Patent Publication Number: US-2023143589-A1

Title: Medical analysis apparatus

Description:
This application claims priority to Italian Patent Application IT102021000028373 filed Nov. 8, 2021, the entirety of which is incorporated by reference herein. 
     This invention relates to a medical apparatus for X-ray analyses. 
     There are known medical X-ray apparatuses which comprise a source configured to emit X-rays and a detector configured to receive the X-rays emitted by the source. 
     Such apparatuses can be machines to perform, for example, mammography, tomosynthesis, breast CT, biopsies, CESM. 
     In order to perform the above-mentioned medical tests, the patient&#39;s breast is interposed between the X-ray source and the detector. 
     In this way, the breast may be passed through by the X-ray radiation which has been emitted by the source, so that the image of the breast is generated on the detector. 
     Some apparatuses are designed to allow examinations with the patient in a vertical position in such a way that the procedure is easy for the patient, for breasts of any size. 
     Prior art systems, which are generally apparatuses dedicated specifically to a particular examination, have a supporting table for the patient so as to perform an examination in a prone position. 
     The prone position allows the operators to work in a more comfortable manner around the patient and to reduce the occurrence of vasovagal reactions, that is, fainting, in particular for performing the biopsy. 
     However, the vertical position may be uncomfortable to maintain, or even impracticable, for elderly or disabled patients. 
     Moreover, an examination with the patient in a vertical position may be less comfortable for the operators. 
     At the same time, however, for these patients, the prone position may also be difficult, or even impossible, to be achieved due to any limitations to the motor functions. 
     A need felt in the trade is to speed up and facilitate the positioning of the patient for examinations performed using X-ray medical apparatuses. 
     An aim of the invention is to provide an apparatus for X-ray examinations which overcomes the above-mentioned drawbacks and satisfy the above-mentioned need. 
     More specifically, an aim of the invention is to provide an apparatus for X-ray medical examinations which improves the speed, ease and comfort of the procedures for positioning the patient for these examinations. 
     Another aim of the apparatus for X-ray examinations described in the invention is to ensure ease of operation of the apparatus for the operators who operate it. 
     A further aim of the invention is to provide an apparatus for X-ray examinations which guarantees a high level of safety during these examinations both to the patient and to the operators in charge. 
    
    
     
       The features of the invention are clearly described in the claims below and its advantages are more apparent from the detailed description which follows, with reference to the accompanying drawings which illustrate a preferred, non-limiting example embodiment of the invention and in which: 
         FIG.  1    is a schematic view of an embodiment of the apparatus according to the invention; 
         FIGS.  2  and  3    are schematic perspective views of the apparatus of  FIG.  1   ; 
         FIG.  4    is a schematic perspective view of a detail of the apparatus of  FIG.  1   ; 
         FIGS.  5  and  6    are schematic side views of the apparatus of  FIG.  1    in two different positions without some parts, in order to better illustrate others; 
         FIGS.  7  and  8    are schematic perspective views of the apparatus of  FIG.  1    in two different configurations; 
         FIG.  9    is a schematic perspective view of the apparatus of  FIG.  1   ; 
         FIGS.  10 A and  10 B  schematically illustrate cross sections of a detail of the apparatus of  FIG.  1   ; 
         FIG.  11    schematically illustrates a detail of the apparatus of  FIG.  1   . 
     
    
    
     It should be noted that all the drawings are schematic and are therefore not representative of the actual dimensions of the system. 
     With reference to the accompanying drawings, the numeral  1  denotes a medical apparatus for X-ray analysis. 
     According to the invention, the apparatus  1  comprises at least one support device  10  for a patient, a control unit U and a machine  40  to allow a diagnosis using X-rays. 
     According to this invention, the control unit U comprises a first control module U 1 . 
     Preferably, the first control module U 1  is associated with the machine  40 . 
     According to the invention, the machine  40  comprises at least one X-ray source  41  and at least one X-ray detector  42 . 
     The support device  10  for a patient comprises a portion  11  which can be inclined between a non-operating position P 1  and an operating position P 2 . 
     According to and aspect of the invention, the support device  10  comprises a base portion  19 . 
     According to an aspect of the invention, the apparatus  1  comprises a first actuator  21 . 
     The control unit U is configured to control the first actuator  21 . 
     In the accompanying drawings the control unit U has not, for simplicity, been connected to the various actuators. 
