Cone-beam breast computed tomography system with patient support subsystem

Abstract

In the present invention, a cone-beam breast computed tomography (CBBCT) scanning system includes a vertical planar gantry and a patient support subsystem, wherein the patient support subsystem is equipped with a patient support chair 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 April 14, 2022, entitled “OMNIBUSDISCLOSURE”; U.S. Provisional Application No. 63 / 401,475, filed August 26, 2022, entitled “FIXTURING AND SUPPORT FOR MEDICAL IMAGING”; U.S. Provisional Application No. 63 / 401,493, filed August 26, 2022, entitled “ERGONOMIC IMPROVEMENTS IN CONE BEAM BREAST COMPUTED TOMOGRAPHY”; and U.S. Provisional Application No. 63 / 401,513, filed August 26, 2022, entitled “STATIONARY DETAIL IMAGING IN CONE BEAM BREAST COMPUTED”. “Cone BEAM BREAST COMPUTED TOMOGRAPHY”; U.S. Provisional Application No. 63 / 401,546, filed August 26, 2022, entitled “Cone BEAM BREAST COMPUTED TOMOGRAPHY WITH PATIENT SUPPORT SUBSYSTEM”; U.S. Provisional Application No. 63 / 401,548, filed August 26, 2022, entitled “Cone BEAM BREAST COMPUTED TOMOGRAPHY WITH PIVOTAL GANTRYSUBSYSTEM”; U.S. Provisional Application No. 63 / 430,571, filed December 6, 2022, entitled “ULTRASONICHYBRID IMAGING IN CONE BEAM BREAST COMPUTED TOMOGRAPHY”; and “CALCIFICATION DETECTION SYSTEMS, METHODS AND APPARATUS IN CONE BEAM BREAST”. "ComputedTomogramhy", the filing date and U.S. provisional application number of which are pending, and all disclosures of the above applications are cited hereinforcingly. Technical Field

[0003] This invention relates to the field of cone-beam computed tomography (CBCT), and particularly to the field of patient ergonomics in cone-beam computed tomography for breast imaging. Background Technology

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

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

[0006] While mammography (which can detect cancers as small as approximately 12 mm on average) is currently the most effective tool 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 capability, which is common in all types of projection imaging techniques (projection imaging has a contrast detection capability of only about 10%), and mammography initially detected only 65-70% of breast cancers. In dense breasts, the sensitivity of mammography further decreases 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-scale clinical trial—the Digital Mammography Screening Trial (DMIST)—showed that DM and SFM had the same false positive rate.

[0007] Mammography has relatively low specificity, leading to the need for biopsies in indeterminate cases, despite increased costs and patient stress. In the United States, nearly 80% of the more than one million breast biopsies performed annually to evaluate suspicious mammogram results are benign. This not only subjects patients to excessive anxiety but also places a significant cost burden on the healthcare system. Therefore, there is an urgent need for more accurate characterization of breast lesions to reduce biopsy rates and false positive rates in pre-biopsy mammography.

[0008] Phantom studies have shown that cone-fasciculation breast computed tomography (CBBCT) can achieve a spatial resolution of up to approximately 2.8 line pairs / mm, enabling the detection of cancers as small as 2 mm and microcalcifications as small as 0.2 mm. In an average-sized breast (chest wall diameter of approximately 13 cm), this imaging can be performed at a total dose of approximately 5 mGry. This dose is lower than that of a single mammogram, assuming two views are required for each breast.

[0009] CBBCT offers excellent image quality in visualizing breast tissue, breast tumors, and calcified lesions, with breast coverage (including the chest wall region) at least equivalent to mammography. It also provides excellent visualization of major blood vessels without the use of contrast agents. Therefore, CBBCT offers a significant improvement in detecting and biopsiing suspicious lesions in patients.

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

[0011] For example, a characteristic of mammography is that the patient's breast needs to be inserted into a fixation device before imaging, resulting in significant transverse compression of the breast tissue 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 contributing to lower rates of breast cancer screening and diagnosis overall, as well as in specific racial and cultural groups.

