Calcification detection system, method and equipment in cone-beam mammary gland computed tomography

Abstract

In the present invention, a method of imaging breast microcalcification features by acquiring a tomographic imaging dataset and a static imaging dataset and combining the tomographic imaging dataset and the static imaging dataset to improve resolution and reduce blurring in the resulting composite image. The resulting improved resolution image dataset is used to assess the identification of mammary gland calcification for breast cancer screening, diagnosis and / or treatment.

Description

[0001] Related Applications

[0002] This application claims the benefit of the following provisional patent applications: U.S. Patent Application No. 63 / 331,153, filed on April 14, 2022, for "Comprehensive Disclosure", U.S. Patent Application No. 63 / 401,475, filed on August 26, 2022, for "Immobilization and Support for Medical Imaging", U.S. Patent Application No. 63 / 401,493, filed on August 26, 2022, for "Ergonomic Improvements in Cone Beam Breast Computed Tomography", U.S. Patent Application No. 63 / 401,513, filed on August 26, 2022, for "Static Detail Imaging in Cone Beam Breast Computed Tomography", U.S. Patent Application No. 63 / 401,513, filed on August 26, 2022, for "Static Detail Imaging in Cone Beam Breast Computed Tomography", U.S. Patent Application No. 63 / 401,513, filed on August 26, 2022, for "Static Detail Imaging in Cone Beam Breast Computed Tomography", U.S. patent application No. 63 / 401,546, “Cone beam breast computed tomography with patient support subsystem,” U.S. patent application No. 63 / 401,548, “Cone beam breast computed tomography with pivoting stand,” filed on August 26, 2022, U.S. patent application No. 63 / 430,571, “Ultrasound hybrid imaging in cone beam breast computed tomography,” filed on December 6, 2022, and U.S. patent application No. 63 / 459,250, “Calcification detection systems, methods, and devices in cone beam breast computed tomography,” filed on April 13, 2023, all of the above disclosures are hereby incorporated by reference in their entirety. Technical Field

[0003] The present invention relates to the field of cone beam tomography, and in particular to the field of calcification detection in tomography. Background Art

[0004] According to the National Cancer Institute, one in eight women will be diagnosed with breast cancer in her lifetime, and although published reports show breast cancer mortality rates have declined, the disease still kills 40,000 women each year.

[0005] The best breast imaging technology is able to detect tumor masses when the tumor is less than 10 mm in diameter. The 16-year survival rate for patients with invasive breast cancers 1-10 mm detected by mammography is reported to be 93%. In addition, the likelihood of metastasis decreases dramatically as the diameter of the tumor decreases at the time of detection. If a breast tumor is detected when it is 10 mm or smaller, the probability of metastasis will be 7.31%. If a 4 mm cancer is detected, the probability of metastasis will decrease by more than 10 times to 0.617%.

[0006] Mammography can detect cancers as small as about 12 mm on average and was the most effective tool for early detection of breast cancer until the advent of cone-beam breast computed tomography. Mammography has relatively low sensitivity for small breast cancers (less than a few millimeters). The specificity and positive predictive value of mammography remain limited due to structural and tissue overlap. The limited sensitivity and specificity of mammography in breast cancer detection stem from its poor contrast detectability, which is common to all types of projection imaging techniques (contrast detectability for projection imaging is only 10% at best), and mammography initially detected only 65-70% of breast cancers. In dense breasts, mammography sensitivity is further reduced to less than 30%. Digital mammography (DM) aims to overcome the limitations inherent in conventional film mammography (SFM) by providing improved contrast resolution and digital image processing; however, a large-scale clinical trial, the Digital Mammography Screening Trial (DMIST), showed that DM and SFM had the same false-positive rate.

[0007] The relatively low specificity of mammography results in biopsies being performed for indeterminate cases despite the increased cost and stress this causes to patients. In the United States, of the more than one million breast biopsies performed each year to evaluate suspicious mammographic findings, nearly 80% are benign, causing undue anxiety for patients and significant costs to the healthcare system. Therefore, there is an urgent need to more accurately characterize breast lesions to reduce biopsy rates and false-positive rates of pre-biopsy mammography.

[0008] To address the limitations of mammography described above, one of the inventors previously developed Cone Beam Breast Computed Tomography (CBBCT). In brief, the key features of CBBCT include: a horizontal, ergonomically designed table with modular inserts to optimize coverage of the uncompressed breast, including the chest wall; 1-meter-wide openings on either side of the table to facilitate breast localization and provide easy access for image-guided biopsies and other procedures without significantly altering the basic platform; and slip-ring technology to facilitate efficient dynamic contrast imaging studies and future angiogenesis imaging.

[0009] Results from phantom studies have shown that CBBCT is able to achieve a spatial resolution of approximately 2.8 lp / mm, allowing detection of 2 mm carcinomas and microcalcifications of approximately 0.2 mm in size, and is suitable for average-sized breasts (chest wall diameter is approximately 13 cm) with a total dose of approximately 5 mGy. Assuming that two views are required for each breast, this dose is lower than that of a single mammogram. CBBCT has excellent image quality in visualizing breast tissue, breast tumors, and calcifications, and coverage of the breast (including the chest wall area) is at least equivalent to that of mammography. Visualization of major blood vessels is excellent without the use of contrast agents.

[0010] Therefore, CBBCT offers significant improvements in the detection and biopsy of suspicious lesions. Additionally, in many procedures using CBBCT, images can be acquired without compression of breast tissue, which is commonly associated with mammography. Compressive breast immobilization devices used for mammography are widely considered to be uncomfortable and are often cited as a factor that prevents patients from seeking ideal breast cancer screening. Additional improvements in CBBCT imaging offer the potential to further expand these benefits. Given the above, the ability to perform improved CBBCT imaging without the use of uncomfortable breast immobilization devices associated with mammography is highly desirable.

[0011] One way to further improve breast cancer detection is to exploit the association between breast tissue calcification and tumor incidence.

[0012] Although calcifications in breast tissue do not necessarily indicate the presence of malignancy, certain calcification patterns, such as irregular shapes and clusters of fine-looking types, are associated with malignancy and / or precancerous changes in breast tissue. In screening mammography programs, the rate of repeat examinations due to calcifications is 1.7%, with 19% of cases ultimately diagnosed as cancer. In the era of digital mammography, approximately one-sixth of all repeat examinations are due to calcifications. As many as 50% of breast cancers may be associated with calcifications, and 15-30% of calcifications biopsied for various reasons tend to be malignant in asymptomatic patients.

[0013] Calcifications are often associated with ductal carcinoma in situ (considered a stage 0 cancer). In addition, the presence of calcifications in one breast and not the other may indicate an increased risk. Therefore, being able to detect and characterize calcifications within the breast is beneficial on both a screening and diagnostic basis.

[0014] Breast calcifications usually appear as either large or small calcifications. Large calcifications are not usually considered an indicator of a significant cancer risk. Small calcifications appear as tiny white dots, and certain patterns of small calcifications are associated with an increased incidence of cancerous tissue.

[0015] Diagnostic breast calcifications include four types of suspicious calcification morphology, arranged in increasing order of concern: coarse and uneven (irregular, usually 0.5-1 mm); amorphous: fuzzy and / or small ("powdery", "cloudy" or "cottony"), so that no other specific shape can be determined; fine and pleomorphic: variable shape ("glass fragments" or "pebble"), usually less than 0.5 mm; fine linear or fine linear branching: thin (<0.5 mm), linear, branching or irregularly arranged ("casting").

[0016] Also important is the distribution of the calcifications (except for diffuse calcifications which are almost always benign), which are listed in increasing order of concern as follows:

[0017] Regional: scattered throughout larger volumes of breast tissue (>2 cm in largest linear dimension) rather than in the expected ductal distribution;

[0018] Clustering: at least 5 calcifications clustered within 1 cm of each other in an area with a maximum linear dimension of 2 cm;

[0019] Linear: calcifications are arranged in a line along the duct, suggesting deposition along the duct;

[0020] Segmental: Calcium deposits in a segment or lobe of the duct and its branches.

[0021] Thus, for suspicious morphologies, a linear or segmental distribution increases the likelihood of malignancy more strongly than a clustered distribution. Although punctate calcifications are not a suspicious morphology per se, they may be suspicious if they are new, increasing, or distributed in a linear or segmental pattern.

[0022] In order to best utilize the features developed above, the inventors believe that it is necessary to improve CBBCT imaging so that the resolution of calcifications can be improved to 0.1 mm or less by in vitro imaging. The results of this improvement will have important implications in both screening and diagnostic applications.

[0023] To consistently achieve image resolutions of 0.1 mm or less requires significant advances over existing CBBCT technology. After careful consideration, the present inventors have come up with novel and advantageous developments and improvements that are intended to achieve previously unobtainable imaging results. These results are improved by improving the imaging apparatus and methods and the apparatus and methods directed to the stability and timing of image acquisition. Summary of the invention

[0024] On the one hand, the inventors have determined that motion artifacts inherent in existing devices are a source of imaging blur. The ability to control and modulate the effects of these motions represents an opportunity to further improve imaging and potentially achieve the resolution required to effectively identify areas of diagnostically significant calcification.

[0025] On the other hand, the inventors have identified reducing patient motion as an opportunity to improve resolution and reduce image blur.Sources of patient motion include the patient's breathing, heartbeat, and various voluntary and involuntary movements of the patient's muscles.

[0026] In view of these recognized opportunities, the inventors have conceived and herein put into practice proposed technical improvements that enable the desired calcification imaging to be achieved.

[0027] For example, in certain embodiments of the present invention, the continuous rotational motion of a structural frame supporting a previously available CBBCT imaging device is replaced with multiple discrete motions. Thus, whereas previously CBBCT exposures were made while the imaging device was in motion, a system in accordance with the principles of the present invention captures images while the imaging device is substantially stationary relative to a stable breast. The result is reduced or eliminated motion-induced image blur and improved effective image resolution.

[0028] Thus, for example, a CBBCT image acquired in accordance with the principles of the present invention is acquired as a plurality of individual exposures, with the gantry being stationary at substantially 2° intervals during a single exposure. Those skilled in the art will appreciate that in certain embodiments of the present invention, images will be captured at rotation intervals of 0° to 0.5°, 0.5° to 1°, 1° to 2°, 2° to 4°, 4° to 10°, or any other combination of angles deemed useful in a particular application.

[0029] In other embodiments of the present invention, the examined breast is fixed, and conventional moving CBBCT images are acquired in a first time interval during the fixed period.

[0030] One or more static images are acquired at different time intervals during the fixation period. The static images are acquired when the imaging device is substantially stationary relative to the stable breast.

[0031] There are relatively few static images compared to the CBBCT image dataset. For example, in an example program or system, 1, 2, 5, 10, 20, or 30 static images may be acquired, while the CBBCT image pulse exposures are 200, 300, or 400. The data representing the static images is then numerically combined with the data for the CBBCT images to provide a CBBCT image of higher effective resolution.

