Calcification detection system, method, and apparatus in cone-beam breast computed tomography

Abstract

In the present invention, a method for imaging breast micro-calcification features by acquiring a tomographic data set and a static imaging data set and combining the tomographic data set with the static imaging data set to improve resolution and reduce blurring in the resulting composite image. The resulting improved resolution image data set is used to assess the identification of breast calcifications 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 April 14, 2022, entitled "Comprehensive Disclosure"; U.S. Patent Application No. 63 / 401,475, filed August 26, 2022, entitled "Fixture and Support for Medical Imaging"; U.S. Patent Application No. 63 / 401,493, filed August 26, 2022, entitled "Ergonomic Improvements in Cone-Band Matrix Computed Tomography"; U.S. Patent Application No. 63 / 401,513, filed August 26, 2022, entitled "Static Detail Imaging in Cone-Band Matrix Computed Tomography"; and U.S. Patent Application No. 63 / 401,513, filed August 26, 2022, entitled "[The last part is missing in the original text]". The following disclosures are incorporated herein by reference in their entirety: U.S. Patent Application No. 63 / 401,546, "Cone fasciculus computed tomography with patient support subsystem"; U.S. Patent Application No. 63 / 401,548, filed August 26, 2022, "Cone fasciculus computed tomography with pivotal frame"; U.S. Patent Application No. 63 / 430,571, filed December 6, 2022, "Ultrasound hybrid imaging in cone fasciculus computed tomography"; and U.S. Patent Application No. 63 / 459,250, filed April 13, 2023, "System, method and apparatus for detecting calcifications in cone fasciculus computed tomography". Technical Field

[0003] This invention relates to the field of cone-beam computed tomography, and particularly to the field of calcification detection in computed tomography. Background Technology

[0004] According to data from the National Cancer Institute, one in eight women will be diagnosed with breast cancer in their lifetime. Although published reports show a decline in breast cancer mortality rates, 40,000 women still die from the disease each year.

[0005] Optimal breast imaging techniques can detect tumors smaller than 10 mm in diameter. The 16-year survival rate for patients with invasive breast cancer measuring 1-10 mm, detected by mammography, is reported to be 93%. Furthermore, the likelihood of metastasis decreases dramatically with the reduction in tumor diameter at detection. If a breast tumor is detected at 10 mm or smaller, the probability of metastasis is 7.31%. If a 4 mm cancer is detected, the probability of metastasis decreases by more than 10 times, dropping to 0.617%.

[0006] Mammography is able to detect approximately 12 mm cancers on average and was the most effective tool for early detection of breast cancer prior to the advent of cone-beam breast computed tomography. Mammography has relatively low sensitivity for small breast cancers (sub-millimeter). Specificity and positive predictive value of mammography remain limited due to structure and tissue overlap. The limited sensitivity and specificity of mammography in breast cancer detection stems from its poor contrast detectability, which is common in all types of projection imaging techniques (projection imaging has a maximum contrast detectability of only 10%), and mammography was originally able to detect only 65-70% of breast cancers. In dense breasts, the sensitivity of mammography is further reduced to less than 30%. Digital mammography (DM) was designed to overcome the inherent limitations of conventional film-screen mammography (SFM) by providing improved contrast resolution and digital image processing; however, a large-scale clinical trial, the Digital Mammographic Imaging Screening Trial (DMIST), showed that DM and SFM had the same false-positive rate.

[0007] The relatively low specificity of mammography results in biopsies for indeterminate cases, despite the added cost and stress to the patient. In the United States, nearly 80% of the more than one million breast biopsies performed each year to evaluate suspicious mammographic findings are benign, causing undue anxiety for the patient and significant cost to the healthcare system. Therefore, there is an urgent need for more accurate characterization of breast lesions to reduce the biopsy rate and the false-positive rate 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 main features of CBBCT include: a horizontal, ergonomically designed examination table with modular inserts to optimize coverage of the uncompressed breast, including the chest wall; 1 meter wide openings on both sides of the table to facilitate positioning of the breast and to provide easy access for image-guided biopsy and other procedures without significant modification of the basic platform; slip-ring technology to facilitate efficient dynamic contrast imaging studies and future angiogenesis imaging.

[0009] Results from phantom studies indicate that CBBCT is able to achieve a spatial resolution of approximately 2.8 lp / mm, allowing detection of 2 mm cancers and approximately 0.2 mm size microcalcifications, suitable for the average size breast (chest wall diameter of approximately 13 cm) with a total dose of approximately 5 mGy. Assuming two views per breast, this dose is lower than that of a single mammogram. The image quality of CBBCT is excellent in visualizing breast tissue, breast tumors, and calcifications, with coverage of the breast (including the chest wall region) at least comparable to mammography. Visualization of major blood vessels is good without the need for contrast.

[0010] Thus, CBBCT offers significant improvements in detecting and biopsying suspicious lesions. In addition, in many procedures using CBBCT, images can be acquired without compression of the breast tissue, which is commonly associated with mammography. The compression breast fixation device used for mammography is widely considered to be uncomfortable and is often cited as a factor that discourages patients from seeking ideal breast cancer screening. Additional improvements in CBBCT imaging offer the potential to further extend these benefits. In view of the foregoing, improved CBBCT imaging without the use of the uncomfortable breast fixation device associated with mammography is highly desirable.

[0011] One method of further improving breast cancer detection is to take advantage of the correlation between breast tissue calcification and tumor incidence.

[0012] Although calcification in breast tissue does not necessarily indicate the presence of a malignant tumor, certain patterns of calcification (such as clusters of the type that are irregularly shaped and fine in appearance) are associated with malignant tumors and / or precancerous changes in breast tissue. In a screening mammography program, the review rate due to calcification is 1.7%, with 19% of the cases ultimately diagnosed as cancer. In the digital mammography era, approximately one in six of all reviews is due to calcification. As many as 50% of breast cancers can be associated with calcification, and of the calcifications that are biopsied for various reasons, 15-30% tend to be malignant in asymptomatic patients.

[0013] Calcification is often associated with ductal carcinoma in situ (which is considered a stage 0 cancer). In addition, the presence of calcification in one breast and not the other can be an indication of increased risk. Thus, it is beneficial to be able to detect and characterize calcification within the breast on a screening and diagnostic basis.

[0014] Breast calcification typically appears as either large calcification or small calcification. Large calcification is generally not considered to be an indication of significant cancer risk. Small calcification appears as a fine white dot, and certain patterns of small calcification are associated with an increased incidence of cancerous tissue.

[0015] Breast calcification of diagnostic significance includes four categories of suspicious calcification morphology, arranged in increasing order of concern as follows: coarse heterogeneous (irregular, typically 0.5-1 mm); amorphous blur and / or small ("powdery", "cloudy", or "cottony") to the point that no other specific shape can be determined; fine pleomorphic: variable shape ("glass shards" or "stone chips"), typically less than 0.5 mm; fine linear or fine linear branching: fine (<0.5 mm), linear, branching, or irregularly arranged ("casting").

[0016] Also important is the distribution of calcification (in addition to diffuse calcification, which is almost always benign), arranged in increasing order of concern as follows:

[0017] Regionality: Scattered in larger volumes of breast tissue (maximum linear size > 2 cm), rather than in the expected ductal distribution;

[0018] Aggregation: Within a region with a maximum linear size of 2 cm, at least 5 calcifications aggregate within 1 cm of each other;

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

[0020] Segmental: Calcium is deposited in a segment or leaf of the vascular bundle and its branches.

