WO2016051005A1

WO2016051005A1 - Electromechanical mechanism for locating non-palpable lesions in mammographies

Info

Publication number: WO2016051005A1
Application number: PCT/ES2015/070714
Authority: WO
Inventors: Cecilia Elisabet GARCÍA CENA; Basil Mohammed AL-HADITHI; Antonio MARTÍN GONZÁLEZ
Original assignee: Fundacion Para La Investigacion Biomedica Del Hospital 12 De Octubre
Priority date: 2014-10-01
Filing date: 2015-10-01
Publication date: 2016-04-07
Also published as: ES2532523A1

Abstract

The invention relates to a mechanism including a laser signalling pointer (1) that can be linearly moved over the corresponding region of study of the breast of the patient, stopping at a point corresponding to previously determined coordinates (x,y), according to the exact point of the lesion to be located, such that once the lesion has been located in the plane, the mechanism or device will return to position (0Ό). Basically the mechanism comprises a base (2) with two linear guides (3) and a bridge (4) that can be moved on said guides and carries another guide and the laser signalling pointer (1), such that the movements can be carried out in any direction by means of two servomotors (16) and (17), controlled by a control unit (14) connected to a digital image viewing station (11) which will receive the exact co-ordinates by means of a computer application, using a screen (12) and the corresponding PC (13). The image showing the lesion is provided by a digital mammogram (6).

Description

ELECTROMECHANICAL MECHANISM INJURY LOCATOR NO

PALPABLE IN MAMMOGRAPHIES

D E S C R I P C I O N

OBJECT OF THE INVENTION

The present invention relates to a locator mechanism of non-palpable lesions on mammography. The object of the invention is to establish a correlation of a lesion obtained by a digital image of a mammogram with the region to be examined, by means of a mechanism capable of moving to a previously determined point of interest, automatically, the marking of said point it will be done with a pointing indicator; Once the point is located, the corresponding radiological procedure will be performed and the mechanism will return to the starting position, to the position (0,0). The final effect of the invention is developed to serve as a positioning instrument.

BACKGROUND OF THE INVENTION In tasks of locating mechanisms of this type for medical applications there are various devices, some of direct use and others consisting of two components.

The evolution of patents for mechanisms consisting of two components is as follows:

The first registered patent of a fenestrated compression plate and positioning mechanism dates from March 1981, which is registered under joint patent number US4259585. The second of June 1994 for the positioner with number US0053201 1 1A, and for the compression plate of June 2003, with number US6507748B2, and a subsequent patent also of compression plate of December 2013 with number US861 1491 B2. With respect to direct use devices, the first registered patent dates from September 1987, with patent number US4691333, multi-hole compressor adaptable to the image and grating system using a grid and strap and the second of July 1990, a multi-hole compression plate adaptable to a mammography body, with patent number US4943986. Subsequently in 2010, radio-transparent multi-grid compressors have been developed in a tennis racket arrangement.

The US4259585 patent presents a locating mechanism consisting of two components. The locator itself, located at the exit of the X-ray beam by means of a mechanical anchor, consists of a sliding system with two degrees of freedom being able to move in the plane (x, y). By means of its manual operation, the slider displaces from its ends, two metal rods coinciding 90 °, which, in the light of the collimator of the mammograph itself, mark the point on the lesion to be marked in the form of coordinate axes. This point is projected through the window of the fenestrated compressor. In said compressor alphanumeric characters are engraved on the edge of the window of the same to facilitate the location. This device has been used for applications in conventional analog mammography, even at the appearance of direct digital mammography. Patents US0053201 1 1A and US006507748B2 describe a locating mechanism also consisting of two components, locator and compressor fenestrated with alphanumeric characters, also located at the exit of the X-ray beam, by means of a mechanical anchor, consists of a flat gear system, for move a carrier head of a laser device in both coordinate axes, said device is fed from the mechanism itself. The actuation of the mechanism for its movement through the plane (x, y) is carried out manually, just like the laser drive, which once positioned at the point of interest, is projected through the window of the Fenestrated compressor. This type of mechanism somewhat more sophisticated than the previous one, is adapted for digital mammography is currently used but given its characteristics does not interact with the applications provided by digital mammography equipment. US4691333 describes a direct use device, main feature is that when performing the radiological technique of location, we only need one component, it is a radiopaque multi-perforating grid, adaptable to a chassis-holder system used in analogue mammograms, in which the processing of the image was obtained by chemical procedures and more recently by digital technology CR (Computer Radiography), the patient was placed on the multi-drilling grid and in turn on the chassis holder, through the holes of said compressor the point of interest is located, thus being able to perform the radiological procedure of location of the lesion.

