The way to recognize the type of tissue and the apparatus for implementing the method

 

(57) Abstract:

The invention relates to medicine and can be used to diagnose as the outer surface of the skin and internal organs, for example for the diagnosis of cervical cancer. The described method and device for recognition of tissue, which is assumed to be physiological changes in the precancerous or cancerous condition. The device comprises a probe configured to contact tissue and includes a device for influencing the fabric by a variety of stimuli, such as electrical, light, heat, sound, magnetic, and determination of many physical responses to these stimuli. The probe is connected to the analog block, which serves as a buffer for signals between the probe and the processor. To classify tissue processor processes the responses in certain combinations and then to recognize tissues compares classified cloth with a catalogue of the expected types of fabrics. The process occurs in real time, and the type of fabric is indicated to the operator. The technical result of the invention is to improve the efficiency for the diagnosis bolitoglossa to a method and device for the diagnosis of various types of fabrics, including cancer, precancerous, pathological, and tissues in the intermediate state.

Diagnosis of different types of fabrics is carried out through a series of measurements of their physical properties.

The present invention relates, in particular, to diagnose these types of fabrics, as the outer surface of the skin, as well as those that can be investigated using endoscopic tools to penetrate directly into the body.

A special application of the present invention associated with a diagnosis of cervical cancer.

Early detection of cancerous or pre-cancerous state of the tissue is very important for successful treatment. Currently used diagnostic technique has a low accuracy depends on operator error and is time consuming.

A good example of this is the way to diagnose cervical cancer through the study sample according to the Papanicolaou (Pap Smear test).

X-ray analysis, which can also be used for the diagnosis of progressive cancers, is associated with harmful radiation.

A positive result obtained with PAP tests, usually resistivity is ravemix areas of the cervix is performed by an experienced doctor, who gives a subjective conclusion about the state of the examined tissue.

The cervix consists of many types of fabrics, some of which are very similar and have similar visual and structural characteristics. This significantly complicates the clinical diagnosis and leads to errors.

The above-mentioned subjective error plays a big role in the definition and treatment of other localizations of precancerous and tumor entities, such as melanoma.

To distinguish cancerous tissue from normal work was done on creating methods and devices based on measuring the physical characteristics of the tissue. The operation of this device is based on measuring the electrical parameters of the skin or tissue. However, such electrical measurements do not provide the information necessary for effective diagnosis.

In U.S. patent N 4,537,203 described device for determining the abnormal cells with two electrodes connected to the body.

Two voltage at different frequencies are applied to the two electrodes. The capacitance value measured at two frequencies, indicates the presence of abnormal cells.

In the U.S. patent of 4.9 N is ly the surface of the skin is measured using an electrode matrix. In U.S. patent N 5,143,079 described device for determining a tumor tissue. The device contains means for determining the dielectric constant of the living human tissue. Surface resistivity depends on the dielectric constant and conductivity of the tissue. Resistance changes associated with the heterogeneity of the tissue.

Also is known about the measurement of the physical characteristics of the tissue by optical methods. An example is the device described in U.S. patent N 5,036,853. This device is intended for detection of cervical tissue, which is assumed to be the physiological changes caused by the tumor or precancerous condition. In the described device to prevent incorrect measurements required to ensure the correct position of the probe relative to the surface of the cervix. As follows from the patent, the device is not provided with means to insure the proper installation of the probe.

A known method for the diagnosis of precancerous or cancerous state of the tissue, including the impact on the fabric energy stimuli, determining the response of the tissue at each energy stimulus, representing modificirovannye USA N 5042494).

In this patent disclosed a device for detection of precancerous or cancerous state of the tissue, containing a single probe for impact on the fabric energy stimuli-sensitive elements, each of which is made with the possibility of perception of the response of the tissue at the corresponding energy stimulus, which represents an energy response signal, the controller connected to the sensors for receiving such feedback tissue, and containing a processor for processing these responses fabric and comparison of the results obtained, and the block of memory.

Then, from the U.S. patent N 5042494 known method for the diagnosis of precancerous or cancerous state of the tissue, including the impact on the fabric of the stimulus in terms of its exposure to electromagnetic radiation of multiple wavelengths, with subsequent processing of the responses of the tissue to electromagnetic radiation representing diffuse tissue radiation response, and analysis of the treated tissue responses.

Finally, this patent a device for detection of precancerous or cancerous state of the tissue containing the source of electromagnetic radiation, made with the possibility of exposure t is for transmitting electromagnetic radiation to the tissue and receiving scattered its radiation on the respective at least two different wavelengths, the receiving device is connected to the probe, and a comparator for comparing the responses of the tissue to electromagnetic radiation representing diffuse tissue radiation response, with known values.

The above methods and devices have drawbacks. In particular, each of these methods and devices intended for diagnosis in relation to a particular kind of cancer that is presented to the physician in idealized conditions. Therefore, such methods and devices may not be used effectively for a large number of varieties of fabrics and cancer, such as cervical, skin, colon and so on, and are difficult to detect cancer in the aforementioned places.

The present invention is the task of creating a method for the diagnosis of precancerous or cancerous state of the tissue, which is due to the choice of certain stimuli fabric allows you to quickly make an objective recognition of tissue types, including both cancerous and precancerous education, in relation to various locations both inside and in other places of living substances, as well as the task of creating a device for implementing the method.

This task soglasna fabric, including the impact on the fabric energy stimuli, determining the response of the tissue at each energy stimulus representing a modified tissue response energy signals, processing of tissue responses, and analysis of the treated tissue responses, which, according to the invention, the tissue is affected by at least two stimuli, the processing of feedback tissue exercise through their combined processing for tissue classification, and analysis of the treated tissue responses performed by comparing the obtained classification of the tissue with a known classifier expected tissue types for its recognition.

Preferably stimuli are selected from the group consisting of sources of electrical energy, a source of light energy, the sources of acoustic energy, sources of magnetic energy and sources of thermal energy.

It is advisable that at least one of the stimuli were chosen from a group containing energy sources, generating continuous irritation of the signal pulse-modulated irritant signal, frequency-modulated irritant signal, fazokodirovannymi irritant signal and the amplitude-estables a light energy source, generating a sequence of sets of pulsed light signals, each of which has its spectral bandwidth, and the sequence was repeated with the ability to essentially simultaneous receipt of the corresponding response of the tissue.

