Cone beam breast CT and ultrasonic hybrid imaging method and device

Abstract

In the invention, the cone-beam breast computed tomography (CBBCT) imaging system comprises a subsystem for ultrasonic scanning, so that the same system can generate a cone-beam breast computed tomography (CBBCT) image, an ultrasonic scanning image and a mixed image formed by fusing the cone-beam breast computed tomography image and the ultrasonic scanning image.

Description

[0001] Related Applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 331,153, filed on April 14, 2022, entitled “Comprehensive Disclosure,” and U.S. Provisional Patent Application No. 63 / 401,475, filed on August 26, 2022, entitled “Immobilization and Support for Medical Imaging,” and U.S. Provisional Patent Application No. 63 / 401,493, filed on August 26, 2022, entitled “Ergonomic Improvements in Cone Beam Breast Computed Tomography,” and U.S. Provisional Patent Application No. 63 / 401,513, filed on August 26, 2022, entitled “Immobilized Detail Imaging in Cone Beam Breast Computed Tomography,” and U.S. Provisional Patent Application No. 63 / 401,514, filed on August 26, 2022, entitled “Immobilized Detail Imaging in Cone Beam Breast Computed Tomography,” and U.S. Provisional Patent Application No. 63 / 401,515, filed on August 26, 2022, entitled “Immobilized Detail Imaging in Cone Beam Breast Computed Tomography,” and U.S. Provisional Patent Application No. 63 / 401,516, filed on August 26, 2022, entitled “Immobilized Detail Imaging in Cone Beam Breast Computed Tomography,” and U.S. Provisional Patent Application No. 63 / 401,517, filed on August 26, 2022 The present invention relates to provisional patent applications No. 3 / 401,546, entitled “Cone Beam Breast Computed Tomography with Patient Support Subsystem,” and provisional patent application No. 63 / 401,548, filed on August 26, 2022, entitled “Cone Beam Breast Computed Tomography with Rotating Gantry Subsystem,” and provisional patent application No. 63 / 430,571, filed on December 6, 2022, entitled “Ultrasound Hybrid Imaging in Cone Beam Breast Computed Tomography,” and provisional patent application No. 63 / 459,250, filed on April 13, 2023, entitled “Calcification Detection Systems, Methods, and Apparatus in Cone Beam Breast Computed Tomography,” the disclosures of all of which are hereby incorporated by reference in their entirety. Technical Field

[0003] The present invention relates to the field of cone beam tomography, in particular to an image mixing technology of ultrasound and X-ray cone beam breast tomography. Background Art

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

[0005] Ideally, breast imaging technology should be able to detect smaller tumors, preferably those less than 10 mm in diameter. It has been reported that 93% of women with 1-10 mm invasive breast cancer detected by mammography have a 16-year survival rate. In addition, the likelihood of metastasis decreases dramatically as the diameter of the detected tumor decreases. If a breast tumor is detected when the tumor is 10 mm or less in diameter, the probability of metastasis is 7.31%. If a 4 mm cancer is detected, the probability of metastasis decreases by more than 10 times, to 0.617%. These statistics clearly demonstrate the importance of early detection, diagnosing tumors while they are still small.

[0006] In the past, mammography (which can detect cancers around 12 mm in size on average) was the most effective tool for early detection of breast cancer. However, mammography has relatively low sensitivity for smaller breast cancers (under a few millimeters). The specificity and positive predictive value of mammography remain limited due to tissue structure and overlap. The limited sensitivity and specificity of mammography in breast cancer detection stems from its poor contrast detection capabilities, which are common to all types of projection imaging technology (projection imaging has a contrast detection capability of only about 10%). Initially, mammography could only detect 65-70% of breast cancers. In cases of high breast density, the sensitivity of mammography drops further, as low as 30%.

[0007] Digital mammography (DM) was developed to overcome the inherent limitations of screen-film mammography (SFM) and aims to improve detection through enhanced contrast resolution and digital image processing. However, a large-scale clinical trial, the Digital Mammography Screening Trial (DMIST), showed that DM and SFM had the same false positive rate.

[0008] The relatively low specificity of mammography results in biopsies being performed in indeterminate cases despite the increased cost and stress on patients. In the United States, of the more than one million breast biopsies performed each year to evaluate suspicious findings on mammography, nearly 80% are benign lesions, which not only causes undue anxiety to patients but also imposes significant costs on the healthcare system. Therefore, more accurate characterization of breast lesions is needed to reduce biopsy rates and false positives on pre-biopsy mammography.

[0009] In traditional mammography, the patient's breast is inserted into a fixture prior to imaging, which significantly compresses the breast tissue transverse to the longitudinal axis of the breast. Patients commonly report physical and psychological discomfort caused by this compression, and studies have shown that this discomfort is a factor in the low rates of screening and diagnostic mammography among patients, especially in certain ethnic and cultural groups.

[0010] Additionally, breast compression during mammography may cause displacement of breast tissue, hampering subsequent localization of features such as lesions and calcifications during biopsy and lumpectomy.

[0011] To address the above limitations, one of the inventors previously developed a cone-beam breast computed tomography (CBBCT). In brief, the main features of CBBCT include: a horizontally placed, ergonomically designed patient table with modular support trays to optimize coverage of the uncompressed breast, including the chest wall; 1-meter-wide openings on both sides of the patient table to facilitate breast positioning while providing good operating space for imaging-guided biopsy and other procedures without significantly changing the basic platform; and slip-ring technology, which facilitates efficient dynamic contrast imaging studies and angiogenesis imaging in the future.

[0012] Results from phantom studies have shown that CBBCT can achieve a spatial resolution of up to about 2.8 lp / mm, capable of detecting 2 mm cancers and microcalcifications of about 0.2 mm in size, suitable for an average-sized breast (about 13 cm in diameter at the chest wall), with a total radiation dose of about 5 mGy. This dose is lower than that of a single mammogram, assuming that each breast needs to be imaged from two viewing angles.

[0013] CBBCT has excellent image quality in visualizing breast tissue, breast tumors, and calcifications, with coverage of the breast (including the chest wall area) at least comparable to mammography. Visualization of major blood vessels is excellent, even without the use of contrast agents. As a result, CBBCT provides a significant improvement in detecting and biopsy suspicious lesions in patients.

[0014] Further improvements to CBBCT imaging are expected to expand these advantages. In particular, combining hybrid imaging techniques with CBBCT X-rays, as described herein, can significantly enhance image resolution and improve cancer detection, especially in cases of high breast density. For example, the inventors recognize that X-ray CBBCT imaging will be significantly improved by a hybrid system that combines X-ray CBBCT with ultrasound scanning, which will provide greater advantages and thus improve the effectiveness of diagnosis.

[0015] Previously, the possibility of hybrid scanning techniques has been explored for a variety of imaging techniques. For example, positron emission tomography (PET) has been combined with magnetic resonance imaging (MRI) and conventional X-ray computed tomography (CT); single photon emission computed tomography (SPECT) has also been combined with MRI and CT; ultrasound imaging has also been combined with MRI and CT, usually by acquiring the data sets in separate imaging systems and then combining them; and MRI has also been combined with conventional CT.

[0016] Also known is a computed tomography ultrasound imaging method in which the breast to be imaged is placed in a bath of liquid that acts as an impedance coupling between the ultrasound transducer and the breast tissue. This requirement for liquid contact presents a number of practical challenges, including maintaining sanitary conditions and overcoming possible patient ergonomic issues.

[0017] As you can imagine, breast tissue is elastic and deformable in nature, with varying degrees of stiffness within the same breast and between different breasts. Therefore, any movement of the patient between scans will cause the tissue to shift and rearrange the perimeter and surface areas of the breast, and in some cases even affect the location of internal features. Summary of the invention

[0018] The present invention provides the ability to scan a breast while the breast remains substantially stationary relative to the reference frame of the imaging system. In some embodiments, a single X-ray CBBCT scan may be performed, followed immediately by an ultrasound imaging scan; in other embodiments, the order of the single scans is reversed. In other embodiments, multiple X-ray CBBCT scans and / or multiple ultrasound scans may be performed in sequence; further, in some embodiments, data acquisition sub-cycles of X-ray CBBCT scans and ultrasound imaging scans may be interleaved.

[0019] A single scan or a portion of a scan will employ a variety of technology modes, depending on the needs of a particular patient or procedure. For example, an ultrasound scan will include, in a corresponding portion, a reflection ultrasound scan, a transmission ultrasound scan, a density image, and a sound velocity image, all in conventional or tomographic format. In other embodiments of the present invention, X-ray CBBCT and ultrasound imaging scans can be performed simultaneously, for example, by synchronously rotating the X-ray gantry and the rotation device of the ultrasound subsystem so that the pulses emitted by the ultrasound transducer are approximately perpendicular to the longitudinal axis of the X-ray beam, thereby positioning the ultrasound transducer outside the X-ray beam.

[0020] In some embodiments of the present invention, the data of the X-ray scan and the ultrasound scan will be fused after the gantry completes a full rotation. In other embodiments, the data of the X-ray scan and the ultrasound scan will be fused in real time when each partial scan is performed.

[0021] In other embodiments of the present invention, the different performance advantages of two or more hybrid scanning modes can complement each other. For example, according to an exemplary method of the present principles, an X-ray CBBCT scan is performed to generate a data set characterizing a breast. X-ray CBBCT imaging has a particular sensitivity in detecting calcifications in breast tissue. However, in some cases, it may not be as sensitive as ultrasound imaging in characterizing benign tumors.

[0022] In some implementations, ultrasound imaging may provide less detailed calcification information than X-ray CBBCT imaging, but has a higher sensitivity in detecting the presence of cysts in dense breast tissue. The sound velocity mode of ultrasound imaging (especially in reflection mode operation) is particularly effective in detecting cancerous tissue at the fat-glandular interface (FGI) in some embodiments and applications. In addition, ultrasound imaging can provide breast density data that complements the high-resolution breast density distribution information provided by X-ray CBBCT examinations.

[0023] X-ray CBBCT can provide an attenuation coefficient matrix for each voxel characterizing the breast, based on the attenuation coefficient of the local tissue region. In addition, in certain applications, CBBCT imaging can generate images with isotropic ultra-high spatial resolution. Through appropriate parameter combination and analysis, the regional hardness of breast tissue can be characterized, which has a particular diagnostic effect in dense breast tissue. According to certain aspects of the present invention, these advantages are achieved at low X-ray doses and do not require the breast compression mechanism that is uncomfortable and causes image distortion in mammographic examinations. Therefore, the techniques, devices, systems and methods of the present invention can effectively provide high-resolution multi-modal characterization of the breast, addressing specific weaknesses of mammographic examinations.

[0024] In certain embodiments of the invention, hybrid scanning is optional. Thus, when a preliminary X-ray CBBCT scan identifies a potential region of interest (e.g., a possible tumor), an ultrasound scan is subsequently performed to further characterize the features within the region of interest. In some cases, a standard ultrasound scanning trajectory is used. In other embodiments of the invention, a specialized and / or customized scanning trajectory is used.