[0021] Therefore, for suspicious morphologies, linear or segmental distributions more strongly increase the likelihood of malignancy than clustered distributions. Although punctate calcifications are not inherently a suspicious morphology, they may be suspicious if they are new, newly added, or exhibit a linear or segmental distribution.

[0022] To best utilize the features developed above, the inventors deemed it necessary to improve CBBCT imaging to increase the resolution of calcifications to 0.1 mm or less via in vitro imaging. This improvement would have significant implications for both screening and diagnostic applications.

[0023] To consistently achieve image resolutions of 0.1 mm or smaller, significant advancements are needed beyond existing CBBCT technology. After careful consideration, the current inventors have proposed novel and advantageous developments and improvements aimed at achieving previously unattainable imaging results. These improvements are achieved through enhancements to imaging equipment and methods, as well as to equipment and methods related 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 for effective identification of diagnostically significant calcified areas.

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

[0026] In light of these recognized opportunities, the inventors conceived and put into practice technical improvements that enabled the desired calcification imaging.

[0027] For example, in certain embodiments of the present application, the continuous rotational motion of the structural gantry supporting the prior art CBBCT imaging apparatus is replaced by a plurality of discrete motions. Thus, whereas the prior art imaging apparatus was moved while CBBCT exposures were being made, a system according to the principles of the present application captures images while the imaging apparatus is substantially stationary with respect to the stabilized breast. As a result, motion-induced image blurring is reduced or eliminated, and effective image resolution is improved.

[0028] Thus, for example, CBBCT images acquired according to the principles of the present application are acquired as a plurality of individual exposures, with the scan gantry being substantially stationary at intervals of 2° during each individual exposure. Those skilled in the art will appreciate that, in certain embodiments of the present application, images will be taken at 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 that are deemed beneficial in a particular application.

[0029] In other embodiments of the present application, the subject breast is immobilized, and a conventional, moving CBBCT image is acquired during a first time interval during immobilization.

[0030] One or more static images are acquired during a different time interval during immobilization. These static images are acquired with the imaging apparatus substantially stationary with respect to the stabilized breast.

[0031] The static images are relatively few in number compared to the CBBCT image data set. For example, in one exemplary procedure or system, 1, 2, 5, 10, 20, or 30 static images can be acquired, while the CBBCT image burst exposure is 200, 300, or 400. The data representing the static images is then numerically combined with the data of the CBBCT images to provide a CBBCT image of higher effective resolution.

[0032] In certain embodiments of the present application, the static images are distributed approximately uniformly around the periphery of the breast, at regular or irregular rotational intervals, such as (but not limited to) 5°, 10°, 20°, 30°, etc. In other embodiments of the present application, the static images are concentrated in a limited sub-region of the rotational arc of the CBBCT images, which in certain cases will be selected to correspond to a particular region of interest identified in the breast tissue for enhanced examination and / or characterization.

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

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

[0035] In certain embodiments of the present application, a static image will be captured using an X-ray source having a focal spot diameter of about 0.1 millimeters (or having its focal spot diameter parameter set to).

[0036] In certain embodiments of the present application, the combination of a CBBCT image with a static image is achieved by a deep learning artificial intelligence algorithm to enhance calcified regions.

[0037] In certain embodiments of the present application, in order to reduce image acquisition time, and thereby minimize the likelihood of motion of the examined tissue, as described above, a CBBCT image is performed in a rotational interval of 180° plus the width of the detector, instead of the default 360° plus the width of the detector.

[0038] In certain embodiments of the present application, in order to reduce image blur due to motion of the imaging device, and thereby improve effective resolution, a CBBCT image will be performed in a longer time interval. Thus, for example, a gantry rotation of 360° will be performed in a time interval of 30 seconds, instead of, for example, 10 seconds, in certain embodiments of the present application. In other embodiments of the present application, for example, a gantry rotation of 180° will be performed in a time interval of 30 seconds, instead of, for example, 10 seconds.

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

[0040] In the current operation, a patient undergoing a CBBCT examination lies prone on a patient bed. The breast to be examined hangs vertically down from an aperture in the bed's upper surface, into the imaging region below the bed. The position of the breast within the imaging room region is maintained by the patient's immobility (i.e. the patient is kept still), as the patient lies on the bed's upper surface.

[0041] The imaging device is attached to a movable scanning gantry, which is supported by a bearing arrangement so as to rotate about a rotational axis. The rotational axis is in a generally vertical orientation, and passes through the aperture in the bed's upper surface. Ideally, the approximate center of mass of the breast to be imaged is arranged at the location where the rotational axis passes through that approximate center of mass.

[0042] During the imaging process, the scanning gantry rotates about the rotational axis, causing the imaging device to move 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 is processed to construct a tomographic model of the breast.

[0043] To avoid blurring during a single x-ray pulse and to maintain consistency between images, the patient remains still during the imaging process. Even small changes in the spatial position of the breast can result in reduced image sharpness.

[0044] In existing CBBCT systems, the breast is freely suspended within the imaging chamber. To provide the required stability to improve breast imaging for calcification detection, certain embodiments of the present application include a breast support device. In certain embodiments, the breast support device includes a stabilizer unit and a positioning device coupled to the stabilizer unit to provide adjustable positioning relative to a reference frame of the tomographic imager.

[0045] In certain embodiments, the stabilizer unit includes a generally rigid body having a major surface area configured to contact a corresponding surface area of the subject breast. In certain alternative embodiments, the generally rigid body comprises a material having desirable transparency at the operating wavelength of the imaging energy. Thus, in certain embodiments, the generally rigid body comprises one or more of expanded polystyrene, polystyrene, polyethylene, acrylonitrile-butadiene-styrene (ABS), polypropylene, acrylate (e.g., polymethyl methacrylate), polyamide, polyimide, aerogel, ceramic, fiber-reinforced composite, and polycarbonate (e.g., Lexan®), among others. ) and the like.

[0046] The following description is intended to enable any person skilled in the art to make and use the disclosed invention and is presented in connection with the best information available to the inventor. The patentable scope of the invention is defined by the appended claims and can include features that vary from the disclosure set forth herein. Descriptions of known techniques are not intended to detail all types of implementations that can fall under the scope of the invention but to highlight aspects of some exemplary implementations. Those skilled in the art will recognize that the disclosure set forth herein includes a number of options for implementing the invention and that the true scope of the invention encompasses not only the described implementations but also other implementations with additional features set forth but not listed, as well as further implementations set forth in connection with the figures. Figure One The detailed description set forth below in connection with the appended drawings is intended as a description of various embodiments of the invention and is not intended to represent the only embodiments in which the inventor contemplates applying the principles of the invention. Rather, the detailed description is intended to demonstrate information

[0047] It should be noted that while the various figures illustrate aspects of the application, no single figure is intended to illustrate the full scope of the present invention. Rather, the various figures collectively illustrate different aspects and principles of the present invention. Thus, no particular figure is necessarily to be construed as solely related to the particular aspect or feature illustrated or described in that figure. Rather, those skilled in the art will appreciate that the figures, taken together, reflect various aspects and embodiments of the present invention.