[0032] In some embodiments of the present invention, the static images are roughly evenly distributed around the breast, and the rotation intervals are regular or irregular, such as (but not limited to) 5°, 10°, 20°, 30°, etc. In other embodiments of the present invention, the static images are concentrated in a limited sub-region of the rotation arc of the CBBCT image, where the limited sub-region will be selected in some cases to correspond to a specific region of interest identified in the breast tissue for enhanced inspection and / or feature description.

[0033] In certain embodiments of the invention, CBBCT images will be captured using relatively high energy X-ray signals from an X-ray source. In certain embodiments of the invention, static images will be captured using relatively low energy X-ray signals from an X-ray source.

[0034] In certain embodiments of the present invention, CBBCT images will be captured using an X-ray source having (or having its focal diameter parameter set to) a focal spot diameter of approximately 0.3 mm.

[0035] In certain embodiments of the invention, static images will be captured using an X-ray source having (or having its focal diameter parameter set to) approximately 0.1 mm.

[0036] In certain embodiments of the present invention, the combination of CBBCT images with static images is achieved through a deep learning artificial intelligence algorithm to enhance the calcified areas.

[0037] In certain embodiments of the present invention, to reduce image acquisition time and thereby minimize the possibility of examined tissue motion, as described above, CBBCT images are performed within a rotation interval of 180° plus the detector width, rather than the default 360° plus the detector width.

[0038] In certain embodiments of the invention, in order to reduce image blurring due to imaging device motion, thereby improving effective resolution, CBBCT images will be performed at longer time intervals. Thus, for example, a 360° gantry rotation will be performed at a 30 second time interval in certain embodiments of the invention, rather than, for example, 10 seconds. In other embodiments of the invention, for example, a 180° gantry rotation will be performed at a 30 second time interval, rather than, for example, 10 seconds.

[0039] As mentioned above, and described further below, in certain embodiments of the invention, a preliminary step is beneficial and implicit in immobilizing the breast to be imaged.

[0040] In current practice, the patient undergoing CBBCT lies prone on a patient bed. The breast to be examined is suspended vertically from a hole on the bed surface into the imaging area below the bed. The position of the breast in the imaging room area is maintained by the patient's stillness (i.e., keeping the patient still) because the patient lies on the upper surface of the bed.

[0041] The imaging device is connected to a movable gantry which is supported by a bearing device so as to rotate about an axis of rotation. The axis of rotation is generally vertical and passes through a hole in the upper surface of the bed. Ideally, the approximate centroid of the breast to be imaged is arranged at a position where the axis of rotation passes through the approximate centroid.

[0042] During imaging, the gantry rotates about the rotation axis so that the imaging device moves along at least a portion of a circular path. As it moves along this path, the imaging device emits a series of X-ray pulses and captures corresponding image data, which are processed to construct a cross-sectional model of the breast.

[0043] To avoid blurring during individual X-ray pulses and to keep the image consistent between pulses, the patient remains still during imaging. Even small changes in the spatial position of the breast can result in reduced image clarity.

[0044] In existing CBBCT systems, the breast is freely suspended in the imaging chamber. In order to provide the desired stability to improve breast imaging for calcification detection, certain embodiments of the present invention include a breast support device. In certain embodiments, the breast support device includes a stabilizer unit and a positioning device connected to the stabilizer unit to provide adjustable positioning relative to the reference frame of the tomograph.

[0045] In some embodiments, the stabilizer unit includes a generally rigid body having a major surface area configured to contact a corresponding surface area of ​​the examined breast. In some selected embodiments, the generally rigid body comprises a material having a desired transparency at an operating wavelength of imaging energy. Thus, in some embodiments, the generally rigid body comprises one or more of expanded polystyrene, polystyrene, polyethylene, acrylonitrile butadiene styrene (ABS), polypropylene, acrylates (e.g., polymethyl methacrylate), polyamides, polyimides, aerogels, ceramics, fiber reinforced composites, and polycarbonates (e.g., )wait.

[0046] The following description is intended to enable anyone with relevant skills to make and use the disclosed invention and sets forth the best mode currently believed by the inventor to implement his invention. In the following description, for the sake of explanation, many specific details are listed in order to provide a comprehensive understanding of the invention. However, it will be apparent to those skilled in the art that the present invention can be implemented without these specific details. In other cases, common structures and devices are shown in block diagram form to avoid unnecessarily obscuring the essence of the disclosure. These and other advantages and features of the present invention will be described below in conjunction with the accompanying drawings. Figure 1 It is easier to understand from the detailed description provided.

[0047] It should be noted that while the various figures illustrate various aspects of the invention, no single figure is intended to illustrate the entire invention. Instead, the figures collectively illustrate different aspects and principles of the invention. Therefore, it should not be assumed that any particular figure is only related to a discrete aspect or feature of the invention. Instead, professionals in the industry will understand that the figures taken together reflect various aspects and embodiments of the invention.

[0048] Therefore, the reference to "one embodiment" or "an embodiment" in the reference material means that the specific features, structures or characteristics associated with the embodiment are included in at least one embodiment of the present invention. Therefore, the phrases "in one embodiment" or "in an embodiment" appearing in different places in the reference material do not necessarily refer to the same embodiment. In addition, the specific features, structures or characteristics can be combined in one or more embodiments in any suitable manner. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] Figure 1 A portion of a CBBCT breast imaging system including an example breast stabilizer unit is shown in schematic cross-sectional perspective view;

[0050] Figure 2 The structure and signal relationships of certain aspects of an exemplary CBBCT breast imaging system, including a calcification detection feature prepared in accordance with the principles of the present invention, are illustrated in block diagram form;

[0051] Figure 3 Certain aspects of an example CBBCT breast imaging system are illustrated in schematic cross-sectional perspective view, including calcification detection features in a first configuration according to the principles of the present invention;

[0052] Figure 4 Certain aspects of an example CBBCT breast imaging system, including calcification detection features in a second configuration according to the principles of the present invention, are illustrated in schematic cross-sectional perspective view;

[0053] Figure 5A Certain aspects of CBBCT imaging systems and methods, including imaging of breast calcification features, are illustrated in schematic block diagram form;

[0054] Figure 5B Further aspects of CBBCT imaging systems and methods are shown in schematic block diagram form, including imaging of breast calcification features;

[0055] Figure 5C Further aspects of CBBCT imaging systems and methods are shown in schematic block diagram form, including imaging of breast calcification features;

[0056] Figure 6 Temporal aspects of CBBCT imaging systems and methods, including imaging of breast calcification features, are presented in the form of schematic graphical diagrams;

[0057] Figure 7 Other temporal aspects of CBBCT imaging systems and methods, including imaging of breast calcification features, are presented in the form of schematic graphical diagrams;

[0058] Fig. 8AA portion of a CBBCT breast imaging system is shown in schematic cross-sectional perspective view, including certain aspects of an example patient stabilization system;

[0059] Figure 8B A portion of a CBBCT breast imaging system is shown in schematic cross-sectional perspective view, including further aspects of an example patient stabilization system;

[0060] Fig. 9A A portion of a CBBCT breast imaging system is shown in schematic cross-sectional perspective view, including certain aspects of an example back support element;

[0061] Fig. 9B A portion of a CBBCT breast imaging system is shown in schematic cross-sectional perspective view, including further aspects of an example back support element;

[0062] Fig.10 Certain aspects of an example CBBCT breast imaging system are illustrated in schematic cross-sectional perspective view, including coupling features of a receiver and a breast stabilizer unit prepared in accordance with the principles of the present invention;

[0063] Fig.11A Certain aspects of an example CBBCT breast imaging system, including certain aspects of an example breast stabilizer unit prepared in accordance with the principles of the present invention, are illustrated in schematic cross-sectional perspective views;

[0064] Fig. 11B Additional aspects of an example CBBCT breast imaging system are illustrated in schematic cross-sectional detail perspective views, including certain aspects of an example breast stabilizer unit prepared in accordance with the principles of the present invention;

[0065] Fig.12 Various aspects of processing systems and methods using exemplary imaging modalities in accordance with the principles of the invention are illustrated in schematic block diagram form. DETAILED DESCRIPTION

[0066] Figure 1 A portion of an exemplary CBBCT imaging system 100 prepared in accordance with the principles of the present invention is shown in a cross-sectional perspective view, including a breast support device. The system 100 includes an X-ray source 102. The X-ray source 102 is mounted on an upper surface 104 of a rotating frame 106. The rotating frame 106 is supported by a bearing and arranged to rotate about a rotation axis 108.

[0067] The X-ray source 102 is configured to emit a beam of X-rays 110. The beam of X-rays 110 defines a beam longitudinal axis 112 that intersects the axis of rotation 108 at an intersection 114 in the illustrated embodiment.

[0068] In some embodiments of the present invention, beam 110 is configured as a cone beam. In some configurations, a cross section of beam 110 taken transversely along longitudinal axis 112 defines a disk having substantially uniform X-ray intensity and a nearly circular perimeter.

[0069] In other configurations within the scope of the present invention, a cross-section of the beam 110 taken transversely along the longitudinal axis 112 defines a region of substantially uniform x-ray intensity having a substantially circular perimeter except for a portion of the perimeter that is located outside of a chord that is located about the circular perimeter. As will be understood from the further disclosure below, in certain embodiments, the chord will be in a generally parallel, spaced relationship with the lower surface of the patient table.

[0070] In further configurations within the scope of the present invention, a cross section of the beam 110 taken transversely along the longitudinal axis 112 defines a region having a polygonal perimeter, which perimeter may, in various embodiments and configurations, include a triangular perimeter, a square perimeter, a pentagonal perimeter, a hexagonal perimeter, a perimeter of any higher geometry, and / or a perimeter having any curve or combination of line segments and curves as desired for a particular application. Furthermore, it is noted that any of the cross-sectional configurations described above may define a beam having non-uniform intensity, including (but not limited to) where the intensity drops to zero within certain cross-sectional regions.

[0071] An X-ray detector 116 is also mounted on the upper surface 104 of the rotating frame 106. In an exemplary embodiment, the X-ray detector 116 includes a planar detector having a generally planar receiving surface 118. The receiving surface 118 is generally perpendicular to the longitudinal axis 112 and is located on the other side of the rotation axis 108 opposite the X-ray source 102.

[0072] During operation of the imaging system 100, rotation of the rotating frame 106 about the rotation axis 108 will cause the receiving surface 118 to move along a motion path about the rotation axis 108. In a typical configuration, the motion path will include at least a portion of a circle centered on the rotation axis 108 and located perpendicular to the rotation axis 108. However, it should be noted that other motion paths (however implemented) are considered to be within the scope of the present invention and will be disclosed herein.