[0025] Therefore, according to the methods and apparatus of certain embodiments of the present invention, a specific scanning trajectory can be determined by an operator or an automatic function of the system. In certain embodiments of the present invention, the determined specialized scanning trajectory is one of a plurality of predefined scanning trajectories prepared in advance, for example, generated during the design and / or manufacturing process of the hybrid scanning system. In such an embodiment, the specialized scanning trajectory is characterized by a set of data that defines the parameters of the scan, such as the transducer path, the instantaneous transducer velocity, the spatial orientation of the ultrasonic transducer, etc. The characterizing data set can be stored in a computer storage device of the system and used to guide various movements of the ultrasonic transducer when needed.

[0026] In other embodiments of the present invention, a specialized scanning trajectory will be prepared during or after the time interval corresponding to the X-ray CBBCT scan, and the specific parameters and characteristics of the trajectory definition will be determined based on the data generated by the X-ray CBBCT scan. In some embodiments, the specialized scanning trajectory will include predefined trajectory elements and customized trajectory elements, which are combined to generate the final overall scanning trajectory.

[0027] The following description is intended to enable those skilled in the art to make and use the disclosed invention, and sets forth the best mode currently considered by the inventor to implement its invention. In the following description, for ease of explanation, many specific details are listed to provide a comprehensive understanding of the present invention. However, it will be apparent to those skilled in the art that the present invention can be implemented without relying on these specific details. In other cases, in order to avoid unnecessary obscuring of the disclosed substance, known structures and devices are shown in block diagram form. These and other advantages and features of the present invention will be more easily understood through the following detailed description in conjunction with the accompanying drawings.

[0028] It should be noted that although the various figures show different aspects of the invention, no single figure is intended to show the entirety of the invention. Instead, the various figures collectively illustrate different aspects and principles of the invention. Therefore, it should not be assumed that any particular figure is only related to a certain independent aspect or type of the invention. Instead, those skilled in the art will understand that the various figures taken together reflect various embodiments that embody the invention as a whole.

[0029] Accordingly, references in the specification to "one embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic associated with the embodiment is included in at least one embodiment of the invention. Thus, phrases such as "in one embodiment," "in an embodiment," or "in some embodiments" when they appear in different places in the specification do not necessarily refer to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 A portion of an exemplary CBBCT imaging system is shown in schematic perspective view;

[0031] Figure 2 A portion of an exemplary CBBCT imaging system including an ultrasound imaging subsystem prepared in accordance with the principles of the present invention is shown in schematic perspective view.

[0032] Figure 3A A portion of an exemplary CBBCT imaging system including an ultrasound imaging subsystem prepared in accordance with the principles of the present invention is shown in schematic cross-sectional perspective.

[0033] Figure 3B A portion of an exemplary CBBCT imaging system is shown in schematic perspective view, including further aspects and configurations of an ultrasound imaging subsystem prepared in accordance with the principles of the present invention.

[0034] Figure 3CA portion of an exemplary CBBCT imaging system is shown in schematic perspective view, illustrating further aspects and modes of operation of an ultrasound imaging subsystem prepared in accordance with the principles of the present invention.

[0035] Figure 4A A portion of an exemplary CBBCT imaging system is shown in schematic perspective view, illustrating certain details of an ultrasound imaging subsystem prepared in accordance with the principles of the present invention.

[0036] Figure 4B A portion of an exemplary CBBCT imaging system is shown in schematic block diagram form, illustrating certain details of an ultrasound imaging subsystem prepared in accordance with the principles of the present invention.

[0037] Figure 5 A portion of an exemplary CBBCT imaging system is shown in schematic perspective view, illustrating further aspects and modes of operation of an ultrasound imaging subsystem including a transmission ultrasound device prepared in accordance with the principles of the present invention.

[0038] Fig. 6A A portion of another exemplary CBBCT imaging system is shown in schematic perspective view, including an ultrasound imaging subsystem prepared in accordance with the principles of the present invention.

[0039] Figure 6B A portion of another exemplary CBBCT imaging system is shown in schematic perspective view, illustrating further aspects and configurations of an ultrasound imaging subsystem prepared in accordance with the principles of the present invention.

[0040] Fig. 7A A portion of another exemplary CBBCT imaging system is shown in schematic cross-sectional perspective view, including an ultrasound imaging subsystem prepared in accordance with the principles of the present invention.

[0041] Figure 7B A portion of another exemplary CBBCT imaging system is shown in schematic perspective view, illustrating further aspects and configurations of an ultrasound imaging subsystem prepared in accordance with the principles of the present invention.

[0042] Fig. 8A A portion of another exemplary CBBCT imaging system is shown in schematic perspective view, including an ultrasound imaging subsystem prepared in accordance with the principles of the present invention.

[0043] Figure 8B A portion of another exemplary CBBCT imaging system is shown in schematic perspective view, including an ultrasound imaging subsystem prepared in accordance with the principles of the present invention.

[0044] Fig. 9 Further aspects of a hybrid CBBCT imaging system are shown in schematic perspective view, including a multi-ring ultrasound imaging subsystem;

[0045] Fig.10 Exemplary aspects of processing systems and methods according to the principles of the invention are shown in schematic block diagram form. DETAILED DESCRIPTION

[0046] The following description is intended to enable those skilled in the art to make and use the disclosed invention, and sets forth the best mode currently believed by the inventor to implement its invention. In the following description, for ease of explanation, numerous specific details are listed to provide a comprehensive understanding of the present invention. However, it will be apparent to those skilled in the art that the present invention can be implemented without relying on these specific details.

[0047] It should be noted that although the specific elements and combinations of elements described in the following exemplary embodiments are for illustrative purposes only, these examples are not definitive. Instead, discrete elements may be combined into integral elements and / or assemblies where appropriate. In addition, the disclosure of certain specific elements as part of an integral whole should also be understood to encompass the disclosure of separate elements and assemblies having the same characteristics and / or functions.

[0048] Figure 1 A portion of an exemplary CBBCT imaging system 100 is shown in a schematic perspective view. 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 bearings and is configured to rotate about an axis of rotation 108.

[0049] The X-ray source 102 is configured to emit an X-ray beam 110. The X-ray beam 110 defines a longitudinal axis 112, which in the illustrated embodiment intersects the rotation axis 108 at a position 114. In some embodiments of the present invention, the beam 110 is configured as a cone beam. In some configurations, a cross-section of the beam 110 exhibits a substantially uniform X-ray intensity and has a substantially circular boundary when viewed in cross-section along the longitudinal axis 112.

[0050] In other configurations within the scope of the present invention, the cross-section of the beam 110, viewed in cross-section along the longitudinal axis 112, defines a generally uniform X-ray intensity region having a generally circular boundary, but with a portion of the circular boundary located outside a chord of the circle. As will be further disclosed, in some embodiments, the chords are arranged in a generally parallel and spaced manner above the lower surface of the patient couch.

[0051] Thus, in some configurations, the cross-section of the beam 110, viewed in cross-section along the longitudinal axis 112, presents a truncated disk having a substantially uniform X-ray intensity and a substantially truncated circular boundary (i.e., the boundary of the circle has a horizontal chord at the upper edge). This configuration optimizes breast imaging while minimizing radiation to the chest wall tissue above the breast. In some embodiments, this configuration is achieved by placing an X-ray opaque collimator plate over a portion of the circular cross-section beam generated by the X-ray source.

[0052] In further configurations within the scope of the present invention, the cross-section of the beam 110, viewed in cross-section along the longitudinal axis 112, presents a region of substantially uniform X-ray intensity having a polygonal boundary. The polygonal boundary may include a triangular boundary, a rectangular boundary, a pentagonal boundary, a hexagonal boundary, a boundary of any higher order geometric shape, or a boundary formed by a combination of any curves and line segments in various embodiments and configurations to meet the needs of a particular application. In addition, it should be understood that any of the cross-sectional configurations described above may define a beam having non-uniform intensity, including but not limited to a situation where the intensity drops to zero in a certain region or regions of the cross-section.

[0053] An X-ray detector 116 is also mounted on the upper surface 104 of the rotating gantry 106. In an exemplary embodiment, the X-ray detector 116 includes a flat panel detector having a substantially planar receiving surface 118. The receiving surface 118 is arranged substantially perpendicular to the longitudinal axis 112 and is located on the other side of the rotation axis 108, opposite to the X-ray source 102. Those skilled in the art will appreciate that the described configuration is only one example of a variety of possible arrangements, wherein the X-ray source, X-ray detector, and any other components of the system may be supported from above, from the side, or in any other appropriate manner to achieve the desired function. The shape and configuration of the gantry and the X-ray detector will also take any useful form in the various embodiments of the present invention.

[0054] Therefore, in some embodiments of the present invention, the X-ray detector 116 will include an X-ray detector having a curved receiving surface 118. In other embodiments, the X-ray detector 116 will include an X-ray detector having a flexible receiving surface 118. In some embodiments of the present invention, the curvature of the X-ray detector surface is variable, while in other embodiments of the present invention, the curvature or other configuration of the receiving surface 118 can be adjusted before or during a particular X-ray CBBCT scan.

[0055] In other embodiments of the present invention, the receiving surface 118 of the X-ray detector 116 will terminate at a position close to the lower surface area of ​​the patient bed. In certain embodiments of the present invention, the upper edge of the receiving surface 118 of the X-ray detector 116 is at least about 10 mm away from the lower surface area of ​​the patient bed. In further embodiments, the upper edge of the receiving surface 118 is at least about 5 mm away from the lower surface area of ​​the patient bed. In further embodiments of the present invention, the upper edge of the receiving surface 118 is at least about 3 mm away from the lower surface area of ​​the patient bed.

[0056] During operation of the imaging system 100, rotation of the gantry 106 about the rotation axis 108 will cause the receiving surface 118 to move along a travel path about the rotation axis 108. In a typical configuration, the travel path will include a portion of a circle that is transverse to and centered on the rotation axis 108. However, it should be noted that other travel paths are within the scope of the present invention and are disclosed herein.

[0057] In certain embodiments of the present invention, the X-ray source 102 and / or the X-ray detector 116 are arranged to be adjustable in their position on the upper surface 104 of the gantry 106. For example, the X-ray source 102 and the X-ray detector 116 may be adjustable in a radial direction, in a circumferential direction, toward or away from the gantry surface 104 relative to the rotation axis 108, or in any other manner deemed beneficial by a designer or user of a particular device of the present invention.

[0058] The patient bed 120 includes an upper surface 122 and a lower surface 124. An opening 126 connects the upper surface 122 and the lower surface 124 of the bed. The upper surface 122 is arranged to support a patient 128, who is generally shown lying on the surface 122 in a prone position. In this arrangement, the patient's breast 130 hangs vertically downward from the chest wall and extends through the opening 126.