     Preferably, the first actuator  21  is an electromechanical actuator. 
     The actuator  21  is designed to move the inclinable portion  11 , with respect to the base portion  19 , in rotation with respect to an axis A 2  transversal to the main direction of extension D 1  of the inclinable portion  11 . 
     Preferably, the transversal axis A 2  is horizontal. 
     In other words, the actuator  21  may be, for example, a piston or a telescopic jack which, by applying a force on the inclinable portion  11 , allows the rotation of the inclinable portion  11  about a pivot located below it, in use, at the axis of rotation A 2 . 
     This rotation allows the inclinable portion  11  to be inclined between the non-operating position P 1  and the operating position P 2 . 
     It should be noted that the inclinable portion  11  may be positioned in any intermediate position between the non-operating position P 1  and the operating position P 2 . 
     According to an aspect, the non-operating position P 1  corresponds to the position of the inclinable portion  11  in which the patient is positioned on the inclinable portion  11 . 
     According to a preferred embodiment, as illustrated in  FIG.  6   , the non-operating position P 1  corresponds to a vertical position of the inclinable portion  11 , that is to say, a position in which the patient can rest on the inclinable portion  11  in a standing position. 
     According to a preferred embodiment, as illustrated in  FIG.  5   , the operating position P 2  corresponds to a position of the inclinable portion  11  inclined at a predetermined angle α relative to the horizontal of between 0° and 90°. 
     According to an aspect of the invention, the support device  10  comprises means  22  for locking the inclinable portion  11 , configured to allow a locking of the inclinable portion  11  in a predetermined position between the non-operating position P 1  and the operating position P 2 . 
     The locking means  22 , for example, may be mechanical and/or electrical. 
     The control unit U is configured to control the locking means  22 . 
     In other words, the inclinable portion  11  can move from a vertical position to a horizontal position and vice versa, locking at any angle α of between 0° and 90°. 
     Preferably, the operating position P 2  corresponds to a position of the inclinable portion  11  inclined at an angle α of between 20° and 40° relative to the horizontal; still more preferably, the angle α is 30° relative to the horizontal. 
     Advantageously, the movement of the inclinable portion  11  from a vertical position to a horizontal position, and vice versa, allows the patient to be positioned easily and comfortably whilst the portion  11  is vertical and, subsequently, by adjusting the inclination of the portion  11 , an optimum positioning can be obtained for the examination. 
     The mobility of the inclinable portion  11  thus favours and speeds up the positioning of the patient, supporting relative limited motor functions, without adversely affecting the correct positioning with respect to the machine  40  for the analysis to be performed. 
     Advantageously, the possibility for the inclinable portion  11  to lock at any angle makes it possible to reach the optimum position for any type of examination. 
     According to an aspect, the inclinable portion  11  of the support device  10  comprises a supporting surface  12  for the patient. 
     According to an aspect, the supporting surface  12  has an opening  13 . 
     The opening  13  is designed to receive at least one breast of the patient. 
     By way of example, the inclinable portion  11  may be an inclinable couch on which the patient can rest with the abdomen facing towards the couch, in such a way that at least one relative breast inserts into the opening  13 . 
     The opening  13 , with reference to the position P 1  of the inclinable portion  11 , is situated in an upper portion of the inclinable portion  11 . 
     The opening  13  is preferably curvilinear in shape; still more preferably circular, elliptical or oval in shape. 
     According to an aspect of the invention, the inclinable portion  11  of the support device  10  comprises an lifting plane  14 . 
     In other words, the inclinable portion  11  comprises an lifting plane  14  which is coupled (preferably movably) to the supporting surface  12 . 
     According to a preferred embodiment, the lifting plane  14  is perpendicular to the supporting surface  12 . 
     According to a preferred embodiment, the lifting plane  14  is a footboard. 
     The lifting plane  14 , with reference to the position P 1  of the inclinable portion  11 , is situated in a lower portion of the inclinable portion  11 . 
     According to a particular embodiment, the lifting plane  14  does not have a mechanical connection with the inclinable portion  11 . 
     The lifting plane  14  can be movable along a main direction of extension D 1  of the inclinable portion  11 . 
     According to an aspect, the apparatus  1  comprises a fifth actuator  25 . 
     The control unit U is configured to control the fifth actuator  25 . 
     Preferably, the fifth actuator  25  is an electromechanical actuator. 
