Breast tomography apparatus

Abstract

The invention relates to a breast tomography apparatus with a self-shielding and movable gantry. According to the breast tomography device, X-rays with extremely low dose can be emitted, and free installation and movement can be achieved through self-shielding of the X-rays. Especially, under the condition that breasts are not pressed, examination without physical and clinical limitation can be achieved through a complete three-dimensional image; various clinical conditions can be examined comfortably and accurately with minimal face-to-face contact without additional examinations such as MRI or ultrasound. The shot image can provide substantive change information, and the utilization rate of the image can be improved to the maximum extent by combining artificial intelligence (AI).

Description

TECHNICAL FIELD

[0001] The present invention relates to a mammography apparatus, and more particularly, to a mammography apparatus having self-shielding and a movable gantry. BACKGROUND

[0002] For early diagnosis of breast cancer, X-rays are generally used in a mammography apparatus. That is, a certain amount of X-rays is transmitted through a breast of a subject, and the transmitted X-rays are converted into a two-dimensional image in a digital manner using a photographic film or an electronic image sensor. In order to improve the quality of the image and reduce the required dose, the mammography apparatus has a structure in which a compression member is provided between an X-ray generating portion and an X-ray detector to compress a subject (including a breast).

[0003] However, since the mammography apparatus has a structure in which compression is performed on the breast using the compression member to improve the quality of the image and reduce the exposure dose, the subject's breast portion often feels pain, and the image is often deformed.

[0004] In addition, when a breast that has undergone a plastic surgery is photographed, there are many limitations, and there are side effects such as an increase in X-ray dose and rupture of a prosthesis.

[0005] In addition, if a breast surgery has been performed, compression cannot be performed on the breast, thereby causing concern about post-operative monitoring.

[0006] In particular, the prior art has difficulty in accurately measuring the volume of a lesion, resulting in difficulty in monitoring neoadjuvant chemotherapy, which requires accurate measurement of volume change, and difficulty in determining the extent of disease (EOD) (breast imaging-reporting and data system (BIRADS)), while diagnosing a three-dimensional subject in a two-dimensional form has a deficiency in performance and function in essence.

[0007] In addition, for a dense breast, since the lower tissue is not visible due to the obstruction of the upper tissue, there is a disadvantage in that the probability of false negative and false positive increases.

[0008] In contrast, breast computed tomography (BCT) has a structure that does not compress the breast, thus eliminating side effects such as pain. It provides a comfortable examination regardless of whether the patient has undergone surgery or plastic surgery, and allows for complete three-dimensional observation unaffected by breast density, enabling precise examination. Furthermore, BCT aids in postoperative monitoring and neoadjuvant chemotherapy, and helps determine the extent of disease (BIRADS).

[0009] Furthermore, due to its physical characteristics, BCT has no clinical limitations (e.g., microcalcification, one of the hallmarks of early breast cancer, is difficult to detect by ultrasound or magnetic resonance imaging (MRI)) and does not require supplemental examination of dense breasts, thus having the advantage of minimizing face-to-face and contact.

[0010] In BCT, positioning is based solely on gravity, allowing for easy and unrestricted observation of the diagnostic area from the nipple to the chest wall, and even easy observation of lymph nodes, thus making it easy to confirm whether metastasis has occurred.

[0011] In particular, BCT has the advantage of being able to easily utilize a durable and well-established AI platform in AI diagnostics, which is expected to be applied to all future diagnostics, regardless of clinical or physical limitations.

[0012] However, even with the aforementioned advantages, BCT still requires a higher X-ray dose than mammography equipment and necessitates the cumbersome shielding of all six sides of the facility. In other words, the floor boundaries of the BCT room are typically constructed of thick concrete. In some cases, only the front, back, left, and right sides of the room are shielded, while in others, all six sides, including the top and bottom, are shielded. Therefore, existing BCTs can only be installed in shielded rooms, and due to the difficulty in resolving installation area and shielding issues, space utilization is limited. Furthermore, excessively long installation cycles, high installation costs, and excessive radiation exposure and environmental pollution are unavoidable.

[0013] In addition, although BCT is more practical in places such as radiology departments, health check-up centers, breast surgery departments, oncology centers, and operating rooms compared to mammography devices, it is also necessary to be mobile when necessary. Fixed BCT is not only inconvenient to move, but also difficult to make efficient use of space and reduce installation costs. Summary of the Invention

[0014] The problem that the invention aims to solve

[0015] The purpose of this invention is to provide a breast tomography device that has many advantages in breast diagnosis, can be miniaturized, produces a low dose of X-rays, and can completely shield X-rays to prevent X-ray leakage to the outside.

[0016] The purpose of this invention is to provide a mammography device that is easy to install and move, and maximizes space utilization.

[0017] The purpose of this invention is to provide a mammography device that can achieve lightweight and miniaturization while reducing energy consumption and improving economy.

[0018] The purpose of this invention is to provide a mammography apparatus that can quickly process signals from captured images to obtain results rapidly.

[0019] The present invention is not limited to the above objectives. Other objectives and advantages of the present invention not mentioned may be understood through the following description and will become clearer through the embodiments of the present invention.

[0020] Solution for solving the problem

[0021] According to one embodiment of the present invention, an apparatus is provided, comprising: a frame having a box shape with an internal space; a rotating gear rotatably coupled inside the frame; an X-ray tube coupled to one side of the rotating gear and used to generate X-rays; an X-ray detector coupled to the other side of the rotating gear and driven to rotate about a rotational central axis and move back and forth relative to a subject, and capable of receiving X-rays generated from the X-ray tube and penetrating the subject, and converting them into electrical signals; and a shielding portion formed on one side of the frame, covering the upper surface except for the opening for insertion of the subject. The entire inner surface of the frame is used to shield the X-rays generated from the X-ray tube from leaking to the outside of the frame; an image reconstruction unit is used to reconstruct an image formed by the signal converted by the X-ray detector; and an image display unit is used to display the image reconstructed by the image reconstruction unit; wherein the image reconstruction unit calculates the change in pixel value by pixel shifting an image before the shooting date to an image on the shooting date, performing digital subtraction on the same pixels between the image before the shooting date and the image on the shooting date, and reconstructs an image that reflects the calculated change for each pixel.