[0012] In addition, breast compression during mammography may cause displacement of breast tissue, which increases the difficulty of locating features such as lesions and calcifications in subsequent biopsies and mass excision procedures.

[0013] This article describes further improvements to CBBCT imaging that not only expand its imaging advantages but also provide significant ergonomic enhancements. These improvements include technological advancements, methodologies, and equipment designed to better facilitate patient access to the CBBCT system. These improvements include loading devices, patient seating arrangements, and improved equipment layout and configuration to enhance patient comfort and facilitate technician and medical staff assistance in positioning patients to the equipment.

[0014] In the current procedure, the patient undergoing the CBBCT examination lies prone on the examination table. The breast being examined is lowered through an opening on the surface of the examination table into an imaging chamber located below. The position of the breast in the imaging chamber is maintained by the patient remaining still, as the patient must lie on the surface of the examination table.

[0015] The imaging device is attached to a movable frame supported on a bearing assembly for rotation about a rotation axis. This rotation axis is typically arranged vertically and passes through an opening in the examination table. The approximate center of the breast to be imaged is positioned on the rotation axis such that the axis passes through this approximate center.

[0016] During imaging, the moving gantry rotates around a rotation axis, causing the imaging device to move along at least a 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 is then processed to generate a tomographic model of the breast.

[0017] Despite the many advantages of CBBCT, some patients find it difficult or impossible to assume a prone position on the examination table. These patients may be unable to properly position themselves on the table or place the breast to be imaged into the aperture. For elderly, obese, pregnant, disabled, or paralyzed or amputated patients, climbing onto the examination table and lying in a specific prone position is extremely difficult or even impossible. Summary of the Invention

[0018] After extensive and thoughtful consideration, the inventors of this invention have developed new and practical systems, devices, and methods to address ergonomic issues in breast imaging, particularly CBBCT imaging, representing a significant improvement over existing methods. This invention includes devices, systems, and methods for patient access to the CBBCT system, while also providing support for the patient during computed tomography (CT) imaging.

[0019] Therefore, in some embodiments of the present invention, a CBBCT system suitable for patient upright positioning 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 scan positioning. In some embodiments, the patient moves toward the gantry together with the seat after scan positioning.

[0020] The following description is intended to enable any person skilled in the art to make and use the disclosed invention, and provides what the inventors currently consider to be the best implementation. In the following description, numerous specific details are provided for ease of explanation to aid in a comprehensive understanding of the invention. However, those skilled in the art will understand that the invention can be practiced without including these specific details. In other instances, well-known structures and devices are shown in block diagram form to avoid unnecessarily obscuring the disclosure. These and other advantages and features of the invention will be more readily understood from the following detailed description taken in conjunction with the accompanying drawings.

[0021] It should be noted that although each figure illustrates a different aspect of the invention, not every figure is intended to represent the entire invention. Rather, these figures collectively illustrate various aspects and principles of the invention. Therefore, it should not be assumed that any particular figure relates only to a single aspect or specific form of the invention. Rather, those skilled in the art will understand that these figures, as a whole, reflect different embodiments of the invention.

[0022] Accordingly, the phrase "one embodiment" or "a particular embodiment" mentioned in the specification indicates that a specific feature, structure, or characteristic described in relation to that embodiment is included in at least one embodiment of the invention. Therefore, the phrases "in one embodiment" or "in a particular embodiment" appearing in different places in the specification do not necessarily refer to the same embodiment. Furthermore, these specific features, structures, or characteristics will be combined in any suitable manner in one or more embodiments. Attached Figure Description

[0023] Figure 1 A partial structure of an exemplary CBBCT imaging system is shown in a cross-sectional perspective view.

[0024] Figure 2 A partial structure of an exemplary CBBCT imaging system is shown in a high-level schematic perspective view, including a vertical plane gantry subsystem designed according to the principles of the present invention.