     The fifth actuator  25  is configured for moving the lifting plane  14  along the main direction of extension D 1  of the inclinable portion  11 . 
     In other words, it is possible to move the lifting plane  14  on the supporting surface  12  along the direction D 1 . 
     Considering the embodiment wherein the lifting plane  14  is perpendicular to the supporting surface  12 , the perpendicularity between the lifting plane  14  and the supporting surface  12  remains during and after the movement of the lifting plane  14 . 
     The control unit U is configured to control the fifth actuator  25 . 
     Advantageously, the presence of the lifting plane  14  facilitates the patient in positioning relative to the apparatus  1 . 
     Advantageously, the movable lifting plane  14  allows the patient to be positioned on the inclinable portion  11  of the support device  10  in an optimum manner regardless of the anthropometric measurements of the patient. 
     In other words, the lifting plane  14  is raised and lowered allowing the patient to always be positioned on the inclinable portion  11  in such a way that at least one breast is at the opening  13 . 
     According to an aspect of the invention, the support device  10  comprises at least one lateral support  15  (illustrated schematically in  FIG.  3   ). 
     Advantageously, the presence of at least one lateral support  15  facilitates the approach to the lifting plane  14  by the patient. 
     In other words, the patient can rest on the lateral support  15  to climb with the feet on the lifting plane  14 . 
     Advantageously, the at least one lateral support  15  makes it possible to avoid any falls of the patient, especially in the case of fainting, at the sides of the inclinable portion  11 , especially when the latter is in the operating position P 2  or during the movement from the non-operating position P 1  to the operating position P 2  (and vice versa) of the inclinable portion  11 . 
     According to an aspect of the invention, the support device  10  comprises further aids and supports, not illustrated in the accompanying drawings, designed to widen the supporting surface  12  for the patient and to improve the comfort of the patient. 
     Preferably, the further aids and supports can be removably coupled to the inclinable portion  11 . 
     According to an aspect of the invention, the support device  10  comprises a breast protection support  16 . 
     According to an aspect, the breast protection support  16  may be made of metallic or plastic material. 
     The breast protection support  16  is located below, in use, the inclinable portion  11  at the opening  13 . 
     The breast protection support  16  is removable with respect to the inclinable portion  11 . 
     In particular, the breast protection support  16  can be attached to or removed from the inclinable portion  11  without moving the patient already positioned. 
     According to an aspect, the breast protection support  16  has sheet-like shape and is curved to adapt to the shape of the opening  13  and of the breast of the patient. 
     The breast protection support  16  may be coupled to the inclinable portion  11  at different possible inclinations relative to the inclinable portion  11 . 
     Advantageously, the breast protection support  16  makes it possible to prevent any impact between the breast and the machine  40  during an operational analysis step. 
     It should be noted that the protection support  16  is removable relative to the inclinable portion  11  since it is not necessary in all the examinations and could even become a disturbing element. 
     According to a preferred embodiment, the breast protection support  16  has graphical marking elements. 
     The graphical marking elements are, for example, graphical aids, which can also be luminous, which provide visual references in such a way as to guarantee the correct positioning of the breast. 
     Advantageously, the graphical marking elements make it possible to compensate for alignment errors between the support device  10  and the machine  40 . 
     According to an aspect of the invention, the apparatus  1  comprises a radiofrequency identification element  17 . 
     According to a preferred embodiment, the radiofrequency identification element  17  is associated with the breast protection support  16 . 
     The radiofrequency identification element  17  is operatively connected to the control unit U. 
     The control unit is configured for reading the RFID signal coming from the radiofrequency identification element  17  and adjusting the collimation process of the X-rays as a function of it. 
     Advantageously, the radiofrequency identification element  17  makes it possible to compensate for the shape of the protection support  16  during reconstruction of the image. 
     The base portion  19  of the support device  10  comprises a plurality of wheels  20 . 
     According to an aspect of the invention, the support device  10  comprises parking brakes  18 . 
     The parking brakes  18  are configured so that, once activated, they prevent any movements of the support device  10 . 
     According to an aspect of the invention, the apparatus  1  comprises a manual lever designed to actuate the parking brakes  18 . 
     According to an embodiment, the parking brakes  18  are configured to be actuated automatically when the patient climbs onto the lifting plane  14 . 
     In other words, the lifting plane  14  may comprise sensors designed to detect the presence of a patient on it. 