[0022] In this invention, the image reconstruction unit assembles multiple sets of voxels, which are three-dimensional pixels in the image, and shifts the central voxel of the image formed by the voxel sets to a voxel with a voxel value of 0. After calculating the change in voxel value by digital subtraction, the unit reconstructs an image that reflects the calculated change based on the voxel reconstruction.

[0023] In this invention, the shielding part is composed of lead plates.

[0024] In this invention, the subject of examination includes the breast.

[0025] In this invention, the frame can be tilted relative to the horizontal plane. By tilting, the subject located at the opening is kept facing downward by its own weight.

[0026] In this invention, the device includes a moving device located below the frame and containing rollers, so that the frame can be moved.

[0027] Invention Effects

[0028] The breast computed tomography (BCT) apparatus according to embodiments of the present invention has the following effects.

[0029] According to the present invention, for the pixel values ​​of images captured by a mammography device, accurate examination results can be derived by comparing the pixels between two images taken on the day of the capture and before the day of the capture, and deriving the differences between the pixels.

[0030] According to the present invention, in the process of comparing two images taken on the same day as the shooting date and before the shooting date, the differences between the pixel values ​​of each pixel set can be derived by moving pixels or comparing pixel sets consisting of multiple pixels, thereby achieving rapid inspection. Attached Figure Description

[0031] Figure 1 This is a conceptual structural diagram of a mammography apparatus according to an embodiment of the present invention.

[0032] Figure 2 This is a structural diagram of the X-ray detector that makes up a mammography apparatus according to an embodiment of the present invention.

[0033] Figure 3 This is a schematic perspective view illustrating a mammography apparatus according to an embodiment of the present invention.

[0034] Figure 4 This is a structural diagram of a support for a mammography apparatus according to an embodiment of the present invention.

[0035] Figures 5 to 7This is a conceptual diagram illustrating the process of acquiring pixel values ​​of an image captured by a mammography apparatus according to an embodiment of the present invention. Detailed Implementation

[0036] The following will be referenced Figures 1 to 6 A detailed description of the mammography apparatus 100 according to an embodiment of the present invention is provided.

[0037] Figure 1 This is a conceptual structural diagram of a mammography apparatus according to an embodiment of the present invention; Figure 2 This is a structural diagram of the X-ray detector constituting a mammography apparatus according to an embodiment of the present invention; Figure 3 This is a schematic perspective view illustrating a mammography apparatus according to an embodiment of the present invention; Figure 4 This is a structural diagram of a support for a mammography apparatus according to an embodiment of the present invention; Figures 5 to 7 This is a conceptual diagram illustrating the process of acquiring pixel values ​​of an image captured by a mammography apparatus according to an embodiment of the present invention.

[0038] like Figures 1 to 4 As shown, a mammography apparatus 100 according to an embodiment of the present invention includes a gantry 200. The gantry 200 includes: a frame 210 having a space formed therein; a rotating gear 220 rotatably coupled inside the frame 210; an X-ray tube 230 coupled to one side of the rotating gear 220 for generating X-rays by applying a high voltage; an X-ray detector 240 coupled to the other side of the rotating gear 220 for receiving X-rays generated from the X-ray tube 230 and penetrating the subject, and converting them into electrical signals; and a data acquisition unit 610 for storing data generated based on the electrical signals converted by the X-ray detector 240.

[0039] Furthermore, the mammography apparatus 100 according to an embodiment of the present invention may include a structure that supplies power to the gantry 200 via linkage with the gantry 200 and processes images captured by the gantry 200. Specifically, this structure may include: a control unit 500, which includes an operation console 510 for operator input and for controlling the X-ray tube 230, the X-ray detector 240, and the data acquisition unit 610; an image display unit 620 for displaying images; an X-ray power supply unit 630 for generating a high voltage under the control of the control unit 500 and supplying it to the X-ray tube 230; and an image reconstruction unit 640 for calculating the pixel values ​​of the image formed by the data acquired by the data acquisition unit 610 and transmitting them to the image display unit 620.

[0040] Furthermore, the mammography apparatus 100 according to embodiments of the present invention may also include a support 300 and a moving device 400.

[0041] like Figure 2 and Figure 4 As shown, the gantry 200 includes a frame 210, which can combine an X-ray tube 230 and an X-ray detector 240 for acquiring medical images. The height or angle of the frame 210 can be adjusted by a tilting device 310 of the support 300.

[0042] In the accompanying drawings and the above description, the X-ray tube 230, X-ray detector 240, and data acquisition unit 610 are provided inside the frame 210 of the rack 200 as an example. However, in another embodiment, the rack 200 may also be provided with at least one of the following: a control unit 500 including an operation console 510, an image reconstruction unit 640, and an image display unit 620.

[0043] The rotating gear 220 is disc-shaped and can be coupled with the X-ray tube 230, the X-ray detector 240, and the rotating gear 220. The rotating gear 220 is circular plate-shaped and can rotate around a central axis (see...). Figure 2 The rotation of “CL” in the figure can be controlled by a motor (not shown) according to the control of the control unit 500.

[0044] The frame 200, which is roughly rectangular and box-shaped, has an opening 213 for inserting the subject's breast as the subject of examination; it also has a recessed part 215 for inserting the subject's arms, legs, etc.

[0045] The entire inner surface of the frame 200 (more specifically, the frame 210, hereinafter the same) is provided with a shielding part 250 that can shield X-rays.

[0046] The shielding part 250 can completely shield the X-rays generated by the X-ray tube 230 and radiated into the frame 210, thereby preventing X-rays from leaking to the outside of the frame 210. Thus, the shielding part 250 can protect the examinee, the operator of the surrounding equipment, and even other people near the frame 200 from X-rays.