It is possible to process each response was carried out by one or more specific processing steps of obtaining one or each step of the processing, and if there are multiple processing steps each processing result of the combined set method for classifying tissue.

It is useful that the number of processing steps was greater than the number of the used stimuli by an amount equal to 1.

Preferably, as the stimuli used sources of electrical energy and the sources of light energy, allowing you to get eight processing results.

It is advisable that the processing results are combined through a weighted summation with a preset weight coefficient for each of the processing based on the tissue types in the classifier and on the compliance of each of the processing classifier.

It is desirable that the neural networks.

It is possible that the classifier is expected tissue types were created by cross-matching investigated manually and classified pathological methods samples of recognized types of fabrics treated with the responses of tissue samples taken at the impact on the fabric of the stimuli and the combined processing of tissue responses to each stimulus.

It is useful to have studied one or more types of tissue of the cervix, breast, skin, prostate, or colon.

Preferably, the combined treatment and comparison classified tissue classifier produced in real time, and use statistical metopes comparing the classified tissue classifier.

It is advisable that investigated the tissue that is part of a living organism.

It is desirable that as the stimuli used, at least, the sources of electrical energy and the sources of magnetic energy, and combined treatment response tissue was performed by processing the amplitude response, frequency response, absolute amplitude determination, phase response, spectral response, response p is="ptx2">

It is possible that the stimuli used, at least, the sources of light energy, and combined treatment response tissue was performed by processing the amplitude response, spectral response or spatial response.

It is useful to have as the stimuli used, at least, the sources of acoustic energy, and combined treatment response tissue was performed by processing the amplitude response, phase response, and frequency response.

This task, according to a further aspect of the invention is solved by a device for detection of precancerous or cancerous state of the tissue, containing a single probe for impact on the fabric energy stimuli-sensitive elements, each of which is made with the possibility of perception of the response of the tissue at the corresponding energy stimulus, which represents an energy response signal, the controller connected to the sensors for receiving such feedback tissue, and containing a processor for processing these responses fabric and comparison of the results obtained, and the memory block, in which, according to izobretalnosti store known classifier expected tissue types, the processor is made with the possibility of the combined treatment of tissue responses to each stimulus for tissue classification and comparison of the obtained classification of the tissue with a known classifier expected tissue types for its recognition.

Preferably, the controller includes an indicator for indicating to a user the type of recognizable tissue.

It is advisable that a single probe was controlled by the operator of the probe for contact with the tissue, and the probe were built energy sources and sensors for studies of tissue within or on the outer surface of a living organism.

It is desirable that the controller contains a means of identification of deciding probe irritation to the tissue for recording in digital form each use of the probe and to automatically limit the number of repeated its uses.

This task, according to another aspect of the invention, is solved by a device for detection of precancerous or cancerous state of the tissue containing the source of electromagnetic radiation configured to irradiate the tissue with electromagnetic radiation of at least two different dlego its radiation on the respective at least two different wavelengths, a receiving device that is connected to the probe and a comparator for comparing the responses of the tissue to electromagnetic radiation representing diffuse tissue radiation response, with known values, which, according to the invention, the probe comprises at least one electrode for application of electrical signals to the tissue and the corresponding electrical measurement means for measuring the resulting response of the tissue to electrical signals, and a comparator configured to compare the responses of the tissue to electromagnetic radiation fabric and the resulting tissue response to electric signals with the corresponding known values to identify the tissue type.

This task, according to the last aspect of the invention, is solved by a method for the diagnosis of precancerous or cancerous state of the tissue, including the impact on the fabric of the stimulus in terms of its exposure to electromagnetic radiation of multiple wavelengths, with subsequent processing of the responses of the tissue to electromagnetic radiation representing diffuse tissue radiation response, and analysis of the treated tissue responses, which, according to the invention, electromagnetically with the measurement result of the response of tissue to electrical signals, combined handle the response of the tissue to electromagnetic radiation and the resulting tissue response to electrical signals, and diagnostic analysis of the tissue is carried out by comparing the treated tissue responses in advance with the expected response of the tissue.

Preferably, on the basis of the combined treatment responses fabric exercised for the classification and compared the classification of the tissue with the existing classifier expected tissue types to identify it.

It should be noted that in those cases, when the term "wavelength" is used in connection with a source of electromagnetic radiation, the bandwidth of such a source should be limited.

You should also pay attention to the fact that the radiation backscatter includes radiation due to reflection.

Embodiments of the present invention will be described with reference to the following drawings:

Fig. 1 illustrates a section of one of the variants of the design of the probe;

Fig. 2 is a schematic illustration of a first variant implementation of the probe;

Fig. 3 is a schematic illustration of a second variant implementation of the probe;

Fig. 4 is a graph of a sequence, the sequence of electrical pulses, used in the embodiment shown in Fig. 3;

Fig. 6 is a block diagram of the detection system of one of embodiments of the invention;

Fig. 7 is an example graphical representation showing a group of tissue types as a function of the three discriminant, the resulting electrical and optical measurements;

Fig. 8 illustrates the use of a variant of implementation of the probe designed for the detection of precancerous lesions of the cervix;

Fig. 9 illustrates another variant of implementation of the probe designed for the detection of skin cancer or like him;

Fig. 10 is a view in isometric partial section of another variant embodiment of the invention for the detection of skin cancer or like him;

Fig. 11 is a side view of an optical sensor including a spherical refracting head;

Fig. 12 is a view of another variant implementation, which includes ultrasonic transducers;

Fig. 13A and 13B is a rear view and a side view of a variant of implementation of the probe, which contains thermal and optical stimulants;

Fig. 14A and 14B rear view and side view of a variant of implementation of the probe, which contains electrical, optical and magnetic stimulators;

Fig. 15 and 16 Il is trojstva for calibration of the probe;

Fig. 18 is a block diagram of the preferred alternative implementation of the apparatus for detection.

The cancer detection using optical sensing is to display the analyzed tissue on the matrix of sensors. This method has several limitations.

First, upon detection of cancer passing through the fabric and scattering tissue and adjacent areas is more important than the reflection from the surface of the fabric. Sensors as optical image initially respond to the reflection from the surface of the fabric.