     The control unit U is connected to these sensors and is configured to operate or not the parking brakes  18  as a function of the signal detected by the sensors. 
     Advantageously, the parking brakes  18  guarantee that the support device  10  is not moved whilst the patient is already positioned on the inclinable portion  11 . 
     Advantageously, the parking brakes  18  guarantee that the support device  10  does not move in an unexpected manner during the X-ray examinations. 
     According to an aspect of the invention, the apparatus  1  comprises movement sensors  24  of the support device  10  and/or of the patient. 
     The movement sensors  24  are, for example, in a non-limiting manner, video cameras and/or lasers and/or radar. 
     According to a preferred embodiment, the movement sensors  24  are accelerometers. 
     The movement sensors  24  are connected to the control unit U and are configured to send a signal to the control unit U. 
     The control unit U is configured to derive images as a function of the signal. 
     In other words, if there is an unexpected movement of the support device  10  or, as is more likely, of the patient, the movement sensors  24  are able to detect it and transmit information to the control unit U in such a way that it derives the image taking into account this movement. 
     Advantageously, thanks to the connection between the movement sensors  24  and the control unit U it is possible to increase the level of precision of the images derived from the X-ray analysis, even in the presence of unpredictable movements caused by external forces or in any case not controllable in advance. 
     According to an aspect of the invention, the control unit U comprises a second control module U 2 . 
     Preferably, the second control module U 2  is associated with the support device  10 . 
     The second control module U 2  is electrically coupled to the lifting plane  14  and/or to the first actuator  21 . 
     The second control module U 2  is configured to control the movement of the lifting plane  14  and/or the first actuator  21 . 
     According to an embodiment, the second control module U 2  is configured to receive the signal sent by the movement sensors  24 . 
     According to the invention, the machine  40  comprises a source  41  configured to emit X-rays, an X-ray detector  42  and a supporting frame  43 . 
     The supporting frame  43  supports at least the source  41  and the detector  42 . 
     According to an aspect, the machine  40  comprises a base frame  49 . 
     According to an aspect, the machine  40  comprises an arm  51 . 
     The supporting frame  43  is connected (indirectly) to the base frame  49  by the arm  51 . 
     The arm  51  is rotatably connected (hinged) to the base frame  49 . 
     The arm  51  supports the supporting frame  43 . 
     According to the invention, the apparatus  1  comprises coupling means  30  between the support device  10  for a patient and the base frame  49 . 
     The coupling means  30  are configured to allow a removable coupling between the support device  10  for a patient and the base frame  49 . 
     Advantageously, a removable coupling between the support device  10  and the base frame  49  allows, for example, the positioning of the patient on the support device  10  to be disengaged from the presence of the machine  40  and/or to perform maintenance individually on the support device  10  or machine  40  or to replace one or the other if necessary. 
     It should be noted that the machine  40 , once the support device  10  has been detached from it, can be adapted easily and extremely quickly also for other examinations, in particular its configuration may be modified, by moving, for example, the supporting frame  43  between a first operating position P 3  and a second operating position P 4  to allow a diagnostic examination to be performed in the second operating position P 4 . This aspect is described in more detail below, where the advantages connected to the mobility of the supporting frame  43  may be inferred in a clearer manner. 
     Advantageously, a removable coupling between the support device  10  and the base frame  49  makes it possible to make the maintenance and transport operations of the machine  40  and/or of the support device  10  more comfortable since they can be performed individually. 
     Advantageously, the removable coupling between the support device  10  and the base frame  49 , together with the possible inclination of the supporting frame  43  between a first and a second operating position (P 3 , P 4 ) and of the inclinable portion  11  at various angles, makes it possible to quickly pass from a configuration of the apparatus  1  for mammography/tomography with the patient standing to one in which to perform, for example, a Cone Beam Breast Computed Tomography (CBBCT) with the patient in the prone position. 
     The coupling means  30  may be, for example, mechanical or magnetic. 
     According to an embodiment, the coupling means  30  comprise first means  31  and second means  32  removably acting in conjunction with the first means  31 . 
     The first means  31  are associated with one of either the support device  10  or the base frame  49  and the second means  32  are associated with the other between the base frame  49  or the support device  10 . 
     According to an aspect, the first means  31  comprise a protuberance  33 . 
     According to an aspect, the second means  32  comprise a recess  34 . 