[0047] The shielding part 250 can be formed by attaching a lead plate to the plate inside the frame 210, or by coating or attaching barium or other alloys to the inner surface of the frame 200.

[0048] The thickness of the shielding part 250 can be adjusted according to the amount of X-ray irradiation.

[0049] The frame 200 may be integrally equipped with a seat-shaped support device 320 to allow the breasts to be inserted into the opening 213 and the legs to be placed in the recess 215. When the subject sits on the seat-shaped support device 320, and the frame 200 is tilted relative to the ground (see reference...),Figure 4 In the case of “θ”, the upper body of the examinee will also tilt randomly at 200 degrees.

[0050] In addition, the lower part of the support 300 is connected to a moving device 400, which includes rollers to enable the support 300 to move.

[0051] The basic principle of this invention originates from the prediction of the Austrian mathematician Radon, namely that if projection (penetration) data can be obtained from multiple directions, a clear tomographic image can be reconstructed. Projection (penetration) data refers to the measurement of X-ray dose values ​​penetrating the human body from multiple angles (e.g., 360 degrees) using an X-ray detector 240, which detects the X-rays penetrating the human body, and converts this data into electrical intensity data.

[0052] In order to convert the converted electrical signal intensity into individual pixel values ​​(i.e., tomographic images), it is necessary to solve computational equations. It is thanks to the development of computers that fast computation has been made possible, and this is called a computed tomography system.

[0053] X-ray tube 230 is a vacuum tube used to generate and irradiate X-rays. X-ray tube 230 applies a DC voltage of about 100,000 volts between the cathode and anode, causing electrons generated at the cathode to be pulled toward the anode and collide with the anode, converting the kinetic energy carried by the electrons into another form, namely X-rays.

[0054] By measuring the X-rays generated by the X-ray tube 230 and feeding back the X-ray dose to the X-ray power supply unit 630, it is possible to achieve precise adjustment of the X-ray dose, automatic control of the irradiation amount, and protocol-based irradiation, all of which are controlled by the control unit 500.

[0055] X-ray tube 230 may include a novel digital X-ray tube that is highly efficient in terms of X-ray dosing, miniaturized, and capable of easily generating short, strong X-ray pulses with precise control over energy and dose.

[0056] For example, the X-ray tube 230 may include a nano cold-cathode field-emission type digital X-ray tube, which can easily generate short and strong X-rays that ensure excellent image quality while minimizing the required X-ray dose, and can precisely control the energy and dose; since there is no need to heat the cathode, the heating circuit is eliminated, thus enabling ultra-miniaturization.

[0057] X-ray detector 240 detects X-rays that penetrate the X-ray tube 230 and the object being examined, converts them into electrical signal intensity, and transmits the converted data to data acquisition unit 610. In other words, X-rays emitted from X-ray tube 230 reach X-ray detector 240. For example... Figure 3 As shown, with the rotation center axis (CL) as the reference, the X-ray detector 240 is positioned opposite the X-ray tube 230.

[0058] By rotating gear 220, the X-rays generated by X-ray tube 230 are rotated 360 degrees around the breast for irradiation. At the same time, the penetration amount of X-rays penetrating in each direction can be converted into electrical signal intensity in X-ray detector 240. X-ray detector 240 consists of hundreds of semiconductors in each column.

[0059] like Figure 3 As shown, the X-ray detector 240 can be configured to include: a plurality of holes 241, and a plurality of detection units 242 corresponding to the plurality of holes 241 respectively. These holes 241 and detection units 242 are one-to-one and arranged in a grid. Each hole 241 can act as a channel or conduit, guiding X-rays emitted from the X-ray tube 230 and penetrating the subject to the corresponding detection unit 242. These detection units 242 can detect the X-rays received through each hole 241. In this case, the detection units 242 can be composed of hundreds of semiconductors in each column as described above. These detection units 242 can correspond to individual pixels in an image. That is, the size of the X-ray detected by each detection unit 242 can become the pixel value of each pixel in the image.

[0060] To generate penetrating X-rays, electrons are accelerated by a voltage of 100,000 volts to collide with the anode, causing them to brake and convert their kinetic energy into another form of energy, namely X-rays. This is called braking radiation (accounting for more than 90% of the total X-ray dose). In addition, when electrons collide with each other, exciting their energy levels to other angles before returning to their original states, a small amount of characteristic radiation (appearing within a specific frequency band) is produced based on the energy difference. Braking radiation and characteristic radiation are collectively referred to as generated X-rays. This X-ray spectrum (expressed with frequency band as the x-axis and dose as the y-axis) is then processed into the narrowest and strongest possible form (a form with increased average energy).

[0061] In this invention, the X-ray tube 230 is used to generate X-rays that minimize patient radiation exposure while improving image quality, while the X-ray detector 240 is used to measure the X-ray dose that penetrates an object and transmit the value to the data acquisition unit 610.

[0062] The data acquisition unit 610 is responsible for collecting and organizing the values ​​received from each X-ray detector 240 in various directions and transmitting them to the image reconstruction unit 640.

[0063] As mentioned above, the X-ray tube 230 requires a strong and high DC voltage.

[0064] The X-ray power supply unit 630 boosts commercial electricity to high voltage, rectifies the high voltage into DC voltage, and then supplies it to the X-ray tube 230, which requires a high DC voltage. The level of high DC voltage can be varied according to the required X-ray dose.

[0065] The X-ray power supply unit 630 can perform precise dose adjustment, automatic exposure adjustment, and protocol-based automatic adjustment based on X-ray dose feedback, and these adjustments can all be controlled by the control unit 500. Therefore, the control unit 500 can control the overall operation of the mammography apparatus 100 according to the present invention.

[0066] The image reconstruction unit 640 calculates the value of each pixel in the image by performing operations on the data received by the data acquisition unit 610. The image reconstruction unit 640 is used to reconstruct the image; image reconstruction refers to the mathematical process of generating an image based on the original data, i.e., the data transmitted by the data acquisition unit 610.