Secondly, identifiable image depends on the relative influence of a number of characteristics of the state of tissue, such as reflectivity, emissivity, reflection, liquid on the surface and the ambient lighting.

Thirdly, the optical signal passed by each picture element of the matrix sensor, is decomposed in the chamber only a few spectral regions corresponding to red, green and blue (R, G) radiation.

Fourth, it is physically impossible to do simultaneously, electrical, magnetic or acoustic measurements for each of the design element of the fabric. Is that stuff in the field.

In addition to the stated note that the study area is not always enough available for illumination and detection using an instrument such as a camera.

When the tissue is examined with the naked eye or with the formation of the image, the picture that we see is light that is reflected every tiny piece of tissue. This light is the result of reflection from the surface, and it will be able to influence and even to suppress it on the surface of the liquid, oxidizing agents and other chemicals or phenomena that depend on the pH of the surface temperature, as well as the type and angle of lighting. Light reflected from the cells and tissues that are on the surface or surroundings areas, carries less information associated with a precancerous or cancerous condition, in comparison with cells or tissues, deeper, the visibility is greatly attenuated due to surface reflection.

Therefore, highly desirable device that allows you to penetrate, for example, using the signal to the optical properties of superficial cells, eliminating reflections from cells located on the surface.

Means ispolnennom separation and optical isolation between the areas of tissue, where it is irradiated, and the tissue, the radiation of which is analysed.

Inspection with the naked eye or with conventional optical detection system is not equivalent to the above tools in the study of the transmission properties of each element of the tissue segment.

These properties are a consequence of the complex dynamics of the processes of transmission, absorption, scattering and back-reflection, the end result of which can make identification of the tissue more reliable than using only surface reflection.

This complex process, represented by the term "inverse scattering", underlies the base variant of the implementation described below.

When information from a variety of nearby land, the characteristic of the inverse scattering measured, is recovered in the form of an optical image (i.e., restored in the same spatial order in which measurements were made), the formed image back-scattered values of the recovered surface.

This picture, titled "image backscatter", can give valuable display, allowing retene provides the means to create such back-scattered images.

The addition of the above electrical measurements, showing the dielectric properties and impedance of tissue of each picture element, allows you to create a multidimensional picture of the image.

The described mechanism for obtaining images by the method of the inverse scattering based on the concept of measuring any one or more electrical, magnetic, acoustic, ultrasonic, thermal, optical and other physical parameters of each picture element related to the described images.

Thus, each element of the multiple images may contain characteristics of various kinds of energy and physical mechanisms.

Although the changes of the signal backscatter mainly reflect the transfer characteristic excitation/reception, it is not necessary when determining the image backscatter also exclude the measurement of characteristics of each picture element (such as the prevailing temperature, electrostatic potential).

Since the definition of cancer is extremely important asymptotically to seek a zero of a false result, then raspoznavanii.

For example, if the recognized types of tumor cells statistical contribution of this device for excitation/reception, comprising independent form of energy, is 1%, and the overall effect made in the statistical recognition of other forms of energy, such as optical or electrical) is 98%, then 1% contribution due to the magnetic energy, reduce by half the error of the system with(100%- 98%)= 2% to(100%-99%)= 1% (for optical, electrical and magnetic energy). Thus, the contribution of the independent, minor in view of the magnitude of the statistical power of discernment allows to significantly improve the performance of the entire system, which gives evidence of the introduction of independent forms of energy.

For this reason, multiple measurements, which are produced in many forms of energy and mechanisms (although more cumbersome to execute or difficult to embed in a small probe because of the difficulties associated with microminiaturization), it is highly desirable for the preferred design.

So you should use this configuration of the probe, which allows you to have free access to the desired surface of the fabric, and avoid the knowinge which is carried out by means of a physical probe, it is important to have such access to the surface of the examined tissue, which allows you to have visual feedback that improves the efficiency of the doctor.

Therefore structures, which uses the sensor must be attached to this form, which will ensure maximum visibility with minimal shading, allowing the catalytic sensors to follow the contours of the tissue studied. The accuracy with which the tissue type can be determined near the surface, largely depends on the above-mentioned operations.

Management orientation with respect to the surface of the fabric, the pressure on the surface of the fabric, the exclusion of undesirable sources of instrumental noise, such as light background, liquid, stray electromagnetic or mechanical vibrations are important factors influencing the achievement of accurate measurements.

In addition, these factors limiting the accuracy of the measurements, are interrelated and depend on the methods of transmission of the stimulating energy to and from the surface of the fabric, regardless of the fact whether the energy incentives electrical, optical, acoustic, magnetic, thermal or ultrasonic.

Using the image sensor should be novano at the same time and on the set of N samples.

The result of this treatment, samples equivalent to the increase in accuracy is proportional

It is also advisable to have the ability to set the similarity between the resulting "picture" of each cell or each type of fabric of the study area and paintings on the computer screen extracted from the images. To do this, when building apparatus for the detection of precancerous and cancerous conditions, which measure physical changes, there should be a data collection system that can adapt to many types of probes, each of which has a specific structure, determined by the nature of its application. Therefore, the probes should be interchangeable and automatically calibrated when changing.

It is also important to ensure that the doctor conducting the test, feedback for cases of incorrect application of the probe, confusion, inconsistencies or other conditions that may lead to erroneous results in the test process.

This information should be available immediately or be readily available together with other warning alarms associated with an instant approach of the probe is Ana on the manipulation of the probe in the area of the examined tissue, and so he can't focus on the computer screen or other display devices.

Systems that provide the physician with adequate feedback in real time and at the same time allow you to store the necessary data measurements, are important parts of the measuring device for the diagnosis of cancer.

Since the sensors usually operate in an environment containing liquids, optical and electrical characteristics of which vary, when calibrating the transmitting and receiving probes, and electrical conduit difficulties associated with the need to track these changes.

Preferably, the optical measurement was based on the characteristics of the transmission, absorption and back-scattering body, and not on the reflectivity of its surface.

Installation tip of the probe is normal to the Etalon reflection calibration gives the response is mainly due to surface reflection pattern. With this calibration, the ratio of the radiation/reception will not be a monotonic function of the distance between the reference reflection and active part of the probe and will be highly dependent on the distance.

