WO2013174691A1

WO2013174691A1 - Device and method for thermal examination of the female breast

Info

Publication number: WO2013174691A1
Application number: PCT/EP2013/060026
Authority: WO
Inventors: Heinrich M. WEHBERG
Original assignee: Konrad Wehberg Medizintechnik
Priority date: 2012-05-22
Filing date: 2013-05-15
Publication date: 2013-11-28
Also published as: DE102012104419B3

Abstract

A device for thermal examination of the female breast (20) is described, with a first and a second thermosensor plate (15a, 15b) for measuring the temperature of the breast (20), a cooling device (12a, 12b) for cooling the breast (20), and an eveluation unit (8) for evaluating the measured temperatures, wherein the thermosensor plates (15a, 15b) can be oriented relative to each other in such a way that the breast (20) is clamped between the two thermosensor plates.

Description

Apparatus and method for thermal examination of the female breast

description

The present invention relates to a device and a method for the thermal examination of the female breast.

For the diagnosis of breast cancer and their early detection in the

As part of the check-up examinations, mammography, i. an X-ray method, used as the "gold standard." This method is associated with a, albeit low, radiation exposure for the patient

Available, with the help of the skin temperature of the female breast

Mammacarcinomas can be diagnosed.

In thermography, the heat development during the earliest beginnings of a carcinoma development already in the preliminary stages, z. In hyperplastic dysplasia, LCIS and DCIS. Very sensitive high-resolution sensors reproduce an image of the measured radiation of the heat-emitting body during IR thermography. With the

Liquid crystal thermography or ELC thermography can be achieved by contact of the ELC film with the body region to be examined

Heat emission can be detected and documented in fractions of a second. Here, by conduction, heat conduction or heat flow, the heat flows from the place of formation according to the second law of thermodynamics

Direction of lower temperature, ie to the body surface.

In the techniques used today, a distinction is made between distance or IR method and the contact ELC or liquid crystal method. The

Application of the thermography gives priority to a functional, less an anatomical information. In this respect, in the context of breast cancer diagnostics, it basically represents a useful supplement to the routine procedures of mammography and ultrasound, which provide only structural information.

Attempts to reproduce recordings by introducing standards

to make, have not been successful in the past. Efforts to remove nonspecific skin heat with a cold air blower or alcohol casting have resulted uneven in the surface and inconsistent with respect to the temperature

Results that significantly reduced the diagnostic value of the images. Also, the cooling of the patient by prolonged stay in one

air-conditioned room until reaching a "steady state" was a conditionally successful, time-consuming and unpleasant for the patient procedure.

Plate thermography or ELC thermography or contact thermography has traditionally been a technique in which the properties of liquid cholesterol crystals are used to reflect light of different wavelengths depending on the temperature. These liquid crystals are embedded in a rigid or elastic display, which is placed on the body part to be examined. The resulting color image after a short time is qualitatively evaluated by the examiner and possibly photographically documented. By suitable mixture of

Cholesterol crystals is displayed on a display a specific temperature range (temperature window), in which the color of the reflected light corresponds to a certain temperature. This allows a semiquantitative evaluation of the temperature image.

In the prior art different methods have been proposed for this purpose. In one group of methods, the skin temperatures of the female breast are measured directly and, if necessary, electronically

further processed. Thus, for example, WO 79/00594 and US Pat. No. 3,970,074 disclose devices in which the breast is pressed against a plate equipped with temperature sensors in a matrix-like manner and the skin temperature is measured. The measured data are processed electronically, whereby certain temperature distributions on the skin are an indication for a mammary carcinoma.

US 4,005,166 discloses a brassiere that includes a single

Temperature sensors is equipped. This will constantly check the skin temperature at the appropriate points. Certain changes in the skin temperature indicate the development of mammary carcinoma.

A second group of thermography methods forms the so - called plate thermography. A corresponding device is disclosed in DE 83 26 341 U 1. A thermographic plate is pressed against the female breast. A liquid crystal coating of the plate changes depending on the temperature

Influence the refractive index for incident light and so on different colors. As a result, warmer areas of the breast, as they are also in the case of carcinogenesis, are made visually more visible to the cooler areas. Certain structures or others

Characteristics indicate a pathological change. The real thing

The method of diagnosis is described in more detail in the "Atlas of plate thermography" by G. Lauth and G. Mühlberger.This atlas gives a first introduction to the doctor who is still inexperienced with plate thermography.Overall, the performance and evaluation of the thermographic images requires a great diagnostic experience of the otherwise it is particularly prone to inexperienced doctors with a high error rate.