[0067] By acquiring the transmission values ​​of each X-ray detector 240 in various directions (data acquisition), and based on this, calculating the individual pixel values ​​in matrix form (image reconstruction), a single tomographic image or combining multiple tomographic images into a three-dimensional image can be observed.

[0068] like Figure 5 The principle illustrated is that if we solve for the horizontal sums a+b=3 and c+d=7, and the vertical sums a+c=4 and b+d=6 for each pixel in the image, we can obtain the values ​​a=1, b=2, c=3, and d=4. In this way, the values ​​of each pixel can be calculated. However, to obtain a large number of pixel values, a large number of computational equations need to be calculated quickly, thus requiring a computer with high processing speed.

[0069] The image reconstruction unit 640 can also be implemented as a function of the control unit 500, and its performance can be improved by applying techniques superior to conventional filtered back projection (FBP) (e.g., iterative reconstruction algorithms) as analysis techniques. These algorithms are excellent at converting image electrical signals into individual pixel values ​​in a three-dimensional coordinate system, thus compressing noise while obtaining high-quality images, thereby further reducing the required X-ray dose.

[0070] The image display unit 620 displays the final result derived by the image reconstruction unit 640 via a screen, namely: a single-layer image, or a three-dimensional image composed of single-layer images.

[0071] The image display unit 620 can also monitor all captured images simultaneously. In this way, multiple organically connected control elements can be displayed at the same time, thereby facilitating the control of the entire device.

[0072] The operation console 510 includes a touch panel, keyboard, mouse, and trackball, allowing users to control the image and rack 200 in scanning mode by inputting necessary information.

[0073] In order to improve the signal-to-noise ratio by utilizing data deviation and to achieve efficient control through spiral rotation, the communication between the data acquisition unit 610 and the operation control console 510 can also be controlled by the control unit 500.

[0074] The operation of the mammography apparatus 100 with the above-described structure is described in detail below.

[0075] First, the subject sits on the support device 320 of the frame 300 and places the breast, which is the subject of the examination, in the opening 213.

[0076] The X-ray power supply unit 630 boosts and rectifies the voltage from a commercial power supply or battery, processing it into a pulsed high voltage that meets the conditions for X-ray generation, and applies it to the X-ray tube 230. As a result, the X-ray tube 230 emits X-rays.

[0077] The generated X-rays, through the rotation of the rotating gear 220, target the breast of the subject, rotating 360 degrees and irradiating the breast.

[0078] X-rays penetrating the breast are received by X-ray detector 240 and converted into electrical signal intensities corresponding to the X-ray dose. Data acquisition unit 610 organizes the converted electrical signal intensities from each direction and each X-ray detector 240 and sends it to image reconstruction unit 640. Image reconstruction unit 640 processes this data, calculates the values ​​of each pixel, and generates a tomographic image.

[0079] The obtained tomographic images are displayed on the image display unit 620 and can be read instantly, or transmitted to the workstation 710 and the hospital's image information processing system 720 for storage, and viewed when further analysis is needed or when doctors require it.

[0080] All these processes are implemented through the control unit 500 and controlled by doctors or authorized users by inputting commands through the operation console 510.

[0081] This imaging process begins with positioning the breast in the imaging position. A key feature of the mammography device 100 is that, by relying solely on gravity to position the subject, a very wide imaging area, including lymph nodes, is structurally ensured (through gravity), enabling rapid detection of metastasis. Furthermore, it can detect substantial changes at the pixel level, or even close to the cellular level, thus achieving precise diagnosis.

[0082] In other words, the mammography device 100 not only possesses inherent advantages, but also, because it is unaffected by time and space and always sets its imaging position based solely on gravity in a specific direction, it can utilize 3D pixel (spatial pixel, volume pixel: voxel) offset and digital subtraction software. This enables the establishment of a system for early detection and diagnosis of breast cancer at the cellular level, as well as the tracking, observation, and management of substantial changes. Furthermore, it overcomes the technological and scientific limitations of medical AI, as well as operational constraints such as infrastructure deficiencies, thereby enhancing AI's functionality and maximizing its application.

[0083] When using the mammography apparatus 100 according to the present invention to perform breast cancer diagnostic imaging, the breast as the target of the imaging is structurally unaffected by time and space and is always subjected to constant gravity. Therefore, almost identical breast images can be obtained each time the imaging is performed.

[0084] Thus, using Voxel Shift software, it is easy to align all the coordinates of each pixel representing the size of tissue cells in each slice (which together form a 3D image) with the previously captured image.

[0085] Furthermore, by performing digital subtraction on individual pixels with the same coordinates in images prior to and from the image taken on the day of the shooting, the actual value of the change in individual pixel values ​​can be obtained in a uniform unit (the unit of X-ray attenuation called "Huntersfield units").

[0086] Therefore, at the early microscopic stage, changes in the breast tissue can be quickly detected and accurately diagnosed. At the same time, the progression of corresponding tissue changes can be tracked, thereby achieving breast cancer management at the tissue and cell level.

[0087] Therefore, this is a technology application specifically for breast cancer diagnosis, rather than a general or broad AI application. It overcomes the limitations of existing science and technology and the lack of infrastructure in the diagnosis of breast cancer, and is expected to be widely used in the entire field of breast cancer in the future.

[0088] In particular, it will be able to maximize the application value of more useful AI in mobile mammography devices.

[0089] During the operation of the mammography apparatus 100, noise caused by motion artifacts (the movement of the subject) decreases as the rotational X-ray generation time decreases. In other words, the faster the rotational scan speed, the fewer motion artifacts there are, resulting in clearer images.

[0090] The rotating gear 220 can move back and forth during X-ray scanning. Specifically, the rotating gear 220 can move back and forth based on the subject's breast through the insertion opening 213. This is to obtain X-ray images of various parts of the breast by moving and rotating the rotating gear 220 back and forth during X-ray scanning.