[0048] Accordingly, "one embodiment" or "an embodiment" as used herein, refers to a particular named feature, structure, or characteristic with which a specific embodiment can be associated. Thus, "one embodiment" or "an embodiment" appearing at BRIEF DESCRIPTION OF DRAWINGS

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

[0050] Figure 2 Structure and signal relationships of certain aspects of an example CBBCT breast imaging system are illustrated in block diagram form, including calcification detection features prepared in accordance with principles of the present application;

[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 in accordance with principles of the present application;

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

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

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

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

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

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

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

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

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

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

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

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

[0065] Figure 12 Aspects of a processing system and method employing an example imaging modality in accordance with the principles of the present application are illustrated in a schematic block diagram. DETAILED DESCRIPTION

[0066] Figure 1 A portion of an example CBBCT imaging system 100 prepared in accordance with the principles of the present application is illustrated 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 gantry 106. The rotating gantry 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, which in the illustrated embodiment intersects the rotation axis 108 at an intersection point 114.

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

[0069] In other configurations within the scope of the present application, a cross-section of beam 110 taken transversely along longitudinal axis 112 defines a region having a substantially uniform X-ray intensity and a nearly circular periphery, except for an outer portion of a chord located outside the circular periphery. As will be appreciated from further disclosure below, in certain embodiments, the chord will maintain a generally parallel spacing relationship with the lower surface of a patient table.

[0070] In further configurations within the scope of the present application, a cross-section of beam 110 taken transversely along longitudinal axis 112 defines a region having a polygonal periphery, which can include, in various embodiments and configurations, a triangular periphery, a square periphery, a pentagonal periphery, a hexagonal periphery, a periphery of any higher geometric shape, and / or a periphery having any combination of straight lines and curved lines as required by a particular application. Further, it is noted that any of the above cross-sectional configurations can define a beam having a non-uniform intensity, including, but not limited to, instances in which the intensity drops to zero in certain cross-sectional regions.

[0071] X-ray detector 116 is also mounted on upper surface 104 of gantry 106. In one example embodiment, X-ray detector 116 comprises a planar detector having a generally planar receiving surface 118. Receiving surface 118 is generally perpendicular to longitudinal axis 112 and is located on the opposite side of rotational axis 108 from X-ray source 102.

[0072] Rotation of gantry 106 about rotational axis 108 during operation of imaging system 100 will cause receiving surface 118 to move along a path of movement that surrounds rotational axis 108. In typical configurations, the path of movement will include at least a portion of a circle that is located vertically from rotational axis 108 and is centered on the rotational axis. However, it is noted that other paths of movement, however achieved, are considered to be within the scope of the present application and will be disclosed herein.

[0073] In certain embodiments of the present application, 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 gantry 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 gantry surface 104, or in any other direction or manner that a designer or user deems beneficial. Those skilled in the art will appreciate that by appropriately configuring the cross-section of the x-rays and the positions of the x-ray source and / or the x-ray detector, it is possible to preferentially image the entire breast and / or various regions of the breast under examination.

[0074] A patient table 120, also referred to as a patient interface panel, includes an upper surface 122 and a lower surface 124. A bore 126 is defined 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 in a prone position on the upper surface 122, as shown. In this arrangement, the breast 130 of the patient hangs below the chest wall of the patient, through the bore 126.

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

[0076] As noted above, and as will be discussed further below, the effectiveness of calcification detection is related to factors such as improved image resolution and reduced blurring. After careful consideration, the present inventors have concluded that image resolution can be improved and blurring reduced by improved x-ray source apparatus and methods, improved detector apparatus and methods, by improved mechanical systems to reduce motion artifacts, and appropriate signal processing. Accordingly, new combinations of methods and apparatus embodying these desirable features improvements are disclosed herein, certain aspects of which are embodied in the system overview shown below in Figure 2

[0077] Figure 2 A portion of a CBBCT imaging system 200 incorporating improved calcification detection features prepared in accordance with the principles of the present application 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 by a mechanical connection 204. The positioning system 206 is in turn connected to a rotating gantry 210 by a mechanical connection 208.

[0078] The rotating gantry 210 is connected to a rotating bearing 214 by an operating mechanical connection 212 to provide support around the rotation axis. The rotating bearing 214 is in turn connected to a structural foundation element 218 by a mechanical connection 216. ​

[0079] In certain embodiments of the present application, slip ring 220 spans rotational bearing 214 through mechanical connection 222 to transmit measurement, control, and imaging data and signals to and from gantry 210.

[0080] In some embodiments of the CBBCT imaging system, planar x-ray detector 224 is connected to vertical positioning drive 228 through mechanical connection 226. Vertical positioning drive 228 is connected to radial positioning drive 232 through mechanical connection 230, and radial positioning drive 232 is connected to gantry 210 through mechanical connection 234.

[0081] Thus, vertical positioning drive 228 and radial positioning drive 232 are connected to planar detector 224 and gantry 210, respectively. However, those skilled in the art will appreciate that in other embodiments of the present application, the opposite connection order will be employed, and in various embodiments of the present application, a variety of mechanisms and arrangements will be employed to position planar detector 224 relative to gantry 210.

[0082] In one example embodiment of the present application, as shown, photon counting x-ray detector 236 is connected to vertical positioning drive 240 through mechanical connection 238. Vertical positioning drive 240 is connected to radial positioning drive 244 through mechanical connection 242, and radial positioning drive 244 is connected to gantry 210 through mechanical connection 246. As described above for planar detectors, in various embodiments of the present application, a variety of mechanisms and arrangements will be employed to position photon counting detector 236 relative to gantry 210.

[0083] In certain embodiments of the present application, x-ray source 202 is signal connected 248 to controller 254 (e.g., a digital computer) through communication channel 250 of slip ring 220 and further communication channel 252. In certain embodiments of the present application, such signal connections serve to provide power, data signals (e.g., operating parameters), feedback signals, and other useful signals, transmitted unidirectionally and / or bidirectionally between x-ray source 202 and controller 254.

[0084] In various embodiments of the present application, signal connection and / or communication channel hardware (e.g., 248, 250, 252) will include, for example, but not limited to, electrical cables, electro-optical fibers, flexible printed circuit devices, various waveguides for electromagnetic communication of any desired wavelength, including digital, analog, and hybrid signals. In addition, in certain embodiments, free air signaling will be employed for the desired communication, such as electromagnetic signals, acoustic signals, or other known or possible to be recognized in the art.

[0085] In certain embodiments of the application, planar detector 224 is in signal connection 255 with controller 254 through communication channel 250, slip ring 220, and further communication channel 252. In certain embodiments of the application, such signal connection serves to provide power, data signals (e.g., operating parameters), feedback signals, and other useful signals, in unidirectional and / or bidirectional transmission between planar detector 224 and controller 254.

[0086] In certain embodiments of the application, photon counting detector 236 is in signal connection 256 with controller 254 through communication channel 250, slip ring 220, and further communication channel 252. In certain embodiments of the application, such signal connection serves to provide power, data signals (e.g., operating parameters), feedback signals, and other useful signals, in unidirectional and / or bidirectional transmission between photon counting detector 236 and controller 254.

[0087] Likewise, in certain embodiments of the application, vertical positioning drives 228 and 240 are in signal connection 258, 260, respectively, with controller 254 through communication channel 250, slip ring 220, and further communication channel 252. In certain embodiments of the application, such signal connection serves to provide power, data signals (e.g., operating parameters), feedback signals, and other useful signals, in unidirectional and / or bidirectional transmission between vertical positioning drives 228, 240 and controller 254.

[0088] In certain embodiments of the application, horizontal positioning drives 232 and 244 are in signal connection 262, 264, respectively, with controller 254 through communication channel 250, slip ring 220, and further communication channel 252. In certain embodiments of the application, such signal connection serves to provide power, data signals (e.g., operating parameters), feedback signals, and other useful signals, in unidirectional and / or bidirectional transmission between horizontal positioning drives 232, 244 and controller 254.