WO 85/00508 discloses a device for receiving a

thermo-optic image of the female breast with a housing having on its side facing the female breast a frame, a

thermo-optical film which can be fastened to the frame, an illumination device arranged in the housing for illuminating the thermo-optical film and a digital camera arranged in the housing relative to the frame.

WO 00/064332 discloses a device for receiving a

thermo-optic image of the female breast with a housing which has a frame except for its chest-facing side on which it has a frame,

opaque to light, a thermo-optical film which can be fastened to the frame, a arranged on the side facing away from the breast of the frame, transparent cooling box with a disposed on its side facing away from the breast side of the frame anti-reflection disk having a cooling medium inlet and a cooling medium drain u nd in his

Initial position is not in contact with the film, one with respect to the temperature of a cooling medium adjustable thermostat, which is connected to form a cooling circuit via hose lines with the cooling medium inlet and outlet, an arranged in the housing lighting device for illuminating the thermo-optic film, one in the Housing relative to the frame arranged digital camera, a clamping device for clamping the breast between two surfaces, wherein one of the surfaces is formed by the film, a contact making device for establishing a surface contact between a film side facing the cooling box and the side facing away from the breast side of the film , a time measuring device for measuring the

Time from contact making, and one with the timing device connected triggering device for automatically triggering the digital camera after a predetermined period of time. Here, the clamping device comprises a housing connected to the housing, extending parallel to the frame cushion whose distance from the frame is variable. The pad is in this case connected via a bracket arranged at a right angle to the housing. The square frame is held at its four corners by means of pins on the housing with springs concentrically extending to the pins in such a way that the attached to the frame thermo-optical film in unloaded

Condition of the springs is located at a distance from the cooling box. An existing locking device is used to lock the frame in making a contact between the thermo-optic film and the

Cooling box after squeezing the springs.

DE 201 02 858 Ul describes a plate thermography with a mobile cooling box, which from its cooling position by folding down in his

Rest position is brought. The cooling process is thus interrupted by folding down the cooling box.

In the aforementioned, known from the prior art and methods

Devices result in practice various problems:

The application of the film on or on the chest is in principle a simple one

Handling, which, however, finds its problems in the thereby forming Duplikatur of the skin, which form on the outer areas of the slightly compressed breast. This results in a problem with the Abkühlmethode because the Umschlagfalte the skin requires a significantly longer cooling time than the simply stored layer of the skin, which is located above the glandular body. Another problem of developing skin duplication is the lack of sensitivity in this area.

A prolonged cooling time due to the skin duplication until a black discoloration of the foil is achieved leads to a prolonged cooling time for the skin portions lying above the glandular body, which in turn impairs the sensitivity.

When carrying out the current thermography, difficulties arise in choosing the right film, which corresponds to the experience of the investigation person and whose subjective decision is bound. This problem arises from the fact that 3 films with different temperature spectrum and consequently different starting temperatures of 28 ° C, 30 ° C and 32 ° C are available. An incorrect choice of film may result in failure to capture the entire temperature scale of the breast after the cooling process, when rebuilding a thermo-optic image. Or it may happen that when choosing a too sensitive film such as a 28 ° C film, for example

The glandular body of a younger woman, the breast must be cooled to reach black detection or so-called "black-detection" longer and then, however, the reconstruction of the thermo-optical image in the process is too fast, so that the relevant particularly warm areas of the breast is not As you might expect, the reconstruction of the thermo-optic image in such a case can not be captured in one sequence, instead the image becomes one with all

For a younger woman, a film with a lower sensitivity limit of 32 ° C would therefore have to be chosen.

In view of this, it is an object of the present invention to provide a

To provide a device or a method by which a diagnosis of pathological changes of the breast is facilitated. According to the invention this object is achieved by a device for thermal examination of the female breast

a first and a second thermal sensor plate for measuring the

Temperature of the breast,

a cooling device for cooling the chest and

an evaluation unit for evaluating the measured temperatures, wherein the thermal sensor plates are aligned with each other so that the breast is clamped between the two thermal sensor plates.

The object is also achieved by a method for thermo-optic diagnosis of the female breast with the steps

Applying at least two thermal sensor plates for recording the

Temperature of the breast,

Cooling the breast to a predetermined surface temperature of the breast by applying a cooling plate,

Ending the cooling by removing the cooling plate from the chest, Evaluate the heat distribution after removing the cooling plate

According to the invention, the sensitivity of the examination can thus be significantly increased over a simple frontal application of a thermo-optical plate to the breast, because it is ensured that all areas of the breast are brought into contact with the thermosensor plates as far as the axial-axial extension. In particular, by appropriate alignment of the thermal sensor plates, the breast wall near portions of the signaling skin can be detected. In addition, it may be possible to determine the position of a heat source in the breast by evaluating the heat distribution.

