Cone beam mammary gland computed tomography system with patient support subsystem

Abstract

In the present invention, a cone beam mammary gland computed tomography (CBBCT) scanning system comprises a vertical plane gantry and a patient support subsystem, where the patient support subsystem is equipped with a patient support seat for positioning a patient during imaging.

Description

[0001] Related Applications

[0002] This application claims the benefit of the following provisional patent applications: U.S. Provisional Application No. 63 / 331,153, filed on April 14, 2022, entitled “OMNIBUSDISCLOSURE”; U.S. Provisional Application No. 63 / 401,475, filed on August 26, 2022, entitled “FIXTURING AND SUPPORT FOR MEDICAL IMAGING”; U.S. Provisional Application No. 63 / 401,493, filed on August 26, 2022, entitled “ERGONOMIC IMPROVEMENTS IN CONE BEAM BREAST COMPUTED TOMOGRAPHY”; U.S. Provisional Application No. 63 / 401,513, filed on August 26, 2022, entitled “STATIONARY DETAIL IMAGING IN CONE BEAM BREAST COMPUTED TOMOGRAPHY”; U.S. Provisional Application No. 63 / 401,546, filed on August 26, 2022, entitled “CONE BEAM BREAST COMPUTED TOMOGRAPHY WITH PATIENT SUPPORT SUBSYSTEM”; U.S. Provisional Application No. 63 / 401,548, filed on August 26, 2022, entitled “CONE BEAM BREAST COMPUTED TOMOGRAPHY WITH PIVOTAL GANTRY SUBSYSTEM”; U.S. Provisional Application No. 63 / 430,571, filed on December 6, 2022, entitled “ULTRASONIC HYBRID IMAGING IN CONE BEAM BREAST COMPUTED TOMOGRAPHY”; and “CALCIFICATION DETECTION SYSTEMS, METHODS AND APPARATUS IN CONE BEAM BREAST COMPUTED TO MOGRAPHY", the filing date and U.S. provisional application number of which are pending, and the disclosures of all of the above applications are hereby fully cited as reference. Background Art

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

[0005] Optimal breast imaging should be able to detect masses when they are small, ideally less than 10 mm in diameter. It has been reported that 93% of women with invasive breast cancers 1-10 mm detected on mammographic imaging have a 16-year survival rate. In addition, the probability of metastasis decreases dramatically as the diameter of the detected tumor decreases. If a breast tumor is detected at a diameter of 10 mm or less, its probability of metastasis is 7.31%; if a 4 mm cancer is detected, its probability of metastasis decreases by more than 10 times to 0.617%.

[0006] Although mammography (which can detect cancers up to about 12 mm in size on average) is the most effective tool currently available for early detection of breast cancer, it has relatively low sensitivity for small breast cancers (less than a few millimeters). The specificity and positive predictive value of mammography are limited by structural and tissue overlap. The limited sensitivity and specificity of mammography in breast cancer detection are primarily due to its poor contrast detection, which is common to all types of projection imaging techniques (projection imaging has a contrast detection capability of only 10% at best), and the fact that mammography initially detected only 65-70% of breast cancers. In dense breasts, mammography sensitivity is further reduced to 30%. Digital mammography (DM) was developed to overcome the inherent limitations of screen-film mammography (SFM) by providing improved contrast resolution and digital image processing; however, a large 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 leads to the need for biopsy in uncertain cases, despite the increased cost and stress on patients. In the United States, of the more than one million breast biopsies performed each year to evaluate suspicious mammographic findings, nearly 80% are benign. This not only causes undue anxiety to patients, but also imposes a significant cost burden on the healthcare system. Therefore, there is an urgent need to more accurately characterize breast lesions to reduce biopsy rates and false-positive rates of pre-biopsy mammography.

[0008] Results from phantom studies have shown that cone-beam breast computed tomography (CBBCT) can achieve a spatial resolution of up to about 2.8 line pairs per millimeter, enabling it to detect cancers as small as 2 millimeters and microcalcifications as small as about 0.2 millimeters. In an average-sized breast (chest wall diameter of about 13 centimeters), this imaging can be accomplished with a total dose of about 5 milligrays. This dose is lower than that of a single mammogram, assuming two views are required for each breast.

[0009] CBBCT has excellent image quality in displaying breast tissue, breast tumors, and calcified lesions, with coverage of the breast (including the chest wall area) at least equivalent to mammography. The major blood vessels are also very well displayed without the use of contrast agents. Therefore, CBBCT provides a significant improvement in detecting and biopsy suspicious lesions in patients.

[0010] While the imaging benefits of CBBCT are significant, the ergonomic advantages of the technology are equally important. For example, in many CBBCT procedures, images can be acquired without the breast tissue compression typically associated with mammographic imaging.

[0011] For example, one characteristic of mammography is that the patient’s breast is inserted into a fixture prior to imaging, which results in significant compression of the breast tissue laterally along the longitudinal axis. Patients commonly report physical and psychological discomfort associated with the degree of compression required for conventional mammography, and studies have shown that this discomfort is a factor in lower rates of breast cancer screening and diagnosis among patients overall and in specific racial and cultural groups.

[0012] Additionally, breast compression during mammographic imaging may cause displacement of breast tissue, making it more difficult to locate features such as lesions and calcifications during subsequent biopsies and lumpectomy procedures.

[0013] The further improvements to CBBCT imaging described in this article not only extend its imaging benefits, but also provide significant improvements in ergonomics. These improvements include technical enhancements, methods, and equipment to better enable patients to receive CBBCT systems. These improvements include loading devices, patient seating facilities, and improved equipment layout and configuration to improve patient comfort and facilitate technicians and medical staff to assist patients in positioning the equipment.

[0014] In current practice, patients undergoing CBBCT lie prone on an examination table. The breast to be examined is lowered through an opening in the upper surface of the examination table into an imaging chamber located below the table. The position of the breast in the imaging chamber is fixed by the patient maintaining a stationary position as the patient lies on the examination table surface.

[0015] The imaging device is attached to a movable frame supported on a bearing arrangement for rotation about an axis of rotation. The axis of rotation is usually arranged vertically and passes through an aperture in the examination table. The approximate center of the breast to be imaged is arranged on the axis of rotation so that the axis of rotation passes through the approximate center.

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

[0017] Despite the many advantages of CBBCT, some patients have difficulty or are unable to assume a prone position on the examination table. Such patients may not be able to position themselves properly on the examination table or position the breast to be imaged in the orifice. For the elderly, obese, pregnant, disabled patients, and those with medical conditions such as paralysis or amputations, climbing onto the examination table and lying in a specific prone position is extremely difficult or even impossible. Summary of the invention

[0018] The inventors of the present invention have developed new practical systems, devices and methods for ergonomic issues in breast imaging, especially CBBCT imaging, after long and careful consideration, which are significantly improved over existing methods. The present invention includes devices for patients to enter CBBCT systems and corresponding systems and methods, while providing support for patients during tomographic imaging.

[0019] Therefore, in some embodiments of the present invention, a CBBCT system suitable for positioning a patient upright is provided. In some embodiments, the patient is provided with a seat for support during upright scanning. In some embodiments, the seat is designed to be rotatable to facilitate patient entry. In some embodiments, the gantry is adapted to move linearly toward the patient after positioning for scanning. In some embodiments, the patient moves toward the gantry together with the seat after positioning for scanning.

[0020] The following description is intended to enable any person skilled in the art to make and use the disclosed invention, and provides the best mode of implementation currently considered by the inventor. In the following description, for ease of explanation, many specific details are provided to help fully understand the present invention. However, it will be appreciated by those skilled in the art that the present invention can be implemented without including these specific details. In other cases, well-known structures and devices are shown in block diagram form to avoid unnecessary obstruction of the disclosed content. These and other advantages and features of the present invention will be more easily understood by the following detailed description in conjunction with the accompanying drawings.

[0021] It should be noted that, although the various figures show different aspects of the invention, not any one figure is intended to show the entire invention. Instead, the figures collectively illustrate various aspects and principles of the invention. Therefore, it should not be assumed that any particular figure is only related to a certain independent aspect or specific form of the invention. On the contrary, those skilled in the art will understand that the figures as a whole reflect different embodiments of the invention.

[0022] Accordingly, the phrases "one embodiment" or "an embodiment" mentioned in the specification indicate that the specific features, structures, or characteristics described in connection with the embodiment are included in at least one embodiment of the present invention. Therefore, the phrases "in one embodiment" or "in an embodiment" appearing in different places in the specification do not necessarily refer to the same embodiment. In addition, these specific features, structures, or characteristics may be combined in any appropriate manner in one or more embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 A portion of an exemplary CBBCT imaging system is shown in a cutaway perspective view.

[0024] Figure 2 A portion of an exemplary CBBCT imaging system is shown in an elevated schematic perspective view, including a vertical planar gantry subsystem designed in accordance with the principles of the present invention.

[0025] Figure 3 Certain aspects of an exemplary CBBCT imaging system are shown in schematic perspective view, including a vertical planar gantry subsystem designed in accordance with the principles of the present invention.

[0026] Figure 4A Certain aspects of an exemplary CBBCT imaging system designed in accordance with the principles of the present invention are shown in schematic perspective views.

[0027] Figure 4B Other aspects of an exemplary CBBCT imaging system designed according to the principles of the present invention are shown in schematic perspective views.

[0028] Figure 4C Further aspects and operation of an exemplary CBBCT imaging system designed in accordance with the principles of the present invention are illustrated in schematic perspective views.

[0029] Figure 4D Further aspects of a CBBCT imaging system are shown in schematic block diagram form, including exemplary safety features designed in accordance with the principles of the present invention.

[0030] Figure 5 A schematic perspective view shows a portion of an exemplary CBBCT imaging system including a coaxial support subsystem designed according to the principles of the present invention.

[0031] Fig. 6A Some aspects of the use process and method of the CBBCT imaging system designed according to the principles of the present invention are shown in the form of functional block diagrams.

[0032] Figure 6BFurther aspects of the use process and method of the CBBCT imaging system designed according to the principles of the present invention are shown in the form of functional block diagrams.

[0033] Figure 6C Additional aspects of the process and method of using the CBBCT imaging system designed according to the principles of the present invention are shown in the form of functional block diagrams.

[0034] Figure 7 Certain features of an exemplary CBBCT imaging system, including a patient positioning panel designed in accordance with the principles of the present invention, are shown in schematic proximal end view.

[0035] Figure 8 Additional features of an exemplary CBBCT imaging system are shown in schematic proximal view, including a patient positioning panel designed in accordance with the principles of the present invention.

[0036] Fig. 9A Certain features of a CBBCT imaging system designed in accordance with the principles of the present invention are shown in schematic perspective view, including an exemplary handle.

[0037] Fig. 9B Additional features of a CBBCT imaging system designed in accordance with the principles of the present invention are shown in schematic perspective view, including an exemplary handle.

[0038] Fig. 9C Further features of a CBBCT imaging system designed in accordance with the principles of the present invention are shown in schematic perspective view, including an exemplary handle.

[0039] Fig.9D Other features of a CBBCT imaging system designed in accordance with the principles of the present invention are shown in schematic perspective views, including an exemplary handle.

[0040] Fig.9E Further aspects and features of a CBBCT imaging system designed in accordance with the principles of the present invention are shown in schematic perspective views, including an exemplary handle.

[0041] Fig. 10A Certain features of a CBBCT imaging system designed in accordance with the principles of the present invention, including an exemplary subpanel assembly, are shown in schematic proximal end view.