Thus, a difficult task vos is controlled by the operator and periodically in contact with the surface of the fabric, the temperature of semiconductors and other items will vary due to the difference between the temperature of the tissue and the environment. In particular, for elements that contain semiconductor transitions to the active surface of the probe, temperature changes can cause significant changes in the work. Therefore, it is desirable that during the measurements the data processing system is compensated for these temperature changes.

Currently, the main mechanisms that cause physically measurable differences between normal, precancerous and cancerous tissue types are represented only from the point of view of the phenomenological model.

For any type of cancer no one can predict the exact value of each distinguished parameter. As a result, the calibration process and device for the detection of cancer is directly linked to the algorithm to use discernment and baseline measurement, which relies on this algorithm. This means that the algorithm can be properly optimized only when the collection of reliable data on cancer and pre-cancerous condition is by using a stable reproducible probe with the desired geometry and electro-optical synergy the camping part of the calibration process, and the necessary tools are implemented using various devices.

To obtain the discriminant distinguish tissue types can be used one or more electrodes. When one electrode is used, the patient is grounded through contact with other body part. For example, in cardiology using a single electrode for reading data one hand in a saline solution, or on her wrist strengthening the cuff.

The set of electrodes provides an opportunity to use their relative indications for evidence that other dimensions, for example, optical conducted correctly using optical converters, which are properly installed with respect to the surface of the fabric. Asymmetric readings from asymmetrically arranged electrodes indicate the asymmetry of the tip of the probe relative to the tissue surface.

The electrodes can be made in the form of metal discs on the front side of the insulator, which is achieved by using a wire with a truncated surface.

The electrodes can be of any shape, in particular, round, elliptical, square, rectangular, triangular, segm the tra mass plot of the investigated tissue.

The surface of the electrode, in turn, may be metallic or nonmetallic. In particular, the electrode may include a semiconductor material, for example, silicone, graphite or titanium dioxide deposited on the titanium.

In another implementation, the electrode may include an electrolytic cell (for example, silver/silver chloride, or mercury/chloride mercury) associated with the tissue through the salt bridge.

A salt bridge is an electrolyte containing gel, sponge or porous connector, and can also be used together with the metal electrode.

The electrodes can be used to measure the number of electrical characteristics such as:

- Conductivity, by determining the current flowing by applying to the electrodes a voltage sine wave (within the frequency range);

- Impedance of the system in the frequency range;

The current flowing in the attached to the fabric of the electrodes when the voltage is applied. This current can be temporary or frequency methods (e.g., Fourier transform).

Timing analysis can be presented in the form of a curve of the form of current from the - is OK flowing from the electrodes to the tissue after termination of the voltage pulse applied to the electrodes. Here, as in the examples described above, the analysis can be performed both in time and in frequency domains.

- The decline of the voltage without current flow after removal of the applied voltage, which before the removal was maintained constant sufficient to achieve steady state time (i.e., the voltage drop at very high resistance).

An electronic device used for carrying out the above measurements may be a hardware or a computer running software. In the latter case, the type of measurements can vary depending on the results of previous measurements. These tools are important to determine that the probe is installed on the surface of the fabric accurately, and therefore the readings, as well as electrical, optical and other routes can be considered reliable.

Data can be deleted automatically, if the orientation of the probe out of range.

For compatibility with the software you can select different configuration of electrodes and circuits on oznaczony diagnosis, using the standard measurement mode. In this case, the schema may be modified through software or other means by which can be made more definitions.

The probe must be able to move on the surface or inside the human body with the use of a dilator or other accessories, providing the physician with an unobstructed view of the sensed tissue. In addition, must be provided with a clearance sufficient for penetration of the light, for example, when conducting recording sample data.

For most cases, intracavitary applications the dimensions of the surface to which the probe is applied to obtain the response may be less than 2 mm in diameter. Accordingly, the resolution of the probe should be sufficient to permit precancerous tissue size.

Setting the preferred number of criteria that can be useful for identifying precancerous and cancerous tissues, we have to describe specific designs.

In Fig. 1 shows a device for the diagnosis of precancerous and cancerous tissue, comprising the probe 1, associated with the controller 20 poredka cervix. In Fig. 1 also shows the expander 30 that is used to open the vaginal wall 31 of the patient to influence the tip of the probe 1; cervix 32 completes the birth canal 33, leading to the uterus 34.

The probe 1 moves across the surface of the cervix 32 in order to stimulate the tissue of the uterus 32 and to receive responses to the stimuli that can be processed by the controller 20.

As shown in Fig. 2, the probe 1 comprises an outer tube 2, which provides electrical insulation and creates mechanical strength. Located inside the tube 2, the first electrode 3 made in the form of electric wire with the truncated surface and is located in the center of the beam fiber optics 4.

The other three electrodes 5, 6, 7 represent segments of a cylindrical metal tube, which are located adjacent and abuts the inner surface of the outer tube 2. In Fig. 3 shows a second variant of the probe 10, which is used in the device according to Fig. 1. This variant of the probe 10 has a more compact design, which is implemented using only three electrodes 15, 16, 17 having the shape other than the electrodes 5, 6, 7.

The shape of the electrodes 15, 16, 17 PR is 17 are adjacent and abuts the external tube 12 together with the cable of the three fiber optic bundles 14, located between them.

Using the first variant of the probe 1, spend three initial electrical measurements between the first Central electrode 3 and each of the other electrodes 5, 6, 7. The results of these measurements are compared and if they differ significantly, the measurements are discarded, because they point to an uneven contact of the tip of the probe 1 with the cloth.

In a preferred embodiment, the structure for measuring electrical and optical properties of pulsed methods, because they reduce noise and mutual influence between the measured signals. Therefore, in the examples of the invention shown in Fig. 4 and 5, a sequence of electrical impulses.

In Fig. 4 shows the sequence

electrical impulses, which can be used to probe according to Fig. 1 and Fig. 2.

Pulse voltage U3,5 is applied between the electrodes 3 and 5, the electrodes 6 and 7 are disabled.

This pulse is the pulse U3,6 between the electrodes 3 and 6 when the electrodes 5 and 7. Next comes the impulse U3,7 between the electrodes 3 and 7 when the electrodes 5 and 6. During and immediately after the end of each pulse U3,5, U3,camping below. If the measurement results differ significantly, they are discarded, because it indicates that the tip of the probe 1 has a non-uniform contact with the cloth.