There may be provided two cooling plates, which are respectively associated with the first and the second thermal sensor plate.

According to the invention, a controlled pressure can be exerted on the breast and thus a certain compression of the breast can be achieved. This is advantageous especially in studies of older women. The glandular body of older women consists to a greater extent of fatty tissue and is therefore softer and more easily compressible. Adipose tissue-rich glandular tissue conducts the heat worse than the glandular tissue of a younger patient. For this reason, slight compression of the glandular tissue of elderly women is of particular advantage because it shortens the routes of heat conduction from the lesion to the signal-giving skin.

By using more than one thermal sensor plate, it is also possible that the evaluation unit calculates more than just a two-dimensional distribution of the heat sources for evaluating the measured temperatures. So z. B. from a higher measured temperature at one of the two

Thermosensorplatten be concluded that a heat source is closer to this thermosensor plate than the other thermosensor plate.

Advantageously, the thermal sensor plates have flat surfaces.

The thermal sensor plates may be thermo-optical films which change their color as a function of the temperature, the color change being detected by one or two cameras. Advantageously, the cooling plates can thereby cool the breast through the thermoforming films. The cooling plates are included Advantageously enough, behind the thermal films arranged and transparent (with transparent cooling medium), so that cameras through the cooling plates can take a picture of the thermo-films. If necessary, it should be noted that the cooling medium guided through the cooling plates does not form bubbles and does not contain any impurities, otherwise the

Image capture would be disturbed.

The thermal films are preferably taut on a frame, so that there is a barely compliant arrangement, which is suitable to pinch the breast between two thermal films. In particular, the thermal film can be clamped so tightly that a yielding results by at most two mm.

Alternatively, the thermosensor plate may also be a matrix of small thermosensors that directly determine the temperature. When using such a sensor arrangement, however, the use of a previously intended for the patient Fol ie for O-calibration (black detection) is required. The calibration can be carried out in a method according to the invention according to the following steps:

• Fixation of the breast by means of thin transparent tenter foil

• Apply the thermo-optic film to the chest. It builds up

thermo-optic image on.

• Start the cooling process

• Slide appears black

• Automatic cooling removal

(watched and controlled by a digital camera)

• After removing the cooling, the process of image formation can be captured by the thermal imaging camera

In the cooling device for cooling the breast, it may, for. B. by two

Cold plates act, which are flowed through by a cooling medium. The cooling medium can be cooled or warmed up by a heat exchanger. Heat exchangers allow a faster adjustment of the temperature of the cooling circuit to a new required temperature, eg. B. when using another slides for another patient. It can be provided that the cooling plates are automatically applied when it has been determined after applying the thermal sensor plates that there is no significant change in temperature at the surface of the breast. Instead of a fully automatic application of the cooling plates can also be a signal

an assistant to manually create the

Cold plates triggers.

Advantageously, a standardized special automatic cooling can be used which evenly cools the uppermost layer of the skin at a temperature only a few degrees below chest temperature. This avoids reactive hyperemia. Experimental investigations have shown that cooling by about 3 ° C to 5 ° C can be particularly advantageous.

The cooling plate can transmit the cold of the cooling medium to the chest through contact with the breast. The evaluation unit for evaluating the measured temperatures can, for. B. be a computer that receives the signals from the

Evaluates thermal sensor plates.

The thermosensor plates are aligned with each other so that the breast is clamped between the two thermosensor plates, so as a whole as large as possible and tight contact surface between the chest and

To achieve thermal sensor plate. The pinching of the breast according to the invention means a pressure on the breast, which leads to a deformation of the breast, but is not painful for the patient.

The examination of the patients with the device according to the invention can be delegated and can be performed by a helper. In particular, the evaluation unit can also have a display that contains instructions for

Carrying out the method according to the invention.

In embodiments of the invention with a thermal film, the selection of the right for the patient to be examined slide under three available films with different lower sensitivity limit

done automatically. Thus, a source of error is eliminated, which can lead to technically not evaluable image sequences. For this purpose, the test film is inserted into one of the two thermosensor plates, which are in the position for

Frontal recording is located. The test film reacts as soon as the contact with the breast takes place z. B. within about 2 to 3 seconds. On a display the color change of the foil is indicated in the form that the foil to be selected for the diagnostics is indicated by the range of the starting position of the colored change on the test foil. Cooling is not required for automatic slide selection.