[0042] Fig. 10B Additional aspects of a CBBCT imaging system designed in accordance with the principles of the present invention are shown in schematic proximal end views, including an exemplary subpanel assembly.

[0043] Fig. 10C Further exemplary aspects of a CBBCT imaging system designed in accordance with the principles of the present invention are shown in schematic proximal end views, including an exemplary subpanel assembly.

[0044] Fig. 10D Certain features of a CBBCT imaging system designed in accordance with the principles of the present invention, including an exemplary adjustable subpanel assembly, are shown in schematic proximal end view.

[0045] Fig. 10E Further details of a CBBCT imaging system designed in accordance with the principles of the present invention are shown in a schematic proximal end view, including an exemplary adjustable subpanel assembly.

[0046] Fig.10F Additional configurations of a CBBCT imaging system designed in accordance with the principles of the present invention are shown in schematic proximal end views, including an exemplary adjustable subpanel assembly.

[0047] Fig.11 Further features of a CBBCT imaging system designed in accordance with the principles of the present invention are illustrated in schematic perspective views, including an exemplary breast stabilization function.

[0048] Fig.12 Additional aspects and configurations of an exemplary CBBCT imaging system, including a patient support function designed in accordance with the principles of the present invention, are shown in schematic side view.

[0049] Fig.13A Certain aspects of an exemplary CBBCT imaging system, including certain safety features designed in accordance with the principles of the present invention, are shown in an elevated schematic perspective view.

[0050] Fig. 13B Certain aspects of an exemplary CBBCT imaging system, including additional safety features designed in accordance with the principles of the present invention, are shown in an elevated schematic perspective view. DETAILED DESCRIPTION

[0051] The following description is intended to enable those skilled in the art to make and use the disclosed invention and provides the best implementation currently considered by the inventor. In the following description, for ease of explanation, many specific details are listed to help fully understand the present invention. However, it will be appreciated by those skilled in the art that the present invention can be implemented without including these specific details. In other cases, well-known structures and devices are shown in block diagram form to avoid unnecessary obscuring of the disclosed content.

[0052] It should be noted that although the following exemplary embodiments will identify specific components and combinations thereof, these examples are not intended to be definitive. Instead, individual components may be combined into integral components and / or assemblies where appropriate. In addition, the disclosure of specific components as a whole, as well as various aspects and features, should also be understood to include disclosure of separate components and assemblies that provide the same characteristics and / or functions.

[0053] 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 gantry 106. The rotating gantry 106 is supported by a bearing and is arranged to rotate about an axis of rotation 108.

[0054] The X-ray source 102 is configured to emit a beam of X-rays 110. The X-ray beam 110 defines a longitudinal beam axis 112 that intersects the rotation axis 108 at a point 114 in the illustrated embodiment.

[0055] 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 in a direction perpendicular to longitudinal axis 112 defines a disk having a substantially uniform X-ray intensity and a substantially circular perimeter.

[0056] In other configurations within the scope of the present invention, a cross-section of the beam 110 taken in a direction perpendicular to the longitudinal axis 112 defines a region of substantially uniform X-ray intensity having a substantially circular perimeter except for a portion of the perimeter that is located outside of a chord of the circular perimeter. As further disclosed below, in some embodiments, the chord will be substantially parallel to and spaced from the lower surface of the patient table.

[0057] Thus, in some configurations, a cross section of the beam 110 taken in a direction perpendicular to the longitudinal axis 112 defines a truncated disk of substantially uniform x-ray intensity having a substantially truncated circular perimeter (i.e., a circular perimeter except for a horizontal chordal portion at the upper edge). This configuration optimizes imaging of the breast while minimizing irradiation of chest wall tissue above the breast. In some embodiments, this is accomplished by placing a radiopaque collimating plate over a portion of the otherwise circular cross-sectional beam produced by the x-ray source.

[0058] In further configurations within the scope of the present invention, a cross-section of the beam 110 taken in a direction perpendicular to the longitudinal axis 112 defines a region of substantially uniform X-ray intensity having a perimeter that is a polygon. In various embodiments and configurations, the polygonal perimeter may include a triangle, a rectangle, a pentagon, a hexagon, a perimeter of any higher geometry, or a perimeter having any combination of curves or line segments to meet the needs of a particular application. Furthermore, 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 region or regions.

[0059] The 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 perpendicular to the longitudinal axis 112 and is located on the opposite side of the rotation axis 108 from the X-ray source 102. Those skilled in the art will appreciate that the described configuration is only one example of many possible arrangements, and that the X-ray source, X-ray detector, and other components of the system may be supported from above, from the side, or in any other suitable manner to achieve the desired functions, and that the shape and configuration of the gantry and the X-ray detector may also present any suitable form in different embodiments of the present invention.

[0060] 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 along the rotation axis 108. In a typical configuration, the trajectory will include at least a portion of a circular path centered on 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 will be disclosed herein.

[0061] In certain embodiments of the present invention, the relative positions of the x-ray source 102 and / or the x-ray detector 116 are adjustable 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 in radial directions (i.e., degrees of freedom) about the rotation axis 108, in circumferential directions (i.e., degrees of freedom) about the rotation axis 108, or in directions (i.e., degrees of freedom) toward the gantry surface 104, or in any other manner that a designer or user deems beneficial and that is appropriate for a particular device embodying the present invention.

[0062] Patient table 120 includes an upper surface 122 and a lower surface 124. An aperture 126 connects the upper surface 122 and the lower surface 124 of the table. Upper surface 122 is arranged to support a patient 128, who is typically lying on upper surface 122 in a prone position, as shown. In this configuration, the patient's breast 130 hangs from the patient's chest wall and passes downward through aperture 126.

[0063] During operation, the gantry 106 rotates about the rotation axis 108, driving the X-ray source 102 and the X-ray detector 116 along a path around the patient's breast. During this movement, the X-ray detector 116 captures X-ray image data by operating in conjunction with 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. Combined together, the X-ray image data or a subset thereof is processed to provide information about the internal state of the breast.

[0064] Figure 2 A portion of an exemplary CBBCT imaging system 200 is shown in a schematic elevated perspective view and includes a vertical planar gantry subsystem 202. The vertical planar gantry subsystem 202 includes a vertical planar gantry 204 configured to rotate about a substantially horizontal rotation axis 206.

[0065] Similar to the system 100 described above, the system 200 also includes an X-ray source 208. The exemplary X-ray source 208 is mounted on a support surface 210 of a vertical planar gantry 204. The vertical planar gantry 204 is supported by a bearing 212 and is arranged to rotate about the rotation axis 206. The bearing 212 is coupled to and supported by a structural member 214, which is coupled to and supported by a base member 216 of the vertical planar gantry subsystem 202.

[0066] The X-ray source 208 is configured to emit a beam of X-rays 218. The X-ray beam 218 defines a longitudinal beam axis 220 that intersects the rotation axis 206 at a point 222 in the illustrated embodiment.

[0067] In various embodiments, the cross-section of the x-ray beam 218 can take any of the forms discussed above. Thus, in the example shown, a cross-section of the x-ray beam 218 taken along a direction perpendicular to the longitudinal axis 220 defines a rectangular region of substantially uniform x-ray intensity. This configuration optimizes imaging of the breast while minimizing irradiation of the chest wall tissue above the breast. In some embodiments, this is accomplished by placing a radiopaque collimating plate over a portion of the otherwise circular cross-section beam generated by the x-ray source.

[0068] An X-ray detector 224 is also mounted on the support surface 210 of the vertical planar gantry 204. In an exemplary embodiment, the X-ray detector 224 includes a planar detector having a generally planar receiving surface 226. The receiving surface 226 is generally perpendicular to the longitudinal axis 220 and is located on the opposite side of the rotation axis 206 from the X-ray source 208.

[0069] Those skilled in the art will appreciate that the described configuration is only one example of a variety of possible arrangements of the X-ray source, X-ray detector, and other components of the system, which can be supported from above, from the side, or in any other appropriate manner to achieve the desired functions. At the same time, the shape and configuration of the gantry and the X-ray detector will also present any suitable form in different embodiments of the present invention.

[0070] During operation of the imaging system 200, rotation of the vertical planar gantry 204 about the rotation axis 206 will cause the receiving surface 226 to move along a trajectory 228 about the rotation axis 206. In a typical configuration, the trajectory 228 will include at least a portion of a circular path centered on the rotation axis 206. However, it should be noted that other trajectories are also considered to be within the scope of the present invention and will be disclosed herein.

[0071] In the exemplary embodiment shown, the rotation axis 206 is in a generally horizontal orientation and the trajectory 228 is in a generally vertical plane. In general, and in conjunction with the further disclosure below, it should be understood that other orientations of the rotation axis and trajectory are also considered to be within the scope of the present disclosure.

[0072] In certain embodiments of the present invention, the relative positions of the x-ray source 208 and / or the x-ray detector 224 are adjustable on the support surface 210 of the gantry 204. For example, the x-ray source 208 and the x-ray detector 224 may be adjusted in radial directions (i.e., degrees of freedom) about the rotation axis 206, in circumferential directions (i.e., degrees of freedom) about the rotation axis 206, or in directions (i.e., degrees of freedom) toward the gantry surface 210, or in any other manner that a designer or user deems useful and appropriate for a particular device embodying the present invention.

[0073] The patient support subsystem 230 includes a columnar member 232 and a patient back support portion 234. In the illustrated embodiment, the vertical planar gantry subsystem 202 and the patient support subsystem 230 are coupled to each other and supported by a base member 236.

[0074] A patient placement panel 238 (also referred to as a patient examination table) is located between the vertical plane frame 204 and the patient support subsystem 230. The patient placement panel 238 has a first patient placement surface area 240 and a second distal surface area 242, wherein the distal surface area 242 is spaced apart from the patient placement surface area 240.

[0075] An inner peripheral edge 244 of the patient positioning surface area 240 surrounds an aperture 246 in the patient positioning panel 238 that is located between the patient positioning surface area 240 and the distal surface area 242 .

[0076] As will be further described below, the patient positioning surface area 240 is arranged to isolate the patient from the rest of the vertical planar gantry subsystem 202, while the patient's breast is positioned vertically through the aperture 246. In various embodiments and aspects of the present invention, the patient positioning subsystem is located at the aperture 246. In various aspects thereof, the patient positioning subsystem will provide an aperture customized to the size and position of the particular patient and breast to be imaged, protection of the patient's area that may be subject to scattered x-ray photons, and other features such as support and stabilization of the breast to be imaged.

[0077] During operation, the gantry 204 rotates about the rotation axis 206, driving the X-ray source 208 and the X-ray detector 224 along the trajectory 228 of the patient's breast. During this process, the X-ray detector 224 captures X-ray image data by operating in conjunction with 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 206. Combined together, the X-ray image data or a subset thereof is processed to provide information about the internal state of the breast.

[0078] The X-ray detector can be any two-dimensional detector, including a planar detector, a two-dimensional photon counting detector, and a two-dimensional curved detector. In order to optimize the coverage of breast tissue at the chest wall and improve patient comfort, the top edge (dead zone) of the detector should be minimized (as small as possible).

[0079] In the illustrated embodiment, the patient positioning panel 238 is coupled to and supported by the base member 216 of the vertical plane gantry subsystem 202. In alternative embodiments, the patient positioning panel 238 will be coupled to and supported by the base member 236. In other embodiments of the invention, the patient positioning panel 238 will be coupled to and supported by the patient support subsystem 230. In other embodiments, alternative features of the imaging system 200 will also support the patient positioning panel 238.

