US-12616432-B2 - Compression device for breast exams and diagnostic apparatus for breast exams

US12616432B2US 12616432 B2US12616432 B2US 12616432B2US-12616432-B2

Abstract

A breast examination compression device, including a support element defining a flat surface made at least in part of material transparent to light and configured to come into contact with a lower area of the breast; a substantially box-like body made at least in part of transparent material and including at least one elastic and deformable wall configured to compress an upper area of the breast, said elastic wall being opposite the flat surface; and orientation means of the box-like body for moving the body itself with respect to the support element and as a function of the dimensions and shape of the breast.

Inventors

DANILO GENNARI

Assignees

SINCRONIS MEDICAL SRL

Dates

Publication Date: 20260505
Application Date: 20220209
Priority Date: 20210217

Claims (20)

1 . A compression device for breast exams, comprising: a support element defining a flat surface made at least in part of material transparent to light and configured to come into contact with a lower area of a breast; a substantially box shaped body made at least in part of transparent material and comprising at least one elastic and deformable elastic wall configured to compress an upper area of the breast, said elastic wall being opposite the flat surface and comprising a membrane configured to be deformed under action of a pressurized fluid; and an orientation device for moving the box shaped body with respect to the support element and as a function of the dimensions and shape of the breast; wherein said box shaped body comprises: a flat wall opposite said membrane and made of rigid and transparent material, and two side walls made of rigid material and each of which is interposed between the membrane and the flat wall; wherein said orientation device comprises a pair of connection portions each hinged to a respective one of the side walls; each of the connection portions further comprising a respective skid for sliding on the flat surface along a sliding direction away from/approaching a patient's body as a function of the dimensions of the breast.
2 . The compression device according to claim 1 , wherein said box shaped body internally comprises a chamber defined between said flat wall, said membrane, and said side walls; said chamber being configured to be in fluid communication with a supply source of the pressurized fluid.
3 . The compression device according to claim 1 , wherein each of the connection portions comprises a first element integral with the respective skid, and a second element hinged to the respective one of the side walls; said second element being rotatably connected to said first element to rotate with respect to the first element and around a respective first axis perpendicular to the sliding direction of the respective skid.
4 . The compression device according to claim 3 , wherein each element is made in the form of a plate; said first and second element being connected at an end near the patient's body by a first pin; said second element further including a second pin inserted in a first arcuate cavity obtained in the first element; said second element rotatable around the first pin to slide the second pin in said first arcuate cavity.
5 . The compression device according to claim 3 , wherein said box shaped body is rotatably connected to said second element to rotate with respect to the second element and around a respective second axis parallel to the first axis and perpendicular to the sliding direction of the respective skid.
6 . The compression device according to claim 5 , wherein said second element and the respective one of the side walls are connected at a distal end from the patient's body by a third pin; said respective one of the side walls further including a fourth pin insertable in a second arcuate cavity in the second element; said box shaped body rotatable around the third pin to slide the fourth pin in said second arcuate cavity.
7 . A compression device for breast exams, comprising: a support element defining a flat surface made at least in part of material transparent to light and configured to come into contact with a lower area of a breast; a substantially box shaped body made at least in part of transparent material and comprising at least one elastic and deformable elastic wall configured to compress an upper area of the breast, said elastic wall being opposite the flat surface and comprising a membrane configured to be deformed under action of a pressurized fluid; and an orientation device for moving the box shaped body with respect to the support element and as a function of dimensions and shape of the breast; wherein said box shaped body comprises: a flat wall opposite said membrane and made of rigid and transparent material, and two side walls made of rigid material and each of which is interposed between the membrane and the flat wall; wherein said orientation device further comprises at least one pair of flanges each hinged to respective ones of the side walls and slidably engaging respective bars arranged on opposite sides of the flat surface.
8 . The compression device according to claim 7 , wherein each of the flanges comprises the respective skid for sliding on the bar along the sliding direction.
9 . The compression device according to claim 8 , and further comprising a pair of pins each of which protrudes from the respective one of the side walls and extends inside a respective slot in the flange.
10 . The compression device according to claim 9 , wherein the box shaped body is rotatable around a pin axis defined by a longitudinal extension of the pins and is slidable along a direction defined by the slots approaching/away from the flat surface.
11 . The compression device according to claim 9 , wherein said flat wall and said membrane are made of material transparent to light radiations in the visible, infrared and X-ray spectrum.
12 . A diagnostic apparatus for breast examinations, comprising: the compression device in accordance with claim 1 ; a supply source of the pressurized fluid; an illumination system; and an image acquisition device opposite said illumination system.
13 . The diagnostic apparatus according claim 12 , wherein said illumination system is arranged at the support element on an opposite side of the breast to direct a light beam towards the breast and through the flat surface.
14 . The diagnostic apparatus according to claim 12 , wherein said box shaped body internally comprises a chamber defined between said flat wall, said membrane, and said side walls; said chamber being configured to be in fluid communication with the supply source of the pressurized fluid for distributing the pressurized fluid in the chamber and dilating the membrane on the breast.
15 . The diagnostic apparatus according to claim 12 , wherein said image acquisition device is arranged at the flat wall on an opposite side of the breast to acquire images through the flat wall and the membrane.
16 . The diagnostic apparatus according to claim 15 , wherein said image acquisition device comprises an optical and/or radiographic camera and/or an ultrasound.
17 . A diagnostic apparatus for breast examinations, comprising: a compression device for breast exams, comprising: a support element defining a flat surface made at least in part of material transparent to light and configured to come into contact with a lower area of a breast; a substantially box shaped body made at least in part of transparent material and comprising at least one elastic and deformable elastic wall configured to compress an upper area of the breast, said elastic wall being opposite the flat surface and comprising a membrane configured to be deformed under action of a pressurized fluid; and an orientation device for moving the box shaped body with respect to the support element and as a function of dimensions and shape of the breast; wherein said box shaped body comprises: a flat wall opposite said membrane and made of rigid and transparent material, and two side walls made of rigid material and each of which is interposed between the membrane and the flat wall; wherein said orientation device comprises a pair of connection portions each hinged to a respective one of the side walls; a supply source of the pressurized fluid; an illumination system; and an image acquisition device opposite said illumination system.
18 . The diagnostic apparatus according claim 17 , wherein said illumination system is arranged at the support element on an opposite side of the breast to direct a light beam towards the breast and through the flat surface.
19 . The diagnostic apparatus according to claim 17 , wherein said box shaped body internally comprises a chamber defined between said flat wall, said membrane, and said side walls; said chamber being configured to be in fluid communication with the supply source of the pressurized fluid for distributing the pressurized fluid in the chamber and dilating the membrane on the breast.
20 . The diagnostic apparatus according to claim 15 , wherein said image acquisition device comprises an optical and/or radiographic camera and/or an ultrasound.