In an advantageous embodiment of the invention it is provided that the thermal sensor plates are aligned substantially parallel.

Substantially parallel should be parallel or at an angle of a few degrees, z. B. maximum 5 °, mean. A substantially parallel orientation of the thermal sensor plates is technically particularly easy to implement. In addition, it is particularly easy to estimate from the images recorded with the thermal sensor plate, a three-dimensional distribution of the heat sources when the thermal sensor plates are substantially parallel.

In a particularly preferred embodiment of the invention it is provided that the distance of the thermal sensor plates and / or the angle between the

Thermosensorplatten are adjustable.

Adjustability of the distance and orientation of the thermal sensor plates allows adaptation to the shape and size of the patient's breast. This is of particular importance in order to achieve the largest possible contact surface between breast and thermosensor plates and at the same time to make the examination not too uncomfortable or even painful for the patient.

In a simple embodiment, only two degrees of freedom are provided, i. the distance of the thermal sensor plates can be adjusted and an angle of the thermal sensor plates to each other. In other embodiments, however, it may also be provided that the thermal sensor plates can be tilted relative to one another in more than one plane. Thus, an even better adaptation to the patient's breast can be achieved.

Advantageously, it can be provided that the set distance or the angular position can be read or automatically detected by the evaluation unit. This ensures that the recording conditions are accurate

are reproducible. Advantageously, it can also be provided that the position and orientation of the thermal sensor plates are adjusted automatically by a motor-driven device. Thus, the method can be carried out particularly efficiently and the recording conditions are reproduced particularly accurately.

Advantageously, it can be provided that give the thermal sensor plates at a certain pressure and z. B. automatically sets a greater distance between the thermal sensor plates when the pressure between

Thermal sensor plates and breast is too big. Thus, injuries can be prevented by incorrect adjustment of the thermal sensor plates.

In a further embodiment of the invention it is provided that the

Cooling device has a first and a second cooling plate, which are associated with the first and the second thermal sensor plate and are each movably mounted to these. An arrangement of thermosensor plate and associated cooling plate is also referred to below as a thermo-arrangement.

For example, the first cooling plate can be aligned parallel to the first thermal sensor plate and movably mounted at a distance therefrom. The second thermal sensor plate can be designed accordingly.

Due to the mobility of the cooling plates relative to the thermal sensor plates is achieved that the cooling of the breast can be stopped suddenly, z. B. when reaching the target temperature. The mobility can z. B. be designed in the form of a folding or a sliding mechanism.

The folding mechanism has proven to be powerful experimentally, but requires mechatronics but a relatively high load capacity and brings the disadvantage of higher space requirements for the housing of the thermal arrangement with it.

Alternatively, in a simple backward movement of the cooling plate, ie from the cooling position away from the rest position parallel to the thermo-optical film, however, the image recording, especially at high temporal and / or spatial

Resolution, possibly at the expense of recording quality disturbed by the fact that it is due to the constant flow of cooling fluid to streaking can come. Advantageously, an automatic temporary shutdown of the refrigeration cycle is not an option for quality here

from the moment of the black detection, thus beginning with the end of the cooling time. In any case, it is important to avoid any deterioration of the picture quality during the recording of the reconstruction of the thermo-optic image.

Another way of avoiding visual loss of quality is, for example, a clear glass clearing the cooling glass which consists of an elastic thermally conductive material and has only the size of the extension of the beam path of the camera whose lens is located directly on the cooling plate located in the rest position. At the time of the black detection and in the time before that, ie during the cooling time, the camera is at a certain distance from the cooling plate. The task of the camera to detect the time of the black detection to trigger an automatic interruption of the cooling at this moment is not affected by a slight negligible for this quality degradation.

If a thermal foil is used as the thermosensor plate, the view of the thermo foil can be released after the cooling process has ended by moving the cooling plate away for a camera. If the camera is located behind the cooling plate, it may be necessary to provide a small recess in the cooling plate for the camera. The recess may be made with a transparent material, for. As glass or a transparent film.

In one embodiment of the invention it is provided that a displacement device is provided which is adapted to the cooling plates in

Dependence on a temperature and / or time measurement away from the breast.

It is thus possible, for. B. after reaching the target temperature and / or after exceeding a certain maximum cooling time to automatically change from cooling the breast to measure the temperature distribution. The movement of the cooling plates can be designed as a folding away or as a move away from the thermal sensor plate, such that the cooling plates remains parallel to the thermal sensor plate. In a further embodiment of the invention it is provided that the

Cooling plates are supplied via hoses with a cooling medium.