US4943986 describes another device for direct use with multi-hole compressor, improved, and its location is on the body of the mammograph like the rest of compressors. The location of the lesion is done analogously to the previous one, matching the lesion between any of the holes of the same, this can be used in both analog and digital mammographers, the disadvantage of this type of devices is in the difficulty in making coinciding the lesion between a hole and not between the opening of the hole and especially when the approach is by posterior route, the location procedure is laborious.

DESCRIPTION OF THE INVENTION

The electromechanical locator mechanism, with two degrees of freedom from non-palpable lesions in a mammogram of the invention, is intended for use in a digital mammograph. Said mechanism would be placed at the exit of the beam of the equipment by means of a mechanical anchor of easy assembly-disassembly since we will only use it to signal the injury. The mechanism can be adapted to any mammogram through the groove of a protective visor, located on both sides of the collimator window, or by means of an adapter on it.

The mechanism is constituted by a base, on which two linear precision guides for medical applications will be fixed, on its lateral face and a bridge on it that will be fixed another guide with similar characteristics bearing the indicator indicator, both will move in a way automatic in any direction of the plane, by means of the actuation of two servo motors of direct current, controlled by a control unit, this will be connected to a digital image display station, to a computer from where the exact coordinates will be sent, so this would be done at through a computer application. The drive components, the servomotors, will be located in the mechanism itself, the control unit and the power supply in the vicinity thereof, both will adopt a special general connection diagram.

The electromechanical locator mechanism, is accompanied for the realization of the radiological procedure of a fenestrated compression plate, as described above, not object of the invention since any of the existing patented ones can be used, with the exception that it should be placed on the edge Outside the window of the same, a mark will indicate the point for the calibration of the electromechanical mechanism locator. The locator calibration will consist of moving the locator pointer to the position (0,0) of the fenestrated compression plate.

One aspect to take into account with respect to calibration is the degree of compression of the breast, since this is variable according to its characteristics, so once the breast is compressed, the object in this case the Fenestrated compression plate window is enlarged in the FD / FO ratio, (FD detector focus distance) and (FO object focus distance), displacing (+ X or -X) and (+ Y or -Y) the starting point (0,0) of the locator in the image, with respect to (0,0) of the patient's breast. This has its importance in the calibration itself and therefore in the precision of the mechanism when locating the lesion in the image and its correlation with the region to be examined.

The automatic actuation of this mechanism, in the location of the point of the injury that interests us, presents a series of advantages over its predecessors. One of them is that the positioning of the coordinates of the point of the injury, is performed from the application in the viewing station and not from the patient side, you can choose or modify the position of said point quickly and once decided, send the order to the locator. It can be saved in the application in the patient's file and be available for viewing at the desired time, it is not necessary to remove the mechanism until the end of the procedure, thanks to its design.

The main application of this mechanism helps in the following radiological procedures: Pre-surgical Location for Biopsy of non-palpable lesion with needle-harpoon system and fenestrated compression plate; With the locator mechanism, the coordinates of the point chosen by the radiologist where the harpoon will be placed at the point of injury will be determined. Another application will be the location of non-palpable lesions, for its marking by means of a marker clip prior to subsequent treatment. In the location and marking of the x-ray of the surgical piece secondary to the surgery of the lesions included therein by means of a needle to facilitate its identification by the pathologist in the macroscopic study. In surgical pieces throughout the pathological study, in the case that the pathologist does not identify the lesion in the macro and / or microscopic study, by locating and marking the lesion by means of a needle. In this case the pieces are radiographed after fixation in formalin. Given the difficulty of locating the lesion / lesions, in this case, the locator mechanism would be performed immediately.

Another application for this device is the location of lesions in the mammography image and its correlation with the region itself to be examined that will help us to locate these lesions in other stereotactic equipment to perform biopsies by procedures stereotaxics, since mammography can be performed and the exact point of interest on the patient can be marked on the patient, thus facilitating the location of lesions of interest in the most complex cases.

The described locator is designed for use in digital mammography and serves as a positioning instrument, matching the correlation between a lesion obtained in mammography and the patient's own breast, precisely, by interconnecting the elements corresponding to an application computing, a control unit, a linear actuator and two direct current servomotors. The electromechanical locator mechanism can be mounted on any digital mammograph, on the groove of the protective visor or by means of a small adapter on the base of it. Given the characteristics of the preliminary design (dimensions, size, physical characteristics) it is a simple mechanism, easy assembly / disassembly and simple calibration.