To be able to get a large number of samples, the pulse duration and the duration of the sequence should be relatively short: typical values of the pulse duration from tens to hundreds of microseconds in duration sequence units of milliseconds will provide useful information in real time.

If the above measurements show that the probe 1 is installed correctly, is the fourth dimension with symmetrical connection of the electrodes, i.e., the pulse voltage U3 (5, 6, 7) is applied between the electrode 3 and the electrodes 5, 6, 7.

In Fig. 5 presents a similar sequence of electrical pulses used for the variant embodiment of the invention shown in Fig. 3. In this embodiment of the invention, the balancing of the electric field at this point will not be held.

Three electric pulse applied between the electrodes: U15 (16,17) is applied between the electrode 15 and the plug electrodes 16 and 17, U16 17 and the plug electrodes 15 and 16. Relative values of the measured responses indicate the correctness or incorrectness of the installation probe that provides an indication of operator error.

In another embodiment, the invention may use only one probe electrode, a second connection to the skin or tissue may be accomplished in one of many acceptable ways, for example, by using conductive cuff associated with any part of the body.

Using probe 1 or 10 to the described embodiment of the invention, it is possible to determine the electrical properties of tissues in many ways. For example, a rectangular electric pulse may be applied to the electrodes as described above, and the time-varying current that is flowing in and out of the tissue, can be measured either in the form of current in the circuit, either in the form of a time varying potential difference between the electrodes, following the impulse.

The shape of these time-varying signals is a measure electrical characteristics of the tissue. Alternative electrical signals of different frequencies can be used to measure the electrical characteristics of the tissue. The level of voltage applied to tissue in the Nala (which may be present), but in General they should not exceed 2 B, so as not to cause discomfort for the patient.

The optical characteristics of the tissue can be measured in the wavelength range from ultraviolet to infrared.

One of the optical fibers in the probe 1 and 10 is used to direct electromagnetic radiation from one or more sources to the fabric surface, where the energy is absorbed and dissipated. The second fiber, which may be adjacent or next to the first fiber, directs radiation from the tissue to one or several detectors (not shown). The amplitude of the signals from the detectors is a measure of the optical characteristics of tissue.

The electromagnetic radiation source may be a light emitting diode (not shown) or solid-state lasers (not shown).

Multiple wavelengths can be sent over a single fiber 4,14 or for each wavelength can be used to separate fibers 4,14. Among the wavelengths that are most appropriate for the diagnosis, are 540, 650, 660, 940 and 1300 nm.

The controller 20 includes a specialized computer system 21 (Fig. 6) and can perform device management predpochtitelney unit 23 synchronizing electrical signals, applied to the electrodes 3, 5, 6, 7, 15, 16, 17 probes 1 and 10, respectively, and to the optical emitters (not shown). The signals from electrical and optical detectors are processed in the microprocessor unit 22, and the processing result may be presented on the display 24 or may intensify the work of other indicators: visual, aural, the printing device. To enter commands to the computer system 21, the operator can use the keyboard 25.

Data collected by the computer system 21 are processed and compared with data that were laid out in her memory as image data, specific to each tissue type.

In Fig. 7 shows the resulting electrical and optical measurements a typical schedule for the type of tissue as a function of the three discriminant.

When the construction of Fig. 7 used three discriminants: two measurement result of the inverse light scattering (dsc1, dsc2 - each at a respective wavelength), and one is the result of the measurement of the curve of the electric relaxation, obtained by Fourier analysis (dsc3).

Fig. 7 shows the difference of the normal kinds of fabrics - congenital squamous epithelium (OSE1, OSE2, OSE3), cylindrical (CO is s (ATVP) and precancerous (D1, D2, D3).

The results of these comparisons are communicated to the operator via display 24 or other suitable means. For each patient, these results can be stored in the microprocessor unit 22 and then the selected memory or printed.

In shown in Fig. 1-7 options exercise of probes 1 and 10, with in some cases an elongated outer tube can be made with a flexible handle or the probe may be embedded in the capsule by introducing into it by way of the catheter.

In Fig. 8 presents designed for solving specific tasks of the probe 40 having the shape required for studies of tissue samples from the cervix 32 of the patient. In particular, the probe 40 to the cervix has an elongated handle 41 by which the physician can hold the probe and which is connected by a cable (not shown) with the control system. The handle 41 is limited to the main body 42, from which branches off the Central part 43 of the probe going into the birth canal 33 and surrounded by the annular recess 44 having a Cup shape of the cervix.

Along the surface of the probe 43 and the recesses 44 posted by repeating the series of elements 45, exercising stimulation/reception, which given the necessary form for ispy is with the controller through the handle 41.

As the diversity of forms of energy stimulation/reception is applied to the lot adjacent to other areas along all contours of the front part of the probe, the overall picture of the back scattering can be obtained by a simple rotation of the operator handle 41.

In Fig. 9 shows a flexible probe that is designed specifically for the skin, in this case the skin of the arms 36 of the patient. The probe 50 comprises a flexible flat circuit Board 51, which is the number of sensors. The sensors 52 are connected with the cable 54 through the printed connections 53. The cable 54 connects the probe 50, as in the previous embodiment, the implementation of the controller. Due to this construction, the probe 50 can be applied to curved and flat surface, which allows to estimate a relatively large area in a much shorter time than that required for probes of embodiments according to Fig. 2, 3, or 8.

In Fig. 10 shows a further development of the design of Fig. 9, but for a fully integrated detector node. The detector Assembly 60 includes a flexible substrate 61 on which, as on the probe 50 is set to the number of sensors 62. The substrate 61 is held by operatestwo control 65 of the detector Assembly 60. Bearing 63 allows the substrate 61 to bend to fit the contours of the tissue, and is supported by the control device 65. The control unit 65 is connected to the sensors 62 and enters into a compact unit data processing functions required to determine the type of outdoor fabric.

The control unit 65 includes a power supply 66, consisting of a set of batteries, and the processor module 67, section I / o 68 which is connected to the sensors 62 and module control/display 69. Indicators 70 connected to the module control/display 69, provide a visual or audible feedback to the operator and indicate the type of tissue when the aggregate sensor 60 is installed on the surface of living tissue.

