Static detail imaging in cone beam mammary gland computed tomography

Abstract

In the present invention, a cone beam mammary gland computed tomography system (CBBCT) comprises a subsystem for static scanning, enabling the system to generate a cone beam mammary gland computed tomography image and a two-dimensional static scanning image.

Description

[0001] Related Applications

[0002] This application claims the benefit of the following provisional patent applications: OMNIBUS DISCLOSURE, filed April 14, 2022, Patent No. 63 / 331,153; FIXTURING AND SUPPORT FOR MEDICAL IMAGING, filed August 26, 2022, Patent No. 63 / 401,475; ERGONOMIC IMPROVEMENTS IN CONE BEAMBREAST COMPUTED TOMOGRAPHY, filed August 26, 2022, Patent No. 63 / 401,493; STATIONARY DETAIL IMAGING IN CONE BEAM BREAST COMPUTED TOMOGRAPHY, filed August 26, 2022, Patent No. 63 / 401,513; CONE BEAM BREAST COMPUTED TOMOGRAPHY WITH PATIENT SUPPORT SUBSYSTEM, filed on August 26, 2022, Patent No. 63 / 401,546; CONEBEAM BREAST COMPUTED TOMOGRAPHY WITH PIVOTAL GANTRY SUBSYSTEM, filed on August 26, 2022, Patent No. 63 / 401,548; ULTRASONIC HYBRID IMAGING IN CONE BEAM BREAST COMPUTED TOMOGRAPHY, filed on December 6, 2022, Patent No. 63 / 430,571; CALCIFICATION DETECTION SYSTEMS, METHODS AND APPARATUS IN CONE BEAM BREAST COMPUTED TOMOGRAPHY, filed on _______________, Patent No. _____________. The disclosures of all of these applications are hereby incorporated by reference in their entirety. Technical Field

[0003] The invention relates to the field of cone-beam tomography, and in particular to image detail improvement in 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 studies have reported a decrease in breast cancer mortality rates, the disease still kills 40,000 women each year.

[0005] The best breast imaging techniques are able to detect tumors when they are small, preferably less than 10 mm in diameter. The 16-year survival rate for patients with invasive breast cancers 1-10 mm in diameter detected by mammography is reported to be as high as 93%. In addition, the likelihood of metastasis decreases dramatically as the diameter of the tumor decreases at the time of detection. If a tumor is detected when it is 10 mm or smaller 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%.

[0006] Although mammography (detecting cancers up to about 12 mm in size on average) is the most effective of the currently available early breast cancer detection tools, it has a relatively low sensitivity for small breast cancers (less than a few millimeters). The specificity and positive predictive value of mammography remain limited due to structural and tissue overlap. The sensitivity and specificity of mammography in breast cancer detection are limited primarily by its poor contrast detection, a problem common to all types of projection imaging (which can only achieve a contrast detection of 10% at best), and by the fact that mammography can initially detect only 65–70% of breast cancers. In dense breasts, mammography sensitivity drops even further to 30%. Digital mammography (DM) aims to overcome the inherent limitations of conventional film mammography (SFM) by providing improved contrast resolution and digital image processing; however, a large-scale clinical trial, the Digital Mammography Screening Trial (DMIST), showed that DM and SFM had the same false-positive rate.

[0007] The relatively low specificity of mammography results in biopsies being performed in indeterminate cases despite the increased expense and stress this causes to patients. Of the more than one million breast biopsies performed annually in the United States, nearly 80% of cases to evaluate suspicious mammographic findings are benign, causing undue anxiety for patients and a significant cost burden on the healthcare system. Therefore, more accurate characterization of breast lesions is needed to reduce biopsy rates and false-positive rates of pre-biopsy mammography.

[0008] To address the limitations of mammography described above, one of the inventors previously developed a cone-beam breast CT (CBBCT). Briefly, the key features of the CBBCT include: a horizontal, ergonomically designed patient table with modular support trays to optimize coverage of the uncompressed breast (including the chest wall); openings up to 1 meter wide on both sides of the patient table to facilitate breast positioning and provide good access for image-guided biopsies and other procedures without significantly changing the basic platform; and slip-ring technology to provide efficient support for dynamic contrast imaging studies and angiogenesis imaging in the future.

[0009] Results from phantom studies have shown that CBBCT can achieve a spatial resolution of up to approximately 2.8 lp / mm, enabling the detection of carcinomas as small as 2 mm in diameter and microcalcifications as small as approximately 0.2 mm in size, with a total dose of approximately 5 mGy required in an average-sized breast (chest wall diameter approximately 13 cm). This dose is lower than that of a single mammogram, assuming that two views are required for each breast. CBBCT has excellent image quality in visualizing breast tissue, breast tumors, and calcifications, and coverage of the breast, including the chest wall area, is at least comparable to that of mammography. Visualization of major blood vessels is excellent without the use of contrast agents. Therefore, CBBCT provides a significant improvement in the detection and biopsy of suspicious lesions in patients.

[0010] Further improvements in CBBCT imaging offer the potential to extend these benefits. These improvements include technical improvements as well as methods and devices that aid in presenting patients to CBBCT systems. Among them, the addition of static scanning technology to CBBCT imaging has the potential to significantly enhance image resolution and improve detection of small features (including calcifications) within the imaged breast.

[0011] In summary, CBBCT provides the ability to visualize the breast in remarkable three-dimensional detail and to identify potential lesions, calcifications, vascular abnormalities, and other signs of disease, with relatively low costs of radiation risk and patient discomfort. The inventors recognize that, in addition to these advantages, CBBCT imaging would be significantly improved by the ability to align a CBBCT imaging system along a selected axis and image the breast or selected areas of the breast with significantly improved clarity and resolution. In particular, a system that could easily generate multiple such "static scans" could provide significantly increased benefits, including improved diagnostic effectiveness.

[0012] In traditional mammography, the patient's breast is placed in a fixture that significantly compresses the breast tissue perpendicular to the longitudinal axis of the breast. Patients commonly report physical and psychological discomfort associated with this compression, and research suggests that this discomfort is a factor in low rates of screening and diagnostic mammography among patients overall and particularly among certain ethnic and cultural groups.

[0013] Additionally, breast compression associated with mammography can cause displacement of breast tissue, making the subsequent process of locating features such as lesions and calcifications more difficult, especially for biopsies and lumpectomy procedures.

[0014] In current practice, patients undergoing CBBCT lie prone on a table. The target breast is lowered through an opening in the upper surface of the table, suspended below the chest wall, into an imaging room located below the table. The position of the breast in the imaging room is maintained by the patient remaining still, as the patient's upper body rests on the upper surface of the table.

[0015] The imaging device is connected to a mobile rotating frame, which is supported by a bearing device and can rotate around a rotation axis. The rotation axis is generally vertical and passes through an opening in the upper surface of the examination bed. It is designed that the approximate center of gravity of the breast to be imaged is placed at a vertical position of the rotation axis so that the rotation axis passes through the approximate center of gravity.

[0016] During imaging, the mobile gantry rotates about the rotation axis, bringing the imaging device into at least a partially circular path. As it moves along this path, the imaging device emits a series of X-ray pulses and captures corresponding image data, which are processed to prepare a tomographic model of the breast.

[0017] In existing CBBCT systems, the breast hangs freely through an opening in the patient table, which is usually placed horizontally within the imaging area. Summary of the invention

[0018] The inventors of the present invention have developed new and useful systems, devices and methods after long and careful consideration of the improvement of CBBCT imaging, especially the problem of CBBCT image enhancement, which are significant improvements over the known previous methods. The present invention includes devices and corresponding systems and methods for performing auxiliary imaging during the operation of CBBCT imaging systems, including static scanning imaging.

[0019] Thus, in certain embodiments and aspects, the present invention includes a process and method for placing a patient in an operative position with a CBBCT system, orienting an imaging device of the CBBCT system so that it is in a desired positional relationship with the patient's breast so that the longitudinal axis of the X-ray beam generated by the CBBCT system is approximately perpendicular to the desired cross-section of the breast to be imaged, and capturing a static image of the breast (i.e., without movement of the rotating arm of the CBBCT system) using the imaging device of the CBBCT system. The resulting "static" breast image can be evaluated directly, and / or the corresponding data of the static image can be combined and / or blended with additional data, such as CBBCT image data captured by the CBBCT system while the rotating arm is in motion or while multiple static imaging events are alternating with the rotation arm movement.

[0020] In certain further aspects and embodiments, the present invention includes an auxiliary imaging device for supporting, stabilizing and / or in certain embodiments flattening the breast or one or more regions of the breast to be imaged. Thus, the system is able to provide specific images of the entire breast as well as specific regions within the breast in excellent detail.

[0021] It should be understood that the present invention includes methods of performing CBBCT static imaging of the breast without auxiliary equipment, as well as such imaging performed with the use of auxiliary stabilization and / or applanation devices.

[0022] The following description is intended to enable anyone skilled in the art to make and use the disclosed invention and sets forth the best mode currently contemplated by the inventors in carrying out their invention. In the following description, for the purpose of explanation, numerous specific details are listed to provide a thorough understanding of the present invention. However, it will be apparent to those skilled in the art that the present invention may be practiced without these specific details. In other cases, known structures and devices are shown in block diagram form to avoid unnecessarily obscuring the disclosed substance. These and other advantages and features of the present invention will be more readily understood in the detailed description provided below in conjunction with the accompanying drawings.

[0023] It should be noted that although the various figures illustrate different aspects of the present invention, no single figure is intended to illustrate the entire invention. Instead, the figures collectively illustrate various aspects and principles of the present invention. Therefore, it should not be assumed that any particular figure is only related to a single aspect or category of the invention. On the contrary, those skilled in the art will recognize that the figures taken together reflect different examples and are illustrative examples of the present invention.

[0024] Thus, references in the specification to "one embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic associated with that embodiment is included in at least one embodiment of the invention. Thus, the appearance of the term "in one embodiment" or "in an embodiment" in different places in the specification does 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

[0025] Figure 1 A portion of an exemplary CBBCT imaging system is shown in cutaway perspective.

[0026] Figure 2 A portion of an exemplary CBBCT imaging system including a static imaging subsystem prepared in accordance with the principles of the present invention is shown in schematic side elevation view.

[0027] Figure 3 A portion of an exemplary CBBCT imaging system including a static imaging subsystem prepared in accordance with the principles of the present invention is shown in schematic side elevation view.

[0028] Figure 4 A portion of an exemplary CBBCT imaging system including a static imaging subsystem prepared in accordance with the principles of the present invention is shown in schematic side elevation view.

[0029] Figure 5A An exemplary collimator is shown in schematic elevation for use in a static scanning subsystem of a CBBCT imaging system prepared in accordance with the principles of the present invention.