Description

This application is the National Phase of International Application PCT/IB2022/051145 filed Feb. 9, 2022 which designated the U.S. This application claims priority to Italian Patent Application No. 102021000003593 filed Feb. 17, 2021, which applications are incorporated by reference herein. The present invention relates to a compression device for examining a patient's breast as well as a diagnostic apparatus comprising said device. More specifically, the present invention relates to a device for compressing and positioning the breast of a patient during examinations performed with image acquisition for the early detection of breast tumours. Breast compression is a fundamental step in order to be able to conduct such examinations effectively. In fact, in the field of optical imaging technology, compression blocks the circulation of the neoangiogenic vascular network created by the tumour, so that growth of deoxyhemoglobin is stimulated and detected by means of illumination with light at specific frequencies. In addition, compression involves reducing the thickness of the patient's breast in order to ensure better detailing of the images resulting from the optical or radiographic examination (and to reduce the amount of electromagnetic waves needed, in the case of mammographic examinations). It should also be noted that the image acquisition phase is improved by keeping the analysed area immobile. In this context, compression of the patient's breast is necessary for the file to block and immobilise the patient's breast in order to improve the quality of the images collected. With regard to the optical analysis technique used, the patient's breast is illuminated with red light at 640 nm, while the light attenuation values detected by a camera, opposite the light source, correspond to changes in the concentration of deoxyhaemoglobin in the capillary vessels. This makes possible the detection of “neoangiogenesis” areas, i.e. areas of abnormal vascularisation generated to feed the tumour cells, regardless of the density of the tissue to be analysed. As an example of application of this technique, the document U.S. Pat. No. 6,587,578 describes a Diffuse Optical Mammography system (DFOM) in which a breast supporting device is used and arranged between a fixed support and a flexible membrane which is part of a compression system. In particular, the membrane rests on the patient's breast and an external inflation system pushes the membrane into direct contact with the patient's breast providing it with a slight pressure. The device is cumbersome and complex to manage. Moreover, the devices known in the art have important drawbacks in terms of adaptability to the shape of the breast. In fact, the compression devices (inflatable membranes) cannot adapt effectively to the size and morphology of the breasts. In this context, the absence of an adjustment system leads to ineffectiveness in the compression actions with consequent disadvantages in the reliability of the diagnostic examination. In addition, if the membrane is positioned incorrectly with respect to the patient's breast (for example too far in front of or too close to the sternum) the compression action is particularly painful. The purpose of the present invention is therefore to provide a compression device for breast examinations and a diagnostic apparatus for breast examinations capable of resolving the aforementioned drawbacks. In particular, a purpose of the present invention is to provide a compression device for breast exams that is extremely versatile and adaptable to the size and shape of the breast. A further purpose of the present invention is to provide a compression device that is easy to apply, structurally simple, and able to compress the patient's breast effectively in order to optimise diagnostic activity for imaging. Yet another purpose of the present invention is to provide a compression device which is able to compress uniformly the entire surface of the breast, and which is therefore particularly comfortable without causing pain to the patient. A final purpose of the present invention is to provide a breast examination diagnostic apparatus comprising the compression device configured to be used with systems based on X-ray as well as optical technology, and compatible with the use of the ultrasound. In accordance with the present invention, these and other purposes are achieved by a compression device for breast examinations comprising a support element defining a flat surface made at least in part of material transparent to light and configured to come into contact with a lower area of the breast; a substantially box-like body made at least in part of transparent material and comprising at least one elastic and deformable wall configured to compress an upper area of the breast, said elastic wall being opposite to the flat surface; and orientation means of the box-like body to move said body with respect to the support element and according