[0080] Figure 3 A portion of an exemplary CBBCT imaging system 300 is shown in schematic perspective view, including a vertical planar gantry subsystem 302. System 300 illustrates further details of certain embodiments of system 200 and other embodiments of the present invention. Vertical planar gantry subsystem 302 includes a vertical planar gantry 304 configured to rotate about a substantially horizontal rotation axis 306.

[0081] Similar to the system 200 described above, the system 300 also includes an X-ray source 308. The exemplary X-ray source 308 is mounted on a support surface 310 of a vertical planar gantry 304. The vertical planar gantry 304 is supported by a bearing 312 and is arranged to rotate about a rotation axis 306. The bearing 312 is in turn coupled to and supported by a structural member 314, which is coupled to and supported by a base member 316 of the vertical planar gantry subsystem 302.

[0082] Similar to system 200, system 300 also includes a patient support subsystem 330. Patient support subsystem 330 includes a column member 332 and a patient back support portion 334. In the illustrated embodiment, vertical planar gantry subsystem 302 and patient support subsystem 330 are coupled to each other and supported by base member 336.

[0083] The patient positioning panel 338 is located between the vertical plane frame 304 and the patient support subsystem 330. The patient positioning panel 338 has a first patient positioning surface area 340 and a second distal surface area 342, wherein the distal surface area 342 is spaced apart from the patient positioning surface area 340.

[0084] The patient support subsystem 330 also includes an exemplary seating device 344. In the illustrated embodiment, the exemplary seating device 344 is coupled to and supported by the columnar member 332. The seating device 344 includes a seat portion 346 having a structure 348 and a seat upper surface area 350. The seat upper surface area 350 is designed to position and support a patient seated on the seat portion 346 during imaging and during optional supplemental examinations.

[0085] In the illustrated embodiment, the structure 348 is substantially fixedly coupled to an upper end of an exemplary seat post 352 which, in the illustrated embodiment, passes through an aperture or slot 354 into the column member 332 .

[0086] In certain embodiments of the present invention, the lower end of the exemplary seat post 352 is operatively coupled to a seat adjustment mechanism. The seat adjustment mechanism is located in a cavity or recess within the columnar member 332 and is coupled to the columnar member to provide support. Thus, the weight of a patient sitting on the seat upper surface area 350 is transferred through the seat structure 348 to the seat post 352, and then transferred to the columnar member 332 through the seat adjustment mechanism.

[0087] As described above, the columnar member 332 is supported by the base member 336. Therefore, the weight of the patient is ultimately supported by the base member 336 and transferred to the ground supporting the CBBCT imaging system 300 through the base member 336.

[0088] In a desirable aspect of certain embodiments of the invention, the chair adjustment mechanism allows for vertical 356 and lateral 358 positioning adjustments of the seat 346 relative to the longitudinal axis 360 of the base member 336. In certain embodiments, the chair adjustment mechanism also allows for additional degrees of freedom of pivoting of the seat, namely yaw 362 and pitch 363. These various adjustments will enhance patient comfort and optimal positioning.

[0089] In further aspects of the invention, in certain embodiments, the seat will be retractable (e.g., into a cavity or recess within the columnar member), foldable, or otherwise removable so that the patient to be imaged does not sit on the seat, but instead stands on an upper surface of the base member 336, or on a patient platform coupled to the base member 336 or columnar member 332. Thus, the seat is available for use when needed, but may not be used when a support mode in which the patient is standing is desired.

[0090] In further embodiments of the invention, the seat will not be coupled to the patient support subsystem.

[0091] Those skilled in the art will appreciate that the shape and configuration of the seat 346 and the patient back support portion 334 will help optimize the comfort and positioning of the patient relative to the vertical plane gantry subsystem 302. In certain embodiments, the seat 346 and the patient back support portion 334 will be made of biocompatible materials with good rheological properties and elastic hardness.

[0092] Therefore, in various embodiments of the present invention, the seat 346 and the patient back support portion 334 will be made of materials suitable for achieving these goals. These materials include, but are not limited to, various copolymers or block copolymers (such as Provided by Kraton Polymers), such as styrene-butadiene rubber or styrene-isoprene rubber, EPDM (ethylene-propylene-diene monomer) rubber, nitrile (acrylonitrile-butadiene) rubber, polyurethane, polybutadiene, polyisobutylene, chloroprene rubber, natural latex rubber, etc. The foam material can be a closed-cell foam or an open-cell foam, and can include, but is not limited to, polyolefin foams, such as polyethylene foam, polypropylene foam, and polybutylene foam; polystyrene foam; polyurethane foam; any elastic foam made of the above-mentioned elastomer or rubber material; or any biodegradable or compostable polyester, such as polylactic acid resin (including L-lactic acid and D-lactic acid) and polyglycolic acid (PGA); polyhydroxyvalerate / hydroxybutyric acid resin (PHBV) (copolymer of 3-hydroxybutyric acid and 3-hydroxyvaleric acid) and polyhydroxyalkanoate (PHA) copolymer; and polyester / polyurethane resin. Those skilled in the art will understand that the above materials are only some examples of suitable applications that are widely applicable to the present invention.

[0093] Additionally, certain aspects of the present invention will include, in corresponding embodiments, an active back support mechanism coupled between the patient back support portion 334 and the column member 332. In certain embodiments, the active back support mechanism will allow adjustment of the position and orientation of the patient back support 334 with additional degrees of freedom, namely pitch, roll, and yaw, as well as linear positioning relative to the seat in the direction 364. In other embodiments, as will be discussed further below, the active back support mechanism will include a bladder or expandable cushion that, when activated, pushes the patient toward the patient placement surface area 340 of the patient placement panel 338.

[0094] In a further aspect of the present invention, the base member 336 includes a linear bearing device. The linear bearing device is coupled between the base member 316 of the vertical plane gantry subsystem 302 and the base member 336 of the CBBCT imaging system 300. Therefore, the position of the vertical plane gantry subsystem 302 relative to the patient support subsystem 330 can be adjusted along the direction 364.

[0095] This adjustability allows the patient to enter the patient support subsystem 330 and be positioned for scanning with the vertical planar gantry subsystem 302 relatively far from the patient support subsystem 330. Thereafter, as will be further described below, the vertical planar gantry subsystem 302 can be adjusted to be close to the patient for effective scanning.

[0096] In certain embodiments of the invention, such adjustment is accomplished by manually moving the vertical planar gantry subsystem 302. In other embodiments, lateral adjustment of the position of the vertical planar gantry subsystem 302 is controlled by a linear actuator.

[0097] In various embodiments of the present invention, the linear actuator includes an electric motor, through the operation of which the shortening and lengthening of the linear actuator can be achieved. However, those skilled in the art will appreciate that any number of linear actuators, rotary actuators or other operating mechanisms and arrangements can be used in corresponding embodiments of the present invention.

[0098] Thus, for example, in certain embodiments of the present invention, the linear actuator may include one or more electromagnets, pneumatic cylinders, hydraulic cylinders, pneumatic bladders, hydraulic bladders, linear motors, rotary motors, Acme screws and nuts, lead screws, ball screws, cables, pulleys, timing belts, timing pulleys, appropriately sized worm gear reducers, rack and pinion assemblies, rack and worm gear assemblies, and any other appropriately functional actuator assembly that is known or may later become known in the art.

[0099] Figures 4A-4D Aspects and methods of operation of a CBBCT imaging system 400 similar to systems 200 and 300 described above are presented. Figure 4A and Figure 4B The imaging system 400 is shown in loaded and operational configurations, respectively. Figure 4C The operation of a vertical plane rack subsystem according to an example of the present invention is shown. Figure 4D The relationship and safety features of the imaging system 400 are shown.

[0100] exist Figure 4A In the embodiment of the present invention, the CBBCT imaging system 400 includes a vertical plane gantry subsystem 402 and a patient support subsystem 404. The vertical plane gantry subsystem 402 and the patient support subsystem 404 are coupled to a base member 406.

[0101] In certain aspects of the invention, as expressed in respective embodiments, the patient support subsystem 404 is substantially fixedly coupled to the base member 406, while the vertical plane gantry subsystem 402 is movably coupled to the base member 406. In the illustrated embodiment, for example, the vertical plane gantry subsystem 402 is adapted to be adjustable along directions (i.e., degrees of freedom) 408 toward or away from the patient support subsystem 404.

[0102] The reader will appreciate that while the present description relates to a system in which the patient support subsystem 404 is substantially fixedly coupled to the base member 406 and the vertical planar gantry subsystem 402 is movable relative thereto, in alternative embodiments, the reverse is true. That is, in some embodiments, the vertical planar gantry subsystem 402 will be substantially fixedly coupled to the base member 406 and the patient support subsystem 404 will be movable. In other embodiments, both the patient support subsystem 404 and the vertical planar gantry subsystem 402 may be movable - these examples illustrate the adjustability of the distance between the two in the direction 408.

[0103] exist Figure 4A , the CBBCT system 400 is shown in a first state, where the vertical plane gantry subsystem 402 is in a remote position relative to the patient support subsystem 404.

[0104] Figure 4B Further aspects of an exemplary CBBCT imaging system 400 are shown in schematic perspective views. Figure 4B , the CBBCT system 400 is shown in a second state, where the vertical plane gantry subsystem 402 is in a closer position relative to the patient support subsystem 404.

[0105] Reference again Figure 4A Consistent with the above description of systems 200 and 300 , the patient support subsystem 404 of the CBBCT system 400 includes an adjustable seat 410 and a patient positioning panel 412 .

[0106] In typical operation, the CBBCT system 400 is in an initial first state (i.e., Figure 4A The large distance between the vertical plane gantry subsystem 402 and the patient support subsystem 404 enables the patient to easily approach and sit on the seat 410.

[0107] In certain embodiments of the invention, the height and other positional parameters of the seat 410 and the parameters of the patient support subsystem 404 as a whole are adjusted before the patient enters the system. In alternative embodiments of the invention, the seat 410 is adjusted after the patient is positioned on the seat. In further aspects and embodiments of the invention, the parameters of the patient support subsystem are adjusted before and after the patient sits on the seat 410.

[0108] Once the patient is in position, the system will be adjusted to reduce the relative distance between the patient and the system's patient positioning panel 412. Thus, in certain embodiments of the present invention, the vertical plane gantry subsystem 402 will be moved along dimension 408 toward the seated patient until the patient contacting surface area 414 of the patient positioning panel 412 is in close proximity to the patient.

[0109] This places the patient in contact with a portion of the patient contacting surface area 414 of the patient positioning panel 412 while the patient's breast to be imaged is positioned vertically through the aperture 416 .

[0110] As will be discussed further below, in various aspects and embodiments of the present invention, a patient positioning subpanel will be positioned at the aperture (e.g., patient positioning subpanel 710 described below) such that the patient will be in contact with the surface area of ​​the subpanel and the breast to be imaged will be positioned vertically through the aperture of the subpanel.

[0111] Once the patient is positioned as described above, the patient and / or technical and medical staff may make further adjustments to the position of the breast and any other procedural preparations required prior to imaging. Afterwards, CBBCT imaging may proceed.

[0112] Figure 4C The exemplary CBBCT imaging system 400 is shown imaging in progress. Figure 4B , the CBBCT system 400 is shown in a second state, where the vertical plane gantry subsystem 402 is in a closer position relative to the patient support subsystem 404. An imaging scan is in progress, and the vertical plane gantry 418 is rotating 420 about a rotation axis 422.