Fig. 11 illustrates a spherical refracting probe 71, which includes the body of the handle 72 and clear (transparent) spherical refractive ball 73 mounted on the periphery of the housing of the handle 72. Inside the handle 72 is embedded light sources 74 (Fig. 11 shows only one of them), such as LEDs that emit in different spectral regions, and complementary sensors 75 (Fig. 11 for clarity, shows only one of them), such as dependent light of resisting film to prevent the Hilbert rays, emitted by each source 74, forming mainly a spherical waveform to affect large areas of the surface of the fabric 76 in contact with the ball 73. Similarly, back scattered from the tissue 76 light is refracted through the ball 73 in the direction of the sensor 75. Optically opaque barrier 80A prevents direct illumination on the path from source 78 to the sensors 79. To ensure contact with the tissue 76 for the purpose of its electrical stimulation, on the ball 73 has two electrode 78. Signals between the probe 75 and a controller (not shown) are passed through a series of wire guides 80. As can be seen from Fig. 11, the region 80 fabric 76 is illuminated by sources 74, and 81 fabric looks sensors 75, which provide an indication of the optical transmission through the fabric 76 between regions 80 and 81.

In Fig. 12 depicts an ultrasonic sensor 85, which is mounted in the upper part of the handle 86, which built four electric sensor 87, designed differently than in the previous design. In particular, the probe 85 has four ultrasonic transducer 88, each of which can be actuated independently, in order to stimulate the tissue in contact with it. When any of the emitters is. Received ultrasonic signals may be processed to determine differences in characteristics related to the density of the tissue and any changes in density in any part of the tissue where indicated by the bloodstream. This can be done by measuring the time of the run, as it is known in acoustic imaging systems image, such as a sounder or ultrasonic medical devices. In order to compensate for changes in acoustic communication, on the surface of the probe 85 has a number of temperature sensors 89, which can be used to determine the temperature of the tissue studied to compensate for changes in the ultrasonic velocity.

In Fig. 13A and 13B shows the probe 90, using the power of heat and light, which consists of a casing 91, made in the shape of a tube, along which pass the optical fiber 92.

The optical fibers 92 are used to illuminate the analyzed tissue and to receive reflected from the tissue of the light. In the probe 90 also entered the heating element 93, designed for selective heating of the sensed tissue, and a temperature sensor 94, which is designed to measure the temperature of the tissue as a response to vozdejstviju controller, which provides evidence about the blood flow in the tissue, which may be an indication of precancerous and cancerous lesions.

In Fig. 14A and 14B depict a magnetic probe 100, which is similar to the previous variant implementation is made inside the tubular body 101. The probe 100 includes a number of electrodes 102, designed by analogy with the previous version. There is also introduced four optical transmitter 103, such as LEDs, designed to transmit light at different wavelengths such as 1300, 440, and 660 565 nm. For receiving light of different wavelengths, such as 1300 and 500-1000 nm has two optical receiver 104. Additionally, the injected transmitter 105 magnetic radiation, mounted in the center of the probe 100, and three others in the receiver 106 magnetic radiation.

The transmitter 105 and receiver 106 magnetic radiation contain a magnetic core with a winding, and the transmitter of electromagnetic radiation 105 creates a small magnetic field extending from the end of the probe 100. Changes in the magnetic field are detected by the receivers 106, which can carry out the comparison by the imbalance between the signals accepted by each of the receivers 106, which allows to determine the magnetic anomaly in the fabric.

The rapid growth of microminiaturization increases the possibility of implementing in a single probe of a significant number of the previously mentioned forms of energy stimulation/reception, which increases the number of distinguished parameters required to define cancer and precancer.

In Fig. 15 shows the first design alterial 123 simulates quite certain known characteristics of the tissue, for example, backscatter, and other energy characteristics associated with the radiation/reception, such as electric, the controller 121 can be set to automatic reset, at which the output of stimulation pulses with the probe 122 and the received signal can be within normal limits or adjusted so that they are returned within established boundaries. Once calibrated, the probe 122 can be used for work, and an artificial substitute tissue 123 to prevent biological hazards must be sterilized.

In Fig. 16 presents the second design 125, which is fully active as opposed to semi-active design of Fig. 15. In Fig. 16 shows the tip of the probe 126 in contact with its complementary matrix 127, which forms part of the controller 128 which communicate with the probe 126. Thus, the transmitters and receivers of each of the tips of the probe 126 and matrix 127 can be excited, and since the output signal of the matrix 127 probe is known and agreed with precisely calibrated driver configuration 129, the output signals of the driver 129 may be determined by the controller 130 of the calibrator, which can modify the configuration is revogada wire 137, going from a sensor (not shown) and connected to the controller 141. In the probe 136 is embedded programmable permanent memory - PROM (PROM)138, in which the data entered on the special calibration values associated with the sensors of the probe 136. EPROM 138 is directly connected with the calibration module 140 through the wire 139. The calibration module 140 has outputs 142 to adjust the gain associated with the matrix amplifiers 143, to which are connected wires 137, going to the sensors and from them. Thus, the gain of each amplifier 143 is controlled in accordance with data stored in EPROM 138 to compensate for differences between sensors of different probes 136. Circuit EPROM 138 allow digital electronic standardization of the probe and allow the tracking when the probe is used in conjunction with a computer. Introduction EPROM 138 in the probe 136 allows for electronic detection probes, each use of a probe 136 is fixed; if necessary, the number of reuse of the probe 136 is limited a priori automatically.

We turn now to Fig. 18 schematically shows a preferred design of the detection system 150, which includes the probe 151, which is connected through analogy for the user, communication which is carried out by means of control buttons 155 and specialized digital keyboard 156. Computer type of communication via the RS-232 interface (for slow devices) 157 or port IEEE 488 interface (for devices with an average data rate), or COM# port, or direct memory access (DMA); the supply voltage is supplied via connector 158.