It is thus possible that the cooling of the cooling medium takes place in a location which is separate from the thermal sensor plates. Advantageously, the thermosensor plates and their support can thus be designed to save space, while at another point, the possibly consuming or space-demanding cooling of the cooling medium takes place. Thus it is possible to enter

to use a powerful cooling system that allows the breast to be quickly cooled to the target temperature.

In a further embodiment of the invention, it is provided that a 3D camera is additionally provided, in particular a combination of a camera and a sensor for structured light.

By the 3D camera, it is possible to perform a measurement of the shape of the breast or caused by the application of the thermal sensor plates deformation of the breast. By irradiating the chest with structured light and recording the reflected light with a conventional camera, it is thus possible without contact and quickly to precisely determine the contour of the breast in the areas in which it does not abut against the thermal sensor plates.

In particular, the position of the nipple can be detected accurately.

In a preferred embodiment of the invention, the 3D camera is designed to take a picture of the breast from the front.

In a further embodiment of the invention, the evaluation unit for evaluating the measured temperatures is adapted to a spatial distribution and a temporal evolution of the measured

Temperatures estimate the position of a heat source in the chest.

Thus, according to this embodiment of the invention, the device can fully automatically make an estimate of the position of a heat source in the breast. In particular, the heat source to be determined may be a lesion or blood vessels running to and around the lesion. The determination of the position of the heat source can be done much more accurately than if this is estimated by a doctor.

A single physical process, ie the heat source, i. z. The location of the carcinoma formation is the cause of both thermal biosignals on the thermosensor plates. Therefore, the two signals occur at a certain time interval to each other when the physical process is not in the middle between the two thermal sensor plates. The time offset can also have a flatter function curve. In the central position of a single physical process and identical thermal conductivity of the tissue towards both thermal sensor plates cooling time, occurrence of the black detection and thus start of the sequence imaging would take place simultaneously. In this case, the function curve profile is identical on both thermosensor plates. Assuming approximately constant heat conductivity in the breast, it is therefore possible to make statements about a non-central position of the heat source from different measured function curves.

The cooling time in both opposing thermal sensor plates may vary depending on the thermo-optic heat pattern per thermosensor plate, resulting in earlier or later black detection, thus ending the cooling time and thus earlier or later start of sequence imaging (e.g. 15 recording / sec in HD format). This can be taken into account accordingly by the evaluation method.

To get an imaginary function curve, you measure the color

Pixel change and thus the change in temperature on each thermo-optical film and enters this on an imaginary y axis in relation to the time that is entered on the x axis. The resulting function is calculated algorithmically for each pixel on both thermal sensor plates. The curves and the integrals of both functions would be at the center position of a single physical process

be congruent. By every shift of this physical

Process on one side or the other they are no longer congruent.

The steeper the curve, ie the shorter the time in which a maximum temperature is, the more pronounced the physical process is in turn can be considered as an increased heat production and as an indication of increased aggressiveness of a causally growing carcinoma. On the other hand, conclusions about the proximity to the signal-giving skin, ie the proximity to the thermo-optical film, can be drawn from the representation of the function curves. For the differentiation of the proximity of the physical process to the thermal sensor plate, the function resulting from the image composition

Thermosensor plate of the opposite side results, with to be considered.

The calculation of the position of a heat source relative to the two

Thermosensorplatten can z. B. be calculated by measuring for pixels on the left or right thermal sensor plate exceeding a certain threshold temperature. If this limit is measured on a pixel on the first plate 0.5 seconds earlier than on the second plate, z. B. in a method of the invention are determined from the fact that the heat source is approximately 1 cm closer to the first plate than on the second plate.

For a frontal image, the pixel change applies analogously to the creation of a function curve. Further possibilities of algorithmic calculation result from the different distances of the isotherms, i. H. Regions with the same surface temperature, for the position of the heat source.

In addition, it is possible that conclusions about the size and intensity of the heat source can be derived automatically from the spatial distribution and the temporal development of the temperature. The device thus allows a fully automatic help for the diagnosis. For example, a rapid increase in temperature indicates a more perfused and potentially more dangerous lesion. Such a rapid rise in temperature can be determined more accurately and reliably by a camera with high temporal and spatial resolution and a corresponding evaluation unit than with manual analysis by the physician.