[0091] In this way, the rotating gear 220 can be moved back and forth during X-ray scanning to obtain and superimpose biased images. In other words, in Scan Mode, multiple scans can be performed as quickly as possible with an adjustable scan pitch to superimpose biased signals, thereby obtaining images with a better signal-to-noise ratio (S / N ratio) and higher quality, thus further reducing the required dose.

[0092] When the rotating gear 220 rotates 360 degrees, the X-rays irradiate the breast, penetrating the lesion area at all angles of the breast, thereby obtaining an image.

[0093] Therefore, a single rotation of the rotating gear 220 can acquire an image of the lesion area within a 360-degree range of the breast, but this process can be repeated multiple times to obtain the clearest image.

[0094] At this time, the generated X-rays propagate radially. Except for the X-rays reaching the X-ray detector 240, all other X-rays are unnecessary and harmful to the human body. These X-rays are considered harmful radiation. Therefore, considering only human safety, the amount of X-rays used and the amount of leaked X-rays should be as low as possible. Even without considering the examinee, it is best to reduce the exposure of the equipment operator and others to these X-rays. Therefore, shielding to prevent the radiation from propagating outward is crucial. This shielding is achieved by the aforementioned shielding part 250. Specifically, it is best to ensure that the leaked X-ray dose is below the standard value (domestic standard: 2.58C / kg or 100mR / week). To this end, the present invention provides an X-ray shielding part 250, which is formed on the inner surface of the frame 210 of the gantry 200. This structure can shield X-rays leaking to the outside.

[0095] On the other hand, the lower the X-ray dose generated and emitted from the X-ray tube 230, the less X-rays reach the X-ray detector 240, and the lower the probability of obtaining a clear image. Therefore, in order to obtain a clear image, a high voltage needs to be generated from the X-ray power supply unit 630 and an even higher voltage needs to be applied to the X-ray tube 230, thereby generating a large amount of X-rays. Furthermore, although processing X-rays (filtering) can improve image quality while reducing X-ray exposure, the amount of X-rays leaking to the outside is still high, posing a potential risk of harm to the human body.

[0096] To address these issues and reduce the required X-ray dose, the present invention ensures human safety by applying a new technology (active shielding) and forming an X-ray shielding portion 250 (manual shielding) on ​​the inner surface of the frame 210.

[0097] Thus, by shielding its own X-rays internally, there is no need to install an X-ray shielding layer on the entire exterior wall of the room where the mammography device 100 is installed, thereby minimizing the restrictions on the installation site.

[0098] Furthermore, in this invention, high-resolution images can be obtained using a small amount of X-rays (actively shielded) by using a highly sensitive X-ray detector 240. This can be achieved by using a perovskite X-ray detector with sensitivity far superior to conventional X-ray detectors and significantly reducing the required dose, or an X-ray detector with equivalent performance.

[0099] This perovskite X-ray detector 240 is 20 times more sensitive than conventional detectors, or requires less than 1 / 10 of the X-ray dose, making it extremely advantageous for protecting the health of patients and those around them.

[0100] By using a high-sensitivity X-ray detector 240, the present invention enables the frame 210 to be miniaturized and have a small capacity X-ray tube based on a cold cathode method, thereby reducing the overall energy consumption of the device while achieving lightweighting and miniaturization.

[0101] By forming an X-ray shield 250 on the inner surface of the frame 210, the risk of harm to the human body can be reduced. By incorporating a mobility device 400 including wheels onto the frame 200, installation is simplified while improving mobility. The mobile frame 200 also allows for direct imaging of patients in locations difficult to access, such as islands or hospitals.

[0102] According to the present invention, by combining all dose-reducing factors to significantly reduce the dose, and by manually shielding the interior of the frame 210 with heavy metal of a thickness of less than 1 / 10 of the X-ray dose, the exposure dose and exposure risk of patients and nearby personnel can be significantly reduced, energy consumption requirements can be minimized, it can be easily moved, and the application range can be maximized.

[0103] On the other hand, diagnosis relying on human vision can be flawed, and AI-based diagnosis is being applied to compensate for this deficiency. However, in cases based on two-dimensional images, or even using three-dimensional technology, and when currently relying on physically and clinically limited devices, or on inconsistent diagnostic information lacking sufficient clinical research, limitations may arise at the clinical, technological, scientific, and operational levels.

[0104] Therefore, the widespread and long-term lack of clinical research, technological and scientific limitations, and lack of infrastructure are important factors hindering the application of AI technology in the medical field.

[0105] Furthermore, the unpredictable nature of medical data used for AI learning is also a problem. Data varies depending on the patient's gender and age, the conditions under which the data was generated, the treatment environment, and the time of treatment, making it difficult for AI to generalize. Therefore, it is difficult to standardize self-learning data consistently. Ultimately, further development is needed to create AI applicable to the medical field.

[0106] Therefore, providing real-world data specific to each diagnosis would help experts conduct more extensive, convenient, and proactive reviews using clinical data on consistency assessment indicators. Furthermore, providing truly important information unaffected by random variables would enable consistent generalization, making it easier to build the necessary infrastructure and allowing for consistent assessment and management of evolving AI.

[0107] Furthermore, there are currently almost no methods that can achieve a perfect diagnosis in one go, and even if cancerous tissue is detected through visual diagnosis using all available methods, there are very few suitable methods for tracking, observing, or managing it at the tissue and cell level. However, all of the above will become possible if changes in each individual tissue cell can be known immediately in the future.

[0108] However, the reason why it is difficult to detect changes in tissue cells is that even with digital subtraction technology that can detect changes, almost all breast cancer diagnostic devices that can examine the inside of the breast still have physical and clinical limitations.

[0109] Furthermore, because it is difficult to align the pixel values ​​in the images before and after the image is captured (i.e., the pixel coordinates of all the pixels in each tissue cell), it is impossible to compare pixels with the same coordinates.

