Compression device for breast examination and diagnostic device for breast examination

Abstract

1. A breast examination compression device comprising: a support element (2) defining a plane (2a) made at least in part from a light-transmitting material and configured to contact a lower region of the breast (101); a substantially box-like body (3) including at least one elastically deformable wall (4) made at least in part from a transparent material and configured to compress an upper region of the breast (101), said elastic wall (4) being on the opposite side of the plane (2a); and positioning means (9) for the box-like body (3) for moving itself relative to the support element (2) according to the size and shape of the breast (101).

Description

Technical Field

[0001] The present invention relates to a compression device for examining a patient's breast, and a diagnostic apparatus including the device. More specifically, the present invention relates to a device for compressing and positioning a patient's breast during an examination for acquiring an image for early detection of breast cancer.

Background Art

[0002] Compression of the breast is a fundamental step for efficiently performing such an examination.

[0003] In fact, in the field of optical imaging technology, compression blocks the circulation of the angiogenesis vascular network generated by a tumor, stimulating the growth of deoxyhemoglobin and being detected using illumination of light at a specific frequency.

[0004] In addition, compression is involved in reducing the thickness of a patient's breast in order to ensure better details of an image resulting from an optical or X-ray examination (and reducing the amount of electromagnetic waves required in the case of a mammography examination).

[0005] It should also be noted that the image acquisition stage is improved by keeping the area to be analyzed from moving. In this context, for compression of a patient's breast, it is necessary to block and immobilize the patient's breast with a file to improve the quality of the collected image.

[0006] Regarding the optical analysis technique to be used, while a patient's breast is illuminated with red light of 640 nm, the light attenuation value detected by a camera on the opposite side of the light source corresponds to a change in the concentration of deoxyhemoglobin in the capillaries. This enables detection of "angiogenesis" regions, that is, regions of abnormal angiogenesis that have occurred to supply nutrients to tumor cells, regardless of the density of the tissue to be analyzed.

[0007] As an example of the application of this technique, the literature, U.S. Patent No. 6,587,578, describes a diffuse optical mammography (DFOM) system in which a breast support device is used and positioned between a fixed support and a flexible membrane that is part of a compression system. Specifically, the membrane is placed over the patient's breast, and an external inflation system pushes the membrane to bring it into direct contact with the patient's breast, providing slight pressure. The device is cumbersome and complex to manage.

[0008] Furthermore, devices known in the art have significant drawbacks regarding their conformity to the shape of the breast. In fact, compression devices (inflatable membranes) cannot efficiently conform to the size and shape of the breast.

[0009] In this situation, without an adjustment system, the compression effect becomes ineffective, resulting in unreliable diagnostic tests.

[0010] In addition, if the membrane is improperly positioned relative to the patient's breast (for example, too far or too close to the front of the sternum), the compression effect is particularly painful. [Overview of the Initiative] [Problems that the invention aims to solve]

[0011] The object of the present invention is to provide a breast compression device and a breast diagnostic device that can therefore solve the aforementioned drawbacks.

[0012] Specifically, the object of the present invention is to provide a breast examination compression device that is extremely diverse and can be adapted to breast size and shape.

[0013] A further object of the present invention is to provide a compression device that is easy to apply, has a simple structure, and can efficiently compress a patient's breast to optimize the diagnostic action for imaging.

[0014] A further object of the present invention is to provide a compression device that can uniformly compress the entire surface of the breast, and therefore specifically is comfortable without causing pain to the patient.

[0015] A final object of the present invention is to provide a breast examination and diagnostic apparatus that includes a compression device configured for use with X-ray and optical technology-based systems and to be compatible with the use of ultrasound. [Means for solving the problem]

[0016] According to the present invention, these and other objectives are achieved by a breast examination compression device comprising: a support element defining a plane which is at least partly made of a light-transmitting material and configured to contact the lower region of the breast; a substantial box-shaped body which is at least partly made of a transparent material and includes at least one elastically deformable wall configured to compress the upper region of the breast, the elastic wall being opposite the plane; and a positioning means for the box-shaped body to move the body relative to the support element according to the size and shape of the breast.