[0059] During operation, the gantry rotates around the rotation axis 108, driving the X-ray source 102 and the X-ray detector 116 to move along a path around the patient's breast. During this process, the X-ray detector 116 captures X-ray image data by cooperating with corresponding interface electronic devices and computer systems. These X-ray image data correspond to multiple X-ray images taken at various angular positions around the rotation axis 108. By processing these X-ray image data or a subset thereof, information about the internal state of the breast can be provided.

[0060] Figure 2A CBBCT imaging system 200 is shown in a schematic perspective view, including an ultrasound imaging subsystem 202 prepared according to the principles of the present invention. Similar to the system 100 described above, the system 200 includes an X-ray source 204. The X-ray source 204 is mounted on an upper surface 206 of a rotating gantry 208. The rotating gantry 208 is supported by a bearing 210 and is configured to rotate about a rotation axis 212. The bearing 210 is supported by a structural member 211 of the imaging system 200 or the ground.

[0061] The X-ray source 204 is configured to emit an X-ray beam 216. The X-ray beam 216 defines a longitudinal axis 218 that intersects the rotation axis 212 at a location 220 in the illustrated embodiment.

[0062] In the illustrated embodiment, the upper surface 206 of the rotating gantry 208 includes an inner circumferential edge 222. The inner circumferential edge 222 defines an opening 224 in the upper surface 206 of the gantry 208.

[0063] In some embodiments of the present invention, the rotating frame 208 includes a slip ring for transmitting power and / or electronic signals and / or optical signals to or from the frame. In some embodiments, the slip ring includes an opening arranged approximately coaxially with the frame opening 224.

[0064] In other embodiments of the present invention, information and control signals are transmitted to or from the rack via wireless modulated electromagnetic radiation signals, including but not limited to radio frequency, microwave and / or optical frequency electromagnetic radiation.

[0065] In the illustrated embodiment, the rotating device 226 is disposed within the opening 224. In certain aspects and embodiments of the invention, the rotating device 226 is supported by the structural member 211 of the imaging system 200 or the ground.

[0066] As shown, the exemplary rotation device 226 has an upper surface 228. The rotation device 226 allows the upper surface 228 to rotate relative to the ground about the rotation axis 212, and can selectively rotate relative to the longitudinal axis 218 of the x-ray beam 216 (as well as the gantry 208, the x-ray source 204, and the room reference frame 246).

[0067] Thus, in certain embodiments of the present invention, the upper surface 228 of the rotating device 226 will rotate independently of the upper surface 206 of the rack 208. In further embodiments and aspects of the present invention, the upper surface 228 of the rotating device 226 remains stationary relative to the room, while the upper surface 206 of the rack 208 rotates relative to the room. In other embodiments of the present invention, the upper surface 228 of the rotating device 226 rotates synchronously with the upper surface 206 of the rack 208 (hereinafter referred to as "synchronous rotation"); in other embodiments and aspects of the present invention, the upper surface 228 of the rotating device 226 rotates in the opposite direction relative to the upper surface 206 of the rack 208 and the room 246. In addition, in other embodiments and aspects of the present invention, the upper surface 228 of the rotating device 226 rotates synchronously with the upper surface 206 of the rack 208, but out of phase with the upper surface 206 of the rack (hereinafter referred to as "differential rotation"), and remains out of phase with respect to the room 246.

[0068] In certain embodiments of the present invention, the differential rotation and / or synchronous rotation of the upper surface 228 relative to the upper surface 206 is controlled by, for example, a rotary drive device. The drive device may include various elements, such as an electric motor (e.g., a cage motor, a disc motor, or a capacitor start motor), a stepper motor, a DC motor, or other servo motor, in conjunction with a feedback device (e.g., a resolver, an optical encoder, a magnetic encoder, or a resistive encoder), a hydraulic motor, a pneumatic motor, a spring motor, a piezoelectric motor, a gear transmission (e.g., one or more pinions or worm gears), a ratchet drive mechanism, a chain and sprocket mechanism, a belt and pulley mechanism, and / or a synchronous belt and synchronous pulley mechanism, or any combination of the above and any other suitable devices and / or mechanisms known to those skilled in the art or available in the future.

[0069] In certain embodiments of the present invention, the differential rotation and / or synchronous rotation of the upper surface 228 relative to the upper surface 206 is controlled by the output signal of the system digital computer and / or the system digital controller. In other aspects and embodiments of the present invention, the differential rotation and / or synchronous rotation of the upper surface 228 relative to the upper surface 206 is controlled by dedicated hardware, such as embedded dedicated motion control hardware, including motion control integrated circuits, power amplifiers, feedback elements (such as limit switches, Hall effect sensors, optical sensors, resolvers, optical encoders, resistive encoders, etc.), any of which can be used to implement general motion control and / or phase-locked loop control.

[0070] In other embodiments and aspects of the present invention, the differential rotation and / or synchronous rotation of the upper surface 228 relative to the upper surface 206 is controlled by a mechanical coupling between the upper surface 228 and the upper surface 206. In some embodiments, the mechanical coupling can be manually and / or automatically configured and controlled; in some embodiments, the mechanical coupling includes one or more of the following devices: an electromagnetically controlled lock, a rotary motor controlled lock, a pneumatically controlled lock, a hydraulically controlled lock, a manually operated lock, a gear set, a drive chain, a belt or a synchronous belt, a mechanical, hydraulic or electric clutch, or any combination of the above (in a manner that will be understood by those skilled in the art based on this disclosure and a small amount of experimentation), as well as any other suitable mechanism known to those skilled in the art or available in the future.

[0071] The ultrasound imaging subsystem 202 has a base portion 230 including a translation device and a first ultrasound transducer assembly 232. In the exemplary illustration of the system 200, the base portion 230 is connected to and supported on an upper surface 228 of the rotation device 226.

[0072] In the illustrated example, the first ultrasound transducer assembly 232 has a first breast contacting surface area 234 , a rotation device 236 , and a support column 238 .

[0073] In some embodiments of the present invention, the translation device includes a first translation portion. The first translation portion is operatively connected between the base portion 230 and the first ultrasonic transducer assembly 232.

[0074] As previously described, during CBBCT imaging, the gantry 208 rotates about the rotation axis 212, carrying the x-ray source 204 and the imager 240, which are arranged and supported on the upper surface 206, or otherwise connected and supported on the gantry 208, and move along the travel path 242 about the rotation axis 212, while the imaged breast 244 remains substantially stationary relative to the room reference frame 246.

[0075] Those skilled in the art will appreciate that, depending on the material, arrangement, and configuration of the first ultrasonic transducer assembly 232, in some cases, it may be desirable for the X-ray beam 216 not to pass through the first ultrasonic transducer assembly 232 during CBBCT imaging. Thus, during CBBCT imaging, the first ultrasonic transducer assembly will be moved out of the path of the X-ray beam 216. Figure 2 As shown, the system 200 is arranged with the ultrasound imaging subsystem 202 in a stored configuration with the first ultrasound transducer assembly 232 in a retracted state.

[0076] Those skilled in the art will appreciate that in alternative arrangements and embodiments, the ultrasound imaging subsystem 202 will remain in the deployed configuration (described below) during the CBBCT scan, rather than the stored configuration described above. In such embodiments, the X-ray beam will pass parallel to the breast contact surface area 234, so that the first ultrasound transducer assembly 232 has only minimal overlap or no overlap with the generated breast image. In other embodiments of the present invention, image features associated with the first ultrasound transducer assembly 232 will be removed from the generated image by signal processing techniques (including, for example, data filtering techniques, etc.).

[0077] exist Figure 2 In the stored configuration shown, the x-ray beam 216 passes through the breast 244 and reaches the imager 240 without significantly affecting the first ultrasound transducer assembly 232. In certain embodiments of the present invention, this condition is maintained throughout the CBBCT scan by coordinating the rotation of the upper surface 228 with the upper surface 206. Those skilled in the art will appreciate that this coordination will be maintained throughout the travel path 242 in various embodiments, whether the path is 360°, 180°, or any other range of angles as required by a particular CBBCT imaging protocol, through the room reference frame 246.

[0078] As will be appreciated in conjunction with the above discussion, in various embodiments, such coordination between upper surface areas 228 and 206 will be maintained by mechanical control, electronic control, analog or digital servo control, or other control means.

[0079] In other embodiments (such as Figure 2 ), the stored configuration of the first ultrasound transducer assembly 232 will ensure that the x-ray beam 216 will avoid (i.e., not hit) the first ultrasound transducer assembly 232 regardless of the rotation of the surface 206. Therefore, the surface region 228 can remain stationary relative to the room reference frame 246 during the rotation of the surface 206.

[0080] Figure 3A Further aspects of a CBBCT imaging system 300 are shown in a schematic cross-sectional perspective view, including an ultrasound imaging subsystem 302 prepared according to the principles of the present invention. Similar to the previously described systems 100 and 200, the system 300 includes an x-ray source 304. The x-ray source 304 is mounted on an upper surface 306 of a rotating gantry 308. The rotating gantry 308 is supported by bearings 310 and is configured to rotate about an axis of rotation 312. The bearings 310 are supported by a structural member 311 of the imaging system 300 or the ground.

[0081] In the illustrated embodiment, the rotating device 326 is disposed within the opening 324. In certain aspects and embodiments of the invention, the rotating device 326 is supported by the structural member 311 of the imaging system 300 or the ground.

[0082] Consistent with the description of the system 200 above, the ultrasound imaging subsystem 302 has a base portion 330 including a translation device and a first ultrasound transducer assembly 332. In the exemplary illustration, the base portion 330 is connected to and supported on the upper surface 328 of the rotation device 326.

[0083] In the example shown, the ultrasound transducer assembly 332 has an ultrasound transducer portion 334 provided with a first breast contacting surface area 336 , a rotation device 338 and a support column 340 .

[0084] and Figure 2 Unlike the stored configuration of the first ultrasound transducer assembly 232 shown in , the first ultrasound transducer assembly 332 is shown here in a deployed configuration, wherein the breast contact surface area 336 is in contact with a corresponding surface area of ​​a breast 342 to be imaged.

[0085] Therefore, with Figure 2 , the first ultrasound transducer assembly 332 is arranged inwardly in dimension 344 and upwardly in dimension 346 in the frame of the reference base portion 330. This arrangement causes the first breast contact surface area 336 to contact a corresponding surface area of ​​the breast 342. As will be discussed further below, during operation of the ultrasound imaging subsystem 302, the position and orientation of the ultrasound transducer portion 334 are controlled so that the first breast contact surface area 336 moves along a controlled path of travel along the outer surface area of ​​the breast 342.