[0025] Figure 3 A schematic perspective view illustrates certain aspects of an exemplary CBBCT imaging system, including a vertical plane gantry subsystem designed according to the principles of the present invention.

[0026] Figure 4A A schematic perspective view illustrates certain aspects of an exemplary CBBCT imaging system designed according to the principles of the present invention.

[0027] Figure 4B Further aspects of an exemplary CBBCT imaging system designed according to the principles of the present invention are illustrated in a schematic perspective view.

[0028] Figure 4C Further aspects and operation of an exemplary CBBCT imaging system designed according to the principles of the present invention are illustrated in a schematic perspective view.

[0029] Figure 4D A further aspect of a CBBCT imaging system is illustrated in schematic block diagram form, including exemplary safety features designed according to the principles of the present invention.

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

[0031] Figure 6A The functional block diagram illustrates some aspects of the use process and methods of the CBBCT imaging system designed according to the principles of the present invention.

[0032] Figure 6B Further aspects of the use process and method of the CBBCT imaging system designed according to the principles of the present invention are illustrated in the form of a functional block diagram.

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

[0034] Figure 7 The schematic proximal view illustrates certain features of an exemplary CBBCT imaging system, including a patient placement panel designed according to the principles of the present invention.

[0035] Figure 8 An additional feature of an exemplary CBBCT imaging system is shown in a schematic proximal view, including a patient placement panel designed according to the principles of the present invention.

[0036] Figure 9A A schematic perspective view illustrates certain features of the CBBCT imaging system designed according to the principles of the present invention, including an exemplary handle.

[0037] Figure 9B An additional feature of the CBBCT imaging system designed according to the principles of the present invention is shown in a schematic perspective view, including an exemplary handle.

[0038] Figure 9C A schematic perspective view illustrates further features of the CBBCT imaging system designed according to the principles of the present invention, including an exemplary handle.

[0039] Figure 9D Other features of the CBBCT imaging system designed according to the principles of the present invention are illustrated in a schematic perspective view, including an exemplary handle.

[0040] Figure 9E Further aspects and features of the CBBCT imaging system, designed according to the principles of the present invention, are illustrated in a schematic perspective view, including an exemplary handle.

[0041] Figure 10A The schematic near-end view illustrates certain features of the CBBCT imaging system designed according to the principles of the present invention, including exemplary sub-panel components.

[0042] Figure 10BAn additional aspect of the CBBCT imaging system designed according to the principles of the present invention is illustrated in a schematic near-end view, including an exemplary sub-panel assembly.

[0043] Figure 10C A further exemplary aspect of the CBBCT imaging system designed according to the principles of the present invention is illustrated in a schematic near-end view, including an exemplary sub-panel assembly.

[0044] Figure 10D The schematic near-end view illustrates certain features of the CBBCT imaging system designed according to the principles of the present invention, including an exemplary adjustable sub-panel assembly.

[0045] Figure 10E Further details of the CBBCT imaging system designed according to the principles of the present invention are shown in a schematic near-end view, including an exemplary adjustable sub-panel assembly.

[0046] Figure 10F An additional configuration of the CBBCT imaging system designed according to the principles of the present invention is shown in a schematic near-end view, including an exemplary adjustable sub-panel assembly.

[0047] Figure 11 Further features of the CBBCT imaging system designed according to the principles of the present invention are illustrated in a schematic perspective view, including an exemplary breast stabilization function.

[0048] Figure 12 An additional aspect and configuration of an exemplary CBBCT imaging system is shown in a schematic side view, including a patient support function designed according to the principles of the present invention.

[0049] Figure 13A A high-angle schematic perspective view illustrates certain aspects of an exemplary CBBCT imaging system, including certain safety features designed according to the principles of the present invention.