[0113] Figure 4DFurther aspects of the CBBCT imaging system 400, including exemplary safety features thereof, are shown in schematic block diagram form. In conjunction with the above description, in the CBBCT systems 300 and 400, the vertical plane gantry subsystem 402 can move closer to or away from the patient support subsystem 404 along the base member 406 in the direction 408. Those skilled in the art will appreciate that such movement must be limited to ensure the safety of the patient when between the patient support subsystem 404 and the vertical plane gantry subsystem 402.

[0114] Therefore, the CBBCT imaging system will include interlocks and safety release / disconnect mechanisms in its various embodiments. These mechanisms will ensure that the minimum distance and maximum pressure applied between the vertical plane gantry subsystem 402 and the patient support subsystem 404 are limited to defined repeatable values. In addition, in a typical system, an emergency stop / release subsystem 438 will be provided to stop the movement of the subsystem and release any pressure applied.

[0115] As described above, the vertical plane gantry subsystem 402 includes a structural member 430. The structural member 430 is coupled to and supported by a base member 434. The patient placement panel 412 is also coupled to and supported by the base member 434. The structural member 430 is also coupled to and supported by a rotation bearing 440, which is coupled to the vertical plane gantry 418 and supports it to rotate around the rotation axis of the bearing.

[0116] The base member 434 is also coupled to and supported by a linear bearing 446. The linear bearing 446 is coupled to 448 and supported by the base member 406. Thus, the base member 406 supports the sliding movement of the vertical plane rack subsystem 402 in the 408 direction.

[0117] This movement is driven by a linear actuator 450. In accordance with the present discussion, to ensure patient safety, the linear actuator 450 is coupled to the structural member (and therefore also to the patient placement panel) by an exemplary safety feature. Thus, the linear actuator 450 is coupled to a first force limiting clutch 454, which in turn is coupled to the structural member 430. In certain embodiments of the present invention, the linear actuator 450 is also coupled to a second force limiting clutch 460. The second force limiting clutch 460 is coupled to the base member 406.

[0118] When the first force limiting clutch 454 and the second force limiting clutch 460 are engaged, the linear actuator 450 is able to move the structural member 430, and therefore the patient placement panel 412, relative to the base component 406. However, if either the first force limiting clutch 454 or the second force limiting clutch 460 is disengaged, the structural member 430 and the remainder of the vertical plane gantry subsystem 402 are released from the base component 406 relative to movement in the direction 408.

[0119] Thus, if either force limiting clutch 454 or 460 is disengaged, the patient positioning panel 412 will no longer move toward the patient in direction 408 , and the patient (and / or any medical / technician) can push the patient positioning panel 412 away from the patient by pushing on it.

[0120] The patient support subsystem 404 shown also includes exemplary safety features. The patient support subsystem 404 includes a patient back support portion 464 coupled to 468 and supported by a column 470. The column 470 is in turn coupled to a force limiting clutch device 474 including a third force limiting clutch. The force limiting clutch device 474 is coupled to the base member 406.

[0121] As will be apparent, when the force limiting clutch device 474 is engaged, the movement of the column 470 (and therefore the patient back support portion 464) in the direction 408 is substantially fixed relative to the base component 406. When necessary (i.e., to ensure the comfort and safety of the patient), the clutch device 474 is released. This allows the column 470 and the patient back support portion 464 to move relative to the base component 406 in the direction 408 toward the patient placement panel 412.

[0122] Thus, if the force limiting clutch device 474 is disengaged, the patient support subsystem 404 will no longer be fixedly coupled to the base member 406, thereby preventing the patient placement panel 412 from being advanced in the direction 408. As a result, the patient (and / or any medical / technician) will be able to push the patient support subsystem 404 away from the vertical plane gantry subsystem 402 by, for example, pushing against the patient placement panel 412.

[0123] Those skilled in the art will appreciate that in some embodiments, the force limiting clutch device 474 will include a linear bearing that will facilitate movement of the patient support subsystem 404 relative to the base component 406 in the direction 408 after the force limiting clutch device 474 is released.

[0124] In other embodiments of the present invention, release of the force limiting clutch device 474 will allow articulation of the patient support subsystem 404 relative to the base member 406 and away from the vertical plane gantry subsystem 402. In such exemplary embodiments, for example, the force limiting clutch device 474 will include a mechanical hinge, a shaft, a linkage assembly, an active polymer hinge, or other device suitable for the desired articulation.

[0125] In certain embodiments of the present invention, the force limiting clutch device 474 will include an auxiliary mechanism to assist or facilitate movement of the patient support subsystem 404 away from the vertical planar gantry subsystem 402 in the direction 408. In this way, even if the patient lacks sufficient strength to separate the two subsystems, they will still be protected in the event that the force limiting clutch device 474 is released. Similarly, in certain embodiments, an auxiliary mechanism will be provided to assist movement of the vertical planar gantry subsystem 402 away from the patient support subsystem 404 in the direction 408.

[0126] In view of the above, experts in the field will understand that the present invention includes any variety of passive or active assist mechanisms suitable for the requirements of a particular embodiment and can be implemented with minimal experimentation. Therefore, in certain embodiments of the present invention, the assist mechanism may include any pneumatic cylinder, pneumatic airbag, pressurized gas reservoir, gas generator (e.g., explosive gas generator), hydraulic cylinder, hydraulic airbag, hydraulic fluid reservoir, hydraulic pump, spring, such as helical compression spring, helical extension spring, helical spring, torsion spring, any of the above linear actuators and related components, whether used alone or in combination, and any other suitable mechanism known or to be known in the art.

[0127] As shown, the patient support subsystem 404 also includes an active back support mechanism 478 (as described above, for example, in Figure 3 ), the mechanism is operatively coupled to a safety device 482, and the safety device 482 is in turn operatively coupled to the back support portion 464. Consistent with the above discussion, the safety device 482 releases pressure when necessary to prevent the patient from being forced against the patient placement panel 412. Therefore, in various embodiments, the safety device 482 will include a force limiting clutch, a safety valve limited airbag, or other device or apparatus suitable for this purpose.

[0128] Experts in the field will also recognize that any of the force limiting clutches described above may include, for example, one or more mechanical friction clutches, magnetic clutches, pressure release safety valves combined with cylinders or air bags, frangible components (such as frangible metal components, frangible polymer components, frangible glass components), compressible components (such as compressible foam polymer components), plastic or ductile metal bellows or other plastic or ductile metal components in compression or tension, ratchet and pawl assemblies, or any other device or apparatus configured and adapted to release under predictable force, whether once or repeatedly. It should be understood that in various embodiments, the force limiting clutch may include disposable and non-disposable (i.e., reusable) components. For example, the frangible component can be a disposable / disposable component that needs to be replaced in the event of clutch release.

[0129] In certain embodiments of the present invention, the safety features of the CBBCT imaging system 400 will include one or more mechanical stops that provide mechanical interference between the various components of the system, thereby preventing the system components from moving into a state that is dangerous or uncomfortable for the patient.

[0130] Thus, for example, mechanical stop 486 is operatively coupled to base member 406. Mechanical stop 486 is positioned to limit movement of vertical plane gantry subsystem 402 in direction 408 relative to base member 406, and thus relative to patient support subsystem 404.

[0131] In certain embodiments of the present invention, the mechanical stop 486 is substantially permanently coupled to the base member 406. In other embodiments of the present invention, the mechanical stop 486 is substantially fixedly coupled to the base member 406, but can be released. Thus, the position of the mechanical stop 486 relative to the base member 406 can be adjusted according to the requirements of a particular patient or procedure.

[0132] In further aspects or embodiments of the present invention, a further mechanical stop 490 is operatively coupled to the patient placement panel 412. Similar to the mechanical stop 486, the mechanical stop 490 is capable of limiting the distance between the vertical plane gantry subsystem 402 and the patient support subsystem 404 to no less than a minimum distance. Similar to the mechanical stop 486, the mechanical stop 490 can be substantially permanent or removable and / or replaceable, with a variety of mechanical stops of different lengths. Therefore, the length of certain mechanical stops 490 will be selected or adjusted based on the requirements of a particular patient or procedure. A set of mechanical stops 490 of different sizes may be provided with a particular embodiment of the present invention.

[0133] In certain embodiments of the present invention, the safety features of the CBBCT imaging system 400 will include one or more emergency stop / release subsystems 438 to arrest the movement of the vertical plane gantry and patient support subsystems and relieve any applied pressure.

[0134] In the illustrated embodiment, the emergency stop subsystem 438 includes a plurality of patient-accessible stop buttons (or other actuators), such as 493 and 494, respectively coupled to the vertical plane gantry subsystem 402 and / or the patient support subsystem 404. The patient-accessible stop buttons are signal-coupled to a control system 496. Those skilled in the art will appreciate that the control system may be, for example, a pneumatic control system, an electronic control system (including a microcontroller and related components known in the art), a motor control system (e.g., relays, magnets, and power supplies, as known in the art), and any other control components suitable for the system requirements that are known or will become known.

[0135] As shown, additional stop buttons, such as 497, will also be provided at a location accessible to technicians and / or medical personnel, which are operatively coupled to the control system 496 to ensure that the patient and technicians and / or medical personnel can immediately stop the movement of the subsystem and release the patient from the CBBCT imaging system 400. Likewise, a person of ordinary skill will immediately understand that the control system 496 will be operatively coupled to one or more linear actuators 450, active back support mechanism 478, and any safety devices 454, 460, 474, 482, etc. present in the CBBCT imaging system 400 to control them and ensure the safety and comfort of the patient.

[0136] Figure 5 A portion of an exemplary CBBCT imaging system 500 is shown in schematic perspective view, including a vertical planar gantry subsystem 502 and a coaxial support subsystem 504. System 500 illustrates further details of certain embodiments of systems 200, 300, and 400, as well as other embodiments of the present invention. Vertical planar gantry subsystem 502 includes a vertical planar gantry 506 configured to rotate about a generally horizontal rotation axis 508.

[0137] The exemplary coaxial support subsystem 504 includes a vertical column structure 510 and a first horizontal structure 512 and a second horizontal structure 514. The horizontal structures 512 and 514 each have a proximal end 516 and 518 and a distal end 520 and 522. The horizontal structures 510 and 512 are operatively coupled to the vertical column structure 510 at the respective distal ends 520 and 522. Therefore, the horizontal structures 510 and 512 are configured and adapted to support and stabilize the auxiliary subsystem of the CBBCT imaging system.

[0138] It should be noted that the horizontal structures 512 and 514 are shown in a cantilever configuration supported on the vertical column structure 510. However, experts in the technical field will recognize that in various embodiments of the present invention, any of a variety of support arrangements can effectively achieve the goal of supporting at least the horizontal structures 512 and 514.

[0139] Those skilled in the art will recognize that the arrangement described herein, including the two horizontal structural members 512 and 514, is merely an example of a variety of arrangements, including, for example, a single structural member, a solid member (including an I-beam) or any other solid member configuration, a tubular beam (including a cylindrical tubular beam), a box beam, and a truss composed of multiple solid or tubular members, etc. All of the above (and any comparable components that are known or will become known) are intended to be included in the current disclosure.

[0140] According to the exemplary embodiment of the invention shown, the coaxial support subsystem 504 includes a coupling device 524. A first linear bearing device 526 and a second linear bearing device 528 are coupled to the first and second horizontal structures 510 and 512, respectively, and to the coupling device 524, respectively.

[0141] In various aspects and embodiments of the present invention, the coaxial support subsystem 504 will support a variety of auxiliary equipment, including, for example, a breast stabilization unit, a fixed scanning subsystem, an X-ray filtering subsystem and its components, an X-ray grating subsystem and its components, auxiliary cameras and other imaging equipment, or other auxiliary equipment that is known or will become known and can work in conjunction with the rest of the CBBCT imaging system.