[0086] Figure 3B Further aspects and configurations of the CBBCT imaging system 300 are shown in schematic perspective view, including an ultrasound imaging subsystem 302. As described above, the ultrasound imaging subsystem 302 includes a rotation device 326 that supports a base portion 330 and a first ultrasound transducer assembly 332.

[0087] In the exemplary arrangement shown, during operation, the ultrasound transducer portion 334 of the first ultrasound transducer assembly 332 is adapted and controlled to move along a generally circumferential spiral path 350 along the outer surface area of ​​the breast 342. As previously described, this path of travel is achieved in the illustrated embodiment by rotation 352 of the rotation device 326 about the rotation axis 312, while coordinating horizontal and vertical movement of the support column 340 in dimensions 344 and 346, and pitch, yaw and roll movement of the rotation device 338, all within the reference frame of the base portion 330.

[0088] Figure 3CAn alternative arrangement is shown in which a CBBCT scanning system 300 includes an ultrasound subsystem 302 and a first ultrasound transducer portion 334. Figure 3B Unlike the configuration of the imaged breast 342, the breast surface contact area 336 of the first ultrasound transducer portion 334 moves along a travel path 354 that is not spiral along the outer surface of the imaged breast 342, but rather traverses the breast surface in a radial / longitudinal manner 356 with corresponding horizontal circumferential increments 358 between the longitudinal sweeps 356.

[0089] A practitioner of ordinary skill, guided by the present disclosure and with minimal experimentation, will be able to design a variety of other pass paths, including paths with linear and nonlinear portions, and paths containing any combination of the above, that are effective in capturing ultrasound data and blending it with data collected by the X-ray CBBCT portion of the CBBCT imaging system 300. In some embodiments, these pass paths will be hardware fixed in the system (i.e., by actual electromechanical construction or pre-storage of firmware or software), and multiple hardware paths may be available for selection or combination in various embodiments. In other embodiments of the present invention, the pass paths will be programmable and reprogrammable, and in some embodiments, a unique pass path will be prepared based on the characteristics, parameters, and requirements of a specific patient.

[0090] It is noted that the systems, apparatus and methods of the present invention provide unique and novel advantages over methods that combine data from existing CBBCT systems and separate existing ultrasound systems (e.g., conventional ultrasound systems, robotic / automated ultrasound systems, or ultrasound computed tomography systems). In particular, the combined hybrid system described herein allows for imaging of the breast with two or more imaging modalities without physically / spatially shifting the patient. Thus, problems with registration and coordination of data sets, as well as spatial rearrangement of breast tissue between data acquisition cycles, are reduced or eliminated.

[0091] It is understood that breast tissue is elastic and deformable in nature and varies in stiffness both within the same breast and between different breasts. Therefore, any movement of the patient between scans will cause the tissue to shift and realign the perimeter and surface areas of the breast and even, in some cases, affect the position of internal features.

[0092] The present invention provides the ability to perform scans while the breast remains substantially stationary relative to the imaging system's frame of reference 360. In some embodiments, a single X-ray CBBCT scan may be performed, followed immediately by an ultrasound imaging scan; in other embodiments, the order of the single scans is reversed. In other embodiments, multiple X-ray CBBCT scans and / or multiple ultrasound scans may be performed sequentially; further, in some embodiments, data acquisition cycles for X-ray CBBCT scans and ultrasound imaging scans may be interleaved.

[0093] A single scan or portions of a scan will employ a variety of technical modes, depending on the needs of a particular patient or procedure. For example, an ultrasound scan will include, in various portions, a reflection ultrasound scan, a transmission ultrasound scan, a density image, and a sound velocity image, all in conventional and / or tomographic format. In other embodiments of the invention, X-ray CBBCT and ultrasound imaging scans may be performed simultaneously, for example, by synchronously rotating the X-ray gantry and the rotation device of the ultrasound subsystem so that the pulses emitted by the ultrasound transducer are approximately perpendicular to the longitudinal axis of the X-ray beam, thereby positioning the ultrasound transducer outside the X-ray beam.

[0094] In some embodiments of the present invention, the data of the X-ray scan and the ultrasound scan will be fused after the gantry completes a full rotation. In other embodiments, the data of the X-ray scan and the ultrasound scan will be fused in real time when each partial scan is performed.

[0095] In other embodiments of the present invention, the differential performance advantages of two or more hybrid scanning modes are used to complement each other. For example, according to an exemplary method of the present principles, an X-ray CBBCT scan is performed to generate a data set characterizing a particular breast. X-ray CBBCT imaging has a particular sensitivity in detecting calcifications in breast tissue. However, in some cases, it may not be as sensitive as ultrasound imaging in characterizing benign tumors.

[0096] In some implementations, ultrasound imaging may provide less detailed calcification information than X-ray CBBCT imaging, but has a higher sensitivity in detecting the presence of cysts in dense breast tissue. The sound velocity mode of ultrasound imaging (especially in reflection mode operation) is particularly effective in detecting cancerous tissue at the fat-glandular interface (FGI) in some embodiments and applications. In addition, ultrasound imaging can also provide breast density data that complements the high-resolution breast density distribution information provided by the X-ray CBBCT process.

[0097] X-ray CBBCT is able to provide an attenuation coefficient matrix for each voxel, thereby characterizing the breast based on the attenuation coefficient of the local tissue region. In addition, in certain applications, CBBCT imaging will produce images with isotropic ultra-high spatial resolution. By appropriately combining and analyzing the various parameters, the regional hardness of dense breast tissue can be effectively characterized, thereby having a special diagnostic effect. According to certain aspects of the present invention, these advantages are achieved at low X-ray doses and do not require breast compression mechanisms that are uncomfortable and cause image distortion in mammographic examinations. Therefore, the techniques, devices, systems and methods of the present invention are able to effectively provide high-resolution multi-modal characterization of the breast, addressing specific weaknesses of mammographic examinations.

[0098] In certain embodiments of the present invention, hybrid scanning is optional. Thus, when a preliminary X-ray CBBCT scan identifies a potential region of interest (e.g., a possible tumor), an ultrasound scan will be performed to further characterize the features within that region. In some cases, a standard ultrasound scan trajectory will be used, such as Figure 3B Track 350 or Figure 3C 354 in the scanning trajectory. However, in other embodiments of the present invention, a dedicated or customized scanning trajectory will be used.

[0099] Therefore, according to the methods and apparatus of certain embodiments of the present invention, a specific scanning trajectory will be identified, which can be performed by an operator or by an automatic function of the system. In certain embodiments of the present invention, the identified specialized scanning trajectory will be one of a plurality of predefined scanning trajectories prepared in advance, such as generated during the manufacturing process of the hybrid scanning system. In such an embodiment, the specialized scanning trajectory will be characterized by a set of data that defines the parameters of the scan, such as the transducer path, instantaneous transducer velocity, spatial orientation of the ultrasonic transducer, etc. This characterization data set will be stored in the computer storage device of the system and used to guide various movements of the ultrasonic transducer when needed.

[0100] In other embodiments of the present invention, a specialized scan trajectory will be prepared during or after a time interval corresponding to an X-ray CBBCT scan, so that specific parameters and characteristics of the trajectory are determined from data generated by the X-ray CBBCT scan.

[0101] In a further embodiment of the present invention, a specialized scanning trajectory is prepared by a medical or technical staff operating the system. In such an embodiment, the medical or technical staff defines the scanning trajectory of the ultrasound imaging subsystem based on available information, including data generated by an X-ray CBBC scan, and supplementary information, such as external features and appearance of the scanned breast, two-dimensional X-ray images, computed tomography images, MRI images, PET images, SPECT images, etc.

[0102] In certain embodiments of the present invention, a technician or medical staff member operates a user interface of a hybrid CBBCT imaging system. In certain embodiments, the user interface includes a touch screen interface that allows for the selection of a specific region and / or definition of a specific path in the context of a displayed CBBCT three-dimensional image. In certain embodiments, after the path is defined using the touch screen interface, the ultrasound scanning subsystem is operated.

[0103] In other embodiments of the present invention, the user interface of the hybrid CBBCT imaging system includes, for example, multiple buttons, multiple knobs, a sensor-equipped glove system, a joystick or other user interface modes, or a combination of these modes to allow real-time definition of ultrasound scanning trajectories while ultrasound images are being generated.

[0104] While the CBBCT system generates 3D reconstructed attenuation coefficients of the breast, tumor, and calcifications, the CBBCT images can guide ultrasound scans to further characterize the tumor, especially in cases of dense breasts.

[0105] Hybrid CBBCT systems can also guide biopsies and minimally invasive treatments, further improving accuracy, reducing procedure time, and lowering the radiation dose required for CBBCT alone. CBBCT provides true 3D, high-resolution imaging of the breast, as well as the location of breast lesions. However, CBBCT is not suitable for real-time imaging. Ultrasound imaging is well suited for real-time imaging, but is not suitable for 3D, high-resolution mapping, and cannot detect calcifications. Hybrid systems provide both high-resolution 3D localization of breast lesions and real-time imaging guidance.

[0106] Thus, an operator (e.g., a medical or technical person) is able to view an X-ray CBBCT image generated by a preliminary CBBCT scan and then operate a user interface to direct the ultrasound transducer of the ultrasound imaging subsystem to move along a customized trajectory to obtain additional information about the region of interest. In various embodiments and applications of the present invention, the generated scan trajectory will follow any possible trajectory along the surface of the breast, including a generally linear trajectory, a generally curvilinear trajectory, an oscillating and / or recursive trajectory, and any other trajectory that can improve image quality. In certain embodiments of the present invention, data from the ultrasound imaging system is blended with data from the CBBCT imaging system to generate an image with improved resolution, stability, or other desired characteristics to further characterize the region of interest of the breast tissue.

[0107] In certain embodiments of the present invention, hardware or software-based image processing is performed on the CBBCT and / or ultrasound image data to further clarify the image, for example, by adding false colors to represent tissue features, identifying transitions and boundaries within tissue, filtering out redundant information (such as interfering features of the breast or system), or otherwise improving the presentation of the available data.

[0108] Those skilled in the art will appreciate that while there may be other systems that blend X-ray computed tomography with ultrasound imaging results, the system and method of the present invention provides unique advantages because the breast to be imaged remains substantially motionless during the imaging process. Therefore, the requirements of many registration and image stitching systems, including the requirements that may introduce image artifacts, are avoided by the present system.

[0109] Figure 4A A portion of a CBBCT scanning system 400 including an ultrasound imaging subsystem 402 is shown in schematic perspective view with additional details. The ultrasound imaging subsystem 402 has a base portion 404. The base portion 404 is mounted on, for example, a Figure 2 The ultrasound imaging subsystem 402 includes a translation portion 406 and a first ultrasound transducer assembly 408, thereby effectively forming a robotic subsystem.