[0030] Figure 5B A further exemplary collimator is shown in schematic elevation for use in a static scanning subsystem of a CBBCT imaging system prepared in accordance with the principles of the present invention.

[0031] Figure 5C Another exemplary collimator is shown in a schematic elevation view for use in a static scanning subsystem of a CBBCT imaging system prepared in accordance with the principles of the present invention.

[0032] Figure 5D An exemplary shielded collimator including an adjustable aperture mechanism for use in a static scanning subsystem of a CBBCT imaging system prepared in accordance with the principles of the present invention is shown in schematic elevation.

[0033] Figure 5E An exemplary adjustable aperture mechanism is shown in schematic elevation for use with a static scanning subsystem of a CBBCT imaging system prepared in accordance with the principles of the present invention.

[0034] Fig. 5F Another exemplary adjustable aperture mechanism is shown in schematic elevation for use with a static scanning subsystem of a CBBCT imaging system prepared in accordance with the principles of the present invention.

[0035] Figure 6 A portion of another exemplary CBBCT imaging system including a static imaging subsystem prepared in accordance with the principles of the present invention is shown in schematic side view.

[0036] Fig. 7A A portion of an exemplary CBBCT imaging system including a static imaging subsystem prepared in accordance with the principles of the present invention is shown in schematic side view.

[0037] Figure 7B A portion of an exemplary CBBCT imaging system including a static imaging subsystem prepared in accordance with the principles of the present invention is shown in schematic side view.

[0038] Figure 7C A portion of an exemplary CBBCT imaging system including a static imaging subsystem prepared in accordance with the principles of the present invention is shown in schematic side view.

[0039] Fig.7D A portion of an exemplary CBBCT imaging system including a static imaging subsystem prepared in accordance with the principles of the present invention is shown in schematic side view.

[0040] Fig. 7E A portion of an exemplary CBBCT imaging system including a static imaging subsystem prepared in accordance with the principles of the present invention is shown in schematic side view.

[0041] Figure 8 A portion of an exemplary CBBCT imaging system including a static imaging subsystem prepared in accordance with the principles of the present invention is shown in schematic side view.

[0042] Fig. 9 A portion of an exemplary CBBCT imaging system including a static imaging subsystem prepared in accordance with the principles of the present invention is shown in schematic side view.

[0043] Fig.10 A portion of an exemplary CBBCT imaging system including a static imaging subsystem prepared in accordance with the principles of the present invention is shown in schematic side view.

[0044] Fig.11 A portion of an exemplary CBBCT imaging system including a static imaging subsystem prepared in accordance with the principles of the present invention is shown in schematic side view.

[0045] Fig.12 A portion of an exemplary CBBCT imaging system including a static imaging subsystem prepared in accordance with the principles of the present invention is shown in schematic side view.

[0046] Fig.13 A portion of an exemplary CBBCT imaging system including a static imaging subsystem prepared in accordance with the principles of the present invention is shown in schematic side view.

[0047] Fig.14A A portion of an exemplary CBBCT imaging system including an exemplary effector cane prepared in accordance with the principles of the present invention is shown in schematic perspective view.

[0048] Fig. 14B A portion of an exemplary CBBCT imaging system including a further exemplary effector cane prepared in accordance with the principles of the present invention is shown in schematic perspective view.

[0049] Fig. 14C A portion of an exemplary CBBCT imaging system including a further exemplary effector cane prepared in accordance with the principles of the present invention is shown in schematic perspective view.

[0050] Fig.14D A portion of an exemplary CBBCT imaging system including another exemplary effector cane prepared in accordance with the principles of the present invention is shown in schematic perspective view.

[0051] Fig.15A A portion of an exemplary CBBCT imaging system including an effector with a collimator portion prepared in accordance with the principles of the present invention is shown in schematic perspective view.

[0052] Fig. 15B A portion of an exemplary CBBCT imaging system is shown in a schematic perspective view, including an effector further including a collimator portion prepared according to the principles of the present invention.

[0053] Fig.16 A portion of an exemplary CBBCT imaging system is shown in schematic perspective view, including another effector with a collimator portion prepared according to the principles of the present invention.

[0054] Fig.17 A portion of an exemplary CBBCT imaging system is shown in schematic perspective view, including another effector with a collimator portion prepared according to the principles of the present invention.

[0055] Fig.18A portion of an exemplary CBBCT imaging system including an exemplary flexible effector prepared according to the principles of the present invention is shown in schematic perspective view. DETAILED DESCRIPTION

[0056] The following description is intended to enable anyone skilled in the art to make and use the disclosed invention and sets forth the best mode currently considered by the inventor to carry out his invention. In the following description, for the purpose of explanation, numerous specific details are set forth to provide a thorough understanding of the present invention. However, it is apparent that one skilled in the art will be able to practice the present invention without relying on these specific details.

[0057] It should be noted that while any exemplary embodiments described below will identify specific elements and combinations thereof, these examples are not intended to be definitive. Instead, discrete elements will be combined into integral elements and / or components where appropriate. In addition, the various aspects and features of specific elements described herein as a whole should also be understood as a disclosure of individual elements and components that provide the same properties and / or functions.

[0058] Figure 1 A portion of an exemplary CBBCT imaging system 100 is shown in a cutaway 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 frame 106. The rotating frame 106 is supported by a bearing and is arranged to rotate about an axis of rotation 108.

[0059] The X-ray source 102 is configured to emit a beam of X-rays 110. The beam of X-rays 110 defines a beam longitudinal axis 112 that intersects the axis of rotation 108 at an intersection 114 in the illustrated embodiment.

[0060] In some embodiments of the present invention, beam 110 is configured as a cone beam. In some configurations, a cross section of beam 110 taken transversely along longitudinal axis 112 defines a disk having substantially uniform X-ray intensity and a nearly circular perimeter.

[0061] In other configurations of the invention, a cross section of the beam 110 taken transversely along the longitudinal axis 112 defines a region of substantially uniform X-ray intensity and having a substantially circular perimeter except for a portion located outside a chord of the circular perimeter. As will be appreciated by considering the further disclosure below, in certain embodiments, the chord will be substantially parallel to and spaced apart from the lower surface of the patient table.

[0062] Thus, in some configurations, a cross section of the beam 110 taken transversely along the longitudinal axis 112 defines a truncated disk of substantially uniform x-ray intensity having a perimeter that is substantially truncated circular (i.e., the perimeter is circular except for a horizontal chord at the upper edge of the circle). This configuration optimizes breast imaging while minimizing radiation to chest wall tissue above the breast. In some embodiments, this is accomplished by placing an opaque x-ray collimating plate over a portion of an otherwise circular cross-sectional beam produced by the x-ray source.

[0063] In a further configuration of the present invention, a cross section of the beam 110 taken transversely along the longitudinal axis 112 defines a polygonal perimeter having substantially uniform X-ray intensity, wherein the polygonal perimeter may include a triangular perimeter, a rectangular perimeter, a pentagonal perimeter, a hexagonal perimeter, a perimeter of higher geometry, or a perimeter having any curve or combination of line segments and curves, depending on the requirements of a particular application, in various embodiments and configurations. In addition, it should be understood that any of the above cross-sectional configurations may define a beam having non-uniform intensity, including but not limited to situations where the intensity drops to zero in a certain area or certain areas.

[0064] 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 planar detector having a generally planar receiving surface 118. The receiving surface 118 is generally transverse to the longitudinal axis 112 and is located on the opposite side of the rotation axis 108, away from the X-ray source 102. A skilled person will understand that the described configuration is only one example of many possible arrangements, wherein the X-ray source, X-ray detector and any other components of the system can be supported from above, from the side or in any other manner suitable for achieving the desired functions, and the shape and configuration of the gantry, as well as the shape and configuration of the X-ray detector, will also take on any useful form in various embodiments of the present invention.

[0065] 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 trajectory about the rotation axis 108. In a typical configuration, the trajectory will include at least a portion of a circle located transverse to and centered about the rotation axis 108. However, it should be noted that other trajectories are also considered to be within the scope of the present invention and are disclosed herein.

[0066] In certain embodiments of the present invention, one or both of the x-ray source 102 and the x-ray detector 116 are arranged to be adjustable in 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 adjusted relative to the rotation axis 108 in a radial direction, a circumferential direction, a direction close to or away from the gantry surface 104, or in any other manner deemed advantageous by a designer or user.

[0067] Patient examination couch 120 includes an upper surface 122 and a lower surface 124. A hole 126 connects the upper surface 122 and the lower surface 124 of the patient examination couch. Upper surface 122 is used to support a patient 128, and the patient is usually lying prone on surface 122, as shown. In this arrangement, the breast 130 of the patient under the chest wall hangs downward and passes through hole 126.

[0068] During operation, the rotating frame rotates about the rotation axis 108 to place the X-ray source 102 and the X-ray detector 116 in a path around the patient's breast. During this movement, the X-ray detector 116 captures X-ray image data through corresponding interface electronics and computer systems. The X-ray image data corresponds to a plurality of X-ray images taken at various angular positions around the rotation axis 108. The X-ray image data or a subset thereof is processed in combination to provide information about the internal state of the breast.

[0069] Figure 2 A side perspective view of an exemplary CBBCT imaging system 200 is shown including a static imaging subsystem 202 prepared in accordance with the principles of the present invention.

[0070] 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 support 208. The rotating support 208 is supported by a bearing 210 and is designed to rotate about an axis of rotation 212. The bearing 210 is in turn supported by a structural member 214 of the imaging system 200, or supported by the ground.

[0071] The x-ray source 204 is configured to emit a beam of x-rays 216. The x-ray beam 216 defines a beam longitudinal axis 218 which, in the illustrated embodiment, intersects the axis of rotation 212 (at 220).

[0072] In the exemplary embodiment presented here, the static imaging subsystem 202 has a base portion 222 including a moving device, a first touch panel 224 and a second touch panel 226. The first touch panel 224 has a first breast contact surface area 228. The second touch panel 226 has a second breast contact surface area 230.

[0073] In some embodiments of the present invention, the mobile device includes a first mobile part and a second mobile part. The first mobile part is operatively connected between the base part 222 and the first touch panel 224. The second mobile part is operatively connected between the base part 222 and the second touch panel 226.

[0074] In some embodiments, respective first and second moving portions are capable of moving the first touch pad 224 and the second touch pad 226 toward each other along respective first and second directions 232 and 234 of the base 222 in response to respective first and second input signals. In other embodiments of the present invention, a common input signal is effective to activate the first and second moving portions.