[0050] Figure 13B A high-angle schematic perspective view illustrates certain aspects of an exemplary CBBCT imaging system, including additional safety features designed according to the principles of the present invention. Detailed Implementation

[0051] The following description is intended to enable those skilled in the art to make and use the disclosed invention, and provides what the inventors currently consider to be the best implementation. In the following description, numerous specific details are set forth for ease of explanation to aid in a comprehensive understanding of the invention. However, those skilled in the art will understand that the invention can be practiced without including these specific details. In other instances, well-known structures and apparatuses are shown in block diagram form to avoid unnecessarily obscuring the disclosure.

[0052] It should be noted that although the following exemplary embodiments will identify specific components and their combinations, these examples are not definitive. Rather, individual components may be combined into integral components and / or assemblies where appropriate. Furthermore, the aspects and features of the specific components described in this disclosure as a whole should also be understood to include the disclosure of individual 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 cross-sectional perspective. System 100 includes an X-ray source 102. The X-ray source 102 is mounted on the upper surface 104 of a rotating gantry 106. The rotating gantry 106 is supported by a bearing and is arranged to rotate about a rotation axis 108.

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

[0055] In some embodiments of the invention, beam 110 is configured as a conical beam. In some configurations, the cross-section of beam 110, taken along a direction perpendicular to the longitudinal axis 112, defines a disk with substantially uniform X-ray intensity and a substantially circular periphery.

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

[0057] Therefore, in some configurations, the cross-section of the beam 110, truncated along a direction perpendicular to the longitudinal axis 112, defines a truncated disk with substantially uniform X-ray intensity, its perimeter being substantially truncated circular (i.e., circular except for the horizontal chord portion at the upper edge). This configuration optimizes imaging of the breast while minimizing irradiation of the chest wall tissue above the breast. In some embodiments, this is achieved by placing a non-transmissive collimator on a portion of the originally circular cross-section beam generated by the X-ray source.

[0058] In a further configuration within the scope of this invention, the cross-section of the beam 110, taken along a direction perpendicular to the longitudinal axis 112, defines a region with substantially uniform X-ray intensity, the perimeter of which is polygonal. In different embodiments and configurations, this polygonal perimeter may include a perimeter of triangle, rectangle, pentagon, hexagon, or any higher geometry, or a perimeter with 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 can define a beam with non-uniform intensity, including but not limited to cases where the intensity drops to zero in one or more regions.

[0059] X-ray detector 116 is also mounted on the upper surface 104 of the rotating gantry 106. In one exemplary embodiment, X-ray detector 116 includes a planar detector with 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 understand that the described configuration is only one example among many possible arrangements, and the X-ray source, X-ray detector, and other components of the system can be supported from above, from the side, or in any other suitable manner to achieve the desired functionality, and the shape and configuration of the gantry and X-ray detector will also take on any suitable form in different embodiments of the invention.

[0060] During operation of the imaging system 100, rotation of the gantry 106 about the rotation axis 108 causes 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 located at the center of the rotation axis 108. However, it should be noted that other trajectories are also considered to be within the scope of the invention and will be disclosed herein.

[0061] In some embodiments of the 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 frame 106. For example, the X-ray source 102 and the X-ray detector 116 may be adjusted in the radial direction (i.e., degree of freedom) with respect to the rotation axis 108, or in the circumferential direction (i.e., degree of freedom) with respect to the rotation axis 108, or in the direction toward the frame surface 104 (i.e., degree of freedom), or in any other manner that the designer or user deems beneficial, which is suitable for the particular apparatus embodying the invention.

[0062] The patient examination table 120 includes an upper surface 122 and a lower surface 124. An opening 126 connects the upper surface 122 and the lower surface 124 of the examination table. The upper surface 122 is arranged to support the patient 128, who typically lies prone on the upper surface 122, as shown. In this configuration, the patient's breast 130 hangs down from the patient's chest wall through the opening 126.