[0073] In certain embodiments of the present invention, the respective positions of the X-ray source 102 and / or the X-ray detector 116 are adjustable on the upper surface 104 of the rotating frame 106. For example, the X-ray source 102 and the X-ray detector 116 can be adjusted in a radial direction relative to the rotation axis 108, in a circumferential direction relative to the rotation axis 108, in a direction toward or away from the rotating frame surface 104, or in any other direction or manner that a designer or user deems beneficial. Professionals in the industry will understand that by appropriately configuring the X-ray cross-section and the position of the X-ray source and / or the X-ray detector, the entire examined breast and / or various regions of the breast can be preferentially imaged.

[0074] The patient table 120, also referred to as a patient interface panel, includes an upper surface 122 and a lower surface 124. An aperture 126 communicates between the upper surface 122 and the lower surface 124 of the table. The upper surface 122 is arranged to support a patient 128, who typically lies on the upper surface 122 in a prone position, as shown. In this arrangement, the patient's breast 130 is suspended below the patient's chest wall, passing through the aperture 126.

[0075] In the illustrated embodiment, a breast stabilizer unit 132 (shown in cross-section) is disposed at the aperture 126 and extends below the lower surface 124. At least a portion of an outer surface area 134 of the breast 130 contacts an inner peripheral surface area 136 of the stabilizer unit 132.

[0076] As discussed above, and discussed further below, the effectiveness of calcification detection is related to factors such as improved image resolution and reduced blur. After careful consideration, the present inventors have concluded that image resolution can be improved and blur can be reduced through improved X-ray source apparatus and methods, improved detector apparatus and methods, reduced motion artifacts through improved mechanical systems, and appropriate signal processing. Therefore, novel method and apparatus combinations embodying improvements in these desirable properties are disclosed herein, certain aspects of which are described below. Figure 2 This is reflected in the system overview shown in .

[0077] Figure 2 A portion of a CBBCT imaging system 200 including improved calcification detection features prepared in accordance with the principles of the present invention is shown in schematic block diagram form. The system 200 includes an X-ray source 202. The X-ray source 202 is connected to a positioning system 206 via a mechanical connection 204. The positioning system 206 is in turn connected to a rotating frame 210 via a mechanical connection 208.

[0078] The rotating frame 210 is connected to a rotating bearing 214 by an operational mechanical connection 212 to provide support around the rotating axis. The rotating bearing 214 is in turn connected to a structural base element 218 by a mechanical connection 216.

[0079] In certain embodiments of the present invention, a slip ring 220 spans the rotary bearing 214 via a mechanical connection 222 to transmit measurement, control, and imaging data and signals to and from the rotating frame 210 .

[0080] In some embodiments of the CBBCT imaging system, the planar X-ray detector 224 is connected to a vertical positioning drive 228 via a mechanical connection 226. The vertical positioning drive 228 is connected to a radial positioning drive 232 via a mechanical connection 230, and the radial positioning drive 232 is connected to the rotating frame 210 via a mechanical connection 234.

[0081] Therefore, the vertical positioning drive 228 and the radial positioning drive 232 are respectively connected to the flat detector 224 and the rotating frame 210. However, professionals in the industry will understand that in other embodiments of the present invention, the opposite connection order will be adopted, and in various embodiments of the present invention, a variety of mechanisms and arrangements will be adopted to position the flat detector 224 relative to the rotating frame 210.

[0082] In an exemplary embodiment of the present invention, as shown, the photon counting X-ray detector 236 is connected to a vertical positioning drive 240 via a mechanical connection 238. The vertical positioning drive 240 is connected to a radial positioning drive 244 via a mechanical connection 242, and the radial positioning drive 244 is connected to the rotating frame 210 via a mechanical connection 246. As described above, for a planar detector, in various embodiments of the present invention, a variety of mechanisms and arrangements will be used to position the photon counting detector 236 relative to the rotating frame 210.

[0083] In some embodiments of the present invention, the X-ray source 202 is connected to a controller 254 (e.g., a digital computer) via a communication channel 250 and a further communication channel 252 of the slip ring 220 to establish a signal connection 248. In some embodiments of the present invention, the function of such a signal connection is to provide power, data signals (e.g., operating parameters), feedback signals, and other useful signals, which are transmitted unidirectionally and / or bidirectionally between the X-ray source 202 and the controller 254.

[0084] In various embodiments of the present invention, signal connections and / or communication channel hardware (e.g., 248, 250, 252) will include, for example, but not limited to, cables, electrical fiber, flexible printed circuit devices, various waveguides for electromagnetic communication of any desired wavelength, including digital, analog, and mixed signals. In addition, in some embodiments, the desired communication will be achieved through free air signals, such as electromagnetic signals, acoustic signals, or other signals known or likely to be recognized in the art.

[0085] In some embodiments of the present invention, the planar detector 224 is connected to the controller 254 by signal connection 255 via the communication channel 250, the slip ring 220 and the further communication channel 252. In some embodiments of the present invention, the function of such signal connection is to provide power, data signals (such as operating parameters), feedback signals and other useful signals, which are transmitted unidirectionally and / or bidirectionally between the planar detector 224 and the controller 254.

[0086] In some embodiments of the present invention, the photon counting detector 236 is signal-connected 256 to the controller 254 via the communication channel 250, the slip ring 220, and the further communication channel 252. In some embodiments of the present invention, the function of such signal connection is to provide power, data signals (such as operating parameters), feedback signals, and other useful signals, which are transmitted unidirectionally and / or bidirectionally between the photon counting detector 236 and the controller 254.

[0087] Likewise, in certain embodiments of the present invention, vertical positioning actuators 228 and 240 are respectively connected to controller 254 via communication channel 250, slip ring 220, and further communication channel 252 for signal connection 258, 260. In certain embodiments of the present invention, such signal connection is used to provide power, data signals (such as operating parameters), feedback signals, and other useful signals, which are transmitted unidirectionally and / or bidirectionally between vertical positioning actuators 228, 240 and controller 254.

[0088] In some embodiments of the present invention, the horizontal positioning actuators 232 and 244 are respectively connected to the controller 254 through the communication channel 250, the slip ring 220 and the further communication channel 252 for signal connection 262, 264. In some embodiments of the present invention, the function of such signal connection is to provide power, data signals (such as operating parameters), feedback signals and other useful signals, which are transmitted unidirectionally and / or bidirectionally between the horizontal positioning actuators 232, 244 and the controller 254.

[0089] In certain embodiments of the present invention, servo and operational control will be achieved through the above-mentioned communication channels. In other embodiments of the present invention, local servo loops and / or feedback arrangements (such as digital servo loops, analog servo loops, and phase-locked loops) will provide immediate control of the device, and parameter / set point signals will be transmitted from the controller 254 when appropriate. Of course, combinations of the foregoing schemes and other appropriate schemes (such as open-loop control schemes) will be used as appropriate for specific embodiments or application requirements.

[0090] like Figure 2As shown in the exemplary embodiment of FIG. 2 , the imaging system 200 includes a patient support panel 266. The patient support panel 266 is connected to the structural base element 218 via a mechanical connection 268. In some embodiments, the patient support panel 266 will include a hole to receive the patient's breast through.

[0091] According to the exemplary embodiment shown, the receiver 270 is connected to the patient support panel 266 via a mechanical connection 272. In some embodiments of the present invention, the receiver 270 is signal-connected 274 to the controller 254 via a further communication channel 252. In some embodiments of the present invention, the function of such signal connection is to provide power, data signals (such as operating parameters, feedback signals, biometric signals and other useful signals), unidirectional and / or bidirectional transmission between the receiver 270 and the controller 254.

[0092] The breast stabilizer unit 276 is configured and adapted to be removably mechanically connected 278 to the receiver 270 to provide support. In certain embodiments of the present invention, the breast stabilizer unit 276 is signal-connected 280 with the receiver 270 when in operation, and is connected to the controller 254 through the receiver 270 through a signal connection 274 of a further communication channel 252. Professionals in the industry will understand that the role of such a signal connection is to provide power, data signals (such as operating parameters, feedback signals, biometric signals and other useful signals), and unidirectional and / or bidirectional transmission between the breast stabilizer unit 276 and the controller 254.

[0093] As shown, the CBBCT imaging system 200 optionally includes a patient positioning support 282. As shown, in certain embodiments of the present invention, the patient positioning support 282 will be mechanically connected 284 to and / or supported by the patient interface panel 266. In an exemplary embodiment, the patient positioning support 282 will be configured as a mattress, cushion, guardrail, or any other device that effectively positions the patient for effective operation of the imaging system 200 while reducing or optimizing patient movement and maintaining optimal patient comfort.

[0094] In certain embodiments of the invention, the patient positioning support 282 will be a reconfigurable device that allows adjustment or other customization based on the patient's physical and other characteristics, and the requirements of a particular procedure or procedure. In further embodiments of the invention, the patient positioning support 282 will be an active device that allows adjustment or other customization based on the patient's physical and other characteristics, and the requirements of a particular procedure or procedure, automatically and / or without the need for manual intervention by a clinician or technician.

[0095] In some embodiments of the present invention, the patient positioning support 282 is connected to the controller 254 via a further communication channel 252 for signal connection 285. In some embodiments of the present invention, the function of such signal connection is to provide power, data signals (such as operating parameters, feedback signals and other useful signals), and unidirectional and / or bidirectional transmission between the patient positioning support 282 and the controller 254.

[0096] In certain embodiments of the present invention, a signal connection between the patient positioning support 282 and the controller 254 allows the controller 254 to automatically and / or dynamically control the patient positioning.

[0097] As shown, the CBBCT imaging system 200 optionally includes a patient handle 286. As shown, in certain embodiments of the present invention, the patient handle 286 is mechanically coupled 288 to and / or supported by the patient interface panel 266. In an exemplary embodiment, the patient handle 286 is configured for grasping by the patient to facilitate efficient operation of the imaging system 200 while reducing or eliminating patient motion and maintaining optimal patient comfort.

[0098] In certain embodiments of the invention, the patient handle 286 will be a reconfigurable device that allows adjustment or other customization based on the patient's physical and other characteristics, and the requirements of a particular procedure or program. In further embodiments of the invention, the patient handle 286 will be an active device that allows adjustment or other customization based on the patient's physical and other characteristics, and the requirements of a particular procedure or program, automatically and / or without the need for manual intervention by a clinician or technician.

[0099] In some embodiments of the present invention, the patient handle 286 is connected to the controller 254 via a further communication channel 252 for signal connection 290. In some embodiments of the present invention, the function of such signal connection is to provide power, data signals (such as operating parameters, feedback signals, biometric signals and other useful signals), and unidirectional and / or bidirectional transmission between the patient handle 286 and the controller 254.

[0100] In certain embodiments of the present invention, the signal connection between the patient handle 286 and the controller 254 allows the controller 254 to automatically and / or dynamically control the patient positioning. In further embodiments of the present invention, the signal connection between the patient handle 286 and the controller 254 allows the patient's status, such as heart rate and timing, to be sensed during operation of the imaging system 200. It should be noted that in certain aspects of the present invention, image acquisition will be synchronized with the heart rate to minimize image blurring due to internal body vibrations associated with and / or caused by the heartbeat.