[0017] These objectives are further achieved by a mammography diagnostic apparatus comprising a pressurized fluid source, a lighting system, and an image acquisition device on the opposite side of the lighting system, the apparatus being characterized by including such a compression device.

[0018] Further features and advantages of the present invention are disclosed in the dependent claims.

[0019] The features and advantages of the present invention will become apparent from the following detailed description of its practical embodiments, which are shown only as examples in the accompanying drawings. [Brief explanation of the drawing]

[0020] [Figure 1] A perspective view of a device for facilitating breast examination according to the present invention is shown. [Figure 2] Figure 1 shows a disassembled view of the structural details of the device. [Figure 3a-3b] Shows each operating step of the breast examination and diagnosis apparatus equipped with the compression device of FIG. 1 according to the present invention. [Figure 4] Shows a perspective view of the compression device for breast examination according to the second embodiment of the present invention.

Mode for Carrying Out the Invention

[0021] Referring to the accompanying drawings, the compression device for breast examination according to the present invention is collectively regarded as reference numeral 1. The device 1 is advantageously used within the breast diagnostic apparatus 100, which is also the subject matter of the present invention, schematically shown in FIGS. 3a and 3b.

[0022] Specifically, as better shown in FIGS. 1 and 4, the compression device 1 includes a support element 2 that defines a plane 2a made of a material that at least partially allows light to pass through. The plane 2a is configured to contact the lower region of the patient's breast 101. In fact, during use, the patient places their breast 101 on the plane 2a, as best shown in FIGS. 3a and 3b.

[0023] The device 1 further includes a substantially box-shaped body 3 made of at least partially transparent material, and the box-shaped body 3 includes at least one elastic and deformable wall 4. The elastic wall 4 is on the opposite side of the plane 2a and is advantageously configured to compress the upper region of the patient's breast 101. In this way, referring back to FIGS. 3a and 3b, due to the compression action of the elastic wall 4 on the patient's breast 101, the patient's breast 101 is compressed against the plane 2a.

[0024] The device 1 also includes positioning means 9 for the box-shaped body 3 to move the body 3 relative to the support element 2 and thus adapt the position of the elastic wall 4 to the size and shape of the patient's breast 101.

[0025] In other words, the positioning means 9 can move the entire box-shaped body 3 and place the box-shaped body 3 in the correct direction to sufficiently support the elastic wall 4 over the upper region of the patient's breast 101.

[0026] Fortunately, the elastic wall 4 includes a transparent membrane 5 configured to deform under the action of the pressing fluid.

[0027] Preferably, the membrane 5 is made of a soft material that does not allow air to pass through but allows light radiation in the visible, infrared, and X-ray spectra to pass through.

[0028] Furthermore, the membrane 5 is preferably made of a material that is not completely smooth so as to generate frictional force when in contact with the patient's breast 101.

[0029] Referring to the accompanying drawings, the elastic wall 4 formed by the membrane 5 has an arcuate contour that bulges outward from the main body 3.

[0030] This ergonomic configuration, shown merely as an example, anatomically improves the contact with the patient's breast 101 and the adhesion and retention of the patient's breast 101 during compression.

[0031] It should be recalled that in this context, the shape of the elastic wall 4, as well as the shape and dimensions of the entire box-shaped main body 3, can be of any type depending on the specific use.

[0032] Referring to FIGS. 1, 2, and 4, the box-shaped main body 3 includes a flat wall 6 on the opposite side of the membrane 5, which is made of a rigid material and preferably allows light radiation in the visible, infrared, and X-ray spectra to pass through. The flat wall 6 preferably has a rectangular contour with its respective major sides engaged at the edges of the membrane 5.