[0075] As the first and second contact pads 224, 226 move toward each other, the respective breast contacting surface areas 228 and 230 contact corresponding surface areas 236 and 238 of the patient's breast 240. Appropriate further displacement of the contact pads 224 and 226 helps provide applanation, support, and stabilization for imaging, as discussed more fully below.

[0076] Figure 3 A portion of an exemplary CBBCT imaging system 300 is shown, in cut-away side cross-sectional view, including a static imaging subsystem 302 made in accordance with the principles of the present invention.

[0077] Similar to system 200 described above, system 300 includes a static imaging subsystem 302 having a base portion 322 including an actuator, a first contact plate 324 with a first breast contact surface area 328 , and a second contact plate 326 with a second breast contact surface area 330 .

[0078] In the illustrated configuration, the breast 332 is flattened in directions 334, 335 and stabilized by the inward thrust of the touch pads 324, 326. Subsequently, the x-ray source 336 generates a beam of x-rays 338 that passes through the first touch pad 324, the breast 332, and the second touch pad 326. The passage of the x-ray beam 338 through the breast 332 creates an attenuation region 340. The attenuated x-ray beam is received by the x-ray detector 342. The x-ray detector 342 in turn generates image data for display as a static image, or for further processing, including, in some cases, blending with the tomographic image data generated by the CBBCT system 300.

[0079] A practitioner with conventional skills will appreciate that the form, configuration, and material of the touch pads will be selected to provide optimal breast applanation and support. Moreover, as discussed further below, in certain embodiments, the touch pads will be configured or selected to applanate a limited area of ​​the breast. Likewise, in certain embodiments, the applanation directions 334 and 335 will be selected to achieve optimal imaging without the degree of compression (and therefore pain) experienced by the patient in conventional mammography.

[0080] In certain aspects and embodiments of the invention, the contact plate (e.g., 324) will be selected to be curved along a vertical axis 344 to more effectively conform to the breast 332 and distribute pressure across the surface of the breast, thereby improving patient comfort in some cases.

[0081] In certain aspects and embodiments of the invention, the degree of flattening of the breast along directions 334, 335 will be selected based on the requirements of a particular imaging procedure or protocol, characteristics of the breast (including but not limited to tissue density), specific pathological conditions suspected to be present, or any other diagnostic or procedural consideration deemed important by the operating medical or technical staff.

[0082] With the above in mind, in certain embodiments and applications of the present invention, the examined breast will be flattened by at least about 2%, at least about 5%, at least about 10%, at least about 20%, at least about 30%, at least about 40%, or at least about 50% in directions 334, 335. In other applications, any desirable, optimized, or appropriately tolerated degree of flattening will be applied.

[0083] Figure 4 A further exemplary CBBCT imaging system 400 is shown in cutaway side view (similar in many respects to system 300) and includes a static imaging subsystem 402. As shown, system 400 includes a collimator subsystem 404.

[0084] The collimator subsystem 404 includes a collimator device 406. The collimator device 406 includes a substantially x-ray opaque portion 408, and an aperture (or a relatively x-ray transmissive portion, i.e., a window, or both) 410 within the relatively x-ray opaque portion 408. Note that the relative terms "relatively opaque" and "relatively transmissive" represent a comparison of the respective elements 408 and 410.

[0085] In the illustrated embodiment, the collimator subsystem 404 includes a collimator coupler 405. The collimator coupler 405 is adapted to be received and coupled to a collimator receiver 407 of the fixed scanning subsystem 402. Thus, the combination of the collimator coupler 405 and the collimator receiver 407 is used to removably couple the collimator subsystem 404 to the fixed scanning subsystem 402 to provide substantial support and positioning.

[0086] In the illustrated embodiment, collimator subsystem 404 is positioned within an X-ray beam 412 generated by an X-ray source 414. During operation, collimator subsystem 404 is positioned such that a first portion 416 of the X-ray beam strikes and is thereby blocked by a corresponding portion 418 of X-ray opaque portion 408.

[0087] A second portion 420 of the x-ray beam 412 passes through the aperture and / or window 410, thereby striking a limited region 422 of the imaged breast 424. The second portion 420 of the x-ray beam 412 is attenuated after passing through the limited breast region 422, and the attenuated x-ray beam is then detected by a corresponding region 426 of an x-ray detector 428.

[0088] The size 430 of the limited breast region 422 exposed to the second portion 420 of the x-ray beam is determined by the corresponding size of the aperture or window 410. Thus, the presence of the collimator subsystem 404 allows for selective imaging of the limited breast region 422, thereby providing additional detail / resolution in that region, while avoiding unnecessary x-ray exposure of the remainder of the breast 424.

[0089] In certain embodiments and aspects, a CBBCT system 400 including a static imaging subsystem 402 and a collimator subsystem 404 will include a collimator subsystem having a repositionable aperture or window 410. Such a repositionable collimator subsystem will in certain aspects allow the aperture / window to be placed and configured at virtually any effective position within the collimator subsystem, thereby allowing selective X-ray illumination of any desired limited breast region 422 while effectively protecting the rest of the breast from unnecessary X-ray exposure.

[0090] In certain embodiments, the placement and configuration of the aperture / window 410 is accomplished by inserting a preconfigured collimator assembly 406 that includes an aperture / window 410 of a particular desired size and / or position into a receptacle of the collimator subsystem 404. When it is desired to irradiate a different area of ​​the breast, the collimator assembly 406 is removed and a differently configured collimator assembly 406 is installed.

[0091] Figures 5A-5F A variety of collimator bodies and configurations are shown, including respective aperture / window arrangements, each of which would be mounted in a single collimator subsystem 404 to achieve a desired beam area configuration (e.g. Figure 4 420 shown in FIG.

[0092] In the context of the above discussion, Figures 5A-5F Various exemplary collimator configurations are schematically shown, which are within the scope of the present invention and are consistent with the above-mentioned Figure 4The example collimator 406 is similar to .

[0093] Figures 5A-5C Exemplary collimators with various aperture positions and sizes are shown in schematic perspective views, respectively.

[0094] refer to Figure 5A , the collimator 500 includes a collimator surface area 502. An inner circumferential edge 504 defines a collimator aperture 506 through the collimator. Consistent with the above discussion, the aperture 506 is designed to accommodate a patient's breast to be imaged. In the illustrated configuration, the collimator aperture 506 is located to the left of a longitudinal centerline 508 of the collimator 500. Thus, in typical operation of the CBBCT imaging system, the left side of the patient's breast will pass through the collimator aperture 506 during imaging.

[0095] Figure 5B A collimator 512 is shown that is similar to collimator 500. Like collimator 500, collimator 512 also has an inner circumferential edge 514 that defines a collimator aperture 516 through collimator 512. Similar to aperture 506, aperture 516 is located to the left of a longitudinal centerline 518 of collimator 512. However, diameter 520 of aperture 506 is relatively small and is larger than a corresponding diameter 522 of aperture 516.

[0096] Figure 5C A collimator 526 is shown that is similar to collimators 500 and 512. As with collimator 500, collimator 526 has an inner circumferential edge 528 that defines a collimator aperture 530 through collimator 526. Similar to aperture 506, aperture 530 has a diameter 532 that is substantially equal to the corresponding diameter 522 of aperture 516. However, the center of aperture 530 is substantially coincident with a centerline 534 of collimator 526. Thus, while apertures 506 and 516 are primarily configured to receive images from the left side of a patient's breast, aperture 530 is suitable for receiving images from either the left or right side of the breast.

[0097] Those skilled in the art will also recognize that the symmetry of the illustrated panels will be exploited in various embodiments of the present invention so as to image, for example, the left or right side of a breast by symmetrically rotating the collimator 500 or 512 about the centerline 508 and 518, respectively, provided that appropriate peripheral configuration and coupling features are provided.

[0098] Likewise, rotation of the panel about a centerline lateral axis can be used to position the aperture shown relatively higher or lower, adjusting for the needs of taller or shorter breasts.

[0099] In view of the above discussion, the reader will appreciate that in certain embodiments, multiple collimators will be provided for use with an imaging system so that a collimator having an appropriate aperture can be selected based on the patient's height, weight, breast size, and other parameters.

[0100] In another aspect embodiment of the invention, a single reusable collimator will be purchased so that it is available when needed. In other embodiments of the invention, a disposable collimator will be used for a single use per patient and then discarded.

[0101] Figs. 5D-5F show schematic representations of another collimator 550 made in accordance with the principles of the present invention. The collimator 550 is shown in a cut-away view and illustrates an adjustment mechanism 552 included in the collimator 550.

[0102] In the exemplary embodiment shown, the adjustment mechanism 552 includes a mechanical aperture mechanism 554. The adjustable aperture mechanism 554 includes a plurality of blade elements, such as 556 and 558, connected to corresponding operative links 560 and 562, respectively. A skilled artisan will recognize the adjustable aperture mechanism 554 as being similar in form and function to an aperture mechanism used for a camera. Thus, by operating the links 560 and 562, the blade elements 556 and 558 will be urged to rotate, thereby adjusting the diameter of the aperture 564 to a desired value as required for imaging a particular patient's breast.

[0103] By further explanation, in Figure 5E In FIG. 5 , the exemplary aperture mechanism 570 is adjusted and configured to present an aperture 572 having a relatively small diameter 574. Fig. 5F , the exemplary aperture mechanism 570 is adjusted and configured to present the same aperture 572 , but with a relatively larger diameter 576 .

[0104] In certain embodiments, Figure 5D The shielding aperture 550 in the embodiment will be manually adjusted by directly operating the blades (blade elements). In other embodiments, an adjustment mechanism will be provided to reconfigure the blade elements. In other embodiments of the present invention, an automatic adjustment mechanism will be provided to automatically adjust the blade elements, thereby automatically adjusting the size of the aperture.

[0105] In certain embodiments of the present invention, the automatic adjustment mechanism of the blade element will include a linear actuator. In such embodiments, and throughout the application, the linear actuator will include a wide variety of actuators. For example, in certain embodiments, the extension mechanism will include one or more gear and rack arrangements; Acme screws and nuts; ball screw arrangements; linear stepper motors; lateral complementary ramps; pneumatic cylinders; pneumatic air bags; pneumatic bellows; hydraulic cylinders; hydraulic air bags; hydraulic bellows; scissor linkage mechanisms, including scissor linkage mechanisms operated, for example, by lead screws, cylinders, or other actuators discussed herein, or any other suitable actuator; a Sarus linkage mechanism; a thermoelectric actuator; a shape memory alloy actuator; a cable and pulley arrangement; a compression spring; an extension spring; a torsion spring; a blade spring assembly; a spring including a plurality of Belleville washers; or any other linear actuator element, now known or to be discovered in the future, that is suitable for the requirements of a particular application and provides the desired extension and retraction function.