     The protuberance  33  and the recess  34  are configured to be coupled by a shape coupling. 
     According to a preferred embodiment, illustrated in  FIGS.  10 A and  10 B , the coupling means comprise a locking element  35 . 
     The second means  32  comprise a cavity  36 . 
     The locking element  35  is configured to be inserted in the cavity  36 . 
     The protuberance  33  has at least one protrusion  37  and the locking element  35 , when inserted in the cavity  36 , is configured to make contact with the at least one protrusion  37 . 
     In other words, the locking element  35  prevents the protuberance  33  from coming out of the recess  34 . 
     According to another embodiment, the first means  31  are magnets which can be removably coupled directly to the base frame  49 . 
     For example, the base frame  49  is made of a ferromagnetic material. 
     According to an aspect of the invention, the apparatus  1  comprises a manual lever designed to couple or uncouple the support device  10  and the base frame  49  using the coupling means  30 . 
     According to an aspect, the manual lever is also designed to operate the parking brakes  18 . 
     In other words, by actuating the manual lever, it is possible simultaneously couple and lock the support device  10  to the base frame  49  and activate the parking brakes  18  to prevent movements of the apparatus  1 . 
     According to an aspect of the invention, the coupling means  30  are configured to allow a removable coupling between the support device  10  for a patient and the machine  40 . 
     For brevity of description and to prevent repetitions, the coupling is not described in detail. 
     It should be noted, however, that the coupling between the support device  10  and the machine  40  using the coupling means  30  maintains all the features, configurations and advantages described above for coupling between the support device  10  and the base frame  49 . 
     The supporting frame  43  can be inclined, by means of a rotation about an axis of inclination A 1 , between a first operating position P 3  and a second operating position P 4 . 
     According to a preferred embodiment, the axis of inclination A 1  is parallel to the horizontal. 
     According to an embodiment, the axis of inclination A 1  passes through a pivot about which the arm  51  is hinged. 
     By means of the arm  51 , the mechanical connection occurs between the base frame  49  and the supporting frame  43 . 
     The arm  51  is hinged to the base frame  49  and is configured to rotate about the axis of inclination A 1 . 
     The supporting frame  43  is connected to the arm  51  (supported by the arm  51 ) and rotates in an integral fashion about the axis of inclination A 1 . 
     The inclination of the frame  43  between the first operating position P 3  and the second operating position P 4  allows a diagnostic examination to be performed in the first operating position P 3  or in the second operating position P 4 . 
     According to a preferred embodiment, illustrated in  FIG.  11   , the first operating position P 3  corresponds to an arrangement of the supporting frame  43  in such a way as to perform a mammography with the patient standing up. 
     In other words, in the first operating position P 3  the X-ray source  41  and the X-ray detector  42  are positioned, in use, parallel to the horizontal: one below and the other above, or vice versa, relative to the breast of the patient. 
     Advantageously, the possible inclination of the supporting frame  43  at different angles allows the apparatus  1  to be positioned in an optimum manner depending on the type of examination and/or the patient. 
     Preferably, the second operating position P 4  of the supporting frame  43  is associated with the operating position P 2  of the inclinable portion  11  of the support device  10 . 
     Preferably, when the support device  10  and the machine  40  are coupled by the coupling means  30 , the supporting frame  43  is inclined by rotation about the axis of inclination A 1  by the same angle of inclination of the inclinable portion  11  relative to the horizontal. 
     Advantageously, the movement of the support device  10  and the machine  40 —each depending on the movement of the other—allows X-ray analyses to be performed with different positions and geometries. 
     Advantageously, simultaneously inclining the support device  10  and the machine  40  allows the operators to manoeuvre the machine  40  in a more comfortable manner than a prior art apparatus operating at a single fixed inclination. 
     According to an aspect of the invention, the apparatus  1  comprises a second actuator  46 . 
     The second actuator  46  is configured to incline the supporting frame  43  between the first operating position P 3  and the second operating position P 4 . 
     The control unit U is configured to control the second actuator  46 . 
     According to an aspect, the first control module U 1  of the control unit U is configured to control the second actuator  46 . 
     The first control module U 1  is electrically coupled to the X-ray detector  42  to receive a signal relating to the X-rays detected by the X-ray detector  42 . 
     The first control module U 1  is configured to process said signal and derive an image. 
     The images derived may be, for example, two-dimensional or three-dimensional reconstructions of the breast. 