[0089] In certain embodiments of the application, servo and operational control will be effected through the aforementioned communication channels. In other embodiments of the application, local servo loops and / or feedback arrangements (e.g., digital servo loops, analog servo loops, and phase-locked loops) will provide immediate control of the apparatus, with parameter / setpoint signals being transmitted from controller 254 as appropriate. Of course, combinations of the foregoing schemes and other appropriate schemes (e.g., open-loop control schemes) will be employed as appropriate to meet the needs of particular embodiments or applications.

[0090] As Figure 2As shown in the example embodiment, the imaging system 200 includes a patient support panel 266. The patient support panel 266 is connected to the structural base element 218 by a mechanical connection 268. In certain embodiments, the patient support panel 266 will include an aperture to receive the breast of a patient therethrough.

[0091] According to the example embodiment shown, the receiver 270 is connected to the patient support panel 266 by a mechanical connection 272. In certain embodiments of the present application, the receiver 270 is in signal connection 274 with the controller 254 through the further communication channel 252. In certain embodiments of the present application, the purpose 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] A 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 application, the breast stabilizer unit 276 is in signal connection 280 with the receiver 270 while in operation, and through the receiver 270, in signal connection 274 with the controller 254 through the further communication channel 252. Those skilled in the art will appreciate that the purpose 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 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 application, the patient positioning support 282 will be mechanically connected 284 to and / or supported by the patient interface panel 266. In example embodiments, the patient positioning support 282 will be configured as a bed pad, a cushion, a rail, or any other device effective to position a 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 present application, the patient positioning support 282 will be a reconfigurable device, allowing adjustment or other customization according to the patient's body and other characteristics, and the requirements of the particular procedure or program. In further embodiments of the present application, the patient positioning support 282 will be an active device, allowing adjustment or other customization automatically and / or without the need for manual intervention by a clinician or technician, according to the patient's body and other characteristics, and the requirements of the particular procedure or program.

[0095] In certain embodiments of the present application, the patient positioning support 282 is in signal connection 285 with the controller 254 through a further communication channel 252. In certain embodiments of the present application, the role of such signal connection is to provide power, data signals (e.g., operational parameters, feedback signals, and other useful signals), unidirectional and / or bidirectional transmission between the patient positioning support 282 and the controller 254.

[0096] In certain embodiments of the present application, the 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 CBCT imaging system 200 optionally includes a patient handle 286. As shown, in certain embodiments of the present application, the patient handle 286 is in mechanical connection 288 with and / or supported by the patient interface panel 266. In example embodiments, the patient handle 286 will be configured to be grasped by the patient to facilitate effective operation of the imaging system 200 while reducing or eliminating patient motion and maintaining optimal patient comfort.

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

[0099] In certain embodiments of the present application, the patient handle 286 is in signal connection 290 with the controller 254 through a further communication channel 252. In certain embodiments of the present application, the role of such signal connection is to provide power, data signals (e.g., operational parameters, feedback signals, biometric signals, and other useful signals), unidirectional and / or bidirectional transmission between the patient handle 286 and the controller 254.

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

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

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

[0103] In certain embodiments of the present application, the patient back support element 292 is signal coupled 296 to the controller 254 via a further communication channel 252. In certain embodiments of the present application, the purpose of this signal coupling 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 back support element 292 and the controller 254.

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

[0105] Figure 3 A portion of a CBBCT imaging system 300 incorporating improved calcification detection characteristics, prepared according to the principles of the present application, is shown in schematic, cutaway, perspective view. 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, in turn, is mechanically coupled to a rotating gantry 310.

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

[0107] In some embodiments of the invention, the slip ring 320 spans the rotary bearing 314 via a mechanical connection to transmit measurement, control, biometric and imaging signals and data into and out of the rotary frame 310.

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

[0109] Therefore, the vertical positioning actuator 328 and the radial positioning actuator 332 are connected to the planar detector 324 and the rotating frame 310, respectively. However, those skilled in the art will understand that in other embodiments of the invention, the connection order will be reversed, and various mechanisms and arrangements will be employed in different embodiments of the invention to position the planar detector 324 relative to the rotating frame 310.

[0110] In one exemplary embodiment of the invention, as shown, the photon-counting X-ray detector 336 is mechanically connected to a vertical positioning actuator (not visible). This vertical positioning actuator is mechanically connected to a radial positioning actuator 344, which in turn is mechanically connected to a rotating frame 310. As described above, for planar detectors, various mechanisms and arrangements will be employed in different embodiments of the invention to position the photon-counting detector 336 relative to the rotating frame 310.

[0111] It is important to note that, Figure 3 In the diagram, photon counting detector 336 is shown in a stored configuration, such that it is located outside 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 understand that the operation of the aforementioned vertical positioning driver and radial positioning driver 344 will shift photon counting detector 336 from the shown stored configuration to the operational configuration, as described below. Figure 4 As shown.

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

[0113] In some embodiments of the invention, the X-ray source 302 is signal-connected to a controller (e.g., a digital computer) via a communication channel, a slip ring 320, and a further communication channel. In some embodiments of the invention, this signal connection serves 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 302 and the controller.

[0114] In various embodiments of the invention, the signal connection and / or communication channel hardware will include, for example (but not limited to), cables, optical fibers, flexible printed circuit devices, and various waveguides for electromagnetic communication at any desired wavelength, including digital, analog, and mixed signals. Furthermore, in some embodiments, the desired communication will be achieved via 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 invention, the planar detector 324 is signal-connected to the controller via a communication channel, a slip ring 320, and a further communication channel. In some embodiments of the invention, this signal connection serves to provide power, data signals (e.g., operating parameters, feedback signals, and other useful signals), which are transmitted unidirectionally and / or bidirectionally between the planar detector 324 and the controller.

[0116] In some embodiments of the invention, the photon counting detector 336 is signal-connected to the controller via a communication channel, a slip ring 320, and a further communication channel. In some embodiments of the invention, this signal connection serves to provide power, data signals (e.g., operating parameters, feedback signals, and other useful signals), which are transmitted unidirectionally and / or bidirectionally between the photon counting detector 336 and the controller.

[0117] Similarly, in some embodiments of the invention, the vertical positioning driver (e.g., 328) is signal-connected to the controller via a communication channel, slip ring 320, and further communication channels. In some embodiments of the invention, this signal connection serves to provide power, data signals (e.g., operating parameters, feedback signals, and other useful signals), transmitted unidirectionally and / or bidirectionally between the vertical positioning driver (e.g., 328) and the controller.

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

[0119] In some embodiments of the invention, servo and operation control will be implemented through the aforementioned communication channels. In other embodiments of the invention, local servo loops and / or feedback arrangements (e.g., digital servo loops, analog servo loops, and phase-locked loops) will provide real-time control of the device, while parameter / setpoint signals will be transmitted from the controller as appropriate. Of course, combinations of the foregoing solutions and other suitable solutions (including open-loop control) will be employed to meet the requirements of specific embodiments or applications.

[0120] Figure 4 A portion of the CBBCT imaging system 400 is shown in a schematic cross-sectional perspective view, its features being similar to those of the imaging system 300. Among other notable features, the imaging system 400 includes an X-ray source 402 mechanically connected 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 the vertical positioning actuator 428, which in turn is mechanically connected to the radial positioning actuator 432, which in turn is mechanically connected to the rotating frame 410. The photon counting detector 436 is mechanically connected to the vertical actuator 437, which in turn is mechanically connected to the radial actuator 444. The radial actuator 444 is mechanically connected to the rotating frame 410.