[0110] The exemplary translation portion 406 shown includes a first circumferential drive 410, a second radial drive 412, and a third vertical drive 414. The circumferential drive 410 is arranged and configured to move the ultrasonic transducer assembly 408 in a first circumferential dimension / degree of freedom 416, for example relative to Figure 2 The second radial drive 412 is arranged and configured to move the ultrasonic transducer assembly 408 in a second radial dimension / degree of freedom 418, while the third vertical drive 414 is arranged and configured to move the ultrasonic transducer assembly 408 in a third vertical dimension / degree of freedom 420.

[0111] In certain embodiments of the present invention, one or more of the circumferential drive 410, radial drive 412, and vertical drive 414 will be implemented as linear drives. As will be appreciated by those skilled in the art, the linear drives described herein (and any linear drives mentioned herein) may be implemented using a variety of available drives. For example, in certain embodiments, the linear drives will include one or more pneumatic cylinders, pneumatic bladders, pneumatic bellows, hydraulic cylinders, hydraulic bladders, hydraulic bellows, electromagnets, thermoelectric drives, shape memory alloy drives, piezoelectric drives, linear stepper motors, rotary drives (such as electric motors or any of the above), and, for example, rack and pinion devices, rack and worm gear devices, Acme screws and Acme nuts, ball screw devices, lateral complementary ramps, scissor linkages (e.g., scissor linkages operated by lead screws), Sarrus linkages, and the like. Rod mechanisms, cable and pulley arrangements, synchronous belt and synchronous pulley arrangements, ratchet and pawl drives, compression springs, extension springs, torsion springs, coil springs, reducers (including but not limited to gear reducers, worm reducers, harmonic reducers), combinations of leaf springs, springs containing multiple Belleville washers, shock absorbing couplings, flexible couplings, universal joints and / or flexible shafts; and a variety of manual actuators, such as hand cranks and / or ratchet levers; or any other linear actuator known or that may appear in the future in the art that is suitable for specific application requirements and provides the desired extended functionality.

[0112] exist Figure 4A In the example of FIG. 4 , the ultrasonic transducer assembly 408 includes an ultrasonic transducer portion 422, a rotating device 424, and a support column 426. The support column 426 has a first end 428, and the first end 428 is connected to a corresponding portion of the third vertical driver 414. The second end 430 of the support column 426 is connected to a corresponding portion of the rotating device 424. The support column 426 is used to connect the third vertical driver 414 to the rotating device 424, and is connected to the ultrasonic transducer portion 422 through the rotating device 424.

[0113] The exemplary rotation device 424 includes a first rotation drive 432, a second rotation drive 434, and a third rotation drive 436, which allow the ultrasonic transducer portion 422 to perform controlled rotational motion in pitch 438, roll 440, and yaw 442 degrees of freedom. As previously described, the rotation device (e.g. Figure 2 226 or CBBCT frame 208) will provide a further rotational degree of freedom 444 for the range of motion of the ultrasonic transducer portion 422.

[0114] The ultrasound transducer portion 422 will include a body or housing portion 446, and a breast contact surface area 448. In certain embodiments of the invention, the breast contact surface area 448 will have a spatial curvature (e.g., as seen at the peripheral edge 450, including the peripheral edge portion 451) to enhance effective contact between the breast contact surface area 448 and a corresponding outer surface area of ​​the breast to be imaged. In certain embodiments of the invention, the peripheral edge 450 will include rounded corners, such as the rounded corner 452, which will help reduce the possibility of snagging breast tissue during ultrasound scanning.

[0115] In addition, in some embodiments of the present invention, the breast contact surface area 448 will adopt a material with appropriate hardness and elastic recovery to improve the contact with the corresponding breast surface area and improve the comfort of the patient. Therefore, in some embodiments, the breast contact surface area 448 will include, for example, a synthetic polymer material or a synthetic elastomeric material with relatively high lubricity. In some embodiments, a foam polymer material will also be included.

[0116] In some embodiments of the present invention, the ultrasound transducer portion 422 will include one or more ultrasound transducers, such as 454. In some embodiments, the one or more ultrasound transducers 454 will include an independent ultrasound exciter / transmitter and an independent ultrasound sensor / receiver. In other embodiments of the present invention, a single transducer device will act as both an exciter and a sensor, for transmitting and receiving ultrasound signals to breast tissue, respectively.

[0117] In certain embodiments of the present invention, the ultrasound transducer portion 422 will include one or more lubrication ports, such as 456. The lubrication port 456 will dispense and / or receive lubricating material as needed during operation of the ultrasound transducer subsystem 402. As will be appreciated by those skilled in the art, the lubricating material will be used to lubricate movement between the breast contacting surface area 448 and the corresponding breast surface area and provide impedance conversion between the ultrasound transducer 454 and the imaged breast tissue.

[0118] In certain embodiments of the invention, as shown, the ultrasound transducer portion 422 will include one or more feedback sensors, such as 458, 459, 460, and 461. Feedback sensors 458, 459, 460, and 461 will be used to sense, for example, the proximity of the breast interface surface area 448 to the corresponding surface area of ​​the breast to be imaged, the pressure between the breast interface surface area 448 and the corresponding surface area of ​​the breast to be imaged, the speed of movement of the breast interface surface area 448 over the corresponding surface area of ​​the breast to be imaged, the friction between the breast interface surface area 448 and the corresponding surface area of ​​the breast to be imaged, the presence and / or sufficiency of lubricating material between the breast interface surface area 448 and the corresponding surface area of ​​the breast to be imaged, or any other parameter deemed useful for control / feedback parameters of the ultrasound imaging subsystem 402, or for clinical assessment of the breast, imaging, or the patient.

[0119] Figure 4B Certain features, components, elements, and their relationships associated with the ultrasound imaging subsystem 402 are shown in schematic block diagram form, such as Figure 4A Thus, for exemplary purposes only, the monitoring computer system 462 of the CBBCT hybrid imaging system is operatively coupled 464 to an embedded microcontroller subsystem 466. In certain embodiments of the present invention, the microcontroller subsystem 466 will include a dedicated microcontroller, as well as memory elements, communication buses, and input / output devices as are known in the art.

[0120] The microcontroller subsystem 466 is operatively coupled 468 to an output subsystem module 470 that includes, for example, operational amplifiers, output amplifiers, and motor control devices, such as one or more servo control devices, stepper motor control devices, linear amplifiers and switching amplifiers, power semiconductors and optical isolators, ultrasonic signal generator elements, and ultrasonic signal amplification elements.

[0121] The microcontroller subsystem 466 is also operatively coupled 472 to an input subsystem module 474. The input subsystem module 474 includes, for example, signal conditioning circuits and devices including, for example, one or more operational amplifiers, signal preamplifiers, signal amplifiers, dedicated digital signal processors, semiconductor and optical isolators, ultrasound signal receiving elements, and ultrasound signal conditioning elements, and in some embodiments, ultrasound signal interpretation elements.

[0122] The output subsystem module 470 is directly or indirectly coupled to a rotary drive 478 (e.g., a CBBCT rack) via a bus structure 476. Figure 2 The rack 208 in the ultrasound imaging subsystem); the rotation drive 480 of the rotation device (such as Figure 2454); and a lubrication pump 482 that draws lubricant from a lubricant storage tank 484 and supplies it to a lubrication port 456 of the ultrasonic transducer portion 422.

[0123] In the example configuration shown, the input subsystem module 474 is coupled directly or indirectly to, for example, the ultrasonic transducer 454, and any of the sensors described above (e.g., 458, 459, 460, 461), and corresponding feedback elements, such as the feedback element 488 of the rotary drive 478, the feedback element 490 of the linear drive 414, and the feedback element 491 of the rotary drive 432, etc., via a bus structure 486. Those skilled in the art will appreciate that in certain embodiments of the present invention, any of the drives shown will include a dedicated feedback element (as shown) for automatic feedback control thereof.

[0124] Those skilled in the art will appreciate that the feedback element will be any feedback element that is technically suitable in the respective application. Thus, the feedback element may be, for example, but not limited to, an optical encoder, a resolver, a magnetic encoder, a resistive encoder, a Hall effect sensor, and / or any other sensor or device suitable for providing position, speed, temperature or other information that is useful and / or effective in controlling the respective drive or device.

[0125] It should be further noted that although the ultrasound system and sensors in this example embodiment are coupled via exemplary input and output subsystem modules 470, 474, in alternative embodiments, independent subsystems are provided for signal generation, reception, and interpretation of these components and elements. These independent subsystems will be directly coupled to the microcontroller subsystem 466 and / or the monitoring computer system 462 in certain embodiments.

[0126] It should also be understood that in certain embodiments of the present invention, the monitoring computer system 462 will be operatively coupled 492 to a user interface device 494. The user interface device will include various interface devices known in the art, including keyboards, microphones, joysticks, buttons, sliders, gloves with sensors, etc. The user interface mentioned here is, for example, a user interface for selecting and creating ultrasound transducer trajectories, but it should be understood that the user interface will also be used for any appropriate aspects of system control. In addition, in certain embodiments of the present invention, the monitoring computer 462 will be operatively coupled 498 to an X-ray CBBCT system 499.

[0127] Figure 5A hybrid CBBCT imaging system 500 is shown in schematic perspective view, including an ultrasound imaging subsystem 502 prepared according to the principles of the present invention. The ultrasound imaging system 502 can be compared with the ultrasound imaging system 302 shown and discussed above, which is shown as a reflection ultrasound system. The reflection ultrasound imaging system 302 has a single ultrasound transducer portion, such as 334, acting as an ultrasound transmitter / receiver. In contrast, the ultrasound imaging system 502 illustrates a transmission ultrasound imaging system with separate transmitter and receiver elements.

[0128] Although in some embodiments a reflection ultrasound system will use multiple transducers, a transmission ultrasound system as shown in ultrasound imaging system 502 may also be prepared.

[0129] The ultrasound imaging system 502 includes a first ultrasound transmitter 504 and a second ultrasound receiver 506. In the illustrated embodiment, the ultrasound transmitter 504 is located diagonally from the ultrasound receiver 506 relative to the imaged breast 508. Thus, the ultrasound signal transmitted by the ultrasound transmitter 504 is modulated as it passes through the tissue of the breast 508 and is subsequently received at the ultrasound receiver 506. The ultrasound receiver 506 produces a modulated signal that is subsequently interpreted to provide information about the internal state of the breast.

[0130] Those skilled in the art will appreciate that in various embodiments of the present invention, various other arrangements of ultrasound transmitters and receivers will be used. Therefore, in corresponding embodiments, reflection ultrasound devices and methods, transmission ultrasound devices and methods, and combinations of the two will be used.

[0131] Fig. 6A and 6B A hybrid CBBCT imaging system 600 is shown in a schematic perspective view, including an ultrasound imaging subsystem 602. In contrast to the imaging systems shown and described above, the ultrasound imaging subsystem 602 is substantially fixedly coupled to an upper surface area 604 of a CBBCT gantry 606. Thus, the ultrasound transducer assembly 608 will rotate in sync with the CBBCT gantry 606 when the gantry rotates. In certain embodiments of the present invention, the ultrasound imaging subsystem 602 is removable, and the gantry can be removed and reinstalled as required for a particular patient and / or procedure.