[0101] As shown, the CBBCT imaging system 200 optionally includes a patient back support element 292. As shown, in some embodiments of the present invention, the patient back support element 292 is mechanically connected 294 to and / or supported by the patient interface panel 266. In another embodiment of the present invention, the patient back support element 292 is mechanically connected 294 to and / or supported by the structural base element 218.

[0102] In certain embodiments of the invention, the patient back support element 292 will be a reconfigurable device that allows adjustment or other customization based on the patient's physical and other characteristics, as well as the requirements of a particular procedure or procedure. In further embodiments of the invention, the patient back support element 292 will be an active device that allows adjustment or other customization based on the patient's physical and other characteristics, as well as the requirements of a particular procedure or procedure, automatically and / or without the need for manual intervention by a clinician or technician. In an example embodiment, the patient back support element 292 will include an inflatable bladder or expandable cushion that, when activated, is intended to propel the patient toward the patient interface panel 266. According to certain aspects of the invention, the patient back support element effectively positions the patient for effective operation of the imaging system 200 while reducing or eliminating patient motion and maintaining optimal patient comfort.

[0103] In some embodiments of the present invention, the patient back support element 292 is signal-connected 296 to the controller 254 via a further communication channel 252. In some embodiments of the present invention, the signal connection is used to provide power, data signals (such as operating parameters, feedback signals, biometric signals and other useful signals), and unidirectional and / or bidirectional transmission between the back support element 292 and the controller 254.

[0104] In certain embodiments of the invention, the signal connection between the back support element 292 and the controller 254 allows the controller 254 to automatically and / or dynamically control the patient positioning. In further embodiments of the invention, the signal connection between the back support element 292 and the controller 254 allows the patient's status, such as heart rate and timing, to be sensed during operation of the imaging system 200. It should be noted that in certain aspects of the invention, image acquisition will be synchronized with the heart rate to minimize image blurring due to internal body vibrations associated with and / or caused by the heartbeat.

[0105] Figure 3 A portion of a CBBCT imaging system 300 including improved calcification detection features prepared in accordance with the principles of the present invention is shown in schematic cross-sectional perspective. The system 300 includes an X-ray source 302. The X-ray source 302 is mechanically coupled to a positioning system 306. The positioning system 306 is in turn mechanically coupled to a rotating frame 310.

[0106] The rotating frame 310 is connected to a rotating bearing 314 through an operational mechanical connection to provide support around the rotating axis 311. The rotating bearing 314 is in turn mechanically connected to a structural base element 318.

[0107] In certain embodiments of the present invention, slip ring 320 is mechanically coupled across rotating bearing 314 to transmit measurement, control, biometric and imaging signals and data to and from rotating frame 310 .

[0108] In some embodiments of the CBBCT imaging system, the planar X-ray detector 324 is mechanically coupled to a vertical positioning drive 328. The vertical positioning drive 328 is mechanically coupled to a radial positioning drive 332, which in turn is mechanically coupled to the rotating frame 310.

[0109] Therefore, the vertical positioning drive 328 and the radial positioning drive 332 are respectively connected to the flat detector 324 and the rotating frame 310. However, professionals in the industry will understand that in other embodiments of the present invention, the opposite connection order will be adopted, and in various embodiments of the present invention, a variety of mechanisms and arrangements will be adopted to position the flat detector 324 relative to the rotating frame 310.

[0110] In an exemplary embodiment of the present invention, as shown, the photon counting X-ray detector 336 is mechanically coupled to a vertical positioning drive (not visible). The vertical positioning drive is mechanically coupled to a radial positioning drive 344, which in turn is mechanically coupled to the rotating frame 310. As described above, for a planar detector, a variety of mechanisms and arrangements may be used to position the photon counting detector 336 relative to the rotating frame 310 in various embodiments of the present invention.

[0111] It should be noted that in Figure 3 3, the photon counting detector 336 is shown in a storage configuration such that the photon counting detector 336 is located outside of the X-ray beam 338 and does not interfere with the X-ray beam emitted by the X-ray source 302. Those skilled in the art will readily appreciate that the operation of the vertical positioning drive and the radial positioning drive 344 mentioned above will cause the photon counting detector 336 to shift from the storage configuration shown to the operating configuration, as described below. Figure 4 shown.

[0112] When the photon counting detector 336 is in the stored configuration shown, an X-ray beam 338 emitted by the X-ray source 302 can pass through a patient's breast 340 being imaged within the imaging system 300 and impinge upon an imaging surface 342 of the planar detector 324 .

[0113] In some embodiments of the present invention, the X-ray source 302 is connected to a controller (e.g., a digital computer) by signals through a communication channel, a slip ring 320, and a further communication channel. In some embodiments of the present invention, the function of such signal connection is to provide power, data signals (e.g., operating parameters, feedback signals, and other useful signals) for unidirectional and / or bidirectional transmission between the X-ray source 302 and the controller.

[0114] In various embodiments of the present invention, the signal connection and / or communication channel hardware will include, for example (but not limited to), cables, electric fiber, flexible printed circuit devices, various waveguides for electromagnetic communication of any desired wavelength, including digital, analog and mixed signals. In addition, in some embodiments, the desired communication will be achieved through free air signals, such as electromagnetic signals, acoustic signals, or other signals known or likely to be recognized in the art.

[0115] In some embodiments of the present invention, the planar detector 324 is connected to the controller by signals through the communication channel, the slip ring 320 and the further communication channel. In some embodiments of the present invention, the function of such signal connection is to provide power, data signals (such as operating parameters, feedback signals and other useful signals), unidirectional and / or bidirectional transmission between the planar detector 324 and the controller.

[0116] In some embodiments of the present invention, the photon counting detector 336 is connected to the controller via a communication channel, a slip ring 320, and a further communication channel. In some embodiments of the present invention, the signal connection is used to provide power, data signals (such as operating parameters, feedback signals, and other useful signals) for unidirectional and / or bidirectional transmission between the photon counting detector 336 and the controller.

[0117] Likewise, in some embodiments of the present invention, the vertical positioning actuator (e.g., 328) is connected to the controller via a communication channel, a slip ring 320, and a further communication channel. In some embodiments of the present invention, the signal connection is used to provide power, data signals (e.g., operating parameters, feedback signals, and other useful signals), and unidirectional and / or bidirectional transmission between the vertical positioning actuator (e.g., 328) and the controller.

[0118] In some embodiments of the present invention, the horizontal positioning actuators 332 and 344 are respectively connected to the controller via the communication channel, the slip ring 320 and the further communication channel. In some embodiments of the present invention, the function of such signal connection is to provide power, data signals (such as operating parameters, feedback signals and other useful signals), unidirectional and / or bidirectional transmission between the horizontal positioning actuators 332, 344 and the controller.

[0119] In certain embodiments of the invention, servo and operational control will be achieved through the above-mentioned communication channels. In other embodiments of the invention, local servo loops and / or feedback arrangements (such as digital servo loops, analog servo loops, and phase-locked loops) will provide immediate control of the device, and parameter / set point signals will be transmitted from the controller when appropriate. Of course, combinations of the foregoing and other appropriate schemes (including open-loop control) will be used as appropriate for specific embodiments or application requirements.

[0120] Figure 4 A portion of a CBBCT imaging system 400 is shown in schematic cross-sectional perspective view and has features similar to those of the imaging system 300. Among other notable features, the imaging system 400 includes an X-ray source 402 mechanically coupled to a positioning system 406. The positioning system 406 is supported by a rotating frame 410.

[0121] The planar X-ray detector 424 is mechanically connected to a vertical positioning drive 428, which is in turn mechanically connected to a radial positioning drive 432, which is in turn mechanically connected to the rotating frame 410. The photon counting detector 436 is mechanically connected to a vertical drive 437, which is in turn mechanically connected to a radial drive 444. The radial drive 444 is mechanically connected to the rotating frame 410.

[0122] As described above, the photon counting detector 336 is in the storage configuration. In contrast, the photon counting detector 436 is shown in the operating configuration. It will be apparent to the reader that the photon counting detector 436 has been shifted from the storage recess 439 to the operating configuration by the vertical movement 441 of the vertical drive 437 and the radial movement 443 of the horizontal drive 444. Therefore, the photon counting detector 436 is positioned to effectively receive the X-ray beam 438 generated by the X-ray source 402.

[0123] In certain embodiments of the present invention, the x-ray beam 438 is configured (e.g., by passing through a shielding collimator) to have corresponding vertical and horizontal dimensions and is positioned so as to primarily impinge upon the imaged region of interest 445 within the breast 440 being imaged. Optimally, the corresponding vertical dimensions 447 and horizontal dimensions 449 of the imaging region 451 of the photon counting detector 436 correspond to the dimensions of the collimated x-ray beam as it arrives at the imaging region 451.

[0124] Thus, by coordinating the operation of the shielding collimator with the vertical driver 437 and the horizontal driver 444, the target region of interest 445 of the breast 440 can be effectively imaged. As will be discussed further below, in certain embodiments of the present invention, a tomographic image data set will be acquired through the operation of the planar detector 424, and one or more static images will be acquired through the operation of the photon counting detector 436 to provide additional details about the region of interest 445. In certain embodiments of the present invention, the tomographic image data and the static image data will be processed to generate a tomographic image with improved resolution and / or reduced blur. These improvements will help identify and characterize calcified areas within the breast 440.

[0125] Those skilled in the art will appreciate that in various embodiments, an imaging system prepared according to the principles of the present invention will use the same planar detector 424 to acquire static images as tomographic images. Therefore, in some embodiments, the photon counting detector 436 will be omitted.

[0126] In other embodiments of the present invention, a photon counting detector of sufficient size to image the entire subject breast 440 will be used, for example, in place of the planar detector 424. Furthermore, in certain embodiments of the present invention, both the planar detector 424 and the photon counting detector 436 are of sufficient size to image the entire breast at one time. In such embodiments, the x-ray beam can nonetheless be collimated to image one or more target regions of interest, thereby acquiring tomographic images and / or static images of the subject breast 440. These images will, in certain embodiments, be combined or otherwise blended with other acquired tomographic images of the breast 440 to produce improved screening and / or diagnostic and / or treatment results.

[0127] More generally, any X-ray detector can be any of a variety of two-dimensional detectors, including planar detectors, two-dimensional photon counting detectors, and two-dimensional curved detectors. To optimize coverage of breast tissue at the chest wall and patient comfort, the top edge (dead zone) of the detector should be as small as possible. To reduce motion artifacts and improve the clarity of the reconstructed image, the detector frame rate should be at least 20 frames per second and the resolution of each frame should be at least 512x512. To obtain isotropic high spatial resolution for breast CT systems, the cell size of the two-dimensional detector should be equal to or less than 0.5mm x 0.5mm / cell.