[0033] In this way, the flat wall 6 cooperates with the membrane 5 to establish a window through which the patient's breast 101 can be visually accessed.

[0034] The box-shaped main body 3 also includes two side walls 7 made of a rigid material, each of which is sandwiched between the membrane 5 and the flat wall 6.

[0035] Referring more specifically to Figures 2 and 4, each side wall 7 has a substantially arched shape, defining a straight side surface 7a associated with each smaller side surface of the planar wall 6 and an arched side surface 7b that engages with the edge of the membrane 5.

[0036] The resulting box-shaped body 3 has an internal chamber 8 between a planar wall 6, a membrane 5, and two side walls 7.

[0037] Chamber 8 is configured to be in fluid communication with a pressurized fluid source 102 (Figures 3a and 3b). Conveniently, the pressurized fluid (preferably air) is introduced into the chamber 8 to expand the membrane 5 and deform it outward to exert a compressive effect on the patient's breast 101 (Figure 3b).

[0038] As described above, the box-shaped body 3 is moved by the action of the positioning means 9 that supports the body 3 on the plane 2a so that the membrane 5 is properly positioned on the patient's breast 101.

[0039] According to a first embodiment of the present invention, as clearly shown in Figures 1 and 2, the means 9 includes at least one connecting portion 10 that is hinged to the corresponding side wall 7 and slides on a support element.

[0040] Preferably, a pair of connecting parts 10 are provided, with each part 10 hinged to its respective side wall 7. Furthermore, each part 10 includes a lubricant 11 (as schematically shown in Figures 3a and 3b) for sliding on a plane 2a along a direction A toward or toward the patient's body.

[0041] For this purpose, each sliding guide for the lubricant 11 is provided on the edge of the support element 2.

[0042] Referring specifically to Figure 2, it should be noted that each connection 10 consists of a first element 12 integrated with the respective lubricant 11, and a second element 13 attached to the respective side wall 3 by a hinge.

[0043] The first element 12 is created in the shape of a plate with a triangular contour, where the base defining adjacent sides of the triangle engages with the lubricant 11, and the inclined side defining the hypotenuse is oriented toward the patient. Note that the first element 12 does not change its geometric arrangement while moving along direction A.

[0044] The second member 13 is in the shape of a plate with a rectangular trapezoidal contour. However, it should be made clear that the elements can have any configuration depending on their specific use and the overall dimensions of device 1.

[0045] The second element 13 is rotatably associated with the first member 12 so as to rotate relative to the first member 12 about its first X-axis which is perpendicular to the sliding direction A of the lubricant 11.

[0046] For this purpose, elements 12 and 13 are pivoted relative to each other at their ends closest to the patient's body (the angles of the two elements 12 and 13 coincide) by a first pivot 14 extending along the X-axis.

[0047] In addition, the second element 13 has a second pin 15 inserted into a first arc-shaped cavity 15a provided in the first element 12. In this way, the second element 13 rotates around the first pin 14 by the sliding of the second pin 15 inside the first arc-shaped cavity 15a.

[0048] Furthermore, the box-shaped body 3 is rotatably associated with the second element 13 so as to rotate with respect to the second element 13 about its second Y axis, which is parallel to the first X axis and perpendicular to the sliding direction A of the lubricant 11.

[0049] Specifically, referring to Figure 2, the second member 13 and the corresponding side wall 7 are connected at the end furthest from the patient's body by a third pin 16.

[0050] In this case as well, the side wall 7 also has a fourth pin 17 that can be inserted into a second arcuate cavity 17a provided within the second element 13.

[0051] Conveniently, in this configuration, the box-shaped body 3 rotates around a third pin 16 that extends longitudinally along the Y-axis in order to slide the fourth pin 17 along the second arch-shaped cavity 17a.

[0052] In this situation, it should be noted that device 1 can move the box-shaped body 3 supporting the membrane 5 considerably.