[0063] During operation, the gantry 106 rotates around the rotation axis 108, causing the X-ray source 102 and X-ray detector 116 to move along a path around the patient's breast. During this movement, the X-ray detector 116 captures X-ray image data through operation in conjunction with corresponding interface electronics and a computer system. This X-ray image data corresponds to multiple X-ray images taken at various angular positions around the rotation axis 108. Combined, 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 high-level schematic perspective view shows a partial structure of an exemplary CBBCT imaging system 200, including a vertical plane gantry subsystem 202. The vertical plane gantry subsystem 202 includes a vertical plane gantry 204 configured to rotate about a generally horizontal rotation axis 206.

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

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

[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, the cross-section of the X-ray beam 218, truncated along a direction perpendicular to the longitudinal axis 220, defines a rectangular region with substantially uniform X-ray intensity. This configuration optimizes breast imaging while minimizing irradiation of the chest wall tissue above the breast. In some embodiments, this is achieved by placing a non-transmissive collimator on a portion of the beam generated by the X-ray source, which would otherwise have a circular cross-section.

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

[0069] Those skilled in the art will understand that the described configuration is merely one example of many 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 suitable manner to achieve the desired function. Furthermore, the shape and configuration of the gantry and X-ray detector will also take any suitable form in different embodiments of the invention.

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

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

[0072] In some embodiments of the 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 frame 204. For example, the X-ray source 208 and the X-ray detector 224 may be adjusted in the radial direction (i.e., degree of freedom) with respect to the rotation axis 206, or in the circumferential direction (i.e., degree of freedom) with respect to the rotation axis 206, or in the direction toward the frame surface 210 (i.e., degree of freedom), or in any other manner that the designer or user deems beneficial, which is suitable for the particular apparatus embodying the 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 plane gantry subsystem 202 and the patient support subsystem 230 are coupled to each other and supported by a base member 236.

[0074] The patient placement panel 238 (also referred to as the patient examination table) is located between the vertical plane rack 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] The inner peripheral edge 244 of the patient placement surface area 240 surrounds an opening 246 in the patient placement panel 238, which is located between the patient placement surface area 240 and the distal surface area 242.

[0076] As will be further described below, the patient placement surface area 240 is arranged to isolate the patient from the remainder of the vertical plane gantry subsystem 202, while the patient's breast is vertically positioned through the aperture 246. In various embodiments and aspects of the invention, the patient placement subsystem is located at the aperture 246. In various aspects, the patient placement subsystem will provide an aperture tailored to the specific patient and the size and position of the breast to be imaged, protect areas of the patient that may be exposed to scattered X-ray photons, and provide other features such as support and stability for the breast to be imaged.

[0077] During operation, the gantry 204 rotates around the rotation axis 206, causing the X-ray source 208 and X-ray detector 224 to move along the trajectory 228 of the patient's breast. In this process, the X-ray detector 224 captures X-ray image data through operation in conjunction with corresponding interface electronics and a computer system. This X-ray image data corresponds to multiple X-ray images taken at various angular positions around the rotation axis 206. Combined, the X-ray image data, or a subset thereof, is processed to provide information about the internal state of the breast.

[0078] X-ray detectors can be any two-dimensional detector, including planar detectors, two-dimensional photon counting detectors, and two-dimensional curved surface detectors. 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 placement panel 238 is coupled to and supported by the base member 216 of the vertical plane gantry subsystem 202. In an alternative embodiment, the patient placement panel 238 is coupled to and supported by the base member 236. In other embodiments of the invention, the patient placement panel 238 is coupled to and supported by the patient support subsystem 230. In other embodiments, alternative features of the imaging system 200 also support the patient placement panel 238.

[0080] Figure 3 A schematic perspective view illustrates a partial structure of an exemplary CBBCT imaging system 300, including a vertical plane gantry subsystem 302. System 300 illustrates further details of certain embodiments of system 200 and other embodiments of the invention. The vertical plane gantry subsystem 302 includes a vertical plane gantry 304 configured to rotate about a generally horizontal axis of rotation 306.

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

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

[0083] The patient placement panel 338 is located between the vertical