[0122] As described above, photon counting detector 336 is in a storage configuration. In contrast, photon counting detector 436 is shown in an operational configuration. The reader will clearly see that photon counting detector 436 has been moved from storage recess 439 to the operational configuration by the vertical movement 441 of vertical actuator 437 and the radial movement 443 of horizontal actuator 444. Therefore, photon counting detector 436 is positioned to effectively receive the X-ray beam 438 generated by X-ray source 402.

[0123] In some embodiments of the invention, the X-ray beam 438 is configured (e.g., by passing through a shielded collimator) to have corresponding vertical and horizontal dimensions and is positioned to primarily irradiate the region of interest 445 within the imaged breast 440. Ideally, 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 reaching the imaging region 451.

[0124] Therefore, by masking the coordinated operation of the collimator with the vertical actuator 437 and the horizontal actuator 444, the target region of interest 445 of the breast 440 can be effectively imaged. As will be further discussed below, in some embodiments of the invention, a tomographic image dataset is acquired through the operation of the planar detector 424, and one or more still images are acquired through the operation of the photon counting detector 436 to provide additional detail about the region of interest 445. In some embodiments of the invention, the tomographic image data and the still image data are processed to generate tomographic images 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 understand that, in various embodiments, the imaging system prepared according to the principles of the present invention will use the same planar detector 424 as that used for acquiring tomographic images to acquire static images. Therefore, in some embodiments, the photon counting detector 436 will be omitted.

[0126] In other embodiments of the invention, a photon-counting detector of sufficient size to image the entire examined breast 440 will be used, for example, instead of the planar detector 424. Furthermore, in some embodiments of the invention, both the planar detector 424 and the photon-counting detector 436 are of sufficient size to image the entire breast in a single pass. In such embodiments, however, the X-ray beam can still be collimated to image one or more targeted regions of interest, thereby acquiring tomographic and / or static images of the examined breast 440. These images will, in some embodiments, be combined with or otherwise mixed with other acquired tomographic images of the breast 440 to produce improved screening and / or diagnostic and / or treatment outcomes.

[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 surface 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 sharpness of reconstructed images, the detector's frame rate should be at least 20 frames per second, and the resolution per frame should be at least 512x512. To achieve isotropic high spatial resolution in a breast CT system, the element size of the two-dimensional detector should be equal to or less than 0.5mm x 0.5mm / element.

[0128] Cone-beam computed tomography (CBBCT) devices acquire two-dimensional projection data. The geometric path shape for image acquisition can be a single-circle geometry, a double-circle geometry (suitable for larger breasts), a circle plus a straight line geometry, a semi-circle plus a cone angle geometry, or a 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. Reconstruction methods can include filtered backprojection, iterative algorithms, and / or artificial intelligence deep learning algorithms. Specialized imaging processors can be used to perform rapid reconstruction and imaging processing.

[0129] Figure 5A-5C Simultaneously, a method 500 is presented for operating a CBBCT imaging system that includes calcification detection features, in the form of a functional flowchart, as shown below. Figure 2-4 As shown.

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

[0131] In use, an appropriately sized breast stabilizer is installed for operation 504, for example, connected to a patient support panel via a coupler. Consistent with a particular embodiment, signal connections can be made automatically or manually to connect instruments within the breast stabilizer to a system controller. Example instruments would include an accelerometer for identifying and characterizing breast vibrations and movements, and electrodes for sensing muscle activity and / or cardiac activity. However, it is worth noting that various other instruments will be used as required by a particular embodiment of the invention.

[0132] Initial adjustments are made to the patient interface panel and / or patient support features 506, and patient entry into the system is completed 508. Subsequently, 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 initially positioned, additional fixation / support adjustments are performed, 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 a patient support panel. Where available, in some methods according to the principles of the invention, the patient will be guided to grasp one or more handles 512. In some embodiments of the 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 entirety of this disclosure, it will be understood that in some embodiments of the invention, image acquisition is synchronized with the patient's heartbeat and phase-adjusted to minimize motion-related blur.

[0134] As with Figure 2 As described herein, certain embodiments of the invention include a patient back support element (e.g., 292). When this support element is present, and in a suitable relationship with 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 some embodiments of the invention, patient sensing 516 is initiated once the patient is fully positioned. As described above, involving, for example, the mounting of the handle 512 and the breast stabilizer 504, patient sensing in some embodiments will include sensing the patient's breathing, heartbeat, muscle activity, or other patient parameters that may affect image quality.

[0136] Subsequently, in some embodiments of the invention, a static positioning image (i.e., a preliminary image for establishing parameters and target location) 518 is acquired. As understood by those skilled in the art, the static positioning image in some embodiments will provide information helpful in establishing system operating parameters, such as preferred X-ray source location and power level.

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

[0138] In some embodiments of the method of the present invention, X-ray source parameters for imaging are set, for example, a 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 focal spot or a 0.3 mm focal spot. 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 focal spot 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 526 is acquired using a planar detector.

[0140] The tomographic image data is transmitted from the planar detector to the processor, where the image data is processed to generate a tomographic image dataset.

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

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

[0143] In some embodiments of the invention, the tomographic image dataset is configured to be displayed and shown to users, such as technicians, clinicians, or other evaluators. In some embodiments of the invention, the displayed information is annotated to include features identifying regions of interest and is displayed along with annotation 532. These regions of interest will, in some embodiments of the invention, be areas where calcification features may or are very likely to be present.

[0144] In some embodiments of the invention, the user will have the opportunity 534 to provide input to the system, including (but not limited to) identifying regions of high or low interest, including regions within annotated regions of interest and other regions not annotated by the system. In some embodiments, regions marked as requiring further evaluation will be automatically imaged additionally. In some embodiments of the invention, regions identified by the user will be imaged additionally. Additional imaging in various embodiments of the invention will include additional tomographic imaging of a planar detector, additional tomographic imaging of a photon-counting detector, additional static imaging of a planar detector, and additional static imaging of a photon-counting detector.

[0145] Therefore, in some embodiments of the invention, the imaging system activates the photon counting detector position driver 536 to position the photon counting detector for imaging a region of interest. In some embodiments, the system (e.g., a control processor) sets parameters for the X-ray source 538 used for imaging the photon counting detector. In some embodiments of the invention, the X-ray source parameters will include parameters for positioning the collimator to selectively irradiate a specific region of interest with X-rays generated by the X-ray source. In some embodiments of the invention, the X-ray source parameters will include parameters for setting the focal size. In some embodiments of the invention, the focal size selected for illuminating the photon counting detector will be a focal size with a diameter of 0.1 mm.

[0146] According to certain embodiments of the invention, the rotating frame will rotate 540 by an effective rotational 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. This pulsed X-ray will pass through the region of interest of the examined breast, and a photon counting detector will receive the photons of the X-ray pulse to obtain a photon counting image 542.

[0147] The 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 on the data from the photon counting detector 544.

[0148] The processor then integrates the planar detector data and the photon counting detector data 546, and performs comprehensive image processing 548 on the merged dataset, such as (but not limited to) Fourier transform processing, Laplace transform processing, edge recognition processing, etc.

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

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

[0151] In some embodiments of the invention, the integrated model, as well as preliminary and / or intermediate data, will be archived 554 and stored in digital patient records or other ways for future reference.

[0152] According to the method of the present invention, when in use, the patient's back support features will be restored to their initial state 556, and the patient will be removed from the imaging system 558.

[0153] Those skilled in the art will understand that each element of the above method is optional. Alternative aspects of the overall imaging system method and apparatus described in this disclosure will be applied to various embodiments of the method, which will become apparent from the overall disclosure.