DESCRIPTION OF THE DRAWINGS To complement the description that is going to be made below and in order to help a better understanding of the features of the invention, according to a preferred example of practical realization thereof, it is accompanied as an integral part of said description, a set of drawings in which, with an illustrative and non-limiting nature, the following has been represented:

Figure 1. It shows a perspective view of the electromechanical locator mechanism, which shows the output of the X-ray beam, and all the components of the mechanism.

Figure-2 Shows a perspective view of the location of the electromechanical locator mechanism, on a generic digital mammograph, with its main elements assembled.

Figure-3 Shows an exploded view of the mechanism components.

Figure-4 It shows a perspective view of the electromechanical locator mechanism and the fenestrated compression plate.

Figure-5 It shows the general connection diagram of the electromechanical locator mechanism, the components that integrate it and the interrelation between them.

Figure-6. It shows the flowchart of the computer application installed in the display station, where we start from a file in which the same.

Figure-7 Shows the display station, once inside the location application.

Figure-8. It shows the location application, in which we can see the calibration point (14) printed on the mammogram in the two projections as well.

Figure-9 It shows a compressed breast resting on a mammogram detector with a fenestrated compression plate.

Figure-10. It shows an interconnection flow diagram of the application, where the locator mechanism intervenes, with other stereotactic equipment. Figure-1 1. Shows the appearance of a DC servo motor.

Figure-12 Shows the appearance of the control unit.

PREFERRED EMBODIMENT OF THE INVENTION

Based on the aforementioned figures, a description will be made of the preferred embodiment of the electronic locator mechanism, which according to figure 1, comprises a base (2) of the mechanism assembly, in which two linear guides to both are established sides, that is to say on each of the longitudinal sides, said guides corresponding to the reference (3) of that figure 1.

On these linear guides (3), a bridge (4) with its corresponding linear guide (5) is moved, according to a linear displacement on the X axis, and on whose bridge (4) the laser pointing pointer (1) is also mounted. , serving this to mark the point of the injury that interests.

Figure 2 shows the electromechanical mechanism locator on a generic digital mammograph (6), with its main elements assembled. On said body of the digital mammograph (6) a fenestrated compression plate (7) is arranged, which is movable upwards / downwards along said mammograph (6).

The electromechanical locator mechanism to perform the radiological procedure is placed on the groove of the protective visor (8), at the exit of the X-ray beam (9).

In figure 3 the different components of each mechanism are shown in explosion, the linear and longitudinal guides (3), with the appropriate guides (3 ') in those longitudinal guides (3), the bridge (4) as well as the guide ( 5) and the laser pointing pointer (1).

Figure 4 shows a perspective view of the same electromechanical locator mechanism with the components already described, as well as the fenestrated compression plate (7) shown in Figure 2, the point corresponding

(10) the one corresponding to the calibration point of the mechanism with respect to the fenestrated compression plate (7), thus allowing to obtain the starting point when making the correlation of the lesion seen in the image, with the exact point where found in the breast to study, so that the calibration point (10) mentioned, will be located on the upper right edge of the window (1 1) corresponding to the fenestrated compression plate (7), as it seems in that figure 4.

Figure 5 shows the general connection diagram of the electromechanical locator mechanism that is being described, with the components that integrate it and the interrelation between them, including what can be considered a viewing station (1 1), with monitor (12 ) and PC (13) seeing the control unit (14), the linear actuator (15), fed through alternating current control voltage (16) and also showing the blocks corresponding to the servomotors (16) and ( 17), all related to the considered electromechanical locator mechanism represented, in this figure 5, by the block (18).

That is, to put into operation the described locator mechanism and automatically, it will be done from the viewing station (1 1) commented with the computer application installed and responsible for bringing the locator to the desired point, the control unit (14) being responsible for the actuation of the servomotors (16) and (17), which will allow the guides (3) to move, and as Last purpose, bring the pointing pointer (1) to the desired point.

Logically, the referred set will have a supply voltage controlled by the control unit (14) and by the application itself.

Figure 6 shows a flow chart of the computer application installed in the viewing station (1 1), starting from a file (19) in which that viewing station (1 1) is located. Previously, the mechanism will have been placed in the mammograph, on the corresponding groove of the protective visor (8) shown in figure 2. In this figure 6, the block corresponding to the application (20), the block corresponding to the calibration (21), the block (22) corresponding to the pointer in position (0Ό) the synchronization block (23) of the mechanism, the information block (24) to the locator, as well as the lesion location block (25) and the block corresponding to the beginning of the exam (26).