[0128] Cone beam breast CT equipment acquires two-dimensional projection data. The geometric path shape of image acquisition can be single circle geometry, double circle geometry (suitable for larger breasts), circle plus straight line geometry, semicircle plus cone angle geometry, spiral cone beam geometry. One or more of these geometries are then used to construct a CBBCT 3D image from the two-dimensional projection data. The reconstruction method can be filtered back projection, iterative algorithm and / or artificial intelligence deep learning algorithm. Specialized imaging processors can be used to perform fast reconstruction and imaging processing.

[0129] Figures 5A-5C It should be considered that a method 500 is presented for operating a CBBCT imaging system including a calcification detection feature, in the form of a functional flow chart such as Figure 2-4 shown.

[0130] According to the example embodiment shown, patient parameters (e.g., breast dimensions, such as length, circumference, transverse diameter, etc.) are obtained 502, which can be obtained by manually measuring the patient, extracting from the patient's medical records, or by automatic measurement. Once the parameter values ​​are obtained, they can be selectively used to identify and select a breast stabilizer unit of an appropriate size (or prepare one, such as by subtractive or additive manufacturing methods). It should be noted that the use of a breast stabilizer unit is optional and may not be used in every embodiment or patient procedure of the present invention. It should also be understood that in certain embodiments of the present invention, the size of the breast stabilizer is adjustable and is adjusted manually or automatically based on the patient parameters.

[0131] In use, a suitably sized breast stabilizer is mounted for operation 504, for example, by connection to a patient support panel via a coupler. Signal connections may be made automatically or manually, as consistent with a particular embodiment, to connect instruments within the breast stabilizer to a system controller. Example instruments would include accelerometers for identifying and characterizing breast vibrations and motion, and electrodes for sensing muscle activity and / or cardiac activity. However, it is noted that various other instruments would be used as desired in accordance with particular embodiments of the invention.

[0132] Initial adjustments are made to the patient interface panel and / or patient support features 506, and the patient is placed into the system 508. Thereafter, final adjustments are made to the patient support features 510 to optimize patient comfort and stability. That is, after the patient is in place and initial positioning is complete, additional fixation / support adjustments are made, i.e., additional patient parameters are determined from manual observation or automatic sensing of the relative position of the patient's body to the system.

[0133] As described above, embodiments of the present invention will include handles connected to the patient support panel. Where applicable, in certain methods based on the principles of the present invention, the patient will be instructed to grasp one or more handles 512. In certain embodiments of the present invention, one or more handles will be equipped with instruments to detect patient information, such as the timing of the patient's heartbeat. Based on the overall content of this disclosure, it can be understood that in certain embodiments of the present invention, image acquisition is synchronized with the patient's heartbeat and phase adjusted to minimize motion-related blur.

[0134] As Figure 2 In related detail, certain embodiments of the present invention include a patient back support element, such as 292. Where present, and in appropriate relationship to a particular patient and / or procedure, the patient back support element is activated 514 to stabilize patient positioning and minimize movement of the examined breast tissue during imaging.

[0135] In certain embodiments of the present invention, once the patient is fully positioned, patient sensing is initiated 516. As described above with respect to, for example, the installation 504 of the handle 512 and the breast stabilizer, patient sensing in certain embodiments will include sensing the patient's breathing, heartbeat, muscle activity, or other patient parameters that may affect image quality.

[0136] Subsequently, in certain embodiments of the invention, a static scout image (i.e., a preliminary image used to establish parameters and target positions) is acquired 518. As will be appreciated by those skilled in the art, the static scout image will, in certain embodiments, provide information that will aid in establishing system operating parameters, such as preferred X-ray source positions and power levels.

[0137] In some embodiments of the present invention, the positioning actuators 520 are operated, for example, the radial positioning system 406 of the X-ray source, the vertical actuator 428 of the planar detector, and the radial actuator 432, etc. After the actuators are operated, in the method of some embodiments, a shielded collimator, for example, located in the X-ray source or as a separate device (not shown), is operated to establish the desired X-ray beam cross section.

[0138] In some embodiments of the method of the present invention, the parameters of the X-ray source for imaging are set, for example, the planar X-ray detector 522. In some embodiments of the present invention, the X-ray source will provide an option of a 0.1 mm focus or a 0.3 mm focus. In some embodiments of the method of the present invention, setting the X-ray source parameters includes configuring the X-ray source to produce a 0.3 mm focus for tomographic imaging with the planar detector.

[0139] Subsequently, in some embodiments of the method of the present invention, the rotation of the rotating frame is initiated 524 , and tomographic image data is acquired 526 using a planar detector.

[0140] The tomographic image data is transmitted from the planar detector to the processor, and the image data of the planar detector is processed 528 to generate a tomographic image data set.

[0141] In some embodiments, the processed data is immediately used to identify features of the breast, including, for example, calcifications and lesions. In some cases, these features represent newly discovered breast features. In other cases, the CBBCT image data is used to accurately locate previously discovered features and, in some cases, guide supplemental procedures, such as aspiration needle biopsy or other procedures.

[0142] In certain embodiments of the present invention, the tomographic image data set is further evaluated to identify regions of interest for supplemental imaging 530. In various embodiments of the present invention, this further evaluation will include image enhancement processing, human image review and evaluation, and / or automated review and evaluation via conventional image processing software and / or deep learning artificial intelligence processing software.

[0143] In some embodiments of the invention, the tomographic image data set is configured to be displayed and presented to a user, such as a technician, clinician, or other evaluator. In some embodiments of the invention, the displayed information is annotated to include features identifying regions of interest and displayed with annotations 532. These regions of interest in some embodiments of the invention will be areas where calcification features may or are likely to be present.

[0144] In certain embodiments of the invention, the user will be provided with an opportunity 534 to provide input to the system, including, but not limited to, identifying areas of higher or lower interest, including areas within the annotated region of interest and other areas not annotated by the system. In certain embodiments, areas marked for further evaluation will automatically undergo additional imaging. In certain embodiments of the invention, areas identified by the user will undergo additional imaging. The additional imaging will include additional tomographic imaging with a planar detector, additional tomographic imaging with a photon counting detector, additional static imaging with a planar detector, and additional static imaging with a photon counting detector in various embodiments of the invention.

[0145] Thus, in certain embodiments of the invention, the imaging system will activate the photon counting detector position driver 536 to position the photon counting detector to the region of interest for imaging. In certain embodiments, the system (e.g., a control processor) will set the parameters of the X-ray source 538 for imaging with the photon counting detector. In certain embodiments of the invention, the parameters of the X-ray source will include parameters for positioning the collimating plates to selectively illuminate a specific region of interest with the X-rays generated by the X-ray source. In certain embodiments of the invention, the parameters of the X-ray source will include parameters for setting the focal spot size. In certain embodiments of the invention, the focal spot size selected for illuminating the photon counting detector will be a focal spot size of 0.1 mm in diameter.

[0146] According to some embodiments of the present invention, the rotating frame will rotate 540 an effective rotation distance to align the X-ray beam axis of the X-ray source with the selected region of interest. The X-ray source will be operated to generate a pulsed X-ray. The pulsed X-ray will pass through the region of interest of the examined breast, and the photon counting detector will receive photons of the X-ray pulse to obtain a photon counting image 542.

[0147] Data corresponding to the acquired photon counting image will be transmitted from the photon counting detector to the processor, which will perform preliminary image processing 544 on the data of the photon counting detector.

[0148] The processor will then integrate the planar detector data and the photon counting detector data 546 and perform comprehensive image processing 548 on the combined data set, such as (but not limited to) Fourier transform processing, Laplace transform processing, edge recognition processing, etc.

[0149] The processed image data, forming a comprehensive model, will be evaluated 550 by a human and / or an automated image evaluation system, including (but not limited to) an artificial intelligence / deep learning image evaluation system, to identify diagnostic and / or other features of the breast, including, for example, calcification features.

[0150] The resulting composite model, which may include identified features useful for breast diagnosis and / or other features, will be displayed 552 in the form of two-dimensional and / or three-dimensional image data, including, where appropriate, artificial color, wireframe modeling, grayscale imaging, and other imaging modalities known or to be recognized in the art.

[0151] In certain embodiments of the invention, the comprehensive model and preliminary and / or intermediate data will be archived 554, stored in a digital patient record or otherwise, for future reference.

[0152] In use according to the method of the present invention, the patient back support features will be restored to the initial state 556 and the patient will be removed from the imaging system 558.

[0153] Professionals in the industry will understand that each element of the above method is optional. The alternative aspects of the overall imaging system method and device described in the overall content of this disclosure will be applied to various embodiments of the method, and these embodiments will be obvious in the overall content of this disclosure.

[0154] It should be further noted that in some cases, in vivo breast marking or pre-positioning marking may be performed to facilitate integration of data sets and / or to assist in the application of complementary procedures, such as diagnostic, biopsy and / or therapeutic activities. In some embodiments, the positioning markers will be provided as part of the breast stabilizer unit. In other embodiments of the present invention, the positioning markers may be provided by marking the imaged breast with ink, using an adhesive sticker including an X-ray opaque or X-ray translucent element, applying a vitamin E capsule to the breast skin by adhesion or other means, or by any other method known or to be recognized in the art.

[0155] Figure 6 The temporal relationship between a patient's heartbeat and imaging pulses in an imaging system prepared according to the principles of the present invention is illustrated in a schematic graphical plot 600. Thus, the horizontal axis 602 represents time and the vertical axis 604 corresponds to the respective amplitudes of the illustrated signals.

[0156] A schematic representation of a normal sinus heartbeat waveform is shown at 606. Those skilled in the art will appreciate that waveform 606 includes a PR segment during a first time interval 608 and an ST segment during a second time interval 610. It is apparent that upon examination, the waveform during time intervals 608 and 610 is relatively quiet compared to the rest of the waveform.

[0157] Figure 612 shows an example trigger signal for an X-ray source used in a CBBCT imaging system prepared in accordance with the principles of the present invention. One skilled in the art will appreciate that the indicated pulse 614 corresponds to an X-ray emitted by the system and / or the acquisition of a single X-ray image. The reader will recognize that the imaging pulse 614 can be synchronized 616 with the relatively quiet PR segment within the time interval 608 after acquiring the patient's heartbeat signal. Thus, blurring caused by breast tissue motion due to the patient's heartbeat can be reduced. This reduction in blurring will be beneficial for improved calcification detection.

[0158] According to another embodiment of the principles of the present invention (or the same embodiment with different operating parameters), signal 618 shows a similar trigger pulse 620, synchronized 622 with the relatively quiet ST segment of time interval 610. Those skilled in the art will appreciate that in various embodiments of the present invention, image acquisition will be synchronized to time interval 608 or 610 based on various design and / or operating procedure considerations. In certain embodiments of the present invention, where relatively high-speed imaging is desired, X-ray images may be acquired simultaneously during the PR segment 608 and ST segment 610 of a single heartbeat waveform.