[0154] It should also be noted that, in some cases, in vivo breast marking or pre-positioning markers may be performed to facilitate the integration of datasets and / or aid 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 a breast stabilizer unit. In other embodiments of the invention, the positioning markers may be provided by ink marking on the imaged breast, using adhesive stickers comprising X-ray opaque or X-ray translucent elements, applying vitamin E capsules 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 A schematic diagram 600 illustrates the temporal relationship between a patient's heartbeat and an imaging pulse in an imaging system prepared according to the principles of the present invention. Therefore, the horizontal axis 602 represents time, and the vertical axis 604 corresponds to the respective amplitudes of the illustrated signals.

[0156] The diagram illustrates a schematic representation of a normal sinus heartbeat waveform, 606. Industry professionals will understand that waveform 606 contains a PR segment within the first time interval 608 and an ST segment within the second time interval 610. It is evident that, during examination, the waveform within 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 according to the principles of the present invention. Those skilled in the art will understand that the indicated pulse 614 corresponds to the X-ray emitted by the system and / or the acquisition of a single X-ray image. The reader will recognize that after acquiring the patient's heartbeat signal, the imaging pulse 614 can be synchronized 616 with a relatively quiet PR segment within time interval 608. Therefore, blurring caused by breast tissue movement due to the patient's heartbeat can be reduced. This reduction in blurring will contribute to improved calcification detection.

[0158] In another embodiment of the principles of the invention (or the same embodiment with different operating parameters), signal 618 exhibits a similar trigger pulse 620, synchronized 622 with the relatively quiet ST segment of time interval 610. Those skilled in the art will understand that in various embodiments of the invention, image acquisition will be synchronized to time interval 608 or 610, depending on various design and / or operational considerations. In some embodiments of the invention, where relatively high-speed imaging is required, X-ray images can 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 one example embodiment of the invention, the accelerometer signal is generated by an accelerometer that contacts and images a region of the breast surface. In some embodiments of the invention, the accelerometer is attached to or integrally formed with a breast stabilizer unit. In other embodiments of the invention, the accelerometer is placed on the patient's breast before the patient enters the system, for example, via an adhesive device. Those skilled in the art will understand that alternative sensing technologies, such as ultrasound or lidar, can be used to sense heartbeat signals at the breast.

[0160] 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, 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. Those skilled in the art will understand that the time interval Δt corresponds to the time interval between the generation of the sound wave signal from the heart and its arrival at the breast tissue. By applying phase shift 634 640 to the pulse 620 of signal 618, an improved signal 636 can be generated, where the imaging pulse 638 corresponds to the pulse 620 that has been phase-shifted by the time interval (delay).

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

[0162] Those skilled in the art will understand that while signal 606 is typically periodic, signals 612, 618, and 636 will be activated in an ideal state relative to the quiescent state of the breast tissue and the angular position of the imaging device. Those skilled will also understand that, although the foregoing description relates to cardiac rhythm and associated image acquisition time compensation, other embodiments of the invention will similarly involve compensation for lung rhythm and image acquisition time, as well as other periodic and non-periodic movements of the subject. These compensation schemes will be apparent from this disclosure and are intended to be implemented through this demonstration.

[0163] Now for reference Figure 7As described above, in existing CBBCT systems, the imaging gantry rotates continuously during imaging, for example, 180° plus the cone angle width, or 360° plus the cone angle width. During the gantry rotation, the X-ray detector periodically acquires images (e.g., every 2°). Those skilled in the industry will understand that because the image acquisition time, while short, is not instantaneous, and because the X-ray detector is in continuous motion during image acquisition, a certain degree of blurring is introduced into the acquired images.

[0164] According to the principles of the invention, some embodiments of the improved CBBCT system include an image acquisition device that remains stationary and substantially immobile relative to the breast being imaged during each image acquisition cycle.

[0165] Figure 7 The time relationship between the rotational motion of the imaging system and the imaging pulses of the CBBCT system according to the principles of the present invention is shown in schematic diagram 700. Therefore, the horizontal axis 702 represents time, and the vertical axis 704 corresponds to the state of each system element.

[0166] As shown in Figure 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 complete, the device returns to the stationary state 708. Although the state transition 712 is ideally depicted as essentially instantaneous, those skilled in the art will understand that accelerating and decelerating the imaging device actually requires time.

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

[0168] Conversely, Figure 726 illustrates the movement of an imaging gantry designed according to the principles of the present invention. As shown, the gantry begins in a stationary state 728 relative to the breast being imaged. During a first time interval 730, the gantry accelerates 732 and then decelerates 734, thus completing one angular rotation step. Next, the gantry remains substantially stationary relative to the breast being imaged 736. When the imaging system is stationary 736, an imaging signal 738 is pulse-triggered 740, generating an X-ray pulse and acquiring an image. Afterward, the gantry rotates again in a finite number of steps 742, subsequently initiating the next imaging cycle 744.

[0169] Through observation Figure 7As illustrated, those skilled in the art will immediately understand that the alternating cycle of gantry movement and image acquisition ensures that the gantry remains essentially stationary during each image acquisition. Therefore, imaging blur associated with gantry movement is reduced or eliminated, improving overall tomographic image quality. This improvement in image quality, combined with other improvements described herein, contributes to enhancing the effective resolution and sharpness of the system's images and strengthening the system's ability to detect diagnostically important breast calcifications.

[0170] 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. The dimensions of motors and other system components are rationally selected using feedback and feedforward control principles, along with the generation of the required control signals and the minimization of undesirable resonances in the system. In some embodiments of the invention, the frequency of the pulse 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 a cone width) is used instead of a full-circle scan. In some embodiments, this approach may result in a longer overall CBBCT image acquisition time. However, in some embodiments of the invention, this longer acquisition time is justified due to the improved image quality and the ability to more effectively image intramammary microcalcifications.

[0171] Figure 8A and Figure 8B A schematic cross-sectional elevation view illustrates the inactive 800 and active 802 configurations of the dynamic patient support system of the CBBCT imaging system designed according to the principles of this invention. Figure 8A In the image, the patient's chest 804 is displayed in cross-section. The patient is positioned on the upper surface 806 of the patient interface plate 808. The patient's breast 810, to be imaged, is placed through the opening 812 of the patient interface plate 808.

[0172] The patient is relatively free on the patient interface panel, therefore, 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 the imaging process.

[0173] As mentioned above, this displacement of the breast during imaging often blurs the resulting image, introducing errors into the corresponding image data. Therefore, enhancing the stability of the patient's chest and overall body helps in the effective imaging of microcalcifications in breast tissue.

[0174] In some embodiments of the invention, this 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, individual support pads can be easily displaced by the patient. Furthermore, the insertion of support pads can prolong the overall procedure time, leading to patient impatience, reduced patient satisfaction, and decreased screening compliance. Simultaneously, the overall imaging procedure time will be extended, resulting in additional costs.

[0175] Therefore, in some embodiments of the 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) mechanically connected to the patient interface panel 808.

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

[0177] When the linear actuator moves from an inactive state (such as...) Figure 8A (As shown) transition to the active state (e.g.) Figure 8B As shown, the movable portion 834 of the linear actuator 826 extends away from the patient interface plate 808 along direction 836. Therefore, the flexible member 828 is taut. The taut flexible member 828 gently supports and restricts the patient's chest 804, thereby stabilizing the patient and reducing unnecessary movement of breast tissue.