[0132] Rotation of the gantry 606 provides spatial displacement of the scanning device required to perform the X-ray CBBCT and ultrasound scans. In certain embodiments of the present invention, an X-ray CBBCT scan is performed first, followed by an ultrasound scan. In other embodiments of the present invention, an ultrasound scan is performed first, followed by an X-ray CBBCT scan. In further embodiments of the present invention, the collection of X-ray image data is temporally interleaved with the collection of ultrasound data; in other embodiments of the present invention, X-ray data is collected simultaneously with ultrasound data. While the CBBCT system generates three-dimensional reconstructed attenuation coefficients of the breast, tumor, and calcifications, the CBBCT images can guide ultrasound scans to further characterize the tumor, particularly in the case of dense breasts.

[0133] Thus, in one aspect of the method of the present invention, a first rotation of the gantry 606 occurs during a first time interval. During the first time interval, the X-ray source 610 generates an X-ray beam 612, and the X-ray detector 614 receives the beam. During the first time interval, the ultrasound imaging subsystem 602 is in a stored configuration, such as Fig. 6A is shown and is inactive.

[0134] Subsequently, during a second time interval, the X-ray source 610 is inactive and the ultrasound transducer assembly transitions from the first stored configuration to the second deployed configuration, such as Figure 6B shown.

[0135] Subsequently, during a third time interval, the X-ray source remains inactive and the gantry 606 rotates a second time. During the third time interval, the ultrasound transducer assembly 608 moves along all or part of the ultrasound scanning trajectory, for example, along Figure 3B A circular spiral scan trajectory 350 is shown.

[0136] In some embodiments, the gantry performs a full rotation during the first time interval. In other embodiments of the invention, the gantry performs a partial rotation during the first time interval. In some embodiments, the gantry rotates at least 360° during the first time interval. In other embodiments of the invention, the gantry rotates at least 180° plus the width of the x-ray cone beam during the first time interval. In further exemplary embodiments, the gantry rotates at least 1°, at least 5°, at least 10°, at least 20°, at least 45°, at least 90°, at least 180°, at least 270°, at least 720°, or any other rotation angle deemed desirable or useful in relation to the requirements of a particular patient or mode of operation during the first time interval.

[0137] In a further embodiment of the present invention, X-ray and ultrasound slices are captured alternately. Thus, in a first time interval, the X-ray source 610 emits an X-ray pulse, which is captured by the X-ray detector 614. Subsequently, in a second time interval, the ultrasonic transducer assembly 608 moves along a first portion of the ultrasound scan trajectory, such as the single longitudinal portion 356 shown in FIG. 3. Thereafter, in a third time interval, the gantry 606 rotates a limited increment, such as 1°, 2°, or 5°, etc. Then, in a fourth time interval, the X-ray source 610 again emits an X-ray pulse, which is captured by the X-ray detector 614. Subsequently, in a fifth time interval, the ultrasonic transducer assembly 608 moves along a first portion of the ultrasound scan trajectory, such as the further longitudinal portion 356 shown in FIG. 3.

[0138] It will be appreciated that the sequence of events described in the preceding paragraphs will be repeated as many times as necessary to complete the desired hybrid scan. It will also be appreciated that in certain embodiments of the present invention, the ultrasonic transducer assembly 608 will switch between a stored configuration and an expanded configuration between each X-ray pulse cycle. In other embodiments of the present invention, the ultrasonic transducer assembly 608 will remain in the expanded state during the X-ray pulse cycle. It should be noted that in alternative embodiments of the present invention, the ultrasound subsystem is removable and can be installed into the CBBCT system when an ultrasound scan is needed and / or desired. Therefore, in certain embodiments of the present invention, the ultrasound system is removed when a CBBCT scan is being performed and is present in the CBBCT system when a CBBCT scan is not being performed.

[0139] Fig. 7A and 7B Further aspects of the invention in exemplary embodiments are shown. In these figures, the breast to be imaged is supported and immobilized by a breast stabilizer unit. During a first time interval, X-ray CBBCT imaging is applied to acquire a tomographic data set characterizing the breast. During a second time interval, the breast is scanned using ultrasound technology to acquire additional tomographic or other imaging information.

[0140] In the illustrated embodiment, the ultrasound transducer assembly remains in the storage configuration (eg, Fig. 7A ), and moves to the deployed configuration in contact with the breast stabilizer unit during a second time interval (as shown Figure 7B During ultrasound scanning, ultrasound energy is transmitted to the breast to be imaged through the breast stabilizer unit. Therefore, those skilled in the art will understand that Fig. 7A and 7B In the illustrated embodiment, the breast stabilizer unit will comprise a material optimally selected with respect to X-ray transparency and satisfactory impedance matching between the ultrasound transducer and the breast tissue to be imaged.

[0141] In certain embodiments of the invention, the ultrasound transducer assembly will include a circumferential sliding interface with the breast stabilizer unit. In other embodiments of the invention, the ultrasound transducer assembly will include a plurality of ultrasound transducers arranged and configured to effectively image the breast without requiring rotation of the ultrasound transducer assembly.

[0142] According to the above, Fig. 7A A hybrid CBBCT imaging system 700 is shown in schematic cross-sectional perspective view, including an ultrasound imaging subsystem 702.

[0143] Similar to the systems 100, 200, and 300 described above, the system 700 includes an X-ray source 704. The X-ray source 704 is mounted on an upper surface 706 of a rotating gantry 708. The rotating gantry 708 is supported by bearings 710 and is configured to rotate about an axis of rotation 712. The bearings 710 are supported by structural components of the imaging system 700, or alternatively supported by the ground.

[0144] The X-ray source 704 is configured to emit a beam of X-rays 716. The beam of X-rays 716 defines a longitudinal axis 718 of the beam, which in the illustrated embodiment intersects the rotation axis 712 (at 720).

[0145] In the illustrated embodiment, the upper surface 706 of the rotating gantry 708 includes an inner circumferential edge 722. The inner circumferential edge 722 defines an opening 724 in the upper surface 706 of the gantry 708.

[0146] In some embodiments of the present invention, the rotating frame 708 includes a slip ring for transmitting power and / or electronic signals and / or optical signals up and down the frame. In some embodiments, the slip ring includes an opening that is arranged approximately coaxially with the opening 724 of the frame.

[0147] In other embodiments of the present invention, information and control signals are transmitted within and outside the rack via wireless modulated electromagnetic radiation signals, including but not limited to any radio frequency, microwave and / or optical frequency electromagnetic radiation.

[0148] In the illustrated embodiment, the breast stabilizer unit 730 is located above the opening 724. The breast stabilizer unit 730 shown includes a main body portion 732 and a flange portion 734. As an example of some embodiments, the breast stabilizer unit 730 is supported on an opening of the patient examination bed (e.g., Figure 1 126 of the patient table 120). The breast stabilizer unit supports and stabilizes the breast 736 during the imaging process.

[0149] As shown, the breast stabilizer unit 730 includes an inner surface area 738 that defines a recess 740 of the breast stabilizer unit. During imaging, the breast 736 is placed in the recess 740 with the outer surface area of ​​the breast 736 in contact with the inner surface area 738 of the breast stabilizer unit 730.

[0150] Various features and advantages of the breast stabilizer unit, as well as various exemplary embodiments, are shown and discussed in co-pending patent application serial number <...>, filed on <...>, the contents of which are hereby fully incorporated by reference. [K9-01-P2]

[0151] In the illustrated embodiment, the swivel 742 is positioned within the opening 724 of the housing 708. The illustrated exemplary swivel 742 includes a swivel body portion 744 having an interior surface area 746 defining a recess 748 within the swivel body portion 744 of the swivel 742.

[0152] exist Fig. 7A , the ultrasound transducer assembly 750 is shown in a stored configuration within a recess 748 of a rotation device body portion 744 of a rotation device 742. As will be discussed further below, the ultrasound transducer assembly 750 includes an interior interface surface area 752 and an ultrasound transducer 754. During operation of the ultrasound imaging subsystem 702, the interior interface surface area 752 is adjacent to and / or in contact with an exterior surface area 756 of the breast stabilizer unit 730.

[0153] Figure 7B The hybrid CBBCT imaging system 700 is shown in a schematic cross-sectional perspective view with the ultrasound transducer assembly 750 of the ultrasound imaging subsystem 702 in a deployed configuration.

[0154] In the deployed configuration, the inner interface surface area 752 of the ultrasonic transducer assembly 750 is adjacent to, or in close contact with, the outer surface area 756 of the main body portion 732 of the breast stabilizer unit 730. In embodiments where there is a significant distance, a lubricating material having an appropriately selected acoustic impedance may be provided in the space between the outer surface area 756 and the inner interface surface area 752 to reduce friction between the two surfaces and reduce reflection of ultrasonic energy at the interface. In other embodiments of the present invention, the ultrasonic transducer assembly 750 is urged to move along the direction / degree of freedom 758 by applying pressure (e.g., a linear drive of the rotation device 742 applies pressure to the ultrasonic transducer assembly 750) to maintain close contact between the outer surface area 756 and the inner interface surface area 752.

[0155] In certain embodiments of the present invention, lubricating material may be supplied under pressure through a hole or nozzle to provide a sufficient amount of lubricating material and / or a continuous flow of lubricating material between the inner interface surface area 752 and the outer surface area 756 (ie, within the interface area).

[0156] In certain embodiments of the present invention, an ultrasound transducer (e.g., ultrasound transducer 754) will be coupled to an exterior surface area 760 of the ultrasound transducer assembly 750. In other embodiments of the present invention, an ultrasound transducer (e.g., ultrasound transducer 762) will be supported by the ultrasound transducer assembly 750, but the ultrasound transducer 762 will include a transducer surface area 764 that is in direct contact (and sliding contact) with a corresponding surface area 766 of the exterior surface area 756 of the breast stabilizer unit 730.

[0157] In certain embodiments of the present invention, the rotation device 742 will rotate during ultrasound imaging, thereby rotating the ultrasound transducer assembly 750 and the corresponding ultrasound transducers (e.g., 754, 762) together. In other embodiments of the present invention, the rotation device 742 will be omitted and the ultrasound imaging subsystem 702 will be directly coupled to the CBBCT gantry 708. In such an embodiment, the rotation of the ultrasound transducer assembly 750 will be achieved by rotating the entire CBBCT gantry 708. In further embodiments of the present invention, the ultrasound transducer assembly 750 will include a plurality of ultrasound transducers and their arrangement, so that ultrasound imaging (e.g., by direct imaging and / or synthetic aperture technology) can be achieved without rotating the ultrasound transducer assembly 750.