[0159] Figure 624 provides a schematic representation of an exemplary accelerometer signal. In an exemplary embodiment of the invention, the accelerometer signal is generated by an accelerometer in contact with the imaging breast surface area. In certain embodiments of the invention, the accelerometer is connected to or integrally formed with the breast stabilizer unit. In other embodiments of the invention, the accelerometer is placed on the patient's breast before the patient enters the system, such as by an adhesive device. Professionals in the industry will understand that alternative sensing technologies, such as ultrasound or lidar, can be used to sense the heartbeat signal at the breast.

[0160] The accelerometer signal 624 includes a pulse signal 626 caused by and corresponding to the QRS complex pulse 628 of the heartbeat waveform 606. By detecting, for example, through electrocardiogram monitoring, the timing 630 of the QRS complex pulse 628 and the timing 632 of the corresponding accelerometer pulse signal 626, a phase shift (Δt) 634 can be determined. It will be understood by those skilled in the art that the time interval Δt corresponds to the time interval of transmission of the acoustic wave signal from the heart to the arrival of the breast tissue. By applying 640 the phase shift 634 to the pulse 620 of the signal 618, a modified signal 636 can be generated, wherein the imaging pulse 638 corresponds to the pulse 620 that has been phase shifted 634 (delayed) by the time interval.

[0161] Alternatively, in certain embodiments of the present invention, the accelerometer signals 624, 626 are used to identify the quiescent state of breast tissue and are used directly to control image acquisition.

[0162] Those skilled in the art will appreciate that while signal 606 is generally periodic, signals 612, 618, and 636 will be activated under ideal conditions associated with a quiescent state of breast tissue and an angular position of the imaging device. Those skilled in the art will also appreciate that while the above description relates to cardiac rhythm and associated image acquisition time compensation, other embodiments of the present invention will also relate to compensation for pulmonary rhythm and image acquisition time, as well as other periodic and non-periodic motions of the subject. These compensation schemes will be apparent from this disclosure and are intended to be implemented through this demonstration.

[0163] Reference now Figure 7As described above, in existing CBBCT systems, the imaging turret rotates continuously during the imaging process, for example, 180° plus the cone angle width, or 360° plus the cone angle width. During the rotation of the turret, the X-ray detector acquires images periodically (for example, every 2°). Professionals in the industry will understand that since the image acquisition time is short but not instantaneous, and the X-ray detector is in continuous motion during image acquisition, a certain degree of blur is introduced into the acquired image.

[0164] In accordance with the principles of the present invention, certain embodiments of an improved CBBCT system include an image acquisition device that remains stationary and substantially motionless relative to a breast being imaged during each image acquisition cycle.

[0165] Figure 7 The temporal relationship between imaging system rotational motion and imaging system imaging pulses of a CBBCT system in accordance with the principles of the present invention is shown in the form of a schematic graphical diagram 700. Thus, the horizontal axis 702 represents time and the vertical axis 704 corresponds to the state of various system components.

[0166] As shown in diagram 706, the continuous motion of the imaging gantry is divided into two states: a first state 708, in which the gantry remains stationary relative to the breast being imaged, and a second state 710, in which the gantry is in motion relative to the breast. After the rotation is completed, the device returns to the stationary state 708. Although the state transitions 712 are ideally shown as being substantially instantaneous, those skilled in the art will appreciate that accelerating and decelerating the imaging device actually takes time.

[0167] Graph 714 represents an imaging cycle of the imaging device in Graph 706. That is, each pulse (e.g., 716, 718, 720, 722, 724, etc.) represents an X-ray energy pulse and a corresponding image acquisition by the system. As the reader will appreciate, multiple images corresponding to pulses 716-724, etc., will be processed to generate a tomographic image.

[0168] In contrast, diagram 726 illustrates the motion of an imaging gantry designed in accordance with the principles of the present invention. As shown, the gantry begins at rest 728 relative to the imaged breast. During a first time interval 730, the gantry accelerates 732 and then decelerates 734, thereby completing one angular rotation step of the gantry. Next, the gantry remains substantially stationary 736 relative to the imaged breast. While the imaging system is stationary 736, an imaging signal 738 is pulsed 740, generating an x-ray pulse and acquiring an image. Thereafter, the gantry again rotates through a finite number of steps 742, and then the next imaging cycle 744 is initiated.

[0169] By observation Figure 7As will be immediately appreciated by those skilled in the art, the alternating cycles of gantry motion and image acquisition ensure that the gantry remains substantially stationary during each image acquisition. As a result, imaging blur associated with gantry motion is reduced or eliminated, and overall cross-sectional image quality is improved. This improvement in image quality, combined with the other improvements described herein, helps to increase the effective resolution and clarity of the system's images and enhances the system's ability to detect diagnostically important breast calcifications.

[0170] In order to achieve the motion curve shown in Figure 726, the mass of the gantry and imaging equipment (including the X-ray source and X-ray detector) is minimized. Through feedback and feedforward control and the principles of modern control theory, the size of the motor and other system components is reasonably selected, the required control signals are generated, and undesirable resonances in the system are minimized. In certain embodiments of the present invention, the frequency of the pulses in Figure 738 can be selected to be lower than the corresponding frequency in Figure 714. In other embodiments, a half-circle scan (180° plus cone width) is used instead of a full-circle scan. In certain embodiments, this approach may result in a longer overall CBBCT image acquisition time. However, in certain embodiments of the present invention, this longer acquisition time is reasonable due to the improvement in imaging quality and the ability to more effectively image microcalcifications in the breast.

[0171] Fig. 8A and Figure 8B The inactive 800 and active 802 configurations of a dynamic patient support system for a CBBCT imaging system designed in accordance with the principles of the present invention are shown in schematic cross-sectional elevation views. Fig. 8A 8, a patient's chest 804 is shown in cross-section. The patient is positioned on an upper surface 806 of a patient interface plate 808. A patient's breast 810 to be imaged is placed through an opening 812 of the patient interface plate 808.

[0172] The patient is relatively free on the patient interface board, so the patient's chest will tilt 814, pitch 816, yaw 818, and move 820 in various directions due to voluntary or involuntary movements. These movements will cause corresponding rotation, translation, and vibration of the imaged breast 810, dynamically displacing the breast tissue during imaging.

[0173] As mentioned above, such displacement of the breast during imaging tends to blur the resulting image, i.e., introduce errors in the corresponding image data. Therefore, by enhancing the stability of the patient's chest and overall body, it is helpful to effectively image microcalcifications in breast tissue.

[0174] In certain embodiments of the present invention, such stability can be achieved by manually inserting one or more wedge-shaped or other shaped support pads after the patient enters the system and before imaging. However, independent support pads may be easily displaced by the patient. In addition, the process of inserting the support pads may extend the entire operation time, causing patient impatience, reducing patient satisfaction and screening compliance. At the same time, the overall time of the imaging procedure will be extended, thereby adding additional costs.

[0175] Therefore, in certain embodiments of the present invention, an automated patient support device 822 is provided as a dynamic patient support system. In the exemplary embodiment shown, the automated patient support device 822 includes one or more linear actuators (e.g., 824 and 826) that are mechanically connected to the patient interface plate 808.

[0176] In the exemplary embodiment, a first region 830 of flexible member 828 is coupled to patient interface plate 808 and a second region 832 is coupled to a movable portion (eg, 834 ) of a linear actuator (eg, 826 ).

[0177] When the linear actuator is switched from an inactive state (such as Fig. 8A ) to the active state (as shown Figure 8B ), the movable portion 834 of the linear actuator 826 extends away from the patient interface plate 808 in a direction 836. As a result, the flexible member 828 is tensioned. The tensioned flexible member 828 can gently support and constrain the patient's chest 804, thereby stabilizing the patient and reducing unwanted movement of breast tissue.

[0178] In certain embodiments of the invention, the conversion of the patient support system from the inactive state to the active state and back will be controlled by an operator, technician and / or clinician. In other embodiments of the invention, the conversion will be controlled by the patient. In other embodiments of the invention, the conversion will be controlled by a controller, generally similar to the controller 254 described above.

[0179] Those skilled in the art will appreciate that although the illustrated embodiments include mechanical linear actuators, other support methods and devices may be used, such as but not limited to one or more pneumatic air bags and / or one or more hydraulic air bags, as well as any known or future developed actuator assemblies of appropriate functionality.

[0180] In certain embodiments of the present invention, the linear actuator may include (by way of example only and not limitation) one or more of the following: a solenoid valve, a pneumatic cylinder, a hydraulic cylinder, a pneumatic airbag, a hydraulic airbag, a linear motor, a linear stepper motor, a rotary actuator, and: a trapezoidal screw and nut, a lead screw, a ball screw, a cable, a pulley, a timing belt, a timing wheel, a suitably sized worm reducer, a rack and pinion assembly, a rack and worm gear assembly, a piezoelectric actuator, a combination of a piezoelectric actuator and a ratchet pawl drive, a spring-loaded actuator, an actuator containing a shape memory alloy, and any known or future developed actuator assembly of suitable functionality.

[0181] In certain embodiments of the present invention, the linear actuator will be manually activated. In other embodiments, the linear actuator will be driven by a drive device such as an electric motor, a pneumatic motor, a hydraulic motor, a spring, or any known or future development.

[0182] In various embodiments of the present invention, the flexible member 828 may include (by way of example only and without limitation) synthetic polymers, natural polymers, textile materials, molded materials, fabric materials, extruded materials, woven materials, and felt materials, and combinations thereof. In addition, the flexible member 828 may include (by way of example only and without limitation) polyamide, polypropylene, polyethylene (including low-density polyethylene, medium-density polyethylene, high-density polyethylene, and ultra-high molecular weight polyethylene), polyaramid, polyester, polytetrafluoroethylene, leather, cotton, wool, flax, flax fiber, and / or any related materials and combinations thereof.

[0183] In various embodiments of the present invention, elastomers that can be used include various copolymers or block copolymers from Kraton Polymers (eg ), such as styrene-butadiene rubber or styrene-isoprene rubber, EPDM (ethylene propylene diene monomer rubber), nitrile (acrylonitrile-butadiene) rubber, polyurethane, polybutadiene, polyisobutylene, chloroprene rubber, natural latex rubber, etc. The foam material can be a closed-cell foam or an open-cell foam, including but not limited to polyolefin foams, such as polyethylene foam, polypropylene foam, polybutylene foam; polystyrene foam; polyurethane foam; any elastic foam made of any of the above elastomers or rubber materials; or any biodegradable or biocompostable polyester, such as polylactic acid resin (including L-lactic acid and D-lactic acid) and polyglycolic acid (PGA); polyhydroxyvaleric acid / hydroxybutyric acid resin (PHBV) (copolymer of 3-hydroxybutyric acid and 3-hydroxyvaleric acid (3-hydroxyvaleric acid)) and polyhydroxyalkanoate (PHA) copolymers; and polyester / polyurethane resins. Those skilled in the art will understand that the above are only examples of a wide range of possibilities suitable for various applications.