Another advantage of this embodiment is that the analysis can be carried out according to a fixed algorithm and thus in the patient with the same acquisition parameters and evaluation parameters follow-up examinations

in which any increase or increase in the aggressiveness of the lesion can be accurately determined. In an advantageous embodiment of the invention, it is provided that the heat distribution is recorded with a temporal resolution of at least ten images per second and a spatial resolution of at least 500 × 500 points, in particular at least 1280 × 720 points. It has been shown that a particularly accurate diagnosis is possible with a high spatial and temporal resolution. Such HD cameras are also available at low cost and can be read by a commercial computer.

In a further embodiment of the invention it is provided that the

Thermosensorplatten are arranged within a retaining ring and this ring is rotatably mounted in an angular range of at least 180 °.

Such a configuration allows a particularly comfortable movement of the thermal sensor plates and a precise adjustment to the chest of the patient.

In a particularly advantageous embodiment of the invention

Procedure with 5 shots from 5 different perspectives offers the possibility of a 3D model of the breast with the regions of interest projected in it. By calculating the heat propagation times, the ROI ^' s can be determined in their respective location. The benefits to breast-conserving (BE) surgical planning resulting from a 3D presentation are large. For the 3D representation is still a 3D recording of the breast in a natural position, ie without compression, advantageous.

Diagnosis of a suspicious lesion often requires histological clarification for further diagnostic or therapeutic procedures. The exact localization of the lesion for removal of tissue, which is required for this purpose, is an expensive procedure for many of the conventional examination methods, such as mammography or MRI. For some of the lesions, therefore, an examination procedure will, if possible, be simpler, lighter and less invasive great aparativen effort

avoided to be performed localization method. For example, in suspicious desmoplasias diagnosed by mammography

Localization and punch for tissue acquisition is commonly practiced with sonography. The change from one diagnostic method to one localization method with another conventional examination method can certainly be flawed. Ideally, a localization should be performed using the same method as the diagnosis. This is the only way to ensure that tissue is taken from the same lesion and the same area of the lesion. This requirement finds particular justification for localizations in the region of the easily deformable tissue of the glandular body of the female breast.

It is important to reproduce the conspicuous lesion found during a routine examination, from the process of further investigation to the histological diagnosis, observing certain standards that allow for accurate localization. From the time of the required visualization to the extraction of tissue samples from the conspicuous area in question, the position of the breast must not be deformed or deformed

Change the tissue removal device. Such a fixation of the breast can in particular by a on the thermo-arrangement

provided clamping frame can be achieved.

It is understood that the features mentioned above and those yet to be explained below can be used not only in the respectively specified combination but also in other combinations or settings without departing from the scope of the present invention.

Embodiments of the invention are illustrated in the drawings and are explained in more detail in the following description. Show it:

• Fig. La is a schematic side view of an inventive

contraption

FIG. 1b is a schematic top view of the device. FIG

Fig. 2a is a schematic view from the inside of one of the two

Thermo-arrangements of the device of Fig. La and lb

2b is a schematic view from the inside of a

Thermo arrangements with folding mechanism

FIG. 3a shows a schematic representation of the tilted thermal

Arrangements for a frontal image of the breast FIG. 3b is a schematic representation of a non-parallel

Arrangement of the thermal arrangements

• Fig. 4 is a schematic side view of another

Device according to the invention

• Fig. 5 is a schematic view of the further invention

Device from above

6 is a schematic representation of the region of the breast which is detected by the device according to the invention

• Fig. 7 a thermal test film with a bandwidth of 26 ° C to 38 ° C.

FIG. 8a shows a schematic representation of a breast with a lesion and the heat distribution emanating therefrom. FIG

FIG. 8b shows a schematic representation of a breast with a lesion and the heat distribution proceeding therefrom on the surface. FIG

FIG. 9 shows a thermo-arrangement according to the invention with it

mounted clamping frame and clamping frame foil

Fig. La shows a schematic side view of an inventive

Contraption. One of the two thermo-arrangements 1 with housing 2 is shown in rear view here in the position for a lateral admission of the breast in the so-called "oblique" admission. Arrangement slightly compressed, so that a contact surface of the two thermosensor plate is formed with the outside and inside of the chest The thermo-assemblies 1 are each connected to a support 3 with a pedestal 4 and are adjustable in height The thermo arrangements are in turn rotatable in their entirety by 90 ° about an imaginary axis lying between the holders 3. In the vertical column 4 there is a heat exchanger 5, which is connected by a hose connection 6 to a thermostat 7 In a part of the heat exchanger 10, the temperature required for the cooling process by a heating coil with W exchanger tightly regulated and kept constant. Through a separate circuit 11, the connection to the cooling plates 12 (see also Fig. 2) is made in the thermo-arrangements. In addition, a 3-D camera 14 for 3D display is provided. A computer 8 evaluates the recorded measured values. Fig. Lb shows a schematic view of the device seen from above. The two thermo-arrangements la and lb with the housing 2a and 2b and the digital cameras 13a and 13b and foil 15a and 15b are in the "oblique"

Attitude. The 3-D camera 14 is positioned to detect the area of the breast 20 that has no contact with the thermo-arrays 1a and 1b at either the "oblique" setting or the "Cc" setting. In Fig. Lb not shown are hoses that bring the cooling medium from the refrigerator 7 to the thermal arrangements la, lb.