[0106] Thus, for example, in certain embodiments of the invention, the linear actuator will include one or more electromagnets, pneumatic cylinders, hydraulic cylinders, pneumatic airbags, hydraulic airbags, linear motors, linear stepper motors, rotary actuators, and: Acme screws and nuts, lead screws, ball screws, cables, pulleys, timing belts, timing pulleys, appropriately sized worm gear reducers, rack and pinion arrangements, rack and worm arrangements; piezoelectric actuators, piezoelectric actuators combined with ratchet and pawl actuators, spring loaded actuators, actuators including shape memory alloys, and any of a wide range of manual actuators, such as hand cranks and / or ratchet levers, and any other appropriately functional drive components known in the art or discovered in the future.

[0107] Fig. 6 shows a schematic cut-away side view of a further exemplary CBBCT imaging system 600 (similar in many respects to system 400 ) that includes a static imaging subsystem 602 and a collimator subsystem 604 .

[0108] In the illustrated exemplary system 600, the collimator subsystem 604 includes a collimator translation portion 606 and a collimator assembly 608. The collimator translation portion 606 is coupled to and supports the collimator assembly 608. The collimator translation portion 606 is operable to adjust the position of the collimator assembly 608 relative to an x-ray source 612 and a breast 614 being imaged, and thereby relative to an x-ray beam 616 generated by the x-ray source 612.

[0109] It will be apparent to a person skilled in the art that adjusting the collimator assembly 608 between the first position 618 and the second position 620 will result in illuminating corresponding different regions 624 in the breast 614 at a particular opening / window configuration.

[0110] In certain embodiments, it may be desirable to have multiple collimator devices (eg, collimator device 608).

[0111] The system 600 also includes an imager (x-ray detector) moving portion 630. The imager moving portion 630 is connected to and supports an imager 632. The imager moving portion 630 can adjust the position of the imager 632 relative to the x-ray source 612 and the breast 614 being imaged, and thus adjust it relative to the x-ray beam portion 637 generated by the x-ray source 612.

[0112] It will be apparent to the skilled person that, under a particular collimator arrangement 608 configuration, adjusting the position of the imager 632 between the first position 636 and the second position 638 will result in corresponding different regions 640 and 642 of the imager 632 being illuminated.

[0113] Fig. 7A A schematic perspective view of a CBBCT imaging system 700 is shown including a static imaging subsystem 702 prepared in accordance with the principles of the present invention.

[0114] Similar to system 200 and other systems described above, system 700 includes an x-ray source 704. X-ray source 704 is mounted on an upper surface 706 of a rotating support 708. Rotating support 708 is supported by a bearing 710 and is arranged to rotate about an axis of rotation 712. Bearing 710 is in turn supported by structural components of imaging system 700, or supported by the ground.

[0115] The X-ray source 704 is configured to emit an X-ray beam 716. The X-ray beam 716 defines a beam longitudinal axis 718 that, in the illustrated embodiment, intersects the rotation axis 712 (at 720).

[0116] In the illustrated embodiment, the upper surface 706 of the rotating bracket 708 includes an inner circumferential edge 722. The inner circumferential edge 722 defines an opening 724 through the upper surface 706 of the bracket 708.

[0117] In some embodiments, the rotating support 708 includes a slip ring for transmitting power and / or electronic signals and / or optical signals on and outside the support. In some embodiments, the opening of the slip ring is generally coaxial with the opening 724 of the support 708.

[0118] In other embodiments, information and control signals are communicated within and outside the stent via wireless modulated electromagnetic radiation signals, including but not limited to any radio frequency, microwave and / or optical frequency electromagnetic radiation.

[0119] In the illustrated embodiment, the rotating device 726 is positioned within the aperture 724. In certain aspects and embodiments of the invention, the rotating device 726 is supported by a structural member of the imaging system 700, or by the ground.

[0120] As shown, the exemplary rotation device 726 has an upper surface 728. The rotation device 726 allows the upper surface 728 to be rotated about the rotation axis 712 relative to the ground, or relative to the longitudinal axis 718 of the x-ray beam 716 (and the rotating frame 708 and x-ray source 704).

[0121] Thus, in certain embodiments, the upper surface 728 of the rotating device 726 will rotate independently of the upper surface 706 of the rotating frame 708. In further embodiments and aspects, the upper surface 728 of the rotating device 726 will remain stationary within the room, while the upper surface 706 of the rotating frame 708 will rotate relative to the room. In other embodiments and aspects, the rotation of the upper surface 728 of the rotating device 726 will be synchronized with the rotation of the upper surface 706 of the rotating frame 708, and in other embodiments, the upper surface 728 of the rotating device 726 will rotate in the opposite direction relative to the upper surface 706 of the rotating frame 708.

[0122] In some embodiments, differential rotation and / or co-rotation of upper surface 728 relative to upper surface 706 will be controlled by using, for example, a rotational drive, including an electric motor (e.g., a squirrel cage motor, a flat motor, or a capacitor start motor), a stepper motor, a hydraulic motor, a pneumatic motor, a spring motor, a piezoelectric motor, a gear drive (e.g., one or more pinion gears or one or more worm gears), a ratchet drive mechanism, a chain and sprocket mechanism, a belt and pulley mechanism, and a timing belt and timing pulley mechanism, including any combination of the foregoing and other appropriate devices and / or mechanisms, any of which are known or later available to skilled technicians.

[0123] In certain embodiments, differential rotation and / or co-rotation of upper surface 728 relative to upper surface 706 is controlled using output signals of a system digital computer and / or system digital controller. In other aspects and embodiments, differential rotation and / or co-rotation of upper surface 728 relative to upper surface 706 is controlled using dedicated hardware, such as embedded dedicated motion control hardware, including motion control integrated circuits, power amplifiers, feedback elements (e.g., limit switches, Hall effect sensors, optical sensors, resolvers, optical encoders, resistive encoders, etc.), which are used to implement general motion control and / or phase-locked loop control.

[0124] In other embodiments and aspects, differential rotation and / or co-rotation of upper surface 728 relative to upper surface 706 will be controlled by a mechanical coupling between upper surface 728 and upper surface 706. In certain embodiments, the mechanical coupling will be controllable according to manual and / or automatic configuration and control, and in certain embodiments, the mechanical coupling includes one or more of: an electromagnetically controlled lock, a rotary motor controlled lock, a pneumatically controlled lock, a hydraulically controlled lock, a manually operated lock, a gear train, a drive chain, a belt or timing belt, a mechanical, hydraulic or electrical clutch, any combination of the above, and any other suitable mechanism, which is known or available in the future, suitable for the needs of those skilled in the art.

[0125] The static imaging subsystem 702 has a base portion 730 including a transmission device, a first touch plate 732 and a second touch plate 734. In the exemplary illustration of the system 700, the base portion 730 is connected to and supported by the upper surface 728 of the rotating device 726.

[0126] In the example shown, the first contact pad 732 has a first breast contact surface area 736. The second contact pad 734 has a second breast contact surface area 738.

[0127] In some embodiments, the transmission device includes a first transmission portion and a second transmission portion. The first transmission portion is operatively coupled between the base portion 730 and the first contact plate 732. The second transmission portion is operatively coupled between the base portion 730 and the second contact plate 734.

[0128] As previously described, during CBBCT imaging, the gantry 708 rotates about the rotation axis 712, carrying the x-ray source 704 and the imager 740, which are placed and supported on the upper surface 706, or otherwise coupled and supported to the gantry 708, and moves along the orbital path 742 of the rotation axis 712, while the breast 744 being imaged remains stationary in the breast reference frame 746.

[0129] According to the understanding of the skilled person, depending on the material, arrangement and configuration of the touch panels 732 and 734, in some cases, it is more desirable that the x-ray beam 716 does not pass through the touch panels 732 and 734 during CBBCT imaging. Instead, the touch panels will move out of the path of the x-ray beam 716 during CBBCT imaging and only be in the path of the x-ray beam 716 during static imaging. Fig. 7A As shown, static imaging subsystem 702 of system 700 is configured in an idle configuration with breast contact surfaces 736 and 738 generally parallel to beam length axis 718 of x-ray beam 716 and static scanning subsystem's operational rotation axis 712 generally transverse to beam length axis 718 .

[0130] In the idle configuration shown, the x-ray beam 716 passes through the breast 744 and is projected directly onto the imager 740 with little substantial effect on the touch pads 732 and 734. The skilled person will appreciate that in order to maintain this relationship during a CBBCT scan, the rotation device 726 will rotate the upper surface 728 and coordinate the rotation with the upper surface 706 throughout the CBBCT scan. The skilled person will appreciate that this coordination can be maintained throughout the length of the rotation path 742, whether the rotation path passes through the reference frame 746 360°, 180°, or any other angular range as required by a particular CBBCT imaging protocol.

[0131] It is also noted that, as discussed above, such coordination between surfaces 728 and 706 may be maintained in various embodiments by mechanical, electronic, or other control means.

[0132] In contrast, when static imaging is desired, the spatial relationship between the upper surfaces 728 and 706 will be decoupled to allow the surface 728 to be rotated relative to the surface 706. Thus, the surface 706 will be rotated to present the desired orientation between the longitudinal axis 718 and the breast reference frame 746 to capture the desired static image through the corresponding cross-section of the breast 744. At the same time, the rotation device 726 will rotate the surface 728 to position the static imaging subsystem 702 so that the surfaces 736, 738 contacting the breast are approximately perpendicular to the longitudinal axis 718 (at this time in the orientation corresponding to the breast reference frame 746).

[0133] This repositioning of upper surface 728 from upper surface 706 enables static imaging subsystem 702 to be Fig. 7A The idle configuration shown in is adjusted to the imaging configuration in the subsequent discussion.

[0134] Figure 7B Further aspects of a CBBCT imaging system 700 are shown in schematic perspective view, including a static imaging subsystem 702 prepared in accordance with the principles of the present invention and in a static imaging configuration.

[0135] As shown, the rotating frame 708 has been rotated about the rotation axis 712 and is arranged relative to the system reference frame 746 to place the x-ray source 704 in a desired relationship with the target breast 744. Therefore, the longitudinal axis 718 of the x-ray beam 716 generated by the x-ray source 704 is generally transverse to (and generally perpendicular to) a desired cross-section 750 of the breast 744 (as identified relative to the system reference frame 746).

[0136] As shown, the static scanning subsystem 702 has been rotated about the rotation axis 712 and arranged relative to the system reference frame 746 so that the breast contact surface areas 736 and 738 are in a desired relationship with the target breast 744. Therefore, the longitudinal axis 718 of the x-ray beam 716 generated by the x-ray source 704 is arranged generally transverse to (and generally perpendicular to) the breast contact surfaces 736 and 738 (as indicated relative to the system reference frame 746). That is, the static scanning subsystem 702 is in a scanning orientation in relationship to the x-ray source 704 and the imager 740.