[0142] Thus, any of the aforementioned auxiliary devices will be coupled to the coupling device 524 and thus operatively supported by the horizontal structures 512 and 514. It will be appreciated by those skilled in the art that the presence of the linear bearings 526 and 528 allows the auxiliary devices to be positionally displaced in a manner such that the auxiliary devices can be moved from a storage configuration located at the distal ends (e.g., 520 and 522) of the horizontal structures 512 and 514 to an operative configuration located at the proximal ends (516 and 518) of the horizontal structures.

[0143] In some embodiments, the fore-and-aft displacement of the coupling device 524 between the distal storage configuration and the proximal operating configuration along dimension 530 will be manually achieved. In certain further aspects of the present invention, the coaxial support subsystem 504 will include a linear actuator coupled between the coupling device 524 and the remainder of the coaxial support system 504 (e.g., one or more of the horizontal structural members 512, 514 or the vertical column structural member 510). The linear actuator will effectively drive and control the fore-and-aft movement of the coupling device 524 (and auxiliary equipment) along dimension 530 between the distal storage configuration and the proximal operating configuration.

[0144] In certain embodiments of the invention, the linear actuator will be under manual control. In other embodiments of the invention, the linear actuator will be automatically controlled directly or indirectly by a system computer, or directly or indirectly by dedicated embedded hardware (e.g., a dedicated microcontroller).

[0145] It will be appreciated by those skilled in the art that the linear actuators described herein (and any linear actuators referred to herein) may employ a variety of actuators available in the art. For example, in certain embodiments, the linear actuators may include one or more gear racks and gear arrangements, Acme screws and Acme nuts; ball screw arrangements; linear stepper motors; transversely complementary ramps; pneumatic cylinders; pneumatic air bags; pneumatic bellows; hydraulic cylinders; hydraulic air bags; hydraulic bellows; scissor linkage mechanisms, including, for example, scissor linkage mechanisms driven by screws, cylinders, or any other actuator discussed herein, or any other suitable actuator; a Sarus linkage mechanism; a thermoelectric actuator; a shape memory alloy actuator; a rope and pulley arrangement; and any variety of manual actuators, such as hand cranks and / or ratchet levers; compression springs; extension springs; torsion springs; a combination of leaf springs; a spring including a plurality of Belleville washers; or any other currently known or to be known linear actuator that is suitable for the requirements of a particular application and provides the desired telescopic function.

[0146] Thus, for example, in certain embodiments of the present invention, the linear actuator may include one or more solenoid valves, pneumatic cylinders, hydraulic cylinders, pneumatic air bags, hydraulic air bags, linear motors, linear stepper motors, rotary actuators, and: Acme screws and nuts, lead screws, ball screws, ropes, pulleys, timing belts, timing pulleys, appropriately sized worm gear reducers, rack and gear assemblies, rack and worm gear assemblies, piezoelectric actuators, piezoelectric actuators in combination with ratchet and pawl drives, spring driven actuators, and actuators including shape memory alloys, as well as any other appropriately functional actuator assemblies known or to become known in the art.

[0147] In some embodiments, one or more auxiliary equipment units will be detachably coupled to the coupling device so that a specific auxiliary equipment unit can be installed on the coupling device according to the requirements of a specific patient and a specific imaging / diagnostic protocol. In addition, in various embodiments of the present invention, the installation and removal of the auxiliary equipment from the coupling device will be completed manually or automatically by a corresponding motion control system.

[0148] In certain embodiments of the present invention, one or more diagnostic equipment units will be stored in a storage space adapted to be permanently or temporarily fixed to the CBBCT imaging system 500. Therefore, the above-mentioned motion control system will retrieve the required auxiliary equipment unit from the storage space and install it on the coupling device according to the requirements of a specific patient or imaging / diagnostic protocol.

[0149] Figures 6A-6C The process and method 600 of using a CBBCT imaging system according to the principles of the present invention is presented in the form of a functional block diagram. Those skilled in the art will appreciate that the methods described herein will be effectively used with the systems 200, 300, 400, 500 described above as well as other imaging systems.

[0150] therefore, Fig. 6A Steps are shown for arranging 602 a CBBCT imaging system to an initial (distal) state; capturing 604 patient measurements (i.e., body dimensions and characteristics); installing and configuring 606 a patient positioning subpanel; making initial adjustments 608 to patient support system parameters; introducing 610 a patient to the imaging system; seating 612 the patient on the saddle; further adjusting 614 patient support system parameters to ensure patient comfort and optimal imaging position; advancing 616 the imaging subsystem toward the patient so that the imaging subsystem (i.e., the vertical plane gantry subsystem) moves to the secondary (proximal) state described above; adjusting 618 the configuration of the patient positioning subpanel, including, for example, optionally installing a breast stabilization unit; completing configuration 620 of the patient positioning subpanel; further adjusting 622 patient support system parameters to improve patient comfort and imaging positioning; advancing 623 a patient back support pad 624 toward the patient's back to urge the patient against the patient positioning panel and stabilize the patient to prevent accidental movement; activating 626 an X-ray source; rotating 628 the gantry about a rotation axis; and initiating 630 a CBBCT scan.

[0151] In addition to the above steps, the method and process 600 may also selectively include one or more of the following steps: optionally starting 632 a secondary hybrid scan, for example, including but not limited to a CBBCT / ultrasound hybrid scan, a CBBCT / PET hybrid scan, a CBBCT / terahertz hybrid scan, a CBBCT / optical hybrid scan; optionally configuring 634 a fixed scanning subsystem and starting 636 a fixed scan, and optionally deconfiguring 638 the fixed scanning subsystem; optionally configuring 640 a biopsy guidance subsystem to guide a manual biopsy procedure, optionally performing 642 a biopsy procedure, and optionally deconfiguring 644 the biopsy guidance system (or performing the same operation for an automated biopsy procedure). Of course, experts in the art, after having the benefit of this disclosure, will recognize in retrospect that it would be desirable and easy to implement to combine available auxiliary devices and methods with the other optional steps of the method. Therefore, all of the above are intended to be covered within the scope of this disclosure.

[0152] The disclosed method and process further includes the steps of: retracting 646 the patient back support cushion; retracting 648 the imaging subsystem from the patient to an initial (distal) state; and removing 650 the patient from the imaging system.

[0153] See also Figure 2 , the illustrated embodiment shows a patient placement panel 238, which is located between the rotating gantry 204 and the patient support subsystem 230. The patient placement panel 238 has a first patient placement surface area 240 and a second distal surface area 242, wherein the distal surface area 242 is spaced apart from the patient placement surface area 240.

[0154] The inner peripheral edge 244 of the patient positioning surface area 240 surrounds an aperture 246 that passes through the patient positioning panel 238 and is located between the patient positioning surface area 240 and the distal surface area 242 .

[0155] As described above, the arrangement of the patient placement surface area 240 is intended to isolate the patient from the rest of the vertical gantry subsystem 206, and the patient's breast extends through the aperture 246. In various embodiments and aspects of the present invention, a patient placement sub-panel is located at the aperture 246. In various aspects thereof, the sub-panel will provide an aperture designed and positioned according to the characteristics of the specific patient and the imaged breast, protect the area where the patient may be exposed to scattered X-ray photons, support the fixation features of auxiliary equipment, and other features such as support and stabilization of the imaged breast. Further aspects and details of the sub-panel will be provided below.

[0156] Figure 7 Certain aspects of an exemplary CBBCT imaging system 700 prepared in accordance with the principles of the present invention are illustrated in schematic proximal elevation view, including a vertical plane gantry subsystem 702. It will be appreciated that the vertical plane gantry subsystem 702 is similar in its features to the subsystems discussed above, and exhibits further aspects and details of the same invention, as well as other innovative features and aspects. Thus, the vertical plane gantry subsystem 702 includes a patient placement panel 704.

[0157] The patient positioning panel 704 includes a patient positioning surface area 706 adapted to support the patient during scanning. In various embodiments of the present invention, the patient positioning surface area 706 includes an inner peripheral edge 708 defining an aperture through the patient positioning surface area of ​​the patient positioning panel. In some embodiments, the aperture is adapted to receive a patient's breast therethrough. In other embodiments, the aperture includes a patient positioning surface area 706 adapted to support the patient during scanning. Figure 7 As shown in FIG, the aperture is adapted to receive a patient positioning sub-panel 710 through the peripheral edge 708. The patient positioning sub-panel 710 is coupled to and / or supported by the patient positioning panel 704.

[0158] In comparison with the inner edge, for example 244 ( Figure 2) and 708, it is apparent that a particular shape of the perimeter edge will be selected in the respective embodiments to optimize functionality and ease of manufacture, among other considerations. Thus, the geometric shapes shown are merely examples of a variety of configurations that will be immediately apparent to an expert in the art when considering the entirety of this disclosure.

[0159] The patient placement subpanel 710 includes a subpanel surface area 712. A further inner peripheral edge 714 defines an aperture 716 on the subpanel. In the illustrated configuration, the subpanel aperture 716 is located to the right of a longitudinal centerline 718 of the patient placement panel 704. Thus, in typical operation of the CBBCT imaging system, the patient's right breast will be imaged through the subpanel aperture 716.

[0160] Further reference to the above Figure 7 and Figure 3 In certain embodiments of the present invention, the patient support subsystem 330 will include an exemplary seating device 344. As described above, the exemplary seating device 344 is coupled to and supported by the column member 332. The seating device 344 includes a saddle portion 346 having a structural body 348 and a saddle upper surface area 350.

[0161] As described above, the seat adjustment mechanism allows for vertical 356 and lateral 358 displacement adjustment of the saddle portion 346 relative to the longitudinal axis 360 of the base member 336. In certain embodiments, the seat adjustment mechanism also allows for additional rotational degrees of freedom of the saddle portion about the longitudinal axis of the seat post 352, namely 362 (yaw) and 363 (pitch) rotation about the lateral axis 358.

[0162] Thus, the chair adjustment mechanism is adapted to adjust the lateral position of the patient relative to the patient positioning panel 704. Among other degrees of freedom, such a system would allow adjustment of the patient's position in a dimension 720 that is transverse to the table centerline 718. This adjustment would, in advantageous applications, move the patient's breast in one direction (i.e., degree of freedom 722) to the centerline of the CBBCT imaging system (i.e., toward the axis of rotation, such as the rotating gantry 306 described above).

[0163] It will be appreciated by those skilled in the art that in certain embodiments of the present invention, multiple sub-panels will be provided that include holes of different sizes. For example, a sub-panel will be provided having an inner peripheral edge 724 that defines a hole of smaller diameter (compared to the illustrated hole 716 defined by the inner peripheral edge 714). Thus, a technician or medical professional will be able to select and install a sub-panel having a hole that is appropriate for the size and location of a particular patient's breast.

[0164] In other embodiments of the present invention, adjustment of the aperture size will be achieved by operating an adjustment mechanism, such as an iris blade aperture mechanism (see below). Figures 10D-10F ). In certain embodiments, the adjustment mechanism will be substantially permanently coupled to the patient placement panel 704 of the vertical planar gantry subsystem 702. In other embodiments of the invention, the adjustment mechanism will be coupled to the subpanel 710 described above.

[0165] In certain embodiments of the present invention, the aperture for receiving the breast to be imaged generally coincides with the centerline of the patient positioning panel. In such embodiments, the patient will be positioned so that the breast to be imaged is aligned with the centerline of the table. Thus, no additional lateral mechanism is required to align the breast with the axis of rotation of the gantry. It will be appreciated by those skilled in the art that such alignment of the breast aperture may be achieved by providing the aperture directly on the patient positioning panel, or alternatively, on a sub-panel configured to be connected or coupled to the patient positioning panel.