[0184] Fig. 9A and Fig. 9BThe schematic cross-sectional elevation view shows the inactive 900 and active 902 configurations of the patient back support element of the CBBCT imaging system designed according to the principles of the present invention. Fig. 9A , a patient's chest 904 is shown in cross-section. The patient is positioned on an upper surface 906 of a patient interface plate 908, and a breast 910 to be imaged is placed through an opening 912 of the patient interface plate 908.

[0185] The structural member 914 is disposed in a spaced relationship with the patient's back surface area 916. During operation, the structural member maintains a substantially fixed spatial relationship with the patient interface plate 908. However, it should be noted that in certain exemplary embodiments of the present invention, the structural member 914 is removable and / or movable, such as by rotating, sliding, lifting, rolling, etc., to facilitate the patient's entry and exit from the CBBCT imaging system.

[0186] As shown, the structural member 914 supports a support element. In the illustrated embodiment, the support element is an inflatable bladder 918, such as a pneumatic or hydraulically inflatable bladder. Fig. 9A In the embodiment, the inflatable airbag 918 is in a first inactive configuration, i.e., an uninflated state; in Fig. 9B In the embodiment, the inflatable airbag is in the active configuration, i.e. inflated.

[0187] In the inflated configuration, the surface area 920 of the inflated bladder 918 contacts a corresponding portion of the patient's back surface area 916. In this configuration, the inflated bladder 918 tends to push the patient's back surface area 916 toward the opening 912 of the patient support plate 908. This arrangement helps to limit the patient's movement, thereby reducing the aforementioned image blurring artifacts.

[0188] Although the illustrated embodiment shows a separate structural member 914 and inflatable bladder 918, the teachings provided by this disclosure will immediately suggest a variety of configurations and arrangements to those skilled in the art. For example, in certain embodiments of the present invention, the inflatable bladder 918 may be replaced with a cushion, and the structural member 914 may be moved toward or away from the patient's back surface area 916 in response to actuation by, for example, a linear actuator (the actuator is mechanically connected between the structural member 914 and the patient support board 908). In other embodiments, the cushioning component may be omitted entirely.

[0189] In certain embodiments of the invention, the switching of the patient back support element from the inactive state to the active state and back again will be controlled by an operator, technician and / or clinician. In other embodiments of the invention, the switching will be controlled by the patient. In other embodiments of the invention, the switching will be controlled by a controller, generally similar to the controller 254 described above.

[0190] According to the above disclosure, Fig.10 A portion 1000 of a breast imaging system is shown in a cutaway schematic perspective view, including certain aspects of the interface between a receiving device and a breast stabilization unit. Specifically, Fig.10 A portion of a receiving device 1002 is shown, including a receiving device coupling feature 1004 , and a breast stabilization unit 1006 , including a corresponding breast stabilization unit coupling feature 1008 .

[0191] exist Fig.10 In the example device shown, the receiving device coupling feature 1004 and the breast stabilization unit coupling feature 1008 include complementary serrated surface areas 1010 and 1012, respectively. Those skilled in the art will readily appreciate that the generally rectangular protrusions (such as 1014) on the receiving device coupling feature 1004 will be designed to fit tightly into the corresponding generally rectangular recesses 1016 in the breast stabilization unit coupling feature 1008, and vice versa.

[0192] In addition, it will be apparent to those skilled in the art that in some embodiments, if the sizes of the serrations are substantially uniform, the breast stabilization unit can be placed in a variety of symmetrical positions relative to the receiving device. Therefore, the breast stabilization unit can be easily rotated around the longitudinal axis of the receiving device (i.e., around the rotation axis 1008 of the frame 1004 in some embodiments).

[0193] This will be particularly useful in embodiments where the breast stabilization unit has asymmetric features to accommodate the corresponding asymmetry of the patient's breast.Thus, when the patient lies prone on the patient support board, the breast support unit 1018 can be rotated until it is properly aligned with the patient's breast.

[0194] Fig.11A Further features and characteristics of an exemplary imaging system 1100 designed in accordance with the principles of the present invention are illustrated in a schematic perspective cross-sectional view. As shown, the imaging system includes a patient support plate 1102 with an upper surface 1104 and a lower surface 1106. The imaging system 1100 has some particularly desirable features, including a breast stabilization unit 1108, which is designed and configured to allow imaging of substantially the entire target breast, and in some cases, portions of the corresponding chest wall, while effectively stabilizing the breast for detection of calcifications.

[0195] In the illustrated embodiment, a separate receiving device is not used, but a surface area 1110 of the patient support plate 1102 is used as a receiving coupling area 1112.

[0196] Now combine Fig.11A Come and see Fig. 11B ; Fig. 11BMore details of the example imaging system 1100 are shown in a schematic cross-sectional view. As described above, the patient support plate 1102 includes an upper surface area 1104 and a lower surface area 1106.

[0197] During operation, the X-ray beam 1114 fills the spatial region below the lower surface 1106 and spans 1116 a cross-sectional area to irradiate the target breast area until the entire breast is covered.

[0198] It should be understood that in certain applications of the imaging system 1100, it is desirable that the upper boundary 1118 of the x-ray beam 1114 be as close as possible to the lower surface 1106 of the patient support plate 1102 (i.e., minimize or optimize the distance 1120) so that breast imaging can be performed as close as possible to the patient's chest wall. In fact, in certain embodiments of the present invention, the imaging system 1100 can be used to image a portion of the chest wall.

[0199] In the illustrated embodiment, the breast stabilization unit 1108 includes a first body member 1122 and a second edge member 1124. The first body member 1122 will, in certain embodiments, comprise a structural material having sufficient mechanical properties to support the patient's breast and being relatively transparent to x-rays. In certain embodiments of the invention, a single material will possess both of these properties.

[0200] In certain embodiments of the present invention, first body member 1122 will be substantially fixedly connected to respective interface surface regions 1126 and 1128 of second edge member 1124. In various embodiments, such connection can be achieved by using chemical adhesives, physical bonding, mechanical fasteners, mechanical upsetting, welding (such as heat welding, ultrasonic welding, laser welding or chemical welding) or other connection mechanisms suitable for the application requirements, including any combination of the above methods.

[0201] In the illustrated example, the second edge element 1124 includes an edge coupling surface area 1130. The edge coupling surface area 1130 is adapted and configured to engage with a complementary patient support plate coupling surface area 1132 to form a secure connection between the patient support plate 1102 and the breast stabilization unit 1108.

[0202] According to the illustrated example, the properties of the selected materials and their configuration enable the patient support plate 1102 to support the breast stabilization unit 1108 without substantially interfering with the upper boundary 1118 of the X-ray beam 1114. Therefore, the material of the second edge element 1124 will be selected as desired, and in various embodiments may include metal materials, synthetic polymer materials, glass materials, natural polymer materials, or any structural material suitable for the needs of a particular embodiment, including combinations of these materials.

[0203] In the example shown, the second edge element 1124 is fixed to the patient support plate 1102 by keys 1134 and 1136 to limit the rotation 1138 of the breast stabilization unit 1108 about its longitudinal axis. However, in other embodiments of the present invention, the design, material and configuration of the second edge element 1124 and the corresponding coupling surface area 1132 of the patient support plate 1102 will be selected and configured to allow frictional rotation or nearly free rotation of the breast stabilization unit 1108.

[0204] It should also be understood that in various embodiments, the second edge element 1124 will have corresponding radial dimensions so that a single fixed-size opening on the patient support plate 1102 can accommodate a variety of breast stabilization elements (e.g., 1108) having different diameters, configurations, and parameters, and the corresponding radial width of the second edge element 1124 is used to adapt these different sizes to each other.

[0205] Those skilled in the art will appreciate that separate edge elements are not required, and in certain embodiments of the present invention, the first body portion 1122 and the second edge element 1124 of the breast stabilization unit 1108 may be formed of a single uniform material as an integrally formed component. In other embodiments of the present invention, internal reinforcement materials, such as glass fibers, carbon fibers, polymer fibers, or other materials, may be added to one region or another of the breast stabilization unit 1108. It should be understood that the composition transition between these regions may be abrupt or gradual to suit the needs of a particular mode or application of the present invention.

[0206] It will be appreciated in the overall context of the present disclosure that by establishing example characteristics of the opening and interface surface area 1132 of the patient support plate 1102, these characteristics will form a standard interface for equipping and coupling a variety of different breast stabilization units. Therefore, in certain embodiments of the present invention, a breast stabilization unit will be designed with a standard interface whose upper radial edge conforms to the standard interface, but whose dimensions are customized based on the needs and parameters (e.g., size) of a specific patient, surgical, diagnostic, or operating mode. As described above, the breast stabilization unit will be manufactured locally at the imaging facility using additive or subtractive manufacturing equipment and processes.

[0207] In some applications, the breast stabilization unit 1108 is configured and adjusted so that the approximate geometric center of the breast coincides with the intersection of the rotation axis of the rotating gantry and the longitudinal axis of the x-ray beam 1114. However, those skilled in the art will appreciate that different breast positions and configurations may be ideal for a particular patient, application, or imaging goal, which can be achieved by appropriate shape, configuration, and placement of the breast stabilization unit 1108.

[0208] Thus, the breast stabilization unit 1108 is arranged, adapted and configured to support, stabilize and immobilize at least a portion of the target breast relative to the movement path of the X-ray detector when the imaging system 1100 images the breast.

[0209] A variety of different arrangements are well suited for maintaining the breast stabilization unit 1108 substantially stable and immobile relative to the imaging system 1100 during imaging. For example, according to certain aspects of the present invention, the breast stabilization unit 1108 can be supported from above, below, laterally, or in any other manner deemed advantageous and / or consistent with the requirements of a particular system, application, patient, or imaging modality.

[0210] These different arrangements will be used individually and / or in combination according to the specific requirements of a particular application, and the use of one arrangement does not mean that other arrangements or modes are excluded from being used simultaneously. Therefore, it should be understood that the configurations discussed herein are only examples of various devices and arrangements, including combinations of these devices and arrangements, and those of ordinary skill in the art will be clear about these application possibilities after reading this disclosure.

[0211] Fig.12 Example aspects 1200 of a processing system and method according to the principles of the invention are illustrated in schematic block diagram form, including twelve exemplary modes of operation.

[0212] Consistent with the overall description above, the CBBCT system 1202 includes a calcification detection function designed according to the present invention and is configured to prepare an enhanced tomographic dataset for breast CT of a target breast. The CBBCT images generated by the system 1202 are enhanced by image processing one or more tomographic images with one or more static images acquired by the CBBCT system.

[0213] Thus, the CBBCT system 1202 is configured and operated to acquire one or more CBBCT image datasets 1204. Depending on the selected operating mode, the one or more acquired CBBCT image datasets 1204 may be acquired with injected contrast 1206 and / or without injected contrast 1208.