[0110] In traditional techniques, Digital Breast Tomosynthesis (DBT), which most closely resembles 3D imaging and has relatively few clinical and physical limitations, also requires breast compression. In this case, various factors such as the intensity, direction, reaction force, elasticity, gravity, and overlap of the compression simultaneously affect each pixel. This makes it difficult for each pixel to maintain consistent coordinates during each image capture, resulting in misalignment of pixel coordinates between images taken before and on the day of capture. Consequently, it becomes difficult to determine the tissue-cell level changes at each coordinate.

[0111] In other words, apart from the breast tomography apparatus 100 according to the present invention, all image diagnostic devices have clinical and physical limitations, or structural difficulties in aligning all the coordinates of each pixel in the preceding and following images. This makes it difficult to obtain the subtle changes of each pixel (i.e., tissue cells) in a substantial value, resulting in difficulties in achieving early detection, accurate diagnosis, tracking observation and management.

[0112] In other words, in a healthcare environment where comprehensive diagnostic results are directly related to life, the high reliability of data and the accuracy of the specific information provided are crucial. Furthermore, without providing substantial data in a precise and consistent manner, free from clinical and physical limitations, achieving essential functions such as early detection, accurate diagnosis, tracking, observation, and management will be exceptionally difficult. Moreover, the application of AI to compensate for this deficiency will be limited. Therefore, providing reliable and trustworthy breast cancer-specific data is of paramount importance.

[0113] Therefore, the mammography apparatus 100 of the present invention can provide perfect isotropic 3D images for breast diagnosis. It has a structure that allows the breast to be positioned for imaging without external forces such as pressure on the breast, regardless of time and location, and always under constant gravity. Therefore, if the angle of the subject and the imaging conditions are the same, breast images with almost identical shapes can always be obtained, facilitating the alignment of all coordinates of each pixel in images from before and on the day of imaging.

[0114] This invention aims to realize and utilize information on changes at the cellular level in breast tissue without clinical or physical limitations, in order to quickly detect lesions, make accurate early diagnoses, track and observe the progression of breast cancer, and establish a management system.

[0115] Furthermore, to address the uncertainties and limitations of current AI due to the widespread application of AI to uncertain and inconsistent information or data, as well as the susceptibility of data learning to operator influence, a technique specifically designed for breast cancer diagnosis is applied to provide consistent, substantial change values ​​at the tissue cell level. This approach overcomes the current limitations of AI in clinical, scientific, and technological aspects, as well as infrastructure deficiencies.

[0116] In the actual process of generating information through software based on the computer that controls the aforementioned rack and the entire device, the operator can input and issue commands to the computer via the operation console 510, causing the rotating gear 220 of the rack 200 to rotate; X-rays penetrating the subject are received by the X-ray detector 240, which rotates symmetrically with the X-ray tube 230; data is acquired by the data acquisition unit 610 and transmitted to the image reconstruction unit 630; the three-dimensional pixel value (i.e., voxel value) of each image is calculated based on the received data and transmitted to the image display unit 620 for display as an image.

[0117] Therefore, the mammography apparatus 100 that performs this process is always subjected to the same constant gravity during breast imaging, regardless of time and location. Thus, as long as the same imaging conditions (KV, mA, Sec) are applied at the same angle on the gantry 200, the same or substantially the same breast images can be obtained between images taken before the day of imaging and images taken on the day of imaging.

[0118] In fact, since the subject (i.e. the patient's breast) of the mammography apparatus 100 of the present invention is placed in the opening 213 by its own weight, as long as the angle of the gantry 200 remains unchanged or the imaging conditions (KV, mA, Sec) do not change, it is not affected by time and location, and almost the same breast image is obtained in the images before and on the day of the imaging.

[0119] Thus, tomographic images of the pre-shooting date and the shooting date, which have nearly identical morphology, obtained from the mammography apparatus 100 of the present invention, are retrieved and aggregated via H / W (e.g., a workstation). A preset voxel shift software is applied, comparing the pixel values ​​(X-ray attenuation values, in Huntsfield units) of the pre-shooting image with the pixel values ​​of the shooting date image, and shifting each pixel to align with the same values. Referring to the shooting date image, after digital subtraction between pixels at the same location, pixel values ​​that are aligned and unchanged have a value of "0" (or close to "0"), while changed pixel values ​​(non-"0") can be visually emphasized through coloring or provided with specific substantive values.

[0120] Figure 6 This is a diagram that briefly illustrates the principle; Figure 6 (a) is an image taken on the day of the photograph. Figure 6 (b) is an image taken before the date of the photograph. Figure 6 (c) is a graph showing the changes in pixel values ​​after shifting the image pixels from the shooting date to a date prior to the shooting date and performing digital subtraction on the pixel values ​​of each pixel.

[0121] like Figure 6 As shown in (c), if the pixel values ​​of each pixel in the image before the shooting date and the image on the shooting date are the same, the number "0" is displayed; if the pixel values ​​are different, an integer other than "0" is displayed (including decimals if necessary). The numbers displayed for each pixel indicate that the pixel value of the same pixel has changed, and this change in pixel value indicates that there is an abnormality in the subject. In other words, if a change in the pixel value of the same pixel is detected in two images, it can be determined that there is an abnormality in the subject. The image reconstruction unit reconstructs the image that reflects these changes in pixel values.

[0122] In other words, Figure 6 The diagram illustrates the principle of identifying pixel value changes by digital subtraction after aligning prior images of the same patient retrieved from an image information processing system (PACS, not shown) with the image on the day of the photograph transmitted by the image display unit 620 in the H / W (e.g., a workstation) through pixel offset.

[0123] For example, in Figure 6 In example (c), for Figure 6 The image of the day (a) was taken, and the execution Figure 6The pixel shifts of images taken before the shooting date (b) are calculated (e.g., by overlaying two images), and the pixel value differences of each pixel are calculated using digital subtraction. The calculation results show that, for all pixels a to i in the image, except for pixel e, the pixel values ​​of the remaining pixels have not changed. That is, the result of digital subtraction of the pixel values ​​of each pixel is zero. However, the pixel value of pixel e is 8 in the image before the shooting date, but becomes 5 in the image on the shooting date, and the result of digital subtraction is -3. This indicates that the pixel value of pixel e has changed in the image on the shooting date after the image before the shooting date.