Figure 2a shows schematically a thermal arrangement 1 in cross-section with the film 15, the cooling plate in the cooling position 12a and in the rest position 12b, the

Digital camera 13, the lighting 16a and 16b a modified parabolic reflector screen 17, an embedded software device 18 and the mechatronics 19 for the forward and backward movement of the cooling plate. The use of a parabolic reflector screen 17 makes it possible to reduce reflections from the film 15 and thus allows a more accurate recording of the film 15 by the camera 13th

Fig. 2b shows a further thermal arrangement 1, in which the removal of the cooling plate takes place via a folding mechanism.

Fig. 3a shows schematically the tilted thermo-arrangements la and lb, the pedestal 4 and therein contained heat exchanger 5. The tilting direction 21 is shown schematically by dashed arrows. It is understood that in addition to the tilted in 90 ° state and tilting conditions with angles between 0 ° and 90 ° are possible. It can also be provided a locking device with which the thermal assemblies la, lb are locked in a certain angle state.

FIG. 3 b shows thermal sensor plates 1 a, 1 b, which are applied at an angle to the breast 20. With an angle of approximately 45 °, a particularly good coverage of the breast can be achieved while at the same time reducing deformation of the breast. The comfort for the patient is thus increased.

Fig. 4 shows in front view another device according to the invention. In this case, an annular guide rail 31 is provided, in which a second annular mounting rail 33 can be moved. On the mounting rail 33 are shown schematically here, shown in two different positions, the thermo-arrangements 38 for the position of the "Cc" recording and in another position 34 for the "oblique" recording. The heat exchangers 32, 34 are shown behind the thermo-assemblies 38 in the view shown. The 3D camera 37 is between the thermal assemblies 38

intended. The uprights 35, 36 carry the entire arrangement.

Fig. 5 shows the device of Fig. 4 in side view. On the annular rigid guide rail 31, the mounting rail 33 is arranged. On the mounting rail of the heat exchanger 32 is attached to the thermal sensor plates 38. The position of the breast is represented by 39. The position of the 3-D camera is designated 37.

Fig. 6 shows schematically the region of the breast which is detected by the device according to the invention. The skin area of the breast which has no contact with the thermal sensor plates is designated 41. The surface 41 and the contour 42 of the breast is digitally detected by a 3-D camera 37. In particular, the position of the nipple 43 is detected exactly. In the image reproduction of the thermo-optical images from the "Cc" and "oblique" setting, the contour is projected onto the thermo-optical representation, so that a direct comparison of the localization of a lesion on the thermographic image with that on the mammography can be made.

Fig. 7 shows schematically the structure of a test film having a bandwidth of 26 ° C to 38 ° C. Apply the slide to the chest of a new one too

examining patient gives a color reaction on the film in the area corresponding to the minimum and the maximum of the chest temperature. For the examination of the patient, therefore, a diagnostic film would have to be selected with a starting temperature which corresponds to the range of the starting color of the test film and which offers optimal conditions as a prerequisite for a good diagnostic statement. This film to be selected is automatically displayed by the computer and is authorized by an automatic locking device as the only one of the three existing films, for example. After inserting the approved film, the cooling temperature allowed for this film is set automatically. Figures 8a and 8b show schematically how the position of a heat source

algorithmically determined by isotherm 62. In the chest 20 by conduction or heat conduction or heat flow, the heat flows from the place of origin according to the second law of thermodynamics in the direction of lower temperature, ie to the body surface. The heat is distributed approximately along a vector 61 perpendicular to the body surface, but also horizontally. The distances between the isotherms 62 and the center of the vector allow algorithmic conclusions to be drawn about the depth localization of the vector

Heat source to be pulled. By taking into account the corresponding values which result on the opposite thermosensor plate, an estimate of the 3D position of the lesion is possible if the distances of the thermosensor plates are known.

