an autonomous DOT head, after which data from the head are entered into a computer where the program previously used to obtain a thermogram of the form shown in FIG. 2.

In this application, taking into account the new discovered effect, masking the tumor forms of oncology (Fig. 4), a new diagnostic method is proposed in relation to the prototype, which consists not only in the examination, highlighting the typical form of the tumor, as well as the temperature in its center. After that, an algorithm is used based on the statistical processing of differences in the spectrum of tumor nosologies: FCM of the left, PCM of the right mammary glands and norm, as well as breast cancer of the left and breast cancer in the right mammary gland. For greater reliability, the proposed method takes into account the effect of temperature waves in the mammary gland (Fig. 6), the diagnosis should either be repeated after the above time, and then use monitoring in accordance with the cycle of menstruation. Or, at the discretion of the doctor, while maintaining the coordinates of the pole and the temperature characteristic of breast cancer, the patient should undergo a biopsy, after which a medical epicrisis is given about the type of type of disease being observed and appropriate therapy is carried out, corrected by subsequent monitoring. In the future, if malignancy is confirmed by taking a histological sample from this tumor, the doctor should refer the patient for a mastectomy.

As an example, confirming the effectiveness of this technology in FIG. 7, the finding of breast cancer in patient M., 56 years of age, is shown by signs of temperature and three-dimensional coordinates, in which a mastectomy was performed to confirm this finding (upper and lower outer quadrants).

The prognostic value of the information provided by DOT was previously investigated in a number of clinics in Moscow, as directed by the Russian Ministry of Health, and reflected in “Permission to use new medical technology”, FS No. 2010/258 of July 1, 2010. They showed that when using the DOT apparatus, no false positive and false negative results were recorded.

The proposed method for the semi-automatic diagnosis of pathologies of the mammary glands can provide differential diagnosis of the norm, FCM and breast cancer in any of the bilateral mammary glands. The particular significance of this application lies in the fact that the proposed technology can easily be used for widespread prophylaxis of not only breast cancer, but also FCM, as the predecessor of breast cancer.

Claims (3)

1. A method for diagnosing breast pathology, including scanning a stationary gradient field of the temperature of the skin of the mammary glands with a contact temperature sensor of the “Diagram volumetric thermal” (DOT) device through openings in an elastic mask, processing the results by comparing the data obtained during scanning with the data obtained in the result of the statistical processing of control groups of patients with normal fibrocystic mastopathy of the left and right mammary glands, cancer of the right and left mammary glands, display computer comparison data in the form of an epicrisis, characterized in that the following indicators are taken into account during diagnosis: the distance from the poles of the isotherms to the center of the tumor as a percentage of the radius of the mammary gland, the angle of deviation of the poles of the isotherms relative to the horizontal, the depth of the poles of the isotherms normal to the surface of the breast skin, temperature in the center of the tumor, the ratio of the area of the projection of the tumor to the area of the mammary gland in thermograms.   2. The method according to claim 1, characterized in that after a predetermined time interval, the examination and comparison are repeated.   3. The method according to claim 1 or 2, characterized in that it is used to monitor the adequacy of therapy.

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