[0053] This movement, defined by the multiple degrees of freedom of the main body 3, allows the membrane 5 to be moved closer to / away from the patient's breast 101 using sliding along direction A. Simultaneously, by rotating the second element 13 relative to the first element 12 around the X axis, the membrane 5 can be raised / lowered relative to the patient's breast 101.

[0054] The main body 3 can be tilted again by rotating it around the Y-axis relative to the second element 13. This movement of the main body 3 allows the membrane 5 to be positioned by adapting its geometric arrangement to the shape of the patient's breast 101.

[0055] According to the second embodiment of the present invention shown in Figure 4, the lubricant 11 is slidable along direction A within a suitable support rod 20.

[0056] The rod 20 is then supported by a support frame known in the art, which is therefore not disclosed or shown herein.

[0057] Each rod 20 also has a tightening screw 22 appropriately shaped for the operator to grasp, thereby locking the body 3 in the correct position along direction A. More specifically, the tightening screw is inserted into a groove formed within the rod 20. In this way, the screw slides within the groove by moving the body 3 along direction A. Once the correct position is found, the screw 22 is tightened to lock the body 3 in place against the patient's breast 101.

[0058] Inside the rod 20 is a plane 2a, not shown in Figure 4, which allows for a better view of the rest of device 1.

[0059] Furthermore, the membrane 5 of the main body 3 is not shown in Figure 4, in order to allow a better view of the inside of the chamber 8 and wall 6.

[0060] In this embodiment, the positioning means 9 includes each lubricant 11 and a pair of flanges 21 associated with each.

[0061] Each flange 21 has a vertical, and therefore transverse groove 23 in direction A.

[0062] In this configuration, the main body 3 is engaged with both sides of the flange 21 using appropriate rotating pins 24 that pass through each groove 23.

[0063] Specifically, each pin 24 extends from its respective side wall 7 through the groove 23.

[0064] In this way, the body 3 is rotatable about the X-axis defined by the longitudinal extension of the pins 24. In addition, the body 3 slides along direction B, that is, toward / away from surface 2a, in a height-adjustable manner. Sliding along direction B is achieved by sliding the pins 24 along their respective grooves 23.

[0065] In addition, each pin has a locking handle 24a that protrudes outward from the groove 23, which can restrain the main body 3 to a predetermined position relative to the flange 21 and lock the position of the pin 24 in relation to the groove.

[0066] In other words, by screwing the handle 24a onto the pin 24, the main body 3 is released, and the main body 3 is rotated around the X-axis, allowing the main body 3 to be raised or lowered along direction B depending on the position and size of the patient's breast 101. Once the main body 3 is positioned, screwing the handle 24a in permanently restrains the main body 3 in the set position.

[0067] Device 1 described above is conveniently used within the breast examination and diagnostic device 100, which also incorporates some of the present invention.

[0068] The apparatus 100 schematically shown in Figures 3a and 3b includes a supply source 102 of pressurized fluid, preferably air, which is in fluid communication with a chamber 8 of a box-shaped body 3. For this purpose, a supply duct is provided to distribute the pressurized fluid into the chamber 8 by spreading a membrane 5 over the breast.

[0069] In other words, the excessive pressure inside the chamber 8 deforms the membrane 5 outward, compressing the patient's breast 101 relative to the plane 2a.

[0070] The supply source 102 also allows for the introduction of a fluid (air / gas) into the chamber 8, in a temporary manner configurable according to the acquisition and processing of diagnostic images.

[0071] In addition, the supply source 102 can adjust the pressure to reach the chamber 8, and also allows for the stabilization of the set pressure, keeping it constant throughout the examination and compensating for minor patient movements (such as breathing).

[0072] The device 100 further includes an illumination system 103 positioned on a support element 2 opposite the patient's breast 101. Specifically, the illumination system 103 is positioned below the support element 2 to direct a light beam toward the lower region of the breast.