[0214] The CBBCT system 1202 is also configured and operated to acquire one or more static image data sets 1207. Depending on the selected operating mode, the one or more acquired static image data sets 1207 may be acquired using a flat panel X-ray detector 1210; and / or acquired using a photon counting X-ray detector that receives X-rays from an X-ray source configured with a 0.1 mm focal spot 1212; and / or acquired using a photon counting X-ray detector that receives X-rays from an X-ray source configured with a 0.3 mm focal spot 1214.

[0215] The processor of the CBBCT system 1202 is configured and operated to receive the above-mentioned acquired individual data sets and combine them through tomographic calculation to generate a related image 1216. In an alternative operation mode, the CBBCT system 1202 is also configured and operated to receive the above-mentioned acquired individual data sets and generate a fused image 1218 through co-registration and image merging.

[0216] Therefore, when generating the relevant image 1216, the relevant image will be generated by one or more of the following modes:

[0217] The CBBCT image without contrast is correlated 1220 with the flat panel detector static image.

[0218] The CBBCT image with contrast is correlated 1222 with the flat panel detector static image.

[0219] CBBCT images without contrast agent are correlated 1224 with photon counting detector static images (0.1 mm focus).

[0220] The CBBCT image with contrast agent is correlated 1226 with the photon counting detector static image (0.1 mm focus).

[0221] CBBCT images without contrast agent are correlated 1228 with photon counting detector static images (0.3 mm focus).

[0222] The CBBCT image with contrast is correlated 1230 with the photon counting detector static image (0.3 mm focus).

[0223] Therefore, when generating the fused image 1218, the fused image will be generated by one or more of the following modes:

[0224] CBBCT images without contrast agent were fused with static images from the flat-panel detector1232.

[0225] CBBCT images with contrast agent were fused with static images from the flat panel detector1234.

[0226] CBBCT images without contrast were fused with photon counting detector static images (0.1 mm focal spot)1236.

[0227] CBBCT images with contrast were fused with photon counting detector static images (0.1 mm focal spot)1238.

[0228] CBBCT images without contrast were fused 1240 with photon counting detector static images (0.3 mm focal spot).

[0229] CBBCT images with contrast were fused with photon counting detector static images (0.3 mm focal spot)1242.

[0230] In view of Fig.12 Related disclosures, and more broadly considering the overall content of this disclosure, those skilled in the art will readily appreciate that the image acquisition and processing methods and modes presented herein are merely examples of a larger collection of methods and modes. These novel methods and modes, while unexpected and effective, will become clear to those of ordinary skill who have been exposed to the disclosure. Therefore, although an exhaustive list of all possible methods and modes is beyond the reasonable scope of this document, it should be understood that this document is intended to disclose all methods, systems and devices, structures, methods and results that are obvious under this disclosure.

[0231] In certain embodiments, the present invention includes a method for ex vivo imaging of breast calcifications, comprising placing a patient on a CBBCT imaging system and supporting the patient to minimize movement of the breast. The method then includes rotating a gantry of the CBBCT imaging system to rotate an X-ray source.

[0232] The method also includes repeatedly projecting a first set of X-ray beams from an X-ray source, repeatedly passing a portion of the first set of X-ray beams through the breast, and repeatedly detecting the first set of X-ray beams using a flat panel detector to capture a first plurality of image data sets.

[0233] In addition, the method includes processing data from the first set of image data sets to generate a first CBBCT imaging model, and evaluating the imaging model to identify a region of interest that may contain breast calcifications. The method also includes aligning the CBBCT imaging system with the region of interest and keeping the CBBCT imaging system stationary during a static image acquisition period while projecting a second X-ray beam from the X-ray source.

[0234] Further, the method includes passing a second set of X-ray beams through a certain area of ​​the breast, and detecting the second set of X-ray beams using an X-ray detector to capture a static image dataset. At the same time, the first set of image datasets and the static image dataset are processed to generate an improved CBBCT imaging model to resolve the calcification structure.

[0235] In some embodiments, the present invention includes imaging ex vivo breast calcifications by passing the second set of X-ray beams through a shielded collimator, thereby narrowing the second set of X-ray beams to precisely target the region of interest. In some embodiments, the first set of image data sets are processed with the static image data sets, including combining the two to generate an improved CBBCT imaging model.

[0236] According to some embodiments of the present invention, the first set of image data sets and the static image data sets are processed, including using the static image data sets to process the first CBBCT imaging model to generate an improved CBBCT imaging model. In addition, in some embodiments of the present invention, the movement of the patient's breast is reduced by supporting it with a breast stabilization unit.

[0237] According to certain aspects of the present invention, the CBBCT system includes a sensor. The sensor can be selectively disposed in the breast stabilization unit to detect the patient's heartbeat. In other embodiments of the present invention, the sensor can be used to detect the patient's breathing.

[0238] Further embodiments of the invention include synchronizing the detection of the first set of X-ray beams with the patient's heartbeat. Other embodiments include synchronizing the detection of the second set of X-ray beams with the patient's heartbeat.

[0239] In some embodiments of the present invention, the first set of X-ray beams is generated by a 0.3 mm focal spot and the second set of X-ray beams is generated by a 0.1 mm focal spot. Sometimes, a single X-ray source is configured to generate both the first and second sets of X-ray beams. In some embodiments of the present invention, detection of the second set of X-ray beams will be accomplished by a photon counting detector. According to some embodiments of the present invention, the generated data will be evaluated by an artificial intelligence deep learning process.

[0240] In some embodiments of the invention, data of the first set of image data sets are combined with the static image data sets to generate a calculated correlated image. In other embodiments of the invention, data of the first set of image data sets are combined with the static image data sets to generate a co-registered fused image.

[0241] In some embodiments of the invention, the gantry is repeatedly stopped during rotation to capture images between gantry movements. According to some embodiments of the invention, the gantry rotates 180° plus the arc width of the flat panel detector during image acquisition.

[0242] Although the above exemplary embodiments are mainly selected from the field of breast calcification detection, those skilled in the art will understand that the principles of the present invention are equally applicable to various other imaging systems and applications, and can equally effectively achieve the advantages of the present invention.

[0243] Furthermore, although the present invention has been described in detail in conjunction with the currently preferred embodiments, it should be understood that the present invention is not limited to these disclosed embodiments. On the contrary, the present invention may be modified to include any number of variations, modifications, substitutions or equivalent arrangements not described, but these modifications are still consistent with the spirit and scope of the present invention. Therefore, the present invention should not be regarded as being limited only by the above description, but only by the scope of the appended claims.

Claims

1. A method for in vitro imaging of breast calcification, comprising: Position the patient on the CBBCT imaging system; The patient is supported to achieve minimal displacement of the breast; Rotating a gantry of the CBBCT imaging system to generate a rotation of the X-ray source; repeatedly emitting a first set of X-rays from an X-ray source; Repeatedly pass a portion of the first set of x-rays through the breast; Repeatedly using the flat panel detector to detect the first set of X-rays to capture a first set of image data sets; processing data of the first set of image data sets to generate a first set of CBBCT imaging models; The first set of CBBCT imaging models was evaluated to identify regions of interest that may contain breast calcifications; Align the CBBCT imaging system with the region of interest; Keep the CBBCT imaging system still during the static image acquisition cycle; projecting a second set of X-rays from the X-ray source; Pass a second set of X-rays through one area of ​​the breast; detecting a second set of X-rays using an X-ray detector to capture a static image data set; The data from the first image dataset is processed with the static image dataset to generate an improved CBBCT imaging model that accounts for the calcification.

2. The method for in vitro imaging of breast calcification as defined in claim 1, comprising: The second set of X-rays is passed through a shielding collimator to narrow the second set of X-rays to the area of ​​interest.

3. The method for in vitro imaging of breast calcification as defined in claim 1, wherein processing the first set of image data sets and the static image data sets comprises: The first set of image datasets is processed using the static image dataset to produce an improved CBBCT imaging model.

4. The method for in vitro imaging of breast calcification as defined in claim 1, wherein processing the first set of image data sets and the static image data sets comprises: The first set of CBBCT imaging models is processed using a static image dataset to produce an improved CBBCT imaging model.

5. The method for in vitro imaging of breast calcification as defined in claim 1, wherein the support for minimizing displacement of the patient's breast comprises: Use a breast stabilization device to support the patient's breast.

6. The method for in vitro imaging of breast calcification as defined in claim 1, wherein the CBBCT imaging system comprises: A sensor.

7. A method of in vitro imaging of breast calcification as defined in claim 6, wherein the sensor is disposed within a breast stabilization device.

8. The method for in vitro imaging of breast calcification as defined in claim 6, further comprising: Sense the patient's heartbeat.

9. The method for in vitro imaging of breast calcification as defined in claim 6, further comprising: The patient's breathing is sensed.

10. The method for in vitro imaging of breast calcification as defined in claim 6, further comprising: The process of detecting the first set of X-rays is synchronized with the patient's heartbeat.

11. The method for in vitro imaging of breast calcification as defined in claim 6, further comprising: The process of detecting the second set of X-rays is synchronized with the patient's heartbeat.

12. The method for in vitro imaging of breast calcification as defined in claim 1, wherein repeatedly projecting a first set of X-rays from an X-ray source comprises: The first set of X-rays is repeatedly projected from a focal point of 0.3 mm.

13. The method for in vitro imaging of breast calcification as defined in claim 1, wherein projecting a second set of X-rays from the X-ray source comprises: A second set of X-rays is projected from a focus point of 0.1 mm.

14. The method of in vitro imaging of breast calcification as defined in claim 1, wherein the first set of X-rays and the second set of X-rays are projected from the same X-ray source.

15. The method for in vitro imaging of breast calcification as defined in claim 1, wherein detecting the second set of X-rays using an X-ray detector comprises: The second set of X-rays is detected using a photon counting X-ray detector.

16. The method for in vitro imaging of breast calcification as defined in claim 1, wherein evaluating a first set of CBBCT imaging models to identify regions of interest comprises: The first set of CBBCT imaging models were evaluated using an artificial intelligence deep learning process.

17. The method for in vitro imaging of breast calcification as defined in claim 1, wherein processing the first set of image data sets and the static image data sets comprises: Prepare images from the calculated correlations.

18. The method for in vitro imaging of breast calcification as defined in claim 1, wherein processing the first set of image data sets and the static image data sets comprises: Prepare to register the fused images.

19. A method for in vitro imaging of breast calcification as defined in claim 1, comprising: The rotation of the X-ray source is repeatedly stopped by repeatedly stopping the rotation of the gantry between repeatedly projecting the first set of X-rays from the X-ray source.

20. The method for in vitro imaging of breast calcification as defined in claim 1, wherein the rotating of the gantry of the CBBCT imaging system to produce the rotation of the x-ray source comprises: The gantry is rotated through an arc of 180° plus the arc width of the planar detector.

Images