[0166] therefore, Figure 8 Certain aspects of an exemplary CBBCT imaging system 800 are shown in schematic proximal elevation view, including a vertical planar gantry subsystem 802, generally with Figure 7 The vertical plane rack subsystem 802 is similar to the vertical plane rack subsystem 702 in FIG. The vertical plane rack subsystem 802 includes a patient placement panel 804.

[0167] The patient positioning panel 804 includes a patient positioning surface area 806 suitable for supporting a patient during scanning. In various embodiments of the present invention, the patient positioning surface area 806 includes an inner peripheral edge 808 defining an aperture through the patient positioning surface area of ​​the patient positioning panel. Figure 7 Similar to the exemplary embodiment provided in , the aperture is adapted to receive a sub-panel 810 extending through the peripheral edge 808. The sub-panel 810 is coupled to and / or supported by the patient placement panel 804.

[0168] The subpanel 810 includes a subpanel surface area 812. Further, an inner peripheral edge 814 defines an aperture 816 through the subpanel. In the illustrated configuration, the subpanel aperture 816 coincides with a longitudinal centerline 818 of the patient placement panel 804. Thus, in typical operation of the CBBCT imaging system, either side of the patient's breast can be imaged through the subpanel aperture 816, and the chair adjustment mechanism (e.g., as described above) can be adjusted. Figure 3 The associated mechanism) is configured to align the breast to be imaged with the sub-panel aperture 816, and the patient will be positioned accordingly on the upper surface 806 of the patient positioning panel 804.

[0169] Although the inner peripheral edge (e.g., 714, 724, 814) shown and discussed above presents a substantially circular feature, experts in the technical field will understand that the peripheral edge can take any shape that is considered advantageous according to the requirements of the specific application of the present invention. Therefore, in certain embodiments of the present invention, the peripheral edge can be generally elliptical, or can be generally triangular, or any other regular or irregular polygonal shape, or any arc shape, or a combination of arcs and linear segments, or any combination of the above, all of which should be considered within the scope of the present disclosure.

[0170] See also Figure 7 , the exemplary patient positioning panel 704 includes handles 730 and 732. The positioning and configuration of the handles 730 and 732 enable the patient to hold the handles when installing and operating the CBBCT imaging system 700. This improves the patient's ability to position the body on the patient positioning panel 704 and provides stability to the patient during imaging, thereby improving data / image quality.

[0171] In various embodiments of the present invention, the handles 730 and 732 can be rotated in one or more dimensions of the centerline 718, the lateral dimension 720, and about a respective vertical axis that passes through the respective handle and is generally perpendicular to the patient placement surface 706 of the patient placement panel 704. The reader will appreciate that the exemplary handle positions and configurations shown here are only one of many possible configurations.

[0172] Furthermore, in corresponding embodiments of the present invention, the position of any handle may be reconfigured so as to be located at any suitable position of the patient placement surface 706 of the patient placement panel 704. Thus, in certain embodiments of the present invention, a handle (e.g., 730) may be coupled to the patient placement surface 706 by a removable magnetic device, a hook and loop fastener device, a snap fastener device, a protrusion and groove device, an elastic suction cup device, or by any other suitable means or device to achieve a temporary but effectively fixed position of the handle on the patient placement surface 706.

[0173] Figures 9A-9E Exemplary handles to be used in various embodiments of the present invention are shown in schematic perspective views. Those skilled in the art will readily appreciate the advantages of the particular handles shown, as well as other handles suggested in this disclosure, which are considered within its scope. For example, Fig. 9A A handle 900 is shown, adapted to be grasped primarily about a transverse longitudinal axis 902, and substantially fixedly coupled to a patient placement panel at a first end 904 and a second end 906 thereof, either directly or via an adjustment device. Fig. 9A The handle and Figure 7 The handles shown in parts 730 and 732 are somewhat similar.

[0174] Fig. 9B An alternative handle 910 is shown, adapted to be held primarily about a longitudinal axis 912 that is generally perpendicular to the surface of a patient placement panel. The radius of a flange portion 914 of the handle 910 is generally greater than the radius 918 of the grip portion 919. This extended flange effectively couples with the patient placement panel and increases the stability and rigidity of the handle 910.

[0175] Fig. 9C A further alternative handle 920 is shown, adapted to be gripped primarily about a longitudinal axis 922 that is generally perpendicular to the surface of a patient placement panel. A lower flange portion 924 of the handle 920 has a radius that is generally greater than a radius 928 of a grip portion 929. An upper flange portion 930 extends in an arcuate manner away from the longitudinal axis 922 and slopes downwardly to a patient placement panel to which it is coupled at a lower edge 932. The extended upper and lower flanges effectively couple the handle 920 to the patient placement panel and increase the stability and rigidity of the handle.

[0176] Fig.9D A further alternative handle 934 is shown, adapted to be gripped primarily about a raised upper surface 936 that is generally parallel to the surface of the patient placement panel and transverse to a longitudinal axis 938 of the handle 934. The longitudinal axis 938 is generally perpendicular to the surface of the patient placement panel and generally passes through the patient's palm and / or finger joints when in use. A peripheral groove 940 located below the raised upper surface 936 and generally transverse to the longitudinal axis 938 is adapted to accommodate the fingertips of the patient's fingers, thereby enhancing the patient's grip. A lower flange portion 942 of the handle 934 effectively couples the handle 934 to the patient placement panel and increases the stability and rigidity of the handle.

[0177] Fig.9E A further alternative handle 944 is shown, adapted to be grasped primarily about a longitudinal axis 946 that is generally perpendicular to the surface of the patient placement panel. A lower flange portion 948 of the handle 944 has a radius that is generally greater than a transverse dimension 952 of a grip portion 954. A vertical surface region 956 of the handle 944 exhibits a generally convex shape adapted to contact the palm of a patient's hand.

[0178] The opposite vertical surface region 958 includes a plurality of concave grooves, such as 960, 962, 964, each of which is adapted to accommodate a patient's finger. In some embodiments, the handle 944 is substantially fixedly coupled to the patient placement panel of the patient support panel. In other embodiments, the handle is coupled to the patient placement panel via a swivel bearing and is adapted to rotate substantially freely in a circumferential direction 966, or to be released and fixed in place in a swivel manner after adjustment according to the requirements of a particular application. This articulated motion allows the position of the surfaces 956 and 958 to be adjusted to achieve optimal comfort for the patient when holding the handle.

[0179] In the context of the above discussion, Figures 10A-10F Various exemplary subpanel configurations are schematically shown, which are within the scope of the present invention and are similar to those described above. Figure 7 and 8 Related subpanels 710 and 810 are similar.

[0180] Figures 10A-10C Exemplary subpanels with various hole locations and sizes are shown in schematic elevation views.

[0181] See first Fig. 10A , the subpanel 1000 includes a subpanel surface area 1002. The inner peripheral edge 1004 defines an aperture 1006 through the subpanel. Consistent with the above discussion, the aperture 1006 is adapted to receive a patient's breast to be imaged. In the illustrated configuration, the subpanel aperture 1006 is located to the left of a longitudinal centerline 1008 of the subpanel 1000. Thus, in typical operation of the CBBCT imaging system, the patient's left breast will be imaged through the subpanel aperture 1006.

[0182] Fig. 10B A subpanel 1012 is shown, similar to subpanel 1000. Like subpanel 1000, subpanel 1012 has an inner peripheral edge 1014 defining an aperture 1016 through subpanel 1012. Similar to aperture 1006, aperture 1016 is located to the left of a longitudinal centerline 1018 of subpanel 1012. However, a diameter 1020 of aperture 1006 is relatively smaller, being smaller than a corresponding diameter 1022 of aperture 1016.

[0183] Fig. 10CA subpanel 1026 is shown, similar to subpanels 1000 and 1012. Like subpanel 1000, subpanel 1026 has an inner peripheral edge 1028 defining an aperture 1030 through subpanel 1026. A diameter 1032 of aperture 1030 is substantially equal to the corresponding diameter 1022 of aperture 1016. However, the center of gravity of aperture 1030 is substantially coincident with a centerline 1034 of subpanel 1026. Thus, while apertures 1006 and 1016 are primarily configured to receive a patient's left breast for imaging, aperture 1030 is suitable for receiving either a left or right breast.

[0184] Experts in the technical field will also understand that, provided that appropriate peripheral configurations and coupling features are provided, the symmetry of the panels shown will be used for imaging in various embodiments of the present invention, for example, to image the left or right breast by symmetrically rotating sub-panel 1000 or 1012 about center lines 1008 and 1018, respectively.

[0185] Likewise, rotation of the faceplate about an axis transverse to the centerline may be used to adjust the position of the apertures shown relatively higher or lower as required for taller or shorter patients, respectively.

[0186] In view of the above discussion, the reader will understand that in certain embodiments of the present invention, multiple sub-panels and imaging systems will be provided so that a sub-panel with appropriate holes can be selected based on the patient's height, weight, breast size and other parameters.

[0187] In another embodiment of the invention, a separate reusable subpanel will be purchased so that it is available when needed. In other embodiments of the invention, a disposable subpanel will be used, which is disposed of after a single use per patient.

[0188] Figures 10D-10F A schematic representation of a further subpanel 1050 prepared in accordance with the principles of the present invention is shown. The subpanel 1050 is shown in a cutaway view showing an adjustment mechanism 1052 included in the subpanel 1050.

[0189] In the exemplary embodiment shown, the adjustment mechanism 1052 includes a mechanical iris mechanism 1054. The adjustable iris mechanism 1054 includes a plurality of blade members, such as 1056 and 1058, coupled to corresponding operating links 1060 and 1062, respectively. Those skilled in the art will recognize that the adjustable iris mechanism 1054 is similar in shape and function to an iris mechanism used for a photographic camera. Thus, by operating the links 1060 and 1062, the blade members 1056 and 1058 will be caused to rotate to adjust the diameter of the aperture 1064 to a desired value based on the requirements of a particular patient's breast imaging.

[0190] By further explanation, in Fig. 10EIn the exemplary iris mechanism 1070, the exemplary iris mechanism 1070 is adapted and configured to present an aperture 1072 having a relatively small diameter 1074. Fig.10F , the exemplary iris mechanism 1070 is adapted and configured to present the same aperture 1072 , but with a relatively larger diameter 1076 .

[0191] In a further aspect of the invention, Fig.11 A subpanel 1100 is shown in a schematic distal cutaway perspective view, including a breast stabilizer unit 1102 adapted to support and stabilize a patient's breast during imaging. As shown, the breast stabilizer unit 1102 is coupled to the subpanel 1100 with an aperture 1104 on a distal surface 1106 .

[0192] Various benefits and methods of using an exemplary stabilizer unit such as that shown herein will be readily appreciated by those skilled in the art upon reviewing the above-described related applications.

[0193] Fig.12 A portion of an exemplary CBBCT imaging system 1200 is shown in schematic side elevation and is similar to system 200 and includes a vertical planar gantry subsystem 1202. Vertical planar gantry subsystem 1202 includes a vertical planar gantry 1204 configured to rotate about a generally horizontal axis of rotation 1206.

[0194] Similar to the systems 100 and 200 described above, the system 1200 includes an X-ray source 1208. The exemplary X-ray source 1208 is mounted on and supported by a mounting surface 1210 of a vertical planar gantry 1204. The vertical planar gantry 1204 is supported by a bearing 1212 and is configured to rotate about an axis of rotation 1206. The bearing 1212 is in turn coupled to and supported by a structure 1214.