[0073] In this situation, it should be noted that the transparent material used to create plane 2a allows light to pass through toward the patient's breast 101.

[0074] Furthermore, the apparatus 100 includes an image acquisition device 104 on the opposite side of the lighting system 103.

[0075] More specifically, the image acquisition device 104 is positioned on the planar wall 6 opposite the patient's breast 101 in such a manner that it acquires images through a transparent "window" defined by the wall 6 and membrane 5.

[0076] According to the present invention, the image acquisition device 104 may be of any suitable type for performing a diagnostic examination of the breast 101.

[0077] For example, the image acquisition device 104 may consist of an optical camera or an X-ray device.

[0078] Finally, the apparatus 100 includes the above-described device 1, which is configured to compress the patient's breast in order to facilitate and enhance the acquisition of diagnostic images.

[0079] In practice, the patient's breast 101 is then placed on the plane 2a.

[0080] In this situation, the patient's breast cavity is positioned coplanar with the outer edge of surface 2a.

[0081] Subsequently, as device 1 approaches using its associated degrees of freedom, membrane 5 partially comes into contact with the patient's breast 101, which is entirely beneath membrane 5.

[0082] In other words, the main body 3 is moved along direction A, around the X and Y axes.

[0083] Once a suitable position is found, device 1 is restrained (using a locking system known in the art and therefore not disclosed herein) in order to proceed with the inspection.

[0084] The supply source 102 is then activated to introduce pressurized fluid into the chamber 8 of the main body 3.

[0085] As a result, the membrane 5 is stretched against the patient's breast 101. In this way, by increasing its volume, the membrane 5 is gradually positioned and stretched by gradually compressing the patient's breast 101 toward the chest and then toward the plane 2a.

[0086] The servo valve of supply source 102 (which is copyleft and therefore not disclosed or shown herein) ensures that it reaches and maintains the desired pressure and resulting deformation, even when faced with small movements such as breathing.

[0087] Because the membrane 5 adheres to the patient's breast 101, a fixing effect due to friction is also produced, making it difficult, though not impossible, for the patient to move.

[0088] In this way, the image acquisition device 104 that provides a diagnosis to the patient's breast 101 is activated.

[0089] Conveniently, device 1 ensures comfortable and complete fixation of the organ, enabling reliable examination.

[0090] Furthermore, the pressure applied to the patient's breast 101 by membrane 5 momentarily blocks the microcirculation of capillaries, resulting in the formation of deoxyhemoglobin. This phenomenon is more pronounced in angiogenic capillaries than in healthy capillaries, which is due to the lower pressure and lower elasticity required to block the capillaries, suggesting higher deoxyhemoglobin concentrations and longer oxygenation recovery times. Thus, important information is provided about the possibility of a vascular network specifically designed to nourish early tumors.

[0091] Therefore, by searching for the vascular network that nourishes the tumor, it is possible to detect the tumor, which can identify a much wider area than the tumor itself.

[0092] Conveniently, Device 1 is compatible with devices using different diagnostic methods (optical and / or X-ray), facilitating the integration of ultrasound methodologies with Device 1.

[0093] Furthermore, device 1 is particularly easy to use, not very expensive, has a simple structure, and enables efficient and controllable compression throughout all stages of the inspection process.

[0094] In addition, at different stages of adjustment, device 1 can be adapted to the patient's breast 101 and torso. Accordingly, the entire compression action is painless and more comfortable than compression systems known in the art.