[0137] Subsequently, with the above Figure 3 , a drive mechanism within the base 730 of the static scanning subsystem 702 is activated to push the touch plates 732 and 734 inwardly in the directions 752 and 754 of the breast 744, respectively. The resulting stabilization and, if desired, flattening of the breast 744 will be further described below.

[0138] Figure 7C Further aspects of a CBBCT imaging system 700 are shown, including a static imaging subsystem 702, in accordance with the principles of the present invention.

[0139] and Figure 7B The configuration of the system 700 shown in FIG. Figure 7C 7, the static scanning subsystem 702 has been rotated about the rotation axis 712 and aligned with respect to the system reference frame 746 to place the breast contact surface areas 736, 738 in a desired relationship to the examined breast 744. Thus, the x-ray source 704 will generate an x-ray beam 716 whose longitudinal axis 718 is generally perpendicular (and generally normal in relationship to the system reference frame 746) to the two breast contact surfaces 736, 738. That is, the static scanning subsystem 702 is in a scanning direction with the x-ray source 704 and the imager 740.

[0140] In the illustrated example, a drive mechanism disposed within the base 730 of the static scanning subsystem 702 has been activated to propel the contact plates 732, 734 inwardly in directions 752, 754, respectively, toward the breast 744. These forces tend to compress the breast 744 along a cross-section 750 of the breast and stabilize the breast to prevent unwanted movement.

[0141] As a result, the breast is flattened to a certain extent to produce, for example, the cross-section 756 shown (which exhibits a generally flat elliptical shape in a direction perpendicular to the rotation axis 712).

[0142] Of course, the reader will appreciate that some of the actual operation of the methods and apparatus described herein may be difficult to implement. Figure 7CThe images in the drawings may be exaggerated for clarity, and the actual breast cross-section will depend on the configuration of the particular breast, the parameters applied to the system, including the degree of breast flattening, the orientation of the various components, etc. Nevertheless, it will be apparent to one of ordinary skill that operation of the systems described herein will result in stabilization, and in some cases reorientation and / or repositioning of breast tissue, thereby desirably improving the resulting transverse static image.

[0143] Fig.7D Further aspects of a CBBCT imaging system 700 are shown in schematic perspective view, including a static imaging subsystem 702 in accordance with the principles of the present invention.

[0144] Reference again Figure 7C and the system 700 configuration shown therein, in Figure 7C After static imaging is performed in the configuration, that is, the longitudinal axis 718 of the x-ray beam is roughly parallel to the axis 760 of the system reference system 746, the first touch plate 732 and the second touch plate 734 are retracted in the directions 762 and 764 respectively by operating the actuator of the static scanning subsystem, thereby releasing the breast 744.

[0145] After the breast 744 is released by the touch pad, the static scanning subsystem 702 rotates around the rotation axis 712 to Fig.7D Similarly, hinge 708 is also rotated to Fig.7D direction shown.

[0146] The reader will appreciate that the rotation of the static imaging subsystem 702 and the hinge 708 may occur simultaneously or sequentially, with either the static imaging subsystem 702 or the hinge 708 rotating first.

[0147] After completing the rotation, the x-ray source 704 is configured as shown, with the longitudinal axis 718 of the x-ray beam 716 perpendicular to the corresponding contact surfaces 736, 738, respectively contacting the contact surfaces 732, 734. However, it should be noted that the longitudinal axis 718 of the x-ray beam is now in a new direction, generally parallel to the axis 762 of the system reference frame (with respect to the axis 762 of the system reference frame). Figure 7C Thus, system 700 is configured to image breast 744 through cross-section 764 rather than through cross-section 750.

[0148] To perform such imaging, in certain embodiments, including processes and methods according to the present invention, a drive mechanism of static imaging subsystem 702 is activated to push contact surfaces 732 and 734 toward breast 744 in directions 766 and 768, respectively.

[0149] therefore, Fig. 7ESystem 700 is shown with breast 744 compressed and prepared for static imaging, with longitudinal axis 718 of x-ray beam 714 parallel to axis 762 .

[0150] In view of the above, the skilled artisan will appreciate that in addition to performing CBBCT imaging of the breast, a system prepared in accordance with the present invention can also perform one or more static scans in a desired orientation relative to the system reference frame. Furthermore, the results of the static scans can be viewed independently or used in combination with CBBCT data to provide an overall improvement to the CBBCT imaging results. Either or both of these applications will provide numerous benefits, including improved imaging of calcifications and vascular structures within the breast.

[0151] It will be apparent to the skilled person that in certain embodiments and aspects of the invention, the system may be simplified by employing a touch panel that is relatively transparent to the system's X-ray beams. Thus, in certain embodiments of the invention, the touch panel will be permanently aligned with the system's X-ray beam, i.e., in an imaging configuration, rather than in an idle configuration when a CBBCT scan is in operation, when a static scan is not being performed.

[0152] Figure 8 An example system is shown in which a CBBCT system 800 includes a static scanning subsystem 802. The base 804 of the static scanning subsystem is substantially permanently fixed to an upper surface 806 of a rotating frame 808 and always rotates with the rotating frame.

[0153] therefore, Figure 8 The rotating frame of system 800 in FIG. 8 does not require the inner ring 724 of system 700. The rotating device 726 is also not used in system 800. Instead, the static scanning subsystem 802 is permanently fixed, and the touch panels 810 and 812 are arranged generally perpendicular and transverse to the longitudinal axis 814 of the x-ray beam throughout the CBBCT scanning and static scanning imaging processes.

[0154] When a static scan is desired, the rotating frame 808 is positioned and stopped so that the desired orientation is established between the longitudinal axis 814 and the breast reference frame 818. Thereafter, the translation mechanism within the base 804 of the static scanning subsystem 802 is activated to push the contact plates 810 and 812 inwardly, toward the patient's breast 820, in directions 822 and 824, respectively. Once the breast is contacted and properly applanated, imaging proceeds as described above.

[0155] After the static scan is completed, the translation mechanism moves the touch plates in the opposite direction to release the breast. Thereafter, further rotation of the rotating frame 808 about the rotation axis 826 will allow additional CBBCT scans to be performed or reorient the system for additional static scans.

[0156] A skilled artisan will appreciate that in all embodiments described herein, appropriate safety interlocks will be provided to ensure that the breast is released from any contact plate prior to any movement of the rotating frame 808 or any static scanning subsystem rotating device. Such safety interlocks will be implemented as one or more mechanical interlocks, motor interlocks, electromagnetic interlocks, pneumatic interlocks, hydraulic interlocks, or any other interlocks that are effective and applicable in a particular situation.

[0157] Fig. 9 Further aspects of a CBBCT imaging system 900 are shown in schematic perspective view, including a static imaging subsystem 902 prepared in accordance with the principles of the present invention, the subsystem being in a static imaging configuration.

[0158] The system 900 is similar to the system 800 described above in that the base 904 of the static imaging subsystem 902 is maintained in a substantially fixed relationship with the gantry 906. Therefore, the static imaging subsystem 902 rotates in strict synchronization with the gantry 906 at all times.

[0159] However, system 900 differs from system 800 in its touch panels. Unlike touch panels 810, 812 in system 800, which are permanently aligned with x-ray beam 816 so that x-ray beam 816 impacts touch panels 810, 812 whenever the x-ray source is activated, touch panels 908, 910 in system 900 are configured to move into the path of x-ray beam 912 only when a static scan is being performed.

[0160] Thus, in the illustrated embodiment, effector panels 908 and 910 are hingedly connected to base 904 by respective hinges 914 and 916. In this manner, effector panels 908 and 910 will remain in the idle configuration shown until required for static imaging.

[0161] When static imaging is desired, effector panels 908 and 910 are designed to rotate to a position that places them within x-ray beam 912 and into contact with the x-ray beam. Figure 8 Similar imaging configuration.

[0162] Skilled professionals will understand that such articulated configuration of effector panels 908 and 910 will be achieved in various embodiments by corresponding articulation mechanisms, whether through magnetic, electric, hydraulic, pneumatic or other automatic control methods, or through manual reconfiguration by technical or medical personnel.

[0163] It will also be appreciated that the articulation mechanism shown is only one of many mechanisms and arrangements for placing the static scanning subsystem in an idle configuration. These mechanisms and arrangements certainly include the above Figure 8 A and 8B, as well as many other arrangements that will become apparent in the subsequent description.

[0164] Fig.10 Further aspects of a CBBCT imaging system 1000 are illustratively shown, including a static imaging subsystem 1002 prepared in accordance with the principles of the present invention and in a static imaging configuration.

[0165] The imaging system 1000 includes a rotating frame 1004 having an upper surface 1006. The upper surface 1006 includes first 1008 and second 1010 inner circumferential edges defining first 1012 and second 1014 recesses in the rotating frame 1004.

[0166] Notably, recesses 1012 and 1014 are intended to receive respective first 1016 and second 1018 contact pads so that the contact pads are in an idle configuration. In the idle configuration shown, contact pads 1016 and 1018 are substantially out of the path of X-ray beam 1020 when X-ray source 1022 of system 1000 is in operation.

[0167] It will also be apparent that when a static scan is desired, the rotating frame 1004 can be placed in a desired orientation relative to the breast reference frame 1024. While in this orientation, appropriate mechanisms within the base 1026 of the fixed scanning subsystem 1002 will correspondingly raise the touch panels 1016 and 1018, advancing them in directions 1028 and 1030, respectively. Thus, the touch panels 1016 and 1018 will be brought into proximity with the breast 1032 to be imaged, similar to the Fig.7D The arrangement shown is arranged. Subsequently, the touch plate will be pushed inwardly close to the breast, and the specific method will be easy to understand based on the above description.

[0168] Of course, after reading this document, a person skilled in the art will be able to quickly and immediately understand a wide range of other methods and mechanisms by which the touch panels will be positioned in the operational configuration and alternately positioned in the respective idle configurations in the corresponding embodiments of the present invention. Likewise, a person skilled in the art will readily recognize that the specific implementations presented herein are merely exemplary, and that the static imaging subsystem need not have a separate base, and that any necessary mechanisms may be part of the patient examination couch or otherwise integrated into the rotating frame to achieve the desired operation of the touch panels.

[0169] Furthermore, the touch panel need not be the touch panel described and illustrated above, but may be any desired touch panel configuration, such as Fig.11 The handle shown and described.

[0170] Fig.11 Further aspects of a CBBCT imaging system 1100 are illustratively illustrated, including a static imaging subsystem 1102 prepared in accordance with the principles of the present invention and in a static imaging configuration.