[0124] The mammography apparatus 100 of the present invention is capable of performing image analysis based on such pixel offset and diagnosing images through such image analysis.

[0125] On the other hand, even with breast computed tomography (BCT) devices that position the subject solely based on constant gravity and are unaffected by time and location, aligning the coordinates of individual pixels is not always easy due to factors such as the horizontal movement, rotation, expansion, contraction, and new tissue formation of individual tissue cells. This is especially true in 3D BCT. However, by performing a binding voxel shift, which involves shifting the 3D pixels (voxels) of an image taken before the capture date relative to the image taken on the capture date along the X and Y axes, voxel values ​​can be aligned more quickly and accurately (here, the tomographic images are two-dimensional in the X and Y directions, but when these tomographic images are used together, they become three-dimensional, consisting of the X, Y, and Z axes).

[0126] Offset of a single voxel requires a significant amount of processing time. However, as Figure 7 As shown, binding multiple voxels together and then offsetting them allows for faster pixel coordinate alignment. In this case, if coordinates (vectors) for the direction and distance (offset) of the offset of multiple voxel sets towards the alignment coordinates are provided (where the value of the voxel set is the average of the voxels, or the position of the same value obtained by adding all voxel values, or the "0" position obtained by simultaneously performing digital subtraction), results can be obtained faster by applying the vector values ​​to each voxel, and even faster if voxel offset and digital subtraction are performed simultaneously.

[0127] If the coordinate alignment error exceeds the reasonable range due to excessive movement, plastic surgery, breastfeeding, sudden obesity, etc. during shooting (resulting in misalignment or misregistration), then aligning the coordinates may take a lot of time. In this case, you can switch to visual or manual adjustment mode and make adjustments based on prior knowledge and experience.

[0128] With the further development of AI, we can expect it to move beyond the current state of manually diagnosing based on received information, and play a positive role in information generation, encompassing not only the aforementioned functions but also the overall information generation process. Therefore, AI will autonomously generate consistent and concrete substantive values, breaking through scientific, technological, and operational limitations. Through more efficient and accurate AI, it will provide maximized management, enabling responsible physicians to offer patients more proactive and accurate predictions and closer prognostic management.

[0129] Figure 7 Is Figure 6 Building upon this, a diagram is provided to illustrate more realistic and faster voxel bundles. As mentioned above, bundling voxels can significantly speed up processing, but bundling too many may result in insufficient detail; therefore, an appropriate voxel bundle should be selected.

[0130] exist Figure 7 In this process, the values ​​of individual voxel sets can be obtained by summing or averaging the values ​​of all bundled voxels. Alternatively, voxel shifts can be performed on voxel sets with the same values, followed by digital subtraction on a voxel-by-voxel basis to obtain the change value. Or, voxel shifts and digital subtraction can be performed simultaneously to calculate the direction and value of movement towards "0" (or the closest to "0"), i.e., the vector value. Then, applying the same vector value to each voxel in the bundled voxel set allows for faster processing of individual voxel coordinate alignment while simultaneously obtaining their change values.

[0131] For ease of understanding, references will be provided. Figure 7 The example illustrates the process of simultaneous voxel shifting and digital subtraction. Figure 7 In the image, numbers represent voxel values, and letters represent voxel positions. To achieve smooth voxel shifting, preferably, the voxel located at the center of the image is selected and shifted to a voxel with a voxel value of 0.

[0132] For example, in Figure 7 In the example, a voxel offset is performed on voxel m located at the center, using a voxel with a voxel value of 0. This is done by offsetting -2 voxels along the X-axis and -2 voxels along the Y-axis. In other words, the direction and value of the voxel offset are -2 along the X-axis and -2 along the Y-axis, respectively.

[0133] In this case, the voxel values ​​of each voxel change by -4. This can also be verified with other voxels. For example, if voxel e is also offset by -2 voxels in the X-axis direction and -2 voxels in the Y-axis direction, it is offset by m pixels, resulting in a voxel value change of -4 (from 8 to 4). Similarly, voxel c is also offset by k voxels, resulting in a voxel value change of -4 (from 6 to 2). Figure 7 As shown, the values ​​are offset from the image center towards the direction where the values ​​return to "0". Here, all voxels included in the voxel set are assigned the same vector value (X-2, Y-2).

[0134] In this way, by simultaneously performing voxel shifting and digital subtraction in the mammography apparatus 100 of the present invention, the time and cost required to shift all pixels can be reduced, thereby enabling rapid output of results. For this purpose, the image reconstruction unit 630 reconstructs an image that reflects the voxel values ​​and displays it on the image display unit 620 to visually confirm abnormal areas.

[0135] At this point, all voxel offsets and digital subtractions are handled automatically by the software. However, since real-time monitoring is not necessary, this can also be done manually; this method is preferred for scenarios requiring minor corrections.

[0136] The process of acquiring images using the mammography apparatus 100 according to the present invention and the process of acquiring the change values ​​of each pixel are described in detail below.

[0137] First, the subject removes her upper body clothing and places her breast into the breast opening 213. At this time, as... Figure 4 As shown, the frame 200 is preferably tilted relative to the support 300, and the subject is stably supported by the support device 320. The image captured at this time is an image taken on the day of the shooting. Of course, under the same conditions, images also exist before the day of the shooting, and these images are considered to be images taken before the day of the shooting.

[0138] Therefore, in order to obtain images of the same morphology from the same patient, it is necessary to confirm before the start of the imaging process that the same gantry angle and imaging conditions (KV, mA, Sec, Pulse Rate) are used on the previous and current imaging days.

[0139] The operator confirms that the breast, which is the subject of the examination, has been correctly inserted into the breast opening 213 and issues an instruction to start imaging via the operation console 510. Based on the instruction, the control unit 500 activates the X-ray power supply unit 630, applying a high voltage to the X-ray tube 230.