     According to an embodiment, the machine  40  comprises a breast compressor (not illustrated in the accompanying drawings). 
     The compressor is configured to compress the breast between the compressor itself and the X-ray detector  42  and is used, by way of a non-limiting example, during mammography. 
     Compression of the breast makes it possible to reconstruct higher quality images. 
     According to an aspect of the invention, the supporting frame  43  is configured to rotate about an axis of rotation A 3 . 
     According to a preferred embodiment, as illustrated in  FIG.  1   , the axis of rotation A 3  is perpendicular to a direction parallel to the axis of inclination A 1 . 
     The supporting frame  43  can be inclined by rotating about the axis of inclination A 1  and rotated about the axis of rotation A 3 . 
     It should be noted, for a more immediate understanding, that when the supporting frame  43  rotates about the axis of inclination A 1 , the axis of rotation A 3  also rotates in an integral fashion, relative to the supporting frame  43 , about the axis of inclination A 1 . 
     Advantageously, rotating the supporting frame  43  about the axis of rotation A 3  makes it possible to perform examinations, such as, for example, the CBBCT, which require the rotation/oscillation of the X-ray source  41  as one with the X-ray detector  42 . 
     According to an aspect of the invention, the axis of rotation A 3  is situated on the supporting frame  43  at a distance from the X-ray detector  42  of between 10 mm and 300 mm, preferably between 10 mm and 200 mm, even more preferably between 10 mm and 100 mm. 
     Advantageously, the axis of rotation A 3  located at a smaller distance from the detector  42  than the source  41  allows the detector  42  to be kept at an optimum distance from the breast for capturing images for each type of examination. 
     According to an aspect of the invention, the apparatus  1  comprises a third actuator  47 . 
     The third actuator  47  is configured to rotate the supporting frame  43  with respect to the axis of rotation A 3 . 
     The control unit U is configured to control the third actuator  47 . 
     According to an aspect, the first control module U 1  is configured to control the third actuator  47 . 
     According to an aspect of the invention, the supporting frame  43  comprises a first portion  43 A and a second portion  43 B. 
     The first portion  43 A supports the X-ray detector  42 . 
     The second portion  43 B supports the X-ray source  41 . 
     The second portion  43 B is configured to rotate, relative to the first portion  43 A, according to a further axis of rotation A 4 . 
     In other words, it is possible to rotate the X-ray source  41  relative to the X-ray detector  42 . 
     According to an embodiment, the further axis of rotation A 4  is parallel to the axis of rotation A 3 . 
     According to another embodiment, the further axis of rotation A 4  coincides with the axis of rotation A 3 . 
     According to an aspect, the second portion  43 B is configured to rotate between different positions corresponding to different angles of rotation about the further axis of rotation A 4 . 
     Advantageously, rotating the second portion  43 B relative to the first portion  43 A makes it possible to perform examinations, such as, for example, mammary tomosynthesis, which typically require rotation/oscillation of the X-ray source  41  while keeping the X-ray detector  42  stationary. 
     It should be noted that it is possible to combine the rotation of the supporting frame  43  about the axis of inclination A 1  and the rotation of the second portion  43 B relative to the further axis of rotation A 4  maintaining the features and the related advantages described above. 
     According to an aspect of the invention, the apparatus  1  comprises a sixth actuator  50 . 
     The sixth actuator  50  is configured to rotate the second portion  43 B relative to the first portion  43 A, according to the further axis of rotation A 4 . 
     The control unit U is configured to control the sixth actuator  50 . 
     According to an aspect, the first control module U 1  is configured to control the sixth actuator  50 . 
     According to an aspect of the invention, the X-ray detector  42  is movable between a first position P 7  away from the X-ray source  41  and a second position P 8  towards the X-ray source  41  along a direction of movement D 2 . 
     The X-rays mainly develop in a beam. 
     The direction of movement D 2  of the X-ray detector  42  is along a direction at right angles to the plane of receiving the X-rays of the detector  42  itself, joining the X-ray source  41  and the X-ray detector  42  itself. 
     According to an aspect, the supporting frame  43  comprises a flat surface  43 C. 
     The direction of movement D 2  does not intersect the flat surface  43 C. 
     The direction of movement D 2  is at right angles to the axis of rotation A 3 . 