[0171] The static imaging subsystem 1102 includes a feeler handle 1104 and a touch pad 1106. The reader will immediately understand that in different embodiments and applications of the present invention, a variety of feelers will be used to apply pressure to the selected breast area 1108 to improve imaging results. In addition, in some embodiments, two feelers may be used instead of the single feeler handle and single touch pad shown.

[0172] In the illustrated embodiment, the touch handle 1104 and the touch pad 1106 include respective couplers, such as 1107. The coupler 1107 is adapted to be received and connected to respective receivers (e.g., 1110, 1112) of the static scanning subsystem 1102. Thus, the combination of the coupler (e.g., 1107) and the receiver 1110 is used to removably connect the touch surface (e.g., 1106) to the static scanning subsystem 1102 to provide substantial support and positioning.

[0173] In other embodiments of the invention, the static imaging subsystem will be adapted to receive and use a variety of interchangeable touch handles and touch panels to meet the requirements of specific imaging situations. In other aspects of the invention, the selection and positioning of the touch surface (whether it is a rod or a panel) will be done manually in some embodiments and automatically by the corresponding mechanism of the system 1100 in other embodiments.

[0174] In further aspects of the invention, the handles and touch pads will be rotated or lifted into position as required for a particular patient imaging situation. In other aspects and embodiments of the invention, the handles and touch pads will be delivered to their proper positions from a storage box installed in or built into the system. In further aspects and embodiments of the invention, the handles and touch pads will comprise biocompatible materials. In other aspects and embodiments of the invention, the handles and touch pads will be disposable, and in other embodiments and aspects, the handles and touch pads will be easily sterilized.

[0175] Fig.12 Further aspects of a CBBCT imaging system 1200 are illustratively illustrated, including a static imaging subsystem 1202 prepared in accordance with the principles of the present invention, the subsystem being in a static imaging configuration.

[0176] Static imaging subsystem 1202 includes two feelers 1204 and 1206, one on each side of an imaged breast 1208. For illustrative purposes, a cross-section of breast 1210 shows local curvatures 1212 and 1214 of peripheral edge 1216 thereof, indicating relative local flattening of the breast due to local contact between feelers 1204 and 1206 and respective breast surface areas.

[0177] It will also be appreciated that the individual stems 1204 will have specific characteristics and parameters including, for example, the size and shape of the probe stem, the flexibility, elasticity, softness of the shaft 1220 , and the size, shape, elasticity, and rheological properties of the contact head 1218 .

[0178] In light of the above, professionals in the industry will recognize that through careful selection of haptic elements and their respective properties, a variety of desired effects can be achieved for breast stabilization and / or flattening, thereby providing better imaging results as required by a specific patient or protocol.

[0179] Fig.13 Further aspects of a CBBCT imaging system 1300 are shown, including a static imaging subsystem 1302 prepared in accordance with the principles of the present invention and in a static imaging configuration.

[0180] The static imaging subsystem 1302 includes two handles 1304, 1306 and a shielded collimator 1308. The typical shielded collimator 1308 shown includes a relatively X-ray opaque panel portion 1310 having a peripheral edge 1312. A proximal surface region 1314 of the shielded collimator 1308 is located within the peripheral edge. A distal surface region 1316 of the shielded collimator 1308 is spaced from the proximal surface region 1314.

[0181] An inner peripheral edge 1318 of the proximal surface region 1314 surrounds and defines an aperture 1320 between the proximal surface region 1314 and the distal surface region 1316. In certain embodiments, a window of relatively x-ray transparent material is placed within the aperture 1320.

[0182] In certain embodiments, as shown, the aperture 1320 is aligned with the head 1322 of the stem 1304 as shown.

[0183] In other embodiments of the invention, the fixed imaging subsystem will be adapted to receive and work with various touch handles and touch panels in an interchangeable manner to meet the requirements of a particular imaging situation. In other aspects of the invention, the selection and positioning of the touch surface (whether handle or panel) will be done manually in some embodiments and automatically by the corresponding mechanism of the system 1300 in other embodiments.

[0184] Figures 14A-14D Schematic perspective views of various exemplary feeler handles and feeler pads suitable for use with an exemplary fixed imaging subsystem of a CBBCT imaging system prepared in accordance with the principles of the present invention are shown.

[0185] Fig.14AAn exemplary feeler handle 1400 is shown having a head 1402 with a patient contacting surface area 1404. The patient contacting surface area 1404 is generally planar with a generally rectangular peripheral edge 1406. The reader will note that this is different from the Fig.11 This is in contrast to the generally rounded peripheral edge shown for the center handle 1104 .

[0186] The shaft portion 1408 of the handle 1400 is connected to the head portion 1402. In the illustrated embodiment, the shaft portion 1408 has a longitudinal axis 1410. The cross-section of the shaft portion 1408 taken transversely of the longitudinal axis 1410 is generally rectangular.

[0187] It should be noted, particularly with reference to the following examples, that the patient contacting surface area 1404 is not necessarily planar and that the cross-section of the shaft portion 1408 is not necessarily rectangular. It should also be noted that the feeler handle 1400, including the shaft portion 1408 and the head portion 1402 of the feeler handle 1400, will be formed as an integral unit in some embodiments and as an assembly of components in other embodiments.

[0188] Fig. 14B A further example of a feeler handle 1410 is shown, having a head portion 1412 and a shaft portion 1414. In the feeler handle 1410, the head portion 1412 includes a patient contacting surface area 1416, which is generally annular in shape. Thus, the patient contacting surface area 1416 defines an aperture 1418.

[0189] In the illustrated embodiment, the shaft portion 1414 has a longitudinal axis 1420. The cross-section of the shaft portion 1414 taken along a direction perpendicular to the longitudinal axis 1420 is generally circular. However, as previously described, in different embodiments, the cross-section may be rectangular, oval, or any other geometric shape to produce operating characteristics that are considered advantageous in the context of a particular embodiment, patient, or protocol.

[0190] In some embodiments, a window of relatively X-ray transparent material is placed within hole 1418. In some embodiments, it is advantageous to include relatively X-ray opaque material in the remainder of the effector rod. In other embodiments of the invention, the entire handle / rod assembly will include relatively X-ray transparent material.

[0191] In some embodiments, the feeler handle will comprise a relatively flexible material. In other embodiments of the invention, the feeler handle will comprise a relatively rigid material. Thus, the overall characteristics of a particular implementation can be achieved by appropriate selection of materials depending on the particular design, such as providing cushioning and / or deflection to increase patient comfort and other obvious functional aspects, which will be apparent to a person of ordinary skill.

[0192] Fig. 14C Another exemplary handle 1430 is shown having a head 1432 and a stem 1434. In the illustrated embodiment, the head includes a first generally convex surface region 1436 and a second generally concave surface region 1438. A peripheral surface region 1440 is located between edges 1442, 1444 of the first surface region 1436 and the second surface region 1438, respectively.

[0193] As shown, edges 1442 and 1444 are generally rounded, and curved regions 1436 and 1438 are generally hemispherical. Based on the overall content of this disclosure, it will be apparent that other shapes and forms will be used in corresponding embodiments.

[0194] Additionally, in some embodiments, surface region 1438 will be substantially flat, such that the area within annular edge 1442 is substantially disk-shaped. Some such embodiments will contain generally solid material in the spatial region between surface regions 1436 and 1438. In other embodiments, there will be a cavity between surface regions 1436 and 1438, which cavity may be evacuated, filled with air, or filled with other materials having desirable properties in various embodiments.

[0195] A skilled artisan will appreciate that either surface area 1436 or 1438, or a combination of both, will be used as the patient contacting surface area depending on the requirements of a particular patient or protocol.

[0196] Fig.14D Another exemplary feeler handle 1450 is shown, having a head 1452 and a shaft 1454. The head 1452 includes a patient contact surface area 1456, having an outer edge 1458. The edge is shown to have an arbitrary curvature. In view of the above, it is apparent that the outer edge can have any geometric shape in various embodiments, or present a regular or irregular curve as required by a particular patient or protocol.

[0197] Additionally, it is an aspect of the present invention that in certain embodiments, the shape and / or curvature of the outer edge 1458 and the contact surface area 1456 will be selected and / or prepared based on the requirements of a particular patient. Thus, for example, the handle 1450 will have an edge curvature 1458 designed for a particular patient based on parameters such as the presence and / or geometry of a region of interest within the breast to be imaged.

[0198] In certain aspects of the invention, such customized haptic 1450 will be fabricated using conventional machining processes. In other embodiments of the invention, customized effectors may be fabricated by die forming, compacted powder processes, electrochemical machining, electrospark machining, laser machining, subtractive machining (including, for example, photolithography or lithography processes), additive machining (including, for example, 3D printing of thermoplastic polymers, laser sintering of particles, laser curing of polymers), or any other known or emerging process suitable for the requirements of the customized effector rod, including combinations of these methods.

[0199] Fig.15A Another exemplary stylus 1500 is shown having a head 1502 and a shaft 1504. The head 1502 includes a patient-contacting proximal surface region 1506, and an outer peripheral edge 1508. In the example shown, a distal surface region 1510 is in a generally parallel spaced relationship with the proximal surface region 1506.

[0200] In the exemplary embodiment shown, the peripheral edge 1508 is surrounded by a border and supports a generally pyramidal shaped shield collimator 1512. The shield collimator 1512 will, in the exemplary embodiment, comprise a relatively radiopaque material and will function to significantly reduce the transmission of X-rays toward the imaged breast, except in the region of the proximal surface region 1506.

[0201] As is apparent from the figure, the shielded collimator 1512 is generally concave when viewed from a distal perspective. However, the skilled person will appreciate that in other embodiments of the present invention, the shielded collimator may be convex when viewed from a distal perspective. In other embodiments, the shielded collimator may also be substantially planar. In further embodiments of the present invention, the shape of the peripheral edge and surface area of ​​the shielded collimator may be considered beneficial in any form, depending on the requirements of a particular patient or protocol.

[0202] Fig. 15B Another exemplary feeler handle 1550 is shown having a head 1552. The head 1552 includes an outer peripheral edge 1554. The head 1552 is connected to a shield collimator 1556 at the outer peripheral edge 1554. The shield collimator has an outer peripheral edge 1558 and includes a connector 1560 at a lower portion 1562 of the outer peripheral edge 1558.

[0203] The structural features of the shielded collimator 1556 allow, in certain embodiments, the connector 1560 to be directly connected to the static scanning subsystem of the CBBCT imaging system, and the shielded collimator to directly support the head 1552 of the effector probe 1550. Therefore, in such embodiments, a separate feeler handle portion is not required or necessary.