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

[0179] Those skilled in the art will understand that, although the illustrated embodiments include mechanical linear actuators, other support methods and devices may also be used, such as, but not limited to, one or more pneumatic airbags and / or one or more hydraulic airbags, as well as actuator components with any known or future-developed suitable functions.

[0180] In some embodiments of the invention, the linear actuator may include (by way of example only and not limited to) one or more of the following: solenoid valve, cylinder, hydraulic cylinder, pneumatic bladder, hydraulic bladder, linear motor, linear stepper motor, rotary actuator, and: trapezoidal screw and nut, lead screw, ball screw, cable, pulley, synchronous belt, synchronous pulley, worm gear reducer of appropriate size, rack and pinion assembly, rack and worm gear assembly, piezoelectric actuator, combination of piezoelectric actuator and ratchet pawl driver, spring-loaded actuator, actuator containing shape memory alloy, and any actuator assembly of appropriate function known or to be developed in the future.

[0181] In some embodiments of the 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, pneumatic motor, hydraulic motor, spring, or any known or future-developed drive mechanism.

[0182] In various embodiments of the present invention, the flexible member 828 may include (by way of example only, but not limited to) synthetic polymers, natural polymers, textile materials, molding materials, fabric materials, extruded materials, woven materials, and felt materials, and combinations thereof. Furthermore, the flexible member 828 may include (by way of example only, but not limited to) polyamides, polypropylene, polyethylene (including low-density polyethylene, medium-density polyethylene, high-density polyethylene, and ultra-high molecular weight polyethylene), polyaramids, polyesters, polytetrafluoroethylene, leather, cotton, wool, flax, flax fibers, and / or any related materials and combinations thereof.

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

[0184] Figure 9A and Figure 9BA schematic cross-sectional elevation view illustrates 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. Figure 9A In the image, the patient's chest 904 is displayed in cross-section. The patient is positioned on the upper surface 906 of the patient interface panel 908, and the breast 910 to be imaged is placed through the opening 912 of the patient interface panel 908.

[0185] Structural member 914 is arranged in a relationship spaced apart from the patient's back surface area 916. During operation, the structural member maintains a substantially fixed spatial relationship with the patient interface panel 908. However, it should be noted that in some exemplary embodiments of the invention, structural member 914 is removable and / or can be moved by means of, for example, rotation, sliding, lifting, rolling, etc., to facilitate patient entry and exit from the CBBCT imaging system.

[0186] As shown in the figure, structural member 914 supports a support element. In the illustrated embodiment, the support element is an inflatable airbag 918, such as a pneumatic or hydraulic inflatable airbag. Figure 9A In the middle, the inflatable airbag 918 is in the first inactive configuration, that is, in an uninflated state; in Figure 9B In the middle, the inflatable airbag is in the active configuration, that is, it is inflated.

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

[0188] Although the illustrated embodiment shows a single structural member 914 and an inflatable airbag 918, the teachings provided in this disclosure will immediately lead those skilled in the art to various configurations and arrangements. For example, in some embodiments of the invention, the inflatable airbag 918 may be replaced with a cushion, and the structural member 914 may move toward or away from the patient's back surface area 916 in response to, for example, the actuation of a linear actuator (mechanically connected between the structural member 914 and the patient support plate 908). In other embodiments, the cushioning element may be omitted entirely.

[0189] In some embodiments of the invention, the transition of the patient's back support element from an inactive state to an active state and back is controlled by an operator, technician, and / or clinician. In other embodiments of the invention, the transition is controlled by the patient. In still other embodiments of the invention, the transition is controlled by a controller, typically similar to the controller 254 described above.

[0190] According to the above disclosure,Figure 10 A portion 1000 of a breast imaging system is shown in a cross-sectional perspective view, including certain aspects of the interface between the receiving device and the breast stabilization unit. Specifically, Figure 10 A portion of the 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 Figure 10 In the example device shown, the receiving device coupling feature 1004 and the breast stabilization unit coupling feature 1008 each include complementary serrated surface regions 1010 and 1012. Those skilled in the art will readily understand that the generally rectangular protrusion (e.g., 1014) on the receiving device coupling feature 1004 will be designed to fit snugly into the corresponding generally rectangular groove 1016 in the breast stabilization unit coupling feature 1008, and vice versa.

[0192] Furthermore, those skilled in the art will readily understand that in some embodiments, if the dimensions of each serration are approximately uniform, the breast stabilizing unit can be positioned symmetrically relative to the receiving device. Therefore, the breast stabilizing unit can be easily rotated about the longitudinal axis of the receiving device (in some embodiments, i.e., about the rotation axis 1008 of the frame 1004).

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

[0194] Figure 11A Further features and characteristics of an example imaging system 1100 designed according to the principles of the present invention are illustrated in a schematic perspective 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 several particularly desirable features, including a breast stabilization unit 1108, whose design and configuration allow imaging of almost the entire target breast, and in some cases, a portion of the corresponding chest wall, while effectively stabilizing the breast to detect calcifications.

[0195] In the embodiment shown, instead of a separate receiving device, a surface area 1110 of the patient support plate 1102 is used as the receiving coupling area 1112.

[0196] Now combine Figure 11A Let's take a look Figure 11B ; Figure 11BFurther 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 region 1104 and a lower surface region 1106.

[0197] During the operation, the X-ray beam 1114 fills the space below the lower surface 1106 and spans a cross-sectional area of ​​1116 to irradiate the target mammary gland area until it covers the entire mammary gland.

[0198] It should be understood that in some 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) in order to enable breast imaging as close as possible to the patient's chest wall. In fact, in some embodiments of the 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 element 1122 and a second edge element 1124. In some embodiments, the first body element 1122 will comprise a structural material with sufficient mechanical properties to support the patient's breast, and this material will be relatively transparent to X-rays. In some embodiments of the invention, a single material will possess both of these properties.

[0200] In some embodiments of the invention, the first body element 1122 is substantially fixedly connected to the respective interface surface regions 1126 and 1128 of the second edge element 1124. In various embodiments, this connection can be achieved by using chemical adhesives, physical bonding, mechanical fasteners, mechanical upsetting, welding (such as thermal 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 region 1130. The edge coupling surface region 1130 is adapted and configured to engage with the complementary patient support plate coupling surface region 1132, thereby forming a robust connection between the patient support plate 1102 and the breast stabilization unit 1108.

[0202] According to the example shown, 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 needed and may include metallic materials, synthetic polymer materials, glass materials, natural polymer materials, or any structural material suitable for the specific requirements of the embodiment, including combinations of these materials.

[0203] In the illustrated example, the second edge element 1124 is secured to the patient support plate 1102 by keys 1134 and 1136 to restrict rotation 1138 of the breast stabilization unit 1108 about its longitudinal axis. However, in other embodiments of the invention, the design, material, and configuration of the second edge element 1124, as well as the corresponding coupling surface region 1132 of the patient support plate 1102, will be selected and configured to allow frictional rotation or near-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 a corresponding radial dimension such that a single fixed-size opening on the patient support plate 1102 can accommodate various breast stabilizing elements (e.g., 1108) with different diameters, configurations, and parameters, while the corresponding radial width of the second edge element 1124 is used to adapt these different dimensions to each other.

[0205] Those skilled in the art will understand that separate edge elements are not necessary. In some embodiments of the invention, the first main body portion 1122 and the second edge element 1124 of the breast stabilizing unit 1108 may be constructed from a single homogeneous material as a single integrally molded component. In other embodiments of the invention, internal reinforcing materials, such as glass fiber, carbon fiber, polymer fiber, or other materials, may be incorporated into one or more regions of the breast stabilizing unit 1108. It should be understood that the compositional transitions between these regions may be abrupt or gradual to suit the needs of a particular mode or application of the invention.