[0095] Finally, device 1 is compatible with the use of an ultrasound scanner, which allows the ultrasound probe to approach the patient's breast 101 directly at the end of the optical examination, while keeping the patient's breast 101 positioned on the upper surface 2a. [Prior art documents] [Patent Documents]

[0096] [Patent Document 1] U.S. Patent No. 6,587,578

Claims

1. A compression device for breast examination, A support element (2) defines a plane (2a) which is made of a material that is at least partially transparent to light, and is configured to contact the lower region of the breast (101), A substantially box-shaped body (3) made of at least a portion of a transparent material, comprising at least one elastically deformable wall (4) configured to compress the upper region of the breast (101), wherein the elastically deformable wall (4) is opposite the plane (2a) and comprises a membrane (5) configured to deform under the action of a pressurized fluid, The box-shaped body (3) includes a positioning means (9) for moving the box-shaped body (3) itself relative to the support element (2) according to the dimensions and shape of the breast (101), The box-shaped body (3) includes a planar wall (6) made of a rigid, transparent material on the opposite side of the membrane (5), and two side walls (7) made of a rigid material, each sandwiched between the membrane (5) and the planar wall (6). The positioning means (9) includes a pair of connecting parts (10) each hinged to the corresponding side walls (7), and each connecting part (10) includes a lubricant (11) for sliding on the plane (2a) along a sliding direction (A) away from / towards the patient's body according to the dimensions of the breast (101).

2. The device according to claim 1, characterized in that the box-shaped body (3) contains a chamber (8) defined between the planar wall (6), the membrane (5), and the two side walls (7), and the chamber (8) is configured to be in fluid communication with a pressurized fluid supply source (102).

3. The device according to claim 1, wherein each connecting portion (10) includes a first element (12) integrated with each of the lubricants (11) and a second element (13) hinged to each of the side walls (7), the second element (13) being rotatably associated with the first element (12) to rotate with respect to the first element (12) about a first axis (X) perpendicular to the sliding direction (A) of the lubricant (11) moving toward / away from the patient's body.

4. The device according to claim 3, wherein each element (12, 13) is formed in the shape of a plate, the first and second elements (12, 13) are connected at the end closest to the patient's body by a first pin (14), the second element (13) further has a second pin (15) inserted into a first arcuate cavity (15a) provided within the first element (12), and the second element (13) rotates around the first pin (14) to slide the second pin (15) within the first arcuate cavity (15a).

5. The device according to claim 3 or 4, characterized in that the box-shaped body (3) is rotatably associated with the second element (13) so as to rotate with respect to the second element (13) about a second axis (Y) which is parallel to the first axis (X) and perpendicular to the sliding direction (A) of the lubricant (11).

6. The device according to claim 5, wherein the second element (13) and the corresponding side wall (7) are connected at the end furthest from the patient's body by a third pin (16), the side wall (7) further has a fourth pin (17) that can be inserted into a second arcuate cavity (17a) provided in the second element (13), and the box-shaped body (3) rotates around the third pin (16) to allow the fourth pin (17) to slide within the second arcuate cavity (17a).

7. The device according to any one of claims 1 to 6, characterized in that the planar wall (6) and the film (5) are made of a material that transmits visible, infrared, and X-ray spectral light emission.

8. A diagnostic device for breast examination, A pressurized fluid supply source (102) and Lighting system (103), Includes an image acquisition device (104), The apparatus includes a compression device (1) according to any one of claims 1 to 7, wherein the image acquisition device (104) is located on the opposite side of the illumination system (103) with respect to the compression device (1).

9. The apparatus according to claim 8, characterized in that the lighting system (103) is positioned on the support element (2) opposite to the breast (101) in order to direct a light beam toward the breast (101) through the plane (2a).

10. The apparatus according to claim 8, as dependent on claim 2, characterized in that the supply source (102) of the pressurized fluid is in fluid communication with the chamber (8) of the box-shaped body (3) for distributing the pressurized fluid to the chamber (8) itself and spreading the membrane (5) over the breast (101).

11. The apparatus according to claim 8, characterized in that the image acquisition device (104) is positioned on the planar wall (6) opposite to the breast (101) in order to acquire an image through the planar wall (6) itself and the membrane (5).

12. The apparatus according to claim 11, characterized in that the image acquisition device (104) includes an optical and / or X-ray camera and / or ultrasound.

Images