[0204] Skilled practitioners will appreciate that while the example stem 1550 illustrates a generally rectangular head 1552 and a generally tapered shield collimator 1556, components or portions having any suitable features are apparent from this disclosure and are therefore considered to be within the scope thereof.

[0205] So, for example, Fig.16 A handle 1600 is shown in schematic cross-sectional perspective view having a head portion 1602 having a generally convex proximal surface 1604 with a patient contacting surface region 1606. A generally convex distal surface region 1608 is spaced apart from the proximal surface region 1604 of the head portion 1602.

[0206] The feeler handle 1600 includes a shield collimator 1610 having a generally planar proximal surface region 1612. A generally planar distal surface region 1614 is in generally parallel and spaced relationship with the proximal surface region 1612. An inner peripheral edge 1616 of the proximal surface region 1612 defines an aperture 1618 through the shield collimator 1610.

[0207] As shown, the head 1602 is connected to the shield collimator 1610 at an inner peripheral edge 1616 such that the head 1602 spans the aperture 1618 and is supported by the shield collimator 1610 .

[0208] In this configuration, the coupler 1620 is located at the lower outer peripheral edge region 1622 of the shielded collimator 1610 and functions to operatively connect the feeler stem 1600 to the static scanning subsystem of the CBBCT imaging system. Likewise, the structural features of the shielded collimator 1610 enable the shielded collimator to directly support the head 1602 of the feeler stem 1600 during operation. Thus, in this case, a separate feeler stem shaft portion is not required or necessary.

[0209] Fig.17 A schematic cross-sectional perspective view of a feeler handle 1700 is shown having a head 1702. The head 1702 has a generally convex patient-proximal surface region 1704 with a patient-contacting surface region 1706. A generally convex distal surface region 1708 is spaced from the proximal surface region 1704 of the head 1702.

[0210] The feeler handle 1700 includes a shield collimator 1710. The shield collimator 1710 includes a first body member 1712. The first body member 1712 has a generally planar proximal surface region 1714. A generally planar distal surface region 1718 is spaced parallel to the proximal surface region 1714. An inner circumferential edge 1720 of the proximal surface region 1714 defines an aperture 1722 through the shield collimator first body member 1712.

[0211] In the illustrated embodiment, the mechanical aperture mechanism 1724 is coupled to the distal surface 1718 such that a central aperture 1726 of the mechanical aperture mechanism 1724 is substantially coaxially aligned with the aperture 1722 of the first body component 1712 .

[0212] In the exemplary embodiment shown, the mechanical aperture mechanism 1724 includes a plurality of blade elements, such as 1728 and 1730. The blade elements have respective inner ends 1732, 1734 and outer ends, such as 1736. The respective outer ends, such as 1736, are connected to and supported by an operating mechanism 1738. In the illustrated device mechanism, the operating mechanism 1738 includes an operating lever 1740.

[0213] Based on the foregoing description, and the relevant technical field of mechanical apertures, the technician will understand that the operator will push the operating lever 1740 along a circular direction 1742 to adjust and thereby increase and / or decrease the diameter of the aperture central opening 1726.

[0214] In the exemplary embodiment provided herein, the shielding collimator includes a second additional body 1750. The additional body 1750 is connected to the first body 1712 by, for example, a hinge 1752. In various embodiments of the present invention, additional bodies, such as 1754 and 1756, will also be connected to the first body 1712 by respective hinges 1757 and 1758.

[0215] In various embodiments of the present invention, the hinges (e.g., 1752, 1757, 1758) will be designed and configured to allow manual adjustment of the bodies (e.g., 1750, 1754, 1756) while providing appropriate internal frictional resistance to maintain a specific spatial position of the corresponding body.

[0216] As will be appreciated by those skilled in the art, the body members (e.g., 1712, 1750, 1754, 1756) and mechanical blade elements (1728, 1730) will utilize respective materials that, in certain embodiments and aspects of the invention, will exhibit a high degree of opacity to X-rays of the energy used in the CBBCT imaging system.

[0217] In contrast, in certain embodiments and aspects of the present invention, the head 1702 of the feeler stem 1700 will comprise a material that has a high degree of transparency to X-rays at the indicated energies.

[0218] In a further aspect of the present invention, the first body member 1712 will be operatively coupled to a receiving element 1760. In the illustrated embodiment, the receiving element 1760 will include a cylindrical recess or hole 1762 therein.

[0219] The upper end 1763 and the adjacent portion of the shaft element 1764 are adjustably disposed within the cylindrical recess or hole 1762, as shown. The lower end 1765 of the shaft element 1764 includes a connector 1766. The connector 1766 is designed and configured to interface with the complementary effect receiving portion of the static scanning subsystem of the CBBCT imaging system, as previously described (see, e.g., Fig.11 ).

[0220] Those skilled in the art will readily appreciate that by operating an adjustment mechanism (here shown as an adjustment knob 1768 with a threaded shaft 1770 disposed within an internally threaded hole 1772), the height of the head 1702 of the feeler handle 1700 will be adjusted upward or downward in a direction (or degree of freedom) 1774. Thus, the patient contacting surface area 1706 of the head 1702 will be brought into proximity with and contact the corresponding surface area of ​​the breast to be imaged and, in an advantageous manner, arranged to apply a pressure level corresponding to optimal imaging.

[0221] Subsequently, the articulated additional body elements (eg, 1750, 1754, 1756) of the shielding collimator will be adjusted to optimize shielding of the breast to reduce unnecessary or unhelpful X-ray exposure.

[0222] Additionally, in certain embodiments, other shielding elements may be used, such as flexible shielding elements including adhesives, hook and loop, magnetic or other coupling mechanisms to ensure complete coverage and avoid any gaps in the shielding provided by the shielding collimator 1710 .

[0223] In further aspects of the invention, in certain embodiments, there will be a resilient cushioning element 1776, such as an annular resilient cushioning element, coupled and supported on a portion proximal to the proximal surface region 1704. The resilient cushioning element 1776 will be designed to have resilient compression when in contact with a corresponding surface area of ​​the imaged breast, thereby increasing patient comfort.

[0224] Fig.18 A portion 1800 of a CBBCT imaging system prepared in accordance with the principles of the present invention is shown, including a static scanning subsystem 1802 having relatively flexible touch panels, such as 1804 and 1806, similar to Figure 3The middle element 324 and the longitudinal axis 344 are described.

[0225] As shown, once the breast 1808 to be imaged is placed between the touch panels 1804 and 1806, the respective lower regions 1810 and 1812 of the touch panels 1804 and 1806 apply pressure in mutual directions 1814 and 1816, respectively. As they contact corresponding areas of the breast surface, the panels deflect 1818 in a manner that optimizes breast support and applanation, thereby minimizing discomfort to the patient.

[0226] Based on the above disclosure, it is obvious to those skilled in the art that the present invention includes a breast imaging system having a CBBCT rotating frame. The CBBCT rotating frame includes an X-ray source and an X-ray detector. The X-ray source is capable of generating a beam of X-rays, wherein the beam of X-rays has a longitudinal axis of the beam. It is understood that the rotating frame has a first rotation axis.

[0227] The breast imaging system further comprises a rotating device, wherein the rotating device has an upper surface and a second rotating axis, and the second rotating axis is substantially coincident with the first rotating axis.

[0228] The breast imaging system is also equipped with a fixed scanning subsystem. The fixed scanning subsystem is connected and supported on the upper surface of the rotating device and includes a first contact surface receiver and a second contact surface receiver. The first and second contact surface receivers are adapted to receive corresponding couplers of respective contact surfaces. It should be understood that the contact surface can be a contact plate, a contact handle, or other types of contact surfaces that are apparent from the present disclosure.

[0229] In some embodiments, the breast imaging system further comprises a controller. The controller is adapted to synchronize the first rotation of the rotating device with the second rotation of the CBBCT gantry in a first time period, so that the operating axis of the fixed scanning subsystem (see FIG. 7 ) is arranged transversely to the longitudinal axis of the beam. In a second time period, the controller is adapted to stop the first rotation of the CBBCT gantry and stop the second rotation of the fixed scanning subsystem, so that the operating axis of the fixed scanning subsystem is substantially aligned with the longitudinal axis of the beam.

[0230] In certain embodiments of the present invention, the controller includes a mechanical lock that is removably and operatively coupled between the CBBCT frame and the rotating device. In certain embodiments and aspects, the mechanical lock is operatively coupled to an actuator. Those skilled in the art will appreciate that in certain embodiments, the actuator is signal-coupled to the controller so that the controller can control the operation of the mechanical lock. The actuator includes a linear actuator and / or a rotary actuator in corresponding embodiments.

[0231] It should also be understood that the present invention includes a method of operating a breast imaging system, the method comprising providing a CBBCT breast imaging system and a fixed scanning subsystem. In some embodiments, the CBBCT breast imaging system and the fixed scanning subsystem are respectively supported on a common rotation axis to achieve mutual rotation.

[0232] In one step of the method, the method includes synchronously rotating the CBBCT breast imaging system and the fixed scanning subsystem, and simultaneously acquiring a CBBCT scanning image of the breast. In a further step of the invention, the method includes stopping the rotation of the CBBCT breast imaging system. In another step of the invention, the method includes adjusting and positioning the fixed scanning subsystem to support the breast to be imaged, and then acquiring a fixed scanning image of the breast.

[0233] The method according to the present invention in some embodiments further comprises the following steps: generating a first three-dimensional voxel image of the breast based on the CBBCT scan, and generating a second two-dimensional pixel image of the breast based on the fixed scan.

[0234] The method according to the present invention, in some embodiments, comprises a further step of generating a composite image of the breast based on a combination of the CBBCT scan and the fixed scan.

[0235] In another aspect, the present invention includes preparing a breast imaging system, the system including a CBBCT gantry, the CBBCT gantry being configured and adapted to rotate about a rotation axis. The breast imaging system includes an X-ray source in a corresponding embodiment, the X-ray source being adapted to generate an X-ray beam. The X-ray beam has a longitudinal axis. The X-ray source is operatively coupled to the CBBCT gantry. In addition, an X-ray detector is also operatively coupled to the gantry. The breast imaging system also includes a fixed scanning subsystem operatively coupled to the CBBCT gantry.

[0236] The fixed scanning subsystem includes a first contact surface, a second contact surface and a base portion. The first contact surface is connected to the base portion by a first displacement device, and the second contact surface is connected to the base portion by a second displacement device. The first and second displacement devices are respectively adapted to reposition the first and second contact surfaces to a first operating state (i.e., the effector is within the X-ray beam) and a second idle state (i.e., the first and second effectors are located outside the X-ray beam).