In this way, once the mechanism has been placed on the mammogram as previously stated, the locator calibration is continued, consisting of moving the locator pointer to the position (0Ό) of the compression plate (7), this information being sent to the locator via WIFI, afterwards the examination is started and the guided location of the lesion is carried out, by means of a grid that corresponds to the block (27) of that figure 6, grid (27) that is recorded in the application, the position being sent to the locator desired, through the block (28), continuing with the radiological procedures, according to the block (29), moving with the last mammogram (30) so that the locator is outside the radiation field, according to the block (31), ending , by block (32), what is the procedure performed.

Figure 7 shows the display station that had been referenced with (1 1) in Figure 5, once inside the location application, showing at the bottom of the screen, the location grid (32) that logically corresponds to the block (27) corresponding to the diagram of Figure 6. On that location grid (32) the mammogram of the breast (33), compressed, will be performed with the fenestrated compression plate (7).

In the commented figure 7, we wanted to represent the lesion (33) remaining within it, in the two different projections CC (cranio-caudal) and ML (mid-lateral) of the mammogram, so that by clicking with the mouse on the lesion (33), the coordinates of said lesion will be fixed on the digital image of the breast (33), to be able to be sent to the locator mechanism and determine the exact point that corresponds to the patient's breast (33) .

Figure 8 shows the location application, in which you can see the calibration point (34) printed on the mammogram, in the two projections as well.

In figure 9, a compressed breast (35) is shown, resting on a detector (36) of a digital mammograph, with the fenestrated compression plate (7). In this figure you can see the focal point F, the distance between F and D between said focal point F and the detector, and the distance FO between the focal point F and the object, as well as the starting point (0Ό) of the locator .

The window (1 1) of the fenestrated compression plate (7) is enlarged in the ratio FD / FO, an important factor in the calibration and in the precision of the mechanism when locating the lesion.

Figure 10 shows the flow diagram of the interconnection of the application, where the locator flow mechanism ends with the stereotactic equipment, so that the location and marking of an injury, with the locator mechanism, will facilitate the task to the time to perform other radiological procedures such as stereotactic biopsies in the most complex cases.

This block diagram of figure 10 shows the block, the stereotactic equipment (39), the monitor (12) with the PC (13) already referred to in figure 6, the stereotaxy station (40) the mammography station (41), the information block (42), the lesion locator (43) and the corresponding marker (44), and the direct current servo motor and the corresponding control unit to references (17) and (14) respectively of Figure 5.

Claims

R E I V I N D I C A C I O N E S

1 .- electromechanical drive locator nonpalpable lesions on mammograms, intended for use in digital mammography to serve as positioning tool and to match the correlation between lesion obtained on a mammogram and self breast of the subject, characterized because it includes a computer application (20), a control unit (14), a linear actuator and servomotors (16) and (17) of direct current, structurally comprising a base (2), with lateral and longitudinal guides (3) for displacement in both directions, of a bridge (4) with a guide (5) and a laser pointing pointer (1), with the particularity that said longitudinal guides (3) are precision and are fixed on the base (2 ) and over the bridge itself (4), forming an assembly to facilitate the displacement of the laser pointing pointer (1), both on the X axis and on the Y axis, and where the locating electromechanical mechanism goes mon tado on a generic digital mammograph (6) equipped with a fenestrated compression plate (7) movable up and down, on the groove of the protective visor (8) at the exit of the X-ray beam (9). 2 .- electromechanical drive locator nonpalpable lesions on mammograms, according to claim 1, wherein the pointing device (1) is positioned over the fenestrated compression plate (7).

3 .- electromechanical drive locator nonpalpable lesions on mammograms, according to previous claims, characterized in that the computer application (20) includes synchronization means both the mechanism as a whole, as calibration and preparation to begin the examination or corresponding radiological procedure. 4 .- electromechanical drive locator nonpalpable lesions on mammograms, according to previous claims, characterized in that it is configured to be calibrated before performing the medical procedure, by positioning the pointing device in the position (0,0) of fenestrated compression plate ( 10), this position depending on the degree of compression of the breast of the patient.

5 .- electromechanical drive locator nonpalpable lesions on mammograms, according to previous claims characterized in positioning the point coordinates of the lesion is performed from the application, in the viewing station (11).

6 ^a. - Electromechanical mechanism for locating non-palpable lesions in mammograms, according to previous claims, characterized in that said mechanism will move to the starting position, outside the radiation field, once the screening mammogram has been performed, by connecting the locator to the system of mammography shot of a generic digital mammograph.