[0158] Fig. 8A and 8B Further aspects of the invention in exemplary embodiments are shown. In these figures, X-ray CBBCT imaging is performed to characterize a patient's breast. Using the same system, ultrasound imaging is performed on the breast while immersed in an impedance matching liquid (e.g., water).

[0159] In the illustrated embodiment, the ultrasound transducer assembly remains in the storage configuration (eg, Fig. 8A ), and moves to the imaging configuration during the second time interval (as Figure 8B In the first time interval, X-ray CBBCT imaging is applied to obtain a tomographic data set characterizing the breast. In the second time interval, the breast is immersed in an impedance matching fluid and scanned using ultrasound energy to obtain an ultrasound tomographic image (or other ultrasound image) of the breast.

[0160] In certain embodiments of the present invention, the immersed breast will be contained within and supported by a breast stabilizer having a structure similar to that described above. Fig. 7AIn other embodiments of the present invention, the immersed breast will be contained in a flexible membrane made of a synthetic polymer or other material. In further embodiments, the breast will be directly immersed in the impedance matching liquid without any intermediate substance.

[0161] Based on the above, Fig. 8A A hybrid CBBCT imaging system 800 is shown in schematic perspective view, including an ultrasound imaging subsystem 802.

[0162] Similar to the systems 100, 200, 300, and 700 described above, the system 800 includes an x-ray source 804. The x-ray source 804 is mounted on an upper surface 806 of a rotating gantry 808. The rotating gantry 808 is supported by bearings 810 and is configured to rotate about an axis of rotation 812. The bearings 810 are supported by structural components of the imaging system 800, or alternatively supported by the ground.

[0163] The X-ray source 804 is configured to emit a beam of X-rays 816. The beam of X-rays 816 defines a longitudinal axis 818 of the beam, which in the illustrated embodiment intersects the rotation axis 812 (at 820).

[0164] In the illustrated embodiment, the upper surface region 806 of the rotating gantry 808 includes an inner circumferential edge 822. The inner circumferential edge 822 defines an opening 824 in the upper surface 806 of the gantry 808.

[0165] In some embodiments of the present invention, the rotating frame 808 includes a slip ring for transmitting power and / or electronic signals and / or optical signals up and down the frame. In some embodiments, the slip ring includes an opening that is arranged approximately coaxially with the opening 824 of the frame.

[0166] In other embodiments of the present invention, information and control signals are transmitted within and outside the rack via wireless modulated electromagnetic radiation signals, including but not limited to any radio frequency, microwave and / or optical frequency electromagnetic radiation, or by any other known or discovered effective means.

[0167] In the illustrated embodiment, the hybrid CBBCT imaging system 800 includes an ultrasound imaging subsystem 802 positioned within an opening 824 of a gantry 808. The ultrasound imaging subsystem 802 includes a rotation device 826 having a body portion 828 having an interior surface area 830. The interior surface area 830 defines a recess 832, such that the body portion 828 having the recess 832 defines an imaging slot 834.

[0168] When in storage configuration, such as Fig. 8AAs shown, the upper peripheral surface area 836 of the imaging slot 834 is located below the lower end 840 of the x-ray beam 816. Therefore, the presence of the ultrasound imaging subsystem 802 does not interfere with the x-ray CBBCT imaging of the breast 842.

[0169] Figure 8B Further aspects of a hybrid CBBCT imaging system 800 are shown in a schematic perspective view, including an ultrasound imaging subsystem 802. The ultrasound imaging system 802 is in an imaging configuration such that an imaging trough 834 is above an upper surface area 806 of a rotating gantry 808 and an upper peripheral surface area 836 of the imaging trough 834 is adjacent to the chest wall of a patient who is lying prone over the imaging trough and supported on a patient couch (or other equipment, not shown).

[0170] As shown, the breast 842 to be imaged is suspended below the chest wall and is located in the recess 832 of the main body portion 828. The main body portion 828 includes and / or supports at least one ultrasonic transducer 850. In other embodiments of the present invention, the main body portion 828 includes and / or supports at least one second ultrasonic transducer 852. In some embodiments, the ultrasonic transducer 850 operates as both an ultrasonic transmitter and an ultrasonic receiver. In other embodiments of the present invention, the ultrasonic transducer 850 operates as an ultrasonic transmitter, and the ultrasonic transducer 852 operates as an ultrasonic receiver.

[0171] According to the operating principles of the present invention, in some operating methods, the groove 832 of the main body portion 828 contains a coupling material 854, which is located between the inner surface area 830 and the outer surface area 856 of the breast 842. In various embodiments of the present invention, the coupling material can include a liquid material, a gel material, a phase change material, a material mixture (e.g., a combination of materials suitable for curing to exhibit a change in physical properties, such as fluidity and / or hardness), a solid material, or any other material that is considered useful or beneficial for the needs of a particular patient or procedure.

[0172] In some embodiments of the present invention, the rotating device is driven between the first storage configuration and the second imaging configuration by a device, such as a linear drive. It is understood that the linear drive described herein (and any linear drive mentioned) can be implemented using a variety of existing drives. For example, in some embodiments, the linear actuator may include one or more pneumatic cylinders, air bags, pneumatic bellows, hydraulic cylinders, hydraulic bags, hydraulic bellows, solenoid valves, thermoelectric actuators, shape memory alloy actuators, piezoelectric actuators, linear stepper motors, rotary actuators (such as electric motors or any of the above), and, for example, gear and pinion arrangements, gear and worm gear arrangements, Acme screws and Acme nuts, ball screw arrangements, transverse complementary ramps, scissor link mechanisms (such as scissor link mechanisms driven by lead screws), Sarus link mechanisms, cable and pulley arrangements, timing belts and timing pulley arrangements, ratchet and pawl drives, compression springs, extension springs, torsion springs, coil springs, reducers (including but not limited to gear reducers, worm gear reducers, harmonic reducers, leaf spring assemblies), springs including multiple Belleville washers, shock-absorbing couplings, flexible couplings, universal joints and / or flexible shafts, and various manual actuators, such as hand cranks and / or ratchet levers; or any other linear actuator currently known or that may be discovered in the future that is suitable for the requirements of a particular application and provides the desired extension function.

[0173] The CBBCT imaging subsystem generates a 3D reconstructed image of the breast with isotropic resolution. The tomographic ultrasound subsystem generates a 3D ultrasound tomographic image of the breast. The hybrid CBBCT-ultrasound system generates multiple correlated 3D images or fused images to provide complementary imaging information of the breast.

[0174] The hybrid CBBCT-ultrasound system can be used for image-guided biopsy or minimally invasive treatment. The CBBCT imaging subsystem provides the accurate location of the lesion and the three-dimensional treatment space coordinates, while the ultrasound subsystem provides real-time images of the biopsy needle or treatment tools (such as radiofrequency electrodes). By fusing the CBBCT image with the real-time ultrasound image of the biopsy needle, the hybrid CBBCT-ultrasound system can provide real-time imaging guidance for biopsy or treatment.

[0175] In order to fuse the CBBCT image and the ultrasound image, several reference markers will be imaged in the CBBCT and ultrasound systems. In an exemplary embodiment of the invention, the marker may simply be a vitamin E capsule adhered to the skin of the breast. In other embodiments of the invention, a registration marker will be provided on the breast using radiopaque or radiopaque ink. In further embodiments, an adhesive sticker or bandage with a metallic or other radiopaque or translucent material is provided as a registration marker.

[0176] Fig. 9A further exemplary hybrid CBBCT imaging system 900 is shown in schematic perspective view, including an ultrasound imaging subsystem 902. The ultrasound imaging system 902 is in an imaging configuration such that an imaging trough 934 is above an upper surface area 906 of a rotating gantry 908, and an upper peripheral surface area 936 of the imaging trough 934 is adjacent to the chest wall of a patient who is lying prone above the imaging trough and supported on a patient couch (or other equipment, not shown).

[0177] As shown, the breast 942 to be imaged is suspended below the chest wall and positioned within a recess 932 of the main body portion 928. The main body portion 928 includes and / or supports one or more annular ultrasound transducer assemblies, such as 960, 962, 964, 966. In certain embodiments, each ultrasound transducer assembly (e.g., 960) operates as both an ultrasound transmitter and an ultrasound receiver.

[0178] According to the operating principles of the present invention, in some operating methods, the groove 932 of the main body portion 928 contains a coupling material 954, which is located between the inner surface area 930 and the outer surface area 956 of the breast 942. In various embodiments of the present invention, the coupling material can include a liquid material, a gel material, a phase change material, a material mixture (e.g., a combination of materials suitable for solidification to exhibit a change in physical properties, such as fluidity and / or hardness), a solid material, or any other material that is considered useful or beneficial for the needs of a particular patient or procedure. It is understood that the coupling material will act as an impedance matching transformer between the transducer (e.g., 960) and the breast 942.

[0179] Fig.10 Exemplary aspects 1000 of a processing system and method according to the principles of the present invention are shown in schematic block diagram form, including twelve exemplary modes of operation.

[0180] Consistent with the overall description above, the CBBCT system 1002, including the ultrasound hybrid imaging functionality according to the present invention, is intended to prepare an enhanced tomographic dataset for a target breast. The CBBCT images generated by the system 1002 are enhanced by performing image processing on one or more ultrasound images and one or more tomographic images acquired by the hybrid CBBCT system.

[0181] Thus, the CBBCT system 1002 is configured and operated to acquire one or more CBBCT image datasets 1004. Depending on the selected operating mode, the acquired one or more CBBCT image datasets 1004 may be acquired using an injected contrast agent 1006, and / or the acquired one or more CBBCT image datasets 1004 may be acquired without an injected contrast agent 1008.

[0182] The CBBCT system 1002 is also configured and operated to acquire one or more ultrasound image data sets 1007. Depending on the selected operating mode, the acquired one or more ultrasound image data sets 1007 may be acquired as a sound velocity map 1010; and / or the acquired one or more ultrasound image data sets 1007 may be acquired as a reflection map 1012; and / or the acquired one or more ultrasound image data sets 1007 may be acquired as an attenuation map 1014.

[0183] The processor of the CBBCT system 1002 is configured and operated to receive the above-mentioned acquired individual data sets and combine them through tomographic calculation to generate a correlated image 1016. In other operation modes, the CBBCT system 1002 is also configured and operated to receive the above-mentioned acquired individual data sets and combine them through co-registering and merging images to generate a fused image 1018.

[0184] Thus, when the associated image 1016 is generated, the image will be generated in one or more of the following ways:

[0185] 1. CBBCT images without contrast are correlated with the sound velocity map 1020 .

[0186] 2. CBBCT image with contrast agent is associated with the sound velocity map 1022.

[0187] 3. The CBBCT image without contrast agent is associated with the reflectance map 1024 .

[0188] 4. CBBCT image with contrast agent is associated with reflectance map 1026.

[0189] 5. CBBCT image without contrast agent is correlated with attenuation map 1028.