[0237] In some aspects of the invention, the first displacement device includes a hinge, and the first contact surface is positioned outside the X-ray beam by rotational movement of the hinge. Similarly, in some implementations of the invention, the first displacement device includes a linear actuator, and the first contact surface is positioned outside the X-ray beam by linear movement (e.g., moving into a groove).

[0238] The present invention, in certain aspects and embodiments, also includes a method for operating a breast imaging system, the specific steps comprising: providing a CBBCT gantry; providing an X-ray source, the X-ray source being adapted to generate an X-ray beam and being operatively coupled to the CBBCT gantry; providing an X-ray detector, the detector being operatively coupled to the CBBCT gantry; providing a fixed scanning subsystem, the subsystem comprising a first and a second contact surface; rotating the CBBCT gantry around a rotation axis, and generating a first X-ray beam from the X-ray source, while detecting the first X-ray beam at the X-ray detector within a first time interval to capture CBBCT image data; then, stopping the CBBCT gantry at a specific orientation, generating a second X-ray beam from the X-ray source, while detecting the second X-ray beam at the X-ray detector within a second time interval to capture static image data.

[0239] In additional embodiments, the method includes the steps of: placing the first and second contacts outside the first x-ray beam during a first time interval; and placing the first and second contacts within the second x-ray beam during a second time interval. In further embodiments, the method includes placing the first and second contacts within the second x-ray beam by rotating the fixed scanning subsystem about the rotation axis. In still further embodiments, the method includes placing the first and second contacts within the second x-ray beam by rotating the first and second contacts about respective first and second hinges.

[0240] Other embodiments of the present invention include placing the first and second contacts in a second X-ray beam by withdrawing them from their respective recesses; and in other embodiments, further include placing a shielded collimator in the second X-ray beam during a second time interval.

[0241] A further embodiment of the method according to the present invention includes placing a shielding collimator between the X-ray source and the first and second contact surfaces in a second time interval, and adjusting the position of the shielding collimator relative to the X-ray source in a third time interval, wherein the third time interval is located between the first time interval and the second time interval in time sequence.

[0242] In some embodiments, the same method further comprises adjusting the diameter of the shielding collimator aperture within a third time interval, the third time interval being chronologically located between the first time interval and the second time interval. It should be understood that for a circular aperture, its diameter will directly affect the area. However, for apertures of other shapes, this relationship may not necessarily hold true.

[0243] Therefore, in some embodiments of the present invention, the method further specifically comprises adjusting the area size of the shielding collimator aperture within a third time interval, and the third time interval is located between the first time interval and the second time interval in time sequence.

[0244] In an additional aspect, the method of the present invention includes adjusting a position of the X-ray detector relative to the X-ray source during a third time interval, the third time interval being chronologically located between the first time interval and the second time interval.

[0245] Furthermore, in a further aspect, the fixed scanning subsystem is substantially fixedly coupled to the CBBCT gantry. Thus, in certain embodiments of the present invention, the method comprises substantially pivotally coupling the fixed scanning subsystem to the CBBCT gantry via respective bearings of the fixed scanning subsystem and the CBBCT gantry, wherein the bearings are arranged to rotate substantially coaxially with each other.

[0246] Those skilled in the art will also appreciate that, although the above description uses a CBBCT system for exemplary purposes, with a generally circular frame that rotates in a generally horizontal plane about a generally vertical axis of rotation, the features of the present invention are equally applicable to CBBCT systems with other arrangements, such as a frame that rotates in a generally vertical plane about a generally horizontal axis of rotation. Again, this is merely an example, and any other frame orientation or frame arrangement (e.g., a tubular truss frame or other arrangements suggested by the present disclosure) is also within the scope of the present disclosure.

[0247] Although the above exemplary embodiments are primarily selected from the field of auxiliary imaging devices and corresponding systems and methods during the operation of CBBCT imaging systems, including fixed scanning imaging, those familiar with the present technology will understand that the principles of the present invention are equally well applicable to various other imaging technologies, such as imaging of other body parts and imaging of other objects such as industrial and technological products. In addition, although the present invention is described in detail in the presently preferred embodiments, it should be readily understood that the present invention is not limited to the disclosed embodiments. On the contrary, the present invention may be modified to include any number of variations, alterations, substitutions, or equivalent arrangements not described but consistent with the spirit and scope of the present invention. Therefore, the present invention should not be construed as being limited solely to the foregoing description, but only to the scope of the appended claims.

Claims

1. A breast imaging system, comprising: a CBBCT gantry including an X-ray source and an X-ray detector, wherein the X-ray source is capable of generating a beam of X-rays having a longitudinal axis of the beam, and the CBBCT gantry has a first rotation axis; a rotating device having an upper surface and a second axis of rotation substantially coincident with the first axis of rotation; a static scanning subsystem coupled to and supported by the upper surface, the static scanning subsystem comprising a first contact surface receiver and a second contact surface receiver, the first and second contact surface receivers adapted to receive respective couplers of respective contact surfaces; A controller is provided, wherein the controller is capable of synchronizing a first rotation of the rotating device with a second rotation of the CBBCT frame in a first time period, so that the operating axis of the static scanning subsystem is arranged transversely with the longitudinal axis of the beam; and the controller is capable of stopping the second rotation of the CBBCT frame and stopping the first rotation of the static scanning subsystem in a second time period, so that the operating axis of the static scanning subsystem is substantially aligned with the longitudinal axis of the beam.

2. The breast imaging system as defined in claim 1, wherein the controller includes a mechanical lock removably and operatively coupled between the CBBCT frame and the rotation device.

3. A breast imaging system as defined in claim 2, wherein the mechanical lock is operatively coupled to an actuator.

4. A breast imaging system as defined in claim 3, wherein the actuator is signally coupled to the controller so that the controller can control the operation of the mechanical lock.

5. A breast imaging system as defined in claim 3, wherein the actuator comprises a linear actuator.

6. A breast imaging system as defined in claim 3, wherein the actuator comprises a rotary actuator.

7. A method of operating a breast imaging system, comprising: A CBBCT breast imaging system is provided, the system having a static scanning subsystem, wherein the CBBCT breast imaging system and the static scanning subsystem are respectively supported and rotated about a common rotation axis; Synchronize the rotating CBBCT breast imaging system and the static scanning subsystem to simultaneously capture a CBBCT scan of the breast; Stop the rotation of the CBBCT breast imaging system; orienting and positioning the static scanning subsystem to support the breast; Capture a static scan of the breast.

8. A method of operating a breast imaging system as defined in claim 7, further comprising generating a first three-dimensional voxel image of the breast based on the CBBCT scan; and generating a second two-dimensional pixel image of the breast based on the static scan.

9. A method of operating a breast imaging system as defined in claim 7, further comprising generating a composite image of the breast based on a combination of a CBBCT scan and a static scan.

10. A breast imaging system comprising: a CBBCT frame configured and adapted to rotate about a rotation axis; an X-ray source capable of generating a beam of X-rays having a longitudinal axis, the X-ray source being operatively coupled to the CBBCT gantry; an X-ray detector operatively coupled to the CBBCT gantry; A static scanning subsystem is operatively coupled to the CBBCT gantry, the static scanning subsystem comprising a first contact surface, a second contact surface and a base portion, wherein the first contact surface is coupled to the base portion via a first displacement device, the second contact surface is coupled to the base portion via a second displacement device, the first and second displacement devices being adapted to reposition the first and second contact surfaces in a first operating state in which the contact surfaces are located within an X-ray beam; and in a second idle state in which the first and second effectors are located outside the X-ray beam.

11. A method of operating a breast imaging system as defined in claim 10, wherein the first displacement device comprises a hinge, and wherein the first contact surface is positioned outside the x-ray beam by rotational movement of the hinge.

12. The method of operating a breast imaging system as defined in claim 10, wherein the first displacement device comprises a linear actuator, and the first contact surface is moved into the recess by linear motion to be located outside the x-ray beam.

13. A method of operating a breast imaging system, comprising: Provide a CBBCT rack; providing an X-ray source capable of generating a beam of X-rays, the X-ray source being operatively coupled to the CBBCT gantry; providing an X-ray detector operatively coupled to the CBBCT gantry; providing a static scanning subsystem comprising first and second effectors; Rotating the CBBCT gantry about a rotation axis and generating a first beam of X-rays from an X-ray source and detecting the first beam of X-rays at an X-ray detector to capture CBBCT image data in a first time interval; The CBBCT gantry is stopped in a specific direction, and a second beam of X-rays is generated from the X-ray source and simultaneously detected at the X-ray detector to capture static image data in a second time interval.

14. The method of operating a breast imaging system as defined in claim 13, further comprising positioning the first and second contacts outside of a first beam of x-rays during a first time interval; and positioning the first and second contacts within a second beam of x-rays during a second time interval.

15. A method of operating a breast imaging system as defined in claim 14, wherein positioning the first and second contacts within the second beam of x-rays comprises rotating the static scanning subsystem about an axis of rotation.

16. The method of operating a breast imaging system as defined in claim 14, wherein positioning the first and second haptics within the second x-ray beam comprises articulating the first and second haptics about respective first and second hinges.

17. The method of operating a breast imaging system as defined in claim 14, wherein positioning the first and second haptics within the second beam of x-rays comprises withdrawing the first and second haptics from the respective recesses.

18. The method of operating a breast imaging system as defined in claim 13, further comprising positioning a shielded collimator within the second x-ray beam during the second time interval.

19. The method of operating a breast imaging system as defined in claim 13, further comprising positioning a shielded collimator between the x-ray source and the first and second surfaces during the second time interval.

20. A method of operating a breast imaging system as defined in claim 19, further comprising adjusting a position of the shielded collimator relative to the x-ray source during a third time interval, the third time interval being temporally located between the first time interval and the second time interval.

21. A method of operating a breast imaging system as defined in claim 19, further comprising adjusting an aperture diameter of the shielded collimator during a third time interval, the third time interval being temporally located between the first time interval and the second time interval.

22. A method of operating a breast imaging system as defined in claim 19, further comprising adjusting an area size of an aperture of the shielding collimator during a third time interval, the third time interval being temporally located between the first time interval and the second time interval.

23. A method of operating a breast imaging system as defined in claim 13, further comprising adjusting a position of the x-ray detector relative to the x-ray source during a third time interval, the third time interval being temporally located between the first time interval and the second time interval.

24. The method of operating a breast imaging system as defined in claim 13, wherein the static scanning subsystem is substantially fixedly coupled to the CBBCT gantry.

25. A method of operating a breast imaging system as defined in claim 13, wherein the static scanning subsystem is substantially hingedly coupled to the CBBCT gantry via respective bearings thereof, the respective bearings being arranged for substantially coaxial rotation with respect to each other.

Images