     According to an embodiment, the X-ray detector  42  is configured to be positioned, along the direction of movement D 2 , in a third position P 9 , corresponding to any position between the first position P 7  and the second position P 8 . 
     According to an aspect of the invention, the apparatus  1  comprises a fourth actuator  48 . 
     The fourth actuator  48  is configured for moving the X-ray detector  42  between the first position P 7  away from the X-ray source  41  and the second position P 8  towards the X-ray source  41 . 
     The control unit U is configured to control the fourth actuator  48 . 
     According to an aspect, the first control module U 1  is configured to control the fourth actuator  48 . 
     Advantageously, the X-ray detector  42  which can be positioned in various positions between a first position P 7  and a second position P 8  makes it possible to optimise the position of the detector  42  according to the type of examination performed. 
     According to an aspect of the invention, the apparatus  1  comprises anti-collision sensors, not illustrated in the accompanying drawings. 
     The anti-collision sensors are positioned on the X-ray detector  42  and are connected to the control unit U. 
     The anti-collision sensors are configured to detect the contact between the detector  42  and any other element and to send a signal to the control unit U when the contact occurs. 
     The control unit U is configured to receive the signal and block each movement of the apparatus  1 . 
     In other words, the control unit U, when it receives from the anti-collision sensors the signal of contact between the detector  42  and any other element, prevents the movement of each of the components of the apparatus  1 . 
     Advantageously, blocking each movement of the apparatus  1  when the anti-collision sensors detect a contact makes it possible to avoid any unplanned impact or compression of the breast which may cause pain to the patient. 
     Advantageously, locking each movement of the apparatus  1  significantly increases the safety of the patient since it prevents any injury, even serious injuries. 
     It should be noted that the procedure for protection of the patient is particularly suitable for examinations such as CBBCT which requires rotation of the detector  42  around the breast. 
     Advantageously, this automated protection procedure makes it possible to keep the detector at a minimum distance from the breast, thus optimising the breast imaging system, while also maintaining the safeguard of not causing pain to the patient even against drawbacks. 
     According to an aspect, the anti-collision sensors are distance sensors configured to detect the distance between the detector  42  and any other element. 
     According to an aspect of the invention, the apparatus  1  comprises at least one calibration body  23 . 
     The at least one calibration body  23  is removably coupled to the inclinable portion  11  of the support device  10 . 
     Advantageously, the at least one calibration body  23  allows the support device  10  to be positioned in an optimum manner relative to the machine  40 . 
     In particular, the at least one calibration body  23  allows the opening  13  to be correctly positioned relative to the axis of rotation A 3 . 
     According to an aspect of the invention, the graphical marking elements, described above, operatively act in conjunction with the at least one calibration body  23 . 
     It should be noted that in the normal diagnostic procedures it is worthwhile periodically calibrating the positioning of the support device  10 , and in particular of the opening  13  of the inclinable portion  11  relative to the machine  40 . 
     In particular, this calibration is often required when the machine  40  is reactivated following a switching off. 
     The need for a calibration may also be necessary following a movement of the apparatus  1  or a part of it. 
     According to the invention, the control unit U comprises a user interface, not illustrated in the accompanying drawings. 
     Advantageously, the user interface allows the operator to display, set up and control the commands of the apparatus  1 . 
     In particular, thanks to the user interface, the operator is able to control the movement of the support device  10  and of the machine  40  and of each of their components. 
     Advantageously, thanks to the user interface, the operator can thus be automatically informed of the values measured by the sensors of the lifting plane  14  and/or by the movement sensors  24  and/or by the anti-collision sensors. 
     The X-ray analyses which the apparatus  1  can perform may be, for example, without limiting the scope of the invention, Breast CT, Cone Beam Breast CT (CBBCT), mammography, mammary tomosynthesis, CESM. 
     For example, in order to perform a CBBCT, the source  41  must be able to rotate together with the detector  42  about the breast by a predetermined angle, preferably between 120° and 240°, even more preferably between 150° and 220°, even better between 180° and 210°. 
     In that way, the cone-shaped X-ray beam emitted by the source  41  and absorbed by the detector  42  makes it possible to reconstruct a three-dimensional image of the breast by scanning in a single rotation around the breast. 
     The patient is positioned prone on the support device  10 . 
     The 3D reconstruction is performed using software in the control unit U, which also controls the movement of the elements of the apparatus  1  both during positioning of the patient and during analysis during the diagnostic examination.