The probe 151 contains devices that create many different physical stimuli. In particular, the led 159 provide optical stimulation. The electrodes 160 provides electrical stimulation to the tissue, which can be used to determine the value of the discriminant, and to assess the position of the probe 151 relative to the tissue. Additional devices (not shown) for expanding the number of discriminant stimulation/reception can be introduced by analogy with the described. To improve the orientation of the probe 151 is used load cells 161, which provide an indication of the position of the probe 151 relative to the tissue. The sensor 161 also contains indicators 162, which may be audible and/or optical and provide feedback in real time between the doctor and the investigated tissue. F. the Ani. Due to the low level of the output signal of the photodiodes 163 probe 151 is entered preamps 164. The probe 151 is connected with the analog-152, which contains the amplifier and the control amplifier associated with each of the elements of the probe 151. Payment processor 153 includes a controller that uses a Central processing unit (CPU) 178, which is equipped with a digital block input/output (1/0) 176 and sequential block input/output (1/0) 178. A Central processing unit initiates the stimulus that arrives at the output via the serial block input/output 178 to analog Converter 174. The output signal from d / a Converter is supplied to the power amplifier and the control amplifier 165 LEDs. The power amplifier and the control amplifier 165 LEDs used for excitation LEDs 159, while the other input supplies the digital signals from the digital block I/o 176. The digital output block input/output 176 is connected to the AC excitation 166, which is connected with the electrodes 160, and supplies the stimulating pulses that are fed to the fabric. The amplifier 167 amplifies output signals of the electrodes 160, which follow through protection block 172 to the analog-to-digital preobrazovaniya amplifier 171 optical detector, the output of which is converted into digital form by analog-to-digital Converter 177 to refer to the Central processor unit (CPU) 178. Alternatively, you can also enter the emitters stimulation/reception. Driver load cell 168 uses the DC signal from the powerful Converter DC 180 and delivers it to the load cell 161, the output of which is connected with the amplifier 169 load cell. The outputs of the amplifier 169 through protection block 172 go to analog-to-digital Converter 177 for the measurement of forces with which the probe operates on the fabric. The outputs of digital block I/o 176 is connected to the amplifier 170 indicator that excites the indicator. A Central processing unit 178 includes a device reset 181, 182 hours, and outputs connected to the control slot 183. The previously mentioned probe 151 may be provided with a programmable read-only memory (PROM, not shown) to perform the calibration, to facilitate standardization and to write data probe. When using programmable permanent memory device, the latter can be connected directly to the digital block I/o 176. During operation of the apparatus Batista 178 and is used for excitation LEDs electrodes 159 and 160. The number of data recorded by the Central processor unit 178 and is stored in the memory 179, where they are converted into different discriminants. For each related series of images taken numerous discriminants are then combined in accordance with a certain algorithm to provide a classification of tissues. This classification is then compared with the classification stored in the nonvolatile portion of the memory (storage device that retains information when power supply) 179, where the mapping; classification helps to determine whether the tissue is normal, pre-cancerous or cancerous and provide a doctor with the necessary indication. In cases where the tissue type is not defined, the doctor enters a corresponding display, which prompts the doctor to do further research this part of the tissue. When processed, the number of identifiable data, you should choose those characteristics that are not associated with changes that occur from patient to patient. This may include the processing of physical parameters, such as electrical and optical characteristics in the time domain and frequency domain to provide frequency and time portraits Aleka at different frequencies. The temporal characteristics determine the amplitude of the response caused by the energy supplied to the tissue. The frequency sweep excitation creates a spectral response that allows on the basis of the complex impedance to consider the type of fabric, including nine or more individual parameters, each of which has a corresponding spectral characteristic. Electrical time response can be obtained by successive observations of the studied response to known electric effect type step function or impulse.

As noted above, in the optical device, the absolute value of the inverse scattering sample can be determined along with the slope and rate of change of the response, this allows you to use as variables the first and second derivatives as a function of wavelength or time for spectral or temporal characteristics, respectively.

Since the transfer of ultrasound change affects the amplitude and Doppler effect, the various combinations that can be analyzed using techniques of image analysis. For magnetic stimuli can be identified anomalies at certain frequencies. DL the s uterus preferred types of incentives - optical and electrical. For skin tissue optical, electrical, magnetic, acoustic and thermal. To determine the specific type of the investigated tissue obtained physical data and various discriminants should be combined according to a certain algorithm. This can be accomplished by using the technique of discriminant analysis, linear programming, cross-correlation or neural networks.

Preferred is the option discriminant analysis when the expert's opinion or empirically derived correlation is used to refer to data, between which there is a connection to optimize the values of the discriminant. For each variable estimated by various factors and determine how to change variables so that they were displayed in the corresponding type of classification.

In the preferred device for determining cervical cancer are eight discriminant, based on the electrical and optical recognition. These discriminants are backward scattering of light by the wave length of 540, 660, 940, 1300 nm and four of the curve of the attenuation of the voltage. For the classification of tissue used is the aforementioned identification discriminants, have

< / BR>
where VARj- variable in real-time, associated with position j in a linear equation, Aij- constant coefficient when the variable i and Pithe relative probability of the i-th classification of tissue.

To ensure the accuracy of test results requires a large database, whereby the known responses of specific types of cancer and pre-cancerous tissue could be related. For example, when creating a device to detect cancer of the cervix were conducted by research 2000, each of which was analyzed by colposcopists and in special cases by histology, which provided reference data for the major classes of tissues. Each of these people was also investigated using the probe device made in accordance with the preferred embodiment of the design, so that the responses preferred variant embodiment of the invention in a specific tissue types that were classified manually, can be associated with the classification, which was also performed manually. Thus is formed the database for a specific type of cancer, so when the sensor is used for another patient, the responses of this literature to identify a specific tissue type.

Similar experiments were performed for cancer of the breast, skin, colon and prostate, and for these cases was developed database.

Each new type of cancer leads to new problems in the development database. In particular, for cancer of the cervix can be conducted in vivo studies, breast cancer, colon cancer and prostate cancer are the necessary results of the biopsy, and therefore, the database is developed on the basis of in vitro data. In the case of skin cancer can be used the results as dermatological studies, and biopsy. The conclusion about the condition of the samples is given by comparing the results obtained using the probe, with the recognition results in vivo, which provide the reference specifications for each, identify the probe type tissue. Research operational data preferred variant embodiment of the invention has shown that the detection system 150 (Fig. 18) for cervical cancer provides 85 to 99% compliance between colposcopy/histology and diagnosis by means of the probe, depending on the degree of deviation from the norm (well-developed changes of human papilloma virus, little cellular atypia or intraepithelial neoplasia of the cervix is the first step 3rd degree) up to 99% for invasive cancer. Statistical analysis and extrapolation of these results suggest that when using the preferred alternative implementation of the device with the probe, the ratio of false positive and false negative assessments about 10%, and so for cervical cancer the proposed construction of the probe is significant progress compared with 50-60% accuracy, typical of the traditional methods, based on the Papanicolaou test. The above describes only some embodiments of the invention and their modifications, which are obvious to a person skilled in the art and can be performed in the framework of the present invention.