9 shows a schematic representation of a thermo-arrangement 1, the side of which facing the breast 20 is provided with a clamping frame 70 and a tightly stretched, transparent tensioning frame film 71. After this

Disinfecting the breast, a protective film 72 located on the breast side is removed from the tenter foil 71. Thereafter, the self-adhesive coating of the clamping frame film 71 is free and pressed together with clamping frame 70 on the chest. The protective film, which is on the side facing away from the chest

Tent film remains, remains until the end of the investigation process with the thermo-arrangement.

The clamping frame 70 together with clamping frame film 71 is fixed to the holding frame. Then the usual examination is carried out. After removal of the thermal arrangement 1, the evaluation of the recorded takes place

Temperature distributions. In particular, relevant regions of interest (ROI) are marked. These ROIs can then be projected onto the tenter foil with a laser. The tenter foil offers a sterile surface for this purpose. This surface and ROIs projected on it can thus be used for further diagnostics.

In other words, in the case of a lying patient, the clamping frame 70 with the tenter foil 71 for fixing the breast 20 to the affected breast 20 and the respective quadrant of the patient can be placed. Subsequently, the thermo-arrangement 1 is accurately inserted into the clamping frame 70 and with its thermo-optical film 15 with the clamping frame film 71 in contact brought. As a result, a thermo-optical native image builds up. After the usual cooling process with black detection and sequence imaging, the images stored in HD format are examined for the lesion and marked. After removal of the thermal arrangement whose previous position by the clamping frame 70, which has changed in position as little as fixed by the tenter frame breast, given. By means of a laser, which is fastened to the holding frame, the striking position of the ROI can then be projected onto the tenter foil by marking on a display.

Claims

claims

A device for thermally examining the female breast (20) with first and second thermosensor plates (15a, 15b) for measuring the temperature of the breast (20),

a cooling device (12a, 12b) for cooling the breast (20) and an evaluation unit (8) for evaluating the measured

temperatures

wherein the thermal sensor plates (15a, 15b) are aligned with each other so that the breast (20) between the two thermal sensor plates

is trapped.

Apparatus according to claim 1, characterized in that the first and / or second thermal sensor plate comprises a thermo-optical film (15a, 15b) whose color change is detected by a camera (13a, 13b).

Apparatus according to claim 1 or 2, characterized in that the thermal sensor plates (15a, 15b) are aligned substantially parallel.

Device according to one of the preceding claims, characterized

characterized in that the distance of the thermal sensor plates (15a, 15b) and / or the angle between the thermal sensor plates (15a, 15b) are adjustable.

Device according to one of the preceding claims, characterized

characterized in that the cooling device comprises a first and a second cooling plate (12a, 12b), which are the first and the second

Thermosensorplatte (15a, 15b) are assigned and are each movably mounted to these.

6. Apparatus according to claim 5, characterized in that a

Moving device is provided which is adapted to the

To move cooling plates (12a, 12b) away from the breast as a function of a temperature and / or time measurement.

7. Apparatus according to claim 5 or 6, characterized in that the cooling plates (12a, 12b) are supplied via hoses with a cooling medium.

8. Device according to one of the preceding claims, characterized

in that additionally a 3D camera (14) is provided, in particular a combination of a camera and a transmitter for structured light.

9. Apparatus according to claim 8, characterized in that the SD camera (14) is adapted to receive an image of the breast from the front.

10. Device according to one of the preceding claims, characterized

characterized in that the evaluation unit (8) designed to evaluate the measured temperatures, from a spatial

Distribution and a temporal evolution of the measured temperatures to estimate the position of a heat source in the chest (20).

11. Device according to one of the preceding claims, characterized

characterized in that the thermosensor plates (15a, 15b) are arranged within a retaining ring (33) and this ring is rotatably mounted in an angular range of at least 180 °.

12. A method for thermo-optic diagnosis of the female breast (20) with the steps

Applying at least two thermosensor plates (15a, 15b) for recording the temperature of the breast (20), Cooling the breast to a predetermined surface temperature of the breast (20) by applying a cooling plate (12a, 12b),

Ending the cooling by removing the cooling plate (12a, 12b) from the breast,

Evaluation of the heat distribution after removal of the cooling plate (12a, 12b)

A method according to claim 12, characterized in that the cooling automatically ends and recording the heat distribution

is automatically started when a certain surface temperature is reached.

Method according to one of claims 12 and 13, characterized in that the recording of the heat distribution includes recording a temporal change of the heat distribution and that the evaluation of the recorded heat distribution includes, a position of

Determine heat source based on the temporal change of the heat distribution.

Method according to one of Claims 12 to 14, characterized in that the heat distribution is recorded with a temporal resolution of at least 10 frames per second and a spatial resolution of at least 500 by 500 dots, in particular at least 1280 by 720 dots.