[0140] Simultaneously, the control unit 500 drives the motor of the rotating gear 220, causing the rotating gear 220 to rotate. As a result, the X-ray tube 230 and the X-ray detector 240 can rotate while maintaining their point-symmetric relative positions.

[0141] An X-ray tube 230, subjected to a high voltage, emits X-rays while rotating. For example... Figure 2 As indicated by the thick arrow, the X-ray is emitted radially. The emitted X-ray penetrates the breast, which is the subject of the examination, and reaches the X-ray detector 240. The arriving X-ray is converted into an electrical signal in the X-ray detector 240, and after being collected and processed by the data acquisition unit 610, it is transmitted to the outside for reconstruction, thereby completing the preparation work for comparison with the image before the shooting date.

[0142] In H / W (e.g., a workstation), using the image from the day of capture as a reference (mask), images of the same patient from before the capture date stored in the image information processing system are aligned to the coordinates of the capture image automatically or manually by performing Binding VoxelShift software. After the two images are aligned, digital subtraction is performed; or, as... Figure 7 As shown, the change values ​​of each pixel are obtained by simultaneously performing digital subtraction and coordinate alignment. These change values ​​can be displayed as visual enhancements (Colouring), or provided as actual change values ​​in X-ray attenuation values ​​(units: Huntsfields), or they can be provided to AI.

[0143] Therefore, by acquiring changes in tissue cells at the microscopic level, it is possible to achieve very early detection of cellular lesions in breast tissue. Even before breast cancer develops, its progression can be tracked and observed from the microscopic stage. Furthermore, its advantage lies in the fact that tracking and observation can begin as soon as changes in tissue cells appear, not after breast cancer has developed. Moreover, it allows for the establishment of a comprehensive management system for the development of breast cancer in all patients, starting from the stage of minute changes in tissue cells. Based on this, the increasingly widespread application of AI in the future is expected to overcome current technological limitations and maximize its application scope.

[0144] The present invention described above can be substituted, modified and transformed in various ways by those skilled in the art without exceeding the scope of the technical concept of the present invention, and is not limited to the above embodiments and drawings.

[0145] Therefore, the present invention can also be used in devices based on similar principles, such as: a simulated therapeutic tomography device (BCTSimulator), a tomography device (tomotherapy), a veterinary CT, and an extremity & small part CT, etc.

[0146] Furthermore, the objectives and advantages of this invention can be easily achieved through the technical means and combinations thereof described in the patent claims.

[0147] As described above, the present invention aims to provide a self-shielded movable frame and a mammography apparatus including the same, which miniaturizes the mammography apparatus (BCT) which has many advantages in breast diagnosis, enabling it to generate a lower X-ray dose among all X-ray diagnostic devices and to easily and conveniently shield the generated X-ray dose.

[0148] Furthermore, the present invention also aims to provide a self-shielded movable frame and a mammography apparatus including the frame and apparatus, which can be freely installed or moved to maximize space utilization efficiency.

[0149] Furthermore, the present invention also aims to provide a self-shielded movable frame and a mammography device including the frame and device, which can achieve lightweight and miniaturization, thereby reducing energy consumption and improving economy, while being able to move freely in different spaces and improving space utilization.

Claims

1. A mammography apparatus comprising: a housing having a box shape and an interior space formed therein; a rotary gear rotatably coupled to the interior of the housing; an X-ray tube coupled to one side of the rotary gear and configured to generate X-rays; an X-ray detector coupled to the other side of the rotary gear and configured to rotate about a center axis and move forward and backward with respect to a subject, receive X-rays generated from the X-ray tube and penetrate the subject, and convert the X-rays into electrical signals; a shielding portion formed on one side of the housing, covering the entire inner surface of the housing except for an opening portion for insertion of the subject, and configured to shield X-rays generated from the X-ray tube from leaking to the outside of the housing; an image reconstruction portion configured to reconstruct an image formed from the signals converted by the X-ray detector; and an image display portion configured to display the image reconstructed by the image reconstruction portion, wherein the image reconstruction portion performs digital subtraction on the same pixels between a previous image and a current image by shifting the pixels of the previous image to the current image, calculates a change in pixel value, and reconstructs an image reflecting the calculated change for each pixel.

2. The mammography apparatus according to claim 1, wherein when the image is a three-dimensional image, the image reconstruction portion groups voxels, which are three-dimensional pixels, into a plurality of sets, shifts a center voxel of an image formed from the sets of voxels to a voxel having a voxel value of 0, calculates a change in voxel value through the digital subtraction, and reconstructs an image reflecting the calculated change for the voxels.

3. The mammography apparatus according to claim 1, wherein the X-ray detector is configured to include a plurality of holes each guiding X-rays emitted from the X-ray tube and penetrating the subject, and a plurality of detection portions each corresponding to the holes and detecting X-rays received by the corresponding hole, wherein the detection portions are each composed of a semiconductor, and the plurality of detection portions correspond to each pixel of the image.

4. The mammography apparatus according to claim 3, wherein the size of X-rays detected by the plurality of detection portions corresponds to the pixel value of each pixel of the image.

5. The mammography apparatus according to claim 1, wherein the image reconstruction portion performs color display to emphasize a pixel having the change in the image reflecting the calculated change for each pixel.

6. The mammography apparatus according to claim 1, wherein the shielding portion includes a lead plate formed on the entire inner surface of the housing.

7. The mammography apparatus according to claim 1, wherein the subject includes a breast.

8. The mammography apparatus according to claim 1, wherein The stand body can be inclined with respect to a horizontal plane, and by the inclination, the subject located in the opening portion is maintained in a state of being directed downward by its own weight.

9. The mammography apparatus of claim 1, comprising a moving device provided under the stand body and including a roller to enable the stand body to move.

10. The mammography apparatus of claim 1, wherein the X-ray detector moves the rotary gear up and down during scanning of the X-rays, performs a plurality of scans at a set scanning interval, and thereby superimposes image data having a deviation and acquires. ​

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