[0190] 6. CBBCT image with contrast agent is correlated with attenuation map 1030.

[0191] Thus, when the fused image 1018 is generated, the image will be generated in one or more of the following ways:

[0192] 1. CBBCT image without contrast agent is fused with the sound velocity map 1032.

[0193] 2. CBBCT image with contrast agent fused with the sound velocity map 1034.

[0194] 3. CBBCT image without contrast agent is fused with reflectance map 1036 .

[0195] 4. CBBCT image with contrast agent is fused with reflectance map 1038.

[0196] 5. CBBCT image without contrast agent is fused with attenuation map 1040 .

[0197] 6. CBBCT image with contrast agent is fused with attenuation map 1042.

[0198] In view of Fig.10 Related disclosures, as well as the broader overall disclosure, will be readily understood by those of ordinary skill that the image acquisition and processing methods and modes presented herein are merely examples of a larger collection of methods and modes. These novel methods and modes, while surprising and effective, become apparent to practitioners of ordinary skill after exposure to this disclosure. Therefore, while an exhaustive enumeration of all possible methods and modes is beyond the reasonable scope of this document, it is understood that this document is intended to disclose all methods, systems, devices, structures, methods, and results that are apparent to practitioners in possession of this disclosure.

[0199] In some embodiments, the hybrid imaging system includes a structural component and a CBBCT X-ray subsystem coupled to and supported by the structural component. The ultrasound subsystem is also coupled to and supported by the structural component. A processor is signal-coupled to the CBBCT X-ray subsystem and the ultrasound subsystem, and the processor is adapted to receive signals from the CBBCT X-ray system and the ultrasound subsystem, respectively, and generate an X-ray-ultrasound hybrid CBBCT image.

[0200] In certain embodiments, the CBBCT X-ray subsystem includes a rotating gantry supported by structural members via bearings.

[0201] In certain embodiments, the ultrasound subsystem is supported by a rotating gantry.

[0202] In certain embodiments, the ultrasound subsystem includes a rotation device supported by the structural member for rotation independent of the gantry.

[0203] In some embodiments, the ultrasound subsystem includes a rotating device and a base portion, wherein the base portion is mounted on and supported by the rotating device. The ultrasound subsystem also includes a transmission portion and an ultrasound transducer assembly.

[0204] In certain embodiments, the base portion includes a first circumferential drive, a second radial drive, and a third vertical drive.

[0205] In some embodiments, the first ultrasonic component includes an ultrasonic transducer, and in some embodiments, the first ultrasonic component includes a feedback sensor.

[0206] In certain embodiments, the first ultrasonic component includes a lubrication port.

[0207] In certain embodiments, a method of generating a hybrid breast image using an integrated breast imaging system includes: operatively positioning a patient's breast relative to the integrated breast imaging system; imaging the patient's breast using an x-ray CBBCT subsystem of the breast imaging system while maintaining the patient's breast substantially stationary relative to the integrated breast imaging system; imaging the patient's breast using an ultrasound subsystem of the breast imaging system while maintaining the patient's breast substantially stationary relative to the integrated breast imaging system; and maintaining the patient's breast substantially stationary relative to the integrated breast imaging system throughout a period of time between the x-ray CBBCT imaging and the ultrasound CBBCT imaging.

[0208] In some embodiments, a method for generating a hybrid breast image using an integrated breast imaging system includes receiving X-ray CBBCT imaging data from an X-ray CBBCT subsystem to an image processing system, receiving ultrasound imaging data from an ultrasound subsystem to the image processing system, and generating a hybrid image dataset using the image processing system. The hybrid image dataset includes hybrid image data from the X-ray CBBCT imaging data and the ultrasound imaging data.

[0209] In certain embodiments, a method of generating a hybrid breast image using an integrated breast imaging system includes placing a patient on a patient couch.

[0210] In certain embodiments, the ultrasound subsystem comprises a reflection ultrasound system, while in some embodiments, the ultrasound subsystem comprises a transmission ultrasound system.

[0211] In further embodiments, the ultrasound subsystem comprises an ultrasound computed tomography system.In certain embodiments, the ultrasound subsystem comprises an automated ultrasound system.

[0212] In certain embodiments, an automated ultrasound system includes a rotating device, a support column, and an ultrasound transducer portion.

[0213] In some embodiments, the ultrasound transducer portion of the ultrasound imaging subsystem performs a circumferential spiral motion along the surface area of ​​the breast. In some embodiments, the ultrasound transducer portion of the ultrasound imaging subsystem performs a radial / longitudinal motion along the surface area of ​​the breast.

[0214] In certain embodiments, a method for generating a hybrid breast image using an integrated breast imaging system includes: receiving X-ray CBBCT imaging data from an X-ray CBBCT subsystem to an image processing system, and receiving ultrasound imaging data from an ultrasound subsystem to the image processing system. After receiving the X-ray CBBCT imaging data and the ultrasound imaging data, further X-ray CBBCT imaging data is received again at the image processing system. After receiving the X-ray CBBCT imaging data, the X-ray CBBCT system and after receiving the ultrasound imaging data from the ultrasound subsystem, further ultrasound imaging data is received again at the image processing system, and a hybrid image data set is generated. The hybrid image data set includes hybrid image data from the X-ray CBBCT imaging data and the ultrasound imaging data.

[0215] Although the exemplary embodiments described above are primarily selected from the field of auxiliary imaging performed during the operation of a CBBCT imaging system, including hybrid X-ray ultrasound breast imaging, a person of ordinary skill will recognize that the principles of the present invention are equally applicable to a wide range of other imaging technologies and the benefits of the present invention are well realized in other areas, such as imaging of other body parts and imaging of industrial and technical products.

[0216] Furthermore, although the present invention has been described in detail with respect to the presently preferred embodiments, it should be clearly understood that the present invention is not limited to the disclosed embodiments. Rather, the present invention may be modified to include any number of variations, alterations, substitutions, or equivalent arrangements not yet described, but such variations, alterations, substitutions, or equivalent arrangements should be consistent with the spirit and scope of the present invention. Therefore, the present invention should not be construed as being limited by the foregoing description, but only by the scope of the appended claims.

Claims

1. A hybrid imaging system, comprising: a structural component; a cone beam breast computed tomography (CBBCT) x-ray subsystem connected to and supported by the structural member; an ultrasonic subsystem connected to and supported by the structural member; A processor is connected to the CBBCT X-ray subsystem and the ultrasound subsystem by signal. The processor can receive signals from the CBBCT X-ray system and the ultrasound subsystem respectively and generate an X-ray-ultrasound hybrid CBBCT image.

2. The hybrid imaging system as defined in claim 1, wherein the CBBCT X-ray subsystem comprises a rotating gantry supported on the structural member via bearings.

3. The hybrid imaging system as defined in claim 2, wherein the ultrasound subsystem is supported by the rotating gantry.

4. The hybrid imaging system as defined in claim 2, wherein said ultrasound subsystem includes a rotating device supported by said structural member and rotating independently of said gantry.

5. The hybrid imaging system as defined in claim 1, wherein the ultrasound subsystem comprises: a rotating device; a base portion, said base portion being mounted on and supported by said rotating device; a translation part; An ultrasonic transducer assembly.

6. The hybrid imaging system as defined in claim 5, wherein the base portion includes a first circumferential drive, a second radial drive, and a third vertical drive.

7. The hybrid imaging system defined in claim 5, wherein said first ultrasound component comprises an ultrasound transducer.

8. The hybrid imaging system defined in claim 5, wherein said first ultrasound component comprises a feedback sensor.

9. The hybrid imaging system as defined in claim 5, wherein said first ultrasound component includes a lubrication port.

10. A method for generating a hybrid breast image using an integrated breast imaging system, comprising: operatively positioning a patient's breast within the integrated breast imaging system; imaging a patient's breast using the X-ray CBBCT subsystem of the breast imaging system while maintaining the patient's breast substantially still relative to the integrated breast imaging system; imaging a patient's breast using an ultrasound subsystem of the breast imaging system while holding the patient's breast substantially still relative to the integrated breast imaging system; The patient's breast is maintained substantially motionless relative to the integrated breast imaging system throughout the period between the X-ray CBBCT imaging and the ultrasound CBBCT imaging.

11. The method of generating a hybrid breast image using an integrated breast imaging system as defined in claim 10, further comprising: receiving X-ray CBBCT imaging data from the X-ray CBBCT subsystem to an image processing system; receiving ultrasound imaging data from the ultrasound subsystem to the image processing system; The image processing system is used to generate a hybrid image data set, wherein the hybrid image data set includes image data fused by the X-ray CBBCT imaging data and the ultrasound imaging data.

12. The method for generating a hybrid breast image using an integrated breast imaging system as defined in claim 10, wherein the ultrasound subsystem comprises a reflection ultrasound system.

13. A method for generating a hybrid breast image using an integrated breast imaging system as defined in claim 10, wherein said ultrasound subsystem comprises a transmission ultrasound system.

14. The method for generating a hybrid breast image using an integrated breast imaging system as defined in claim 10, wherein said ultrasound subsystem comprises an ultrasound computed tomography system.

15. The method for generating a hybrid breast image using an integrated breast imaging system as defined in claim 10, wherein the ultrasound subsystem comprises an automated ultrasound system.

16. The method of generating a hybrid breast image using an integrated breast imaging system as defined in claim 15, wherein the automated ultrasound system comprises a rotating device, a support column, and an ultrasound transducer portion.

17. The method of generating a hybrid breast image using an integrated breast imaging system as defined in claim 15, further comprising moving an ultrasound transducer portion of the ultrasound imaging subsystem over a surface area of ​​the breast by a circular spiral motion.

18. The method of generating a hybrid breast image using an integrated breast imaging system as defined in claim 15, further comprising moving an ultrasound transducer portion of the ultrasound imaging subsystem over a surface area of ​​the breast by radial / longitudinal motion.

19. The method for generating a hybrid breast image using an integrated breast imaging system as defined in claim 10, further comprising: receiving X-ray CBBCT imaging data from the X-ray CBBCT subsystem to an image processing system; receiving ultrasound imaging data from the ultrasound subsystem to the image processing system; After receiving the X-ray CBBCT imaging data from the X-ray CBBCT system and receiving the ultrasound imaging data from the ultrasound subsystem, further receiving the X-ray CBBCT imaging data from the X-ray CBBCT subsystem to the image processing system; After receiving the X-ray CBBCT imaging data from the X-ray CBBCT system and receiving the ultrasound imaging data from the ultrasound subsystem, further receiving the ultrasound imaging data from the ultrasound subsystem to the image processing system; The image processing system is used to generate a hybrid image data set, wherein the hybrid image data set includes image data fused by the X-ray CBBCT imaging data and the ultrasound imaging data.

20. The method of generating a hybrid breast image using an integrated breast imaging system as defined in claim 11, further comprising positioning the patient on a patient support table.

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