[0195] The base member 1230 is coupled to the structural member 1214. The patient placement panel 1238 is coupled to the structural member 1214 via the base member 1230, so that the structural member 1214 and the base member 1230 support the patient placement panel 1238 together.

[0196] The patient placement panel 1238 has a first patient placement surface area 1240 and a second distal surface area 1242, wherein the distal surface area 1242 is spaced apart from the patient placement surface area 1240. The exemplary patient placement panel 1238 is similar in shape and function to the Figure 2 Similar to the patient placement panel 238 in FIG.

[0197] Therefore, see Figure 2 and Fig.12The patient placement panel includes an inner peripheral edge of the patient placement surface area. The inner peripheral edge surrounds a hole 1246 that passes through the patient placement panel 1238 and is located between the patient placement surface area 1240 and the distal surface area 1242.

[0198] In a manner similar to that described above, the arrangement of the patient placement surface area 1240 is intended to isolate the patient from the rest of the vertical gantry subsystem 1202, with the patient's breast extending through the aperture 1246. In various embodiments and aspects of the present invention, the patient placement subsystem (as shown above) is disposed at the aperture 1246. In various aspects, the patient placement subsystem will provide an aperture designed and positioned according to the characteristics of the particular patient and the breast to be imaged, protect the patient from areas that may be exposed to scattered X-ray photons, and provide other features such as support and stabilization for the breast to be imaged.

[0199] The CBBCT imaging system 1200 also includes an exemplary seating device 1276. In the illustrated embodiment, the exemplary seating device 1276 is coupled to and supported by a corresponding portion 1278 of the patient placement surface area 1240. In other embodiments of the present invention, the exemplary seating device 1276 is coupled to and supported by the base member 1230 and / or the patient step 1250, or coupled to any other location, feature, or aspect of the CBBCT imaging system, or a combination thereof, as appropriate for the requirements of a particular application and embodiment.

[0200] The seating device 1276 includes a saddle-shaped portion 1280 having a structural body 1282 and a saddle-shaped upper surface area 1284. The saddle-shaped upper surface area 1284 is adapted to position and support a patient seated on the saddle-shaped portion 1280 during imaging and during optional supplemental examinations.

[0201] In the illustrated embodiment, structural body 1282 is substantially fixedly coupled to the upper end of an exemplary chair post 1286, which is coupled to CBBCT imaging system 1200 as described above, either directly or through an appropriate position adjustment device. The chair post is optional, and in certain embodiments of the present invention, a saddle-shaped structural body is directly coupled to CBBCT imaging system 1200.

[0202] Thus, in certain embodiments of the present invention, the lower end of the exemplary seat post 1286 is operatively coupled to a seat adjustment mechanism. The seat adjustment mechanism is directly or indirectly coupled to the base member 1230 to provide support. Thus, the weight of a patient seated on the saddle-shaped upper surface area 1284 is transferred through the saddle-shaped structural body 1282 to the seat post 1286, and then to the base member 1230 through the seat adjustment mechanism.

[0203] In a desirable aspect of certain embodiments of the invention, the seat adjustment mechanism allows for positional adjustment of the saddle portion 1280 in a vertical direction 1288, i.e., transverse to the upper surface 1290 of the base member 1230. In certain embodiments, the seat adjustment mechanism also allows for articulation in additional degrees of freedom, i.e., yaw of the saddle portion about the longitudinal axis of the seat post 1286, as well as pitch and roll about respective axes.

[0204] Additionally, in certain embodiments of the present invention, the roll of the saddle portion 1280 may also be adjusted to ensure comfort and optimal positioning of the patient on the vertical planar gantry subsystem 1202 .

[0205] In further aspects of the invention, in certain embodiments, the saddle portion may be removable, foldable, or otherwise displaceable so that the patient to be imaged does not sit on the saddle portion, but instead stands, for example, on the upper surface 1254 of the step portion 1250. Thus, the saddle portion may be used when desired, but may not be necessary in situations where a standing mode of patient support is more appropriate.

[0206] Those skilled in the art will appreciate that the saddle portion 1276 will be shaped and configured to promote optimal comfort and positioning of the patient on the vertical planar gantry subsystem 1202. In certain embodiments, the saddle portion 1276 will comprise a material having desirable rheological and elastomeric hardness properties that facilitate biocompatibility.

[0207] Therefore, in various embodiments of the present invention, the saddle portion 1276 will include appropriate materials to achieve these goals. Figure 3 Various exemplary materials corresponding to various embodiments are provided in the related description.

[0208] In the illustrated embodiment, the patient positioning panel 1238 is coupled to and supported by the base member 1230 of the vertical planar gantry subsystem 1202. In other embodiments of the invention, alternative features of the imaging system will support the patient positioning panel, as further described herein.

[0209] Fig.13A and 13B The security components of the security feature 1260 of the exemplary CBBCT imaging system 1200 are shown in a schematic perspective view.

[0210] Fig.13AA safety belt 1300 of a CBBCT imaging system is shown. The safety belt 1300 includes a generally flexible component 1302. In the illustrated embodiment, the flexible component 1302 includes, for example, a textile material, such as a woven textile material, a knitted textile material, a felt textile material, or a link textile material. In other embodiments of the present invention, the flexible component 1302 includes one or more molded elastic polymers, spray-formed elastic polymers, ropes or cables, natural materials (e.g., natural polymers), leather, plant materials, or other materials or combinations of materials suitable for the above-mentioned purposes and functions.

[0211] The safety belt 1300 shown includes a coupling mechanism (e.g., 1304, 1306) suitable for removably coupling the safety belt 1300 to the patient positioning panel 1238. In various embodiments of the present invention, the coupling mechanism 1304, 1306 will include one or more buckles, buttons, hook and loop fasteners, mechanical snap fasteners, magnetic snap fasteners, adhesive snap fasteners, or any other fasteners known or to be known suitable for the purposes of the present disclosure, and combinations thereof.

[0212] In some embodiments of the present invention, the safety belt 1300 will include a cushioning component 1308. In some embodiments, the cushioning component will include a generally elastic component for distributing forces on the inner surface of the flexible component 1302 to avoid excessive pressure at the point of contact with the patient's back.

[0213] In some embodiments of the present invention, the cushioning assembly 1308 will include an expansion assembly, such as an air bag, a liquid bag, or a mechanical actuator. In some embodiments of the present invention, the expansion assembly is adapted to expand in a controlled manner after the safety belt is coupled to the patient placement panel 1238, thereby pushing the patient onto the patient placement surface 1240.

[0214] Fig. 13B An alternative CBBCT imaging system harness 1310 is shown. Similar to harness 1300, harness 1310 includes a generally flexible member 1312. In the illustrated embodiment, flexible member 1312 includes, for example, a textile material and / or any of the materials provided as examples above.

[0215] The flexible member 1312 has a first end 1314 and a second end 1316, the two ports being adapted to couple to respective regions of the patient placement panel 1238. In certain embodiments of the invention, the respective ports 1314 and 1316 are substantially permanently coupled to the patient placement panel 1238. In other embodiments of the invention, the ports 1314 and 1316 are removably and / or adjustably coupled to the patient placement panel 1238.

[0216] In the illustrated embodiment, the flexible member 1312 has a third end 1318 and a fourth end 1320, the two internal ports being adapted to releasably couple to each other. Thus, the internal ports 1318 and 1320 will include respective complementary coupling features. Thus, for example, the internal ports 1318 and 1320 will include respective complementary portions of buckles, buttons, hook and loop fasteners, mechanical snap fasteners, magnetic snap fasteners, or any other fasteners known or to be known suitable for the purposes of the present disclosure, and combinations thereof.

[0217] In certain embodiments of the present invention, safety belts 1300 and 1310 will comprise, for example, a polymer material such as polyamide or polyaramid.

[0218] In other embodiments of the present invention, seat belts 1300 and 1310 (including their components) will include one or more polyethylene, polypropylene, polybutylene, polystyrene, polyester, acrylic polymer, polyvinyl chloride, polyamide or polyetherimide (such as ULTEM.RTM.); polymer alloys, such as Xenoy.RTM. resin, which is a composite of polycarbonate and polybutylene terephthalate; or Lexan.RTM. plastic, which is a copolymer of polycarbonate and isobutylene terephthalate resin (both available from GE Plastics); liquid crystal polymers, such as aromatic polyesters or aromatic polyester amides containing at least one compound selected from the following groups, including aromatic.

[0219] In addition, any polymer composite material, such as an engineered prepreg or composite material, which is a polymer filled with pigments, carbon particles, silica, glass fibers, conductive particles (such as metal particles or conductive polymers) or mixtures thereof, can also be used. For example, a mixture of polycarbonate and ABS (acrylonitrile-butadiene-styrene) can be used.

[0220] The cone beam breast CT device acquires two-dimensional projection data. The acquisition geometry can be single circle geometry, double circle geometry (suitable for large breasts), circle plus straight line geometry, semicircle plus cone angle geometry, spiral cone beam geometry. One or more of these geometries are then used to construct a CBBCT three-dimensional image from the two-dimensional projection data. The reconstruction method can be filtered back projection, iterative algorithm and / or AI deep learning algorithm. Fast reconstruction and imaging processing can be performed using a dedicated imaging processor.

[0221] In certain embodiments, a CBBCT scanning system includes a base component including a vertical planar gantry subsystem coupled to and supported by the base component. The vertical planar gantry subsystem includes a CBBCT gantry adapted and configured to rotate about a generally horizontal axis of rotation; the vertical planar gantry subsystem includes a patient placement panel having a patient placement surface area through which an aperture is inserted, the vertical planar gantry subsystem includes a patient support subpanel disposed within the patient placement panel aperture, and a patient support subsystem coupled to and supported by the base component. The patient support system includes a saddle portion and a back portion, the saddle portion having a saddle-shaped upper surface area adapted to support a patient seated thereon, proximate to the patient placement surface area. The back portion includes an active back support mechanism adapted to push the patient toward the patient placement surface area when activated, and adapted to position and stabilize the patient's breast when performing CBBCT imaging of the patient's breast.

[0222] In some embodiments, the active back support mechanism of the CBBCT scanning system includes a pneumatic airbag; in some embodiments, the active back support mechanism includes a hydraulic airbag, and in some embodiments, the active back support mechanism includes a release mechanism controlled by the patient.

[0223] In some embodiments, the saddle portion of the CBBCT scanning system is coupled to a seat adjustment mechanism.

[0224] In some embodiments, the seat adjustment mechanism of the CBBCT scanning system is adapted to adjust the saddle-shaped upper surface area of ​​the saddle-shaped portion in a vertical degree of freedom, and in some embodiments, the seat adjustment mechanism is adapted to adjust the saddle-shaped upper surface area of ​​the saddle-shaped portion in a horizontal degree of freedom.

[0225] In some embodiments, the seat adjustment mechanism of the CBBCT scanning system is suitable for adjusting the saddle-shaped upper surface area of ​​the saddle-shaped part in the pitch degree of freedom, and in some embodiments, the seat adjustment mechanism is suitable for adjusting the saddle-shaped upper surface area of ​​the saddle-shaped part in the roll degree of freedom; in a further embodiment, the seat adjustment mechanism is suitable for adjusting the saddle-shaped upper surface area of ​​the saddle-shaped part in the yaw degree of freedom.