[0206] Within the overall context of this disclosure, it can be understood that by establishing the exemplary characteristics of the openings in the patient support plate 1102 and the interface surface region 1132, these characteristics will form a standard interface for equipping and coupling a variety of different breast stabilization units. Therefore, in some embodiments of the invention, breast stabilization units will be designed with a standard interface, wherein the radial edges conform to the standard interface, but their dimensions are customized according to the needs and parameters (e.g., size) of a specific patient, procedure, diagnosis, or mode of operation. As described above, the breast stabilization units 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 such 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 understand that different breast positions and configurations may be ideal for a particular patient, application, or imaging target, and can be achieved through appropriate shape, configuration, and placement of the breast stabilization unit 1108.

[0208] Therefore, the breast stabilization unit 1108 is arranged, adapted, and configured to support, stabilize, and fix 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 invention, the breast stabilization unit 1108 can be supported from above, below, to the side, or in any other manner deemed advantageous and / or suited to the specific system, application, patient, or imaging modality.

[0210] These different arrangements will be used individually and / or in combination, depending on the specific requirements of a particular application. Using one arrangement does not preclude the simultaneous use of other arrangements or modes. Therefore, it should be understood that the configurations discussed herein are merely examples of various devices and arrangements, including combinations thereof, and those skilled in the art will understand these application possibilities after reading this disclosure.

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

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

[0213] Therefore, the CBBCT system 1202 is configured and operated to acquire one or more CBBCT image datasets 1204. Depending on the selected operating mode, one or more acquired CBBCT image datasets 1204 may be acquired with or without the use of an injection contrast agent 1206.

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

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

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

[0217] Correlating contrast-free CBBCT images with static images from a flat panel detector 1220.

[0218] CBBCT images with contrast agent are correlated with static images of flat panel detectors.1222

[0219] Contrast-free CBBCT images are correlated with static images of the photon counting detector (0.1 mm focus)1224

[0220] CBBCT images with contrast agent are correlated with static images of the photon counting detector (0.1 mm focus)1226.

[0221] Contrast-free CBBCT images are correlated with static images of the photon counting detector (0.3 mm focus)1228

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

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

[0224] Contrast-free CBBCT images are fused with static images from a flat panel detector 1232.

[0225] Contrast-treated CBBCT images are fused with static images from a flat panel detector.1234.

[0226] Contrast-free CBBCT images are fused with static images from a photon counting detector (0.1 mm focus) 1236.

[0227] The CBBCT image with contrast agent is fused with the still image (0.1 mm focus) of the photon counting detector 1238.

[0228] Contrast-free CBBCT images are fused with still images from the photon counting detector (0.3 mm focus) 1240.

[0229] The CBBCT image with contrast agent is fused with the still image (0.3 mm focus) of the photon counting detector 1242.

[0230] Given with Figure 12 Given the relevant disclosures, and considering the broader scope of this disclosure, those skilled in the art will readily understand that the image acquisition and processing methods and modes presented herein are merely examples of a larger set of methods and modes. These novel methods and modes, while unexpected and effective, will become clear to those of ordinary skill who have encountered this 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 apparatuses, structures, approaches, and results that are apparent under this disclosure.

[0231] In some embodiments, the present invention includes a method for in vitro imaging of breast calcification, comprising placing a patient on a CBBCT imaging system and supporting the patient to minimize breast movement. The method then includes rotating the gantry of the CBBCT imaging system to rotate the 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 set of multiple image datasets.

[0233] Furthermore, the method includes processing data from a first set of image datasets to generate a first CBBCT imaging model, and evaluating the imaging model to identify regions 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 cycle while projecting a second X-ray beam from an X-ray source.

[0234] Furthermore, the method involves passing a second set of X-ray beams through a region of the breast and detecting the second set of X-ray beams using an X-ray detector to capture a static image dataset. Simultaneously, the first set of image datasets and the static image datasets are processed to generate an improved CBBCT imaging model, thereby resolving calcification structures.

[0235] In some embodiments, the invention includes imaging in vitro breast calcifications by passing a 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, data processing is performed on a first set of image datasets and a static image dataset, including combining the two to generate an improved CBBCT imaging model.

[0236] According to certain embodiments of the invention, a first set of image datasets and a static image dataset are processed, including processing a first CBBCT imaging model using the static image dataset to generate an improved CBBCT imaging model. Furthermore, in some embodiments of the invention, breast movement is reduced by using a breast stabilization unit to support the patient's breast.

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

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

[0239] In some embodiments of the invention, the first set of X-ray beams is generated by a 0.3 mm focal spot, while 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 simultaneously. In some embodiments of the invention, detection of the second set of X-ray beams is performed using a photon counting detector. According to some embodiments of the invention, the generated data is evaluated using an artificial intelligence deep learning process.

[0240] In some embodiments of the invention, data from the first set of image datasets is combined with a static image dataset to generate a computed correlated image. In other embodiments of the invention, data from the first set of image datasets is combined with a static image dataset 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 exemplary embodiments described above are primarily 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 realize the advantages of the present invention.

[0243] Furthermore, although the invention has been described in detail with reference to the presently preferred embodiments, it should be understood that the invention is not limited to these disclosed embodiments. Rather, modifications can be made to include any number of variations, alterations, substitutions, or equivalent arrangements not described, but these modifications shall still conform to the spirit and scope of the invention. Therefore, the invention should not be considered as limited solely to the foregoing description, but only to the scope of the appended claims.

Claims

1. A method for in vitro imaging of breast calcification, comprising: Place the patient on the CBBCT imaging system; Support the patient to achieve minimal displacement of the breast tissue; The scanning gantry of the CBBCT imaging system is rotated to generate the rotation of the X-ray source; The first set of X-rays is repeatedly emitted from the X-ray source; A portion of the first set of X-rays was repeatedly passed through the breast. The first set of X-rays is detected by repeatedly using a flat panel detector to capture the first set of image datasets; Process the data from the first set of image datasets to generate the 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 stationary during the static image acquisition cycle; A second set of X-rays is projected from the X-ray source; The second set of X-rays is passed through a specific area of ​​the breast; A second set of X-rays was detected using an X-ray detector to capture a dataset of static images; The data from the first set of image datasets were processed together with the static image dataset to generate an improved CBBCT imaging model to resolve the calcification.

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

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

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

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

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

7. The method for 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 breast calcification as defined in claim 6, further comprising: Detect the patient's heartbeat.

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

10. The method for in vitro imaging breast calcification as defined in claim 8, further comprising: The process of detecting the first set of X-rays was synchronized with the patient's heartbeat.

11. The method for in vitro imaging breast calcification as defined in claim 8, further comprising: The process of detecting the second set of X-rays was synchronized with the patient's heartbeat.

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

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

15. The method for in vitro imaging breast calcification as defined in claim 1, wherein detecting a second set of X-rays using an X-ray detector comprises: The second group of X-rays was 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 was evaluated using an artificial intelligence deep learning process.

17. The method for in vitro imaging breast calcification as defined in claim 1, wherein the processing of the first set of image datasets and the static image dataset includes: Prepare the relevant images from the calculation.

18. The method for in vitro imaging breast calcification as defined in claim 1, wherein the processing of the first set of image datasets and the static image datasets includes: Prepare the registered and fused images.

19. The method for in vitro imaging 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 the repeated projections of the first set of X-rays from the X-ray source.

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

Images