1. Method for the diagnosis of precancerous or cancerous state of the tissue, including the impact on the fabric energy stimuli, determining the response of the tissue at each energy stimulus representing a modified tissue response energy signals, processing of tissue responses and analysis of the processed responses fabric, wherein the fabric is affected by at least two stimuli, the processing of feedback tissue exercise through their combined oberbuchsiten tissue with a known classifier expected tissue types for its recognition.

2. The method according to p. 1, characterized in that the stimuli are selected from the group consisting of sources of electrical energy, a source of light energy, the sources of acoustic energy, sources of magnetic energy and sources of thermal energy.

3. The method according to p. 2, characterized in that at least one of the stimuli selected from the group consisting of sources of energy, generating continuous irritation of the signal pulse-modulated irritant signal, frequency-modulated irritant signal, fazokodirovannymi irritant signal and amplitude-modulated irritant signal.

4. The method according to p. 3, characterized in that one or each of the selected stimulus is a light energy source, generating a sequence of sets of pulsed light signals, each of which has its spectral bandwidth, and the sequence is repeated with the ability to essentially simultaneous receipt of the corresponding response of the tissue.

5. The method according to p. 1, wherein processing each response shall be implemented by one or more specific processing steps of obtaining one or each step of the about obam to classify tissue.

6. The method according to p. 5, characterized in that the number of processing steps is greater than the number of the used stimuli by an amount equal to 1.

7. The method according to p. 6, characterized in that as the stimuli used sources of electrical energy and a source of light energy, allowing you to get eight processing results.

8. The method according to p. 5, characterized in that the processing results are combined through a weighted summation with a preset weight coefficient for each of the processing based on the tissue types in the classifier and on the compliance of each of the processing classifier.

9. The method according to p. 5, characterized in that the processing results are combined using linear programming, cross-correlation or neural networks.

10. The method according to p. 1, wherein the classifier is expected types of fabrics create by cross-matching investigated manually and classified pathological methods samples of recognized types of fabrics treated with the responses of tissue samples taken at the impact on the fabric of the stimuli and the combined processing of tissue responses to each rasaraj is atki, breast, skin, prostate, or colon.

12. The method according to p. 1, characterized in that the combined treatment and comparison classified tissue classifier produced in real time and use statistical methods to compare the classified tissue classifier.

13. The method according to p. 1, characterized in that it explores the fabric, which is part of a living organism.

14. The method according to p. 2, characterized in that as the stimuli used in at least the sources of electrical energy and the sources of magnetic energy, the combined treatment of tissue responses carried out by processing the amplitude response, frequency response, absolute amplitude determination, phase response, spectral response, response by the coefficient of the first derivative in time or response coefficient of the second derivative in time.

15. The method according to p. 1, characterized in that as the stimuli used in at least the source of light energy and combined processing of tissue responses carried out by processing the amplitude response, spectral response or spatial response.

16. The method according to p. 1, featuring the private treatment response tissue is conducted by processing the amplitude response the phase response or frequency response.

17. Device for detection of precancerous or cancerous state of the tissue, containing a single probe for impact on the fabric energy stimuli-sensitive elements, each of which is made with the possibility of perception of the response of the tissue at the corresponding energy stimulus, which represents an energy response signal, the controller connected to the sensors for receiving such feedback tissue, and containing a processor for processing these responses fabric and comparison of the results obtained, and the memory block, wherein a single probe for impact on the fabric contains many sources of energy, and a memory unit configured to store a known classifier expected tissue types, the processor is made with the possibility of the combined treatment of tissue responses to each stimulus for tissue classification and comparison of the obtained classification of the tissue with a known classifier expected tissue types for its recognition.

18. The device under item 17, characterized in that the controller includes an indicator for indicating to the user recognize the type is implemented by the operator of the probe for contact with the tissue, moreover, in the probe embedded energy sources and sensors for studies of tissue within or on the outer surface of a living organism.

20. The device according to p. 19, wherein the controller includes a means of identifying summarizing probe irritation to the tissue for recording in digital form each use of the probe and to automatically limit the number of repeated its uses.

21. Device for detection of precancerous or cancerous state of the tissue containing the source of electromagnetic radiation configured to irradiate the tissue with electromagnetic radiation of at least two different wavelengths connected to a single transmitter for transmitting electromagnetic radiation to creates and receiving scattered its radiation on the respective at least two different wavelengths, the receiving device is connected to the probe and a comparator for comparing the responses of the tissue to electromagnetic radiation representing diffuse tissue radiation response, with known values, characterized in that the probe contains at least one electrode for application of electrical signals to the tissue and the corresponding system is a means of comparison performed by the comparison of the responses of the tissue to electromagnetic radiation fabric and the resulting tissue response to electric signals with the corresponding known values to identify the tissue type.

22. Method for the diagnosis of precancerous or cancerous state of the tissue, including the impact on the fabric of the stimulus in terms of its exposure to electromagnetic radiation of multiple wavelengths, with subsequent processing of the responses of the tissue to electromagnetic radiation representing diffuse tissue radiation response, and analysis of the treated tissue responses, characterized in that the electromagnetic radiation fabric spend at least two different wavelengths, down to the fabric of the electrical signals from the measurement result of the response to electrical signals, in combination handle the response of the tissue to electromagnetic radiation and the resulting tissue response to electrical signals, and diagnostic analysis of the tissue is carried out by comparing the treated tissue responses in advance with the expected response of the tissue.

23. The method according to p. 22, characterized in that on the basis of the combined treatment response of the tissue is carried out by its classification and compare the classification of the tissue and the existing classifier expected types of fabrics for her identification.

 

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