[0226] In certain embodiments of the present invention, a method for performing a CBBCT scan includes providing an imaging system including a base component, providing a vertical planar gantry subsystem coupled to the base component, providing a patient support subsystem coupled to the base component, setting the imaging system to a first distal configuration relative to a distance between the patient support subsystem and the vertical planar gantry subsystem, adjusting patient support subsystem parameters for patient positioning, seating the patient on a saddle portion of the patient support subsystem, setting the imaging system to a second proximal configuration relative to the distance between the patient support subsystem and the vertical planar gantry subsystem, positioning a breast of the patient within the vertical planar gantry subsystem, activating a back support mechanism of the patient support subsystem, pushing the patient toward the vertical planar gantry subsystem, performing a CBBCT scan of the patient's breast using the vertical planar gantry subsystem, releasing the back support mechanism of the patient support subsystem, returning the imaging system to the first distal configuration, and removing the patient from the saddle portion of the patient support subsystem.

[0227] In some embodiments of the present invention, the method of performing CBBCT scanning further includes providing a patient placement panel having a through hole, installing a patient support sub-panel at the hole, and passing the patient's breast through the breast hole of the patient support sub-panel.

[0228] In some embodiments of the present invention, the method of performing CBBCT scanning further includes receiving a patient parameter value, and selecting a patient support sub-panel according to the patient parameter value.

[0229] In some embodiments of the present invention, selecting the patient support sub-panel based on the patient parameter value includes selecting the patient support sub-panel so that its breast hole diameter corresponds to a breast diameter value of the patient's breast.

[0230] In a further embodiment of the invention, selecting the patient support sub-panel based on the patient parameter value includes selecting the patient support sub-panel so that its breast aperture is advantageously located to one side of a centerline of the patient positioning panel.

[0231] In certain embodiments of the present invention, a method of performing a CBBCT scan includes receiving patient parameter values, and selecting a patient support sub-panel to be installed based on the patient parameter values.

[0232] In certain embodiments of the present invention, a method of performing a CBBCT scan includes adjusting a breast aperture diameter of a patient support sub-panel.

[0233] In certain embodiments of the present invention, placing the patient's breast in the breast aperture of the patient support sub-panel includes positioning the patient's breast within a breast stabilizer unit of the patient support sub-panel.

[0234] In certain embodiments of the present invention, activating a back support mechanism of a patient support subsystem involves inflating a pneumatic bladder assembly of the back support mechanism.

[0235] In certain embodiments of the present invention, activating a back support mechanism of the patient support subsystem includes energizing a motor within the back support mechanism and operating the motor to extend a scissor linkage mechanism within the patient support subsystem.

[0236] In some embodiments of the present invention, adjusting patient support subsystem parameters for patient positioning includes adjusting the height of the saddle portion relative to the upper surface of the base component, and in some embodiments, includes adjusting the pitch of the saddle portion relative to the upper surface of the base component.

[0237] Certain embodiments include seating the patient on a saddle portion of the patient support subsystem and activating a safety feature of the patient support subsystem.

[0238] In certain embodiments of the present invention, activating the safety feature includes tightening a safety belt of the patient support subsystem.

[0239] Some embodiments of the present invention include manually advancing the vertical planar rack subsystem from the distal configuration to the proximal configuration, while some embodiments automatically advance the vertical planar rack subsystem from the distal configuration to the proximal configuration.

[0240] Certain embodiments of the present invention include operating a stationary scanning subsystem of a vertical planar gantry subsystem to capture a stationary scan of a patient's breast.

[0241] Certain embodiments of the present invention include a biopsy guide subsystem that operates a vertical planar gantry subsystem to guide a manual biopsy procedure of a patient's breast.

[0242] In certain embodiments of the present invention, a CBBCT scanning system includes a base component, a vertical planar gantry subsystem coupled to and supported by the base component, the vertical planar gantry subsystem including a patient placement panel having a patient placement surface area with a through hole, and a patient support subsystem coupled to and supported by the base component, the patient support subsystem including a saddle portion, the saddle portion being adapted to support a patient seated thereon during a CBBCT scan of a patient's breast, proximate to the patient placement surface area, wherein the base component is adapted to support horizontal movement between the vertical planar gantry subsystem and the patient support subsystem.

[0243] Although the above exemplary embodiments are primarily from the field of equipment, and systems and methods related to the operation of CBBCT imaging systems, including systems and methods for ergonomic improvements, experts in the field of technology will understand that the principles of the present invention are equally applicable to other imaging technologies, and the benefits of the present invention are equally achievable in a wide range of other imaging technologies, such as imaging of other body parts and imaging of industrial and technological products. In addition, although the present invention has been described in detail in connection with the present preferred embodiments, it should be expressly understood that the present invention is not limited to the disclosed embodiments. On the contrary, the present invention may be modified to incorporate any number of variations, adjustments, substitutions, or equivalent arrangements not yet described, but which are consistent with the spirit and scope of the present invention. Therefore, the present invention should not be construed as being limited by the foregoing description, but only by the scope of the appended claims.

Claims

1. A CBBCT scanning system, including: A basic building block; a vertical plane rack subsystem coupled to and supported by the base member, the vertical plane rack subsystem comprising a CBBCT rack designed and configured to rotate about a substantially horizontal rotation axis; The vertical planar gantry subsystem includes a patient positioning panel having a positioning surface area and an aperture therethrough; The vertical plane rack subsystem also includes a patient support subpanel disposed within the patient placement panel aperture; A patient support subsystem is coupled to and supported by the base structure, the patient support system including a seat and a back portion, the seat portion having a seat upper surface area, the seat upper surface area being designed and configured to support a patient seated thereon so that the patient is close to the patient placement surface area; the back portion includes an active back support mechanism, which when activated pushes the patient toward the patient placement surface area and is used to position and stabilize the patient's breast during CBBCT breast imaging.

2. A CBBCT scanning system as defined in claim 1, wherein the active back support mechanism comprises a pneumatic bladder.

3. A CBBCT scanning system as defined in claim 1, wherein the active back support mechanism comprises a hydraulic bladder.

4. The CBBCT scanning system as defined in claim 1, wherein the active back support mechanism includes a patient-controlled release mechanism.

5. The CBBCT scanning system as defined in claim 1, wherein the seat is coupled to a seat adjustment mechanism.

6. A CBBCT scanning system as defined in claim 5, wherein the seat adjustment mechanism is adapted to adjust a seat upper surface area of ​​the seat portion in a vertical degree of freedom.

7. The CBBCT scanning system as defined in claim 5, wherein the seat adjustment mechanism is adapted to adjust a seat upper surface area of ​​the seat portion in a horizontal degree of freedom.

8. The CBBCT scanning system as defined in claim 5, wherein the seat adjustment mechanism is adapted to adjust a seat upper surface area of ​​the seat portion in a pitch degree of freedom.

9. The CBBCT scanning system as defined in claim 5, wherein the seat adjustment mechanism is adapted to adjust a seat upper surface area of ​​the seat portion in a rolling degree of freedom.

10. The CBBCT scanning system as defined in claim 5, wherein the seat adjustment mechanism is adapted to adjust a seat upper surface area of ​​the seat portion in a deflection degree of freedom.

11. A method for performing CBBCT scanning, comprising the following steps: An imaging system including basic components is provided; providing a vertical planar rack subsystem coupled to the base member; providing a patient support subsystem coupled to the base member; placing the imaging system in a first remote configuration relative to a distance between the patient support subsystem and the vertical planar gantry subsystem; adjusting patient support subsystem parameters for patient positioning; seating a patient on a seat portion of the patient support subsystem; placing the imaging system in a second close configuration relative to the distance between the patient support subsystem and the vertical planar gantry subsystem; positioning a patient's breast within the vertical planar gantry subsystem; activating a back support mechanism of a patient support subsystem; Propel the patient toward the vertical plane gantry subsystem; Performing a CBBCT scan on the patient's breast using the vertical plane gantry subsystem; releasing the back support mechanism of the patient support subsystem; returning the imaging system to a first, remote configuration; Remove the patient from the seat of the patient support subsystem.

12. The CBBCT scanning method according to claim 11, further comprising the following steps: providing a patient positioning panel having a sub-panel aperture therethrough; installing a patient support sub-panel at the sub-panel aperture; The patient's breast is placed through the breast aperture of the patient support sub-panel.

13. The CBBCT scanning method according to claim 12, further comprising the following steps: A patient parameter value is received; A corresponding patient support sub-panel is selected according to the patient parameter value.

14. The CBBCT scanning method defined in claim 13, wherein the step of selecting a patient support sub-panel according to the patient parameter value comprises: Select the patient support subpanel with the breast aperture diameter that corresponds to the patient's breast diameter value.

15. The CBBCT scanning method defined in claim 13, wherein the step of selecting a patient support sub-panel according to the patient parameter value comprises: A patient support sub-panel is selected with a breast aperture advantageously located to one side of the centerline of the patient positioning panel.

16. The CBBCT scanning method according to claim 12, further comprising the following steps: receiving a patient parameter value; Wherein, the step of installing the patient support sub-panel further comprises: A corresponding patient support sub-panel is selected according to the patient parameter value.

17. The CBBCT scanning method according to claim 12, further comprising the following steps: Adjust the diameter of the breast aperture of the patient support sub-panel.

18. The CBBCT scanning method as defined in claim 12, wherein the step of placing the patient's breast through the breast aperture of the patient support sub-panel comprises: The patient's breast is positioned within a breast stabilization device of the patient support subpanel.

19. The CBBCT scanning method defined in claim 11, wherein the step of activating the back support mechanism of the patient support subsystem further comprises: A pneumatic bladder assembly of the back support mechanism is inflated.

20. The CBBCT scanning method defined in claim 11, wherein the step of activating the back support mechanism of the patient support subsystem further comprises: activating a motor within the back support mechanism; The motor is operated to extend a scissor linkage mechanism within the patient support subsystem.

21. The CBBCT scanning method as defined in claim 11, wherein the step of adjusting parameters of the patient support subsystem to position the patient comprises: The height of the seat relative to the upper surface of the base member is adjusted.

22. The CBBCT scanning method as defined in claim 11, wherein the step of adjusting parameters of the patient support subsystem to position the patient comprises: The pitch angle of the seat relative to the upper surface of the base member is adjusted.

23. The CBBCT scanning method as defined in claim 11, wherein the step of seating the patient on the seat of the patient support subsystem further comprises: A safety function of the patient support subsystem is initiated.

24. The CBBCT scanning method as defined in claim 23, wherein the step of activating a safety function of the patient support subsystem comprises: Fasten the patient support subsystem safety belt.

25. The CBBCT scanning method according to claim 11, further comprising the following steps: The vertical planar rack subsystem is manually advanced from the extended configuration to the closed configuration.

26. The CBBCT scanning method according to claim 11, further comprising the following steps: The vertical planar rack subsystem is automatically advanced from the extended configuration to the closed configuration.

27. The CBBCT scanning method according to claim 11, further comprising the following steps: The fixed scanning subsystem of the vertical plane gantry subsystem is operated to capture a fixed scanning image of a patient's breast.

28. The CBBCT scanning method according to claim 11, further comprising the following steps: The biopsy guide subsystem of the vertical planar gantry subsystem is operated to guide a manual biopsy procedure of a patient's breast.

29. A CBBCT scanning system comprising: A basic building block; a vertical planar gantry subsystem coupled to and supported on the base member, the vertical planar gantry subsystem including a patient placement panel having a placement surface area with an aperture; a patient support subsystem coupled to and supported on the base member, the patient support subsystem including a seat designed and configured to support a patient seated thereon during a CBBCT breast scan in proximity to a patient placement surface area, wherein the base member is adapted to support horizontal movement of the vertical plane gantry subsystem and the patient support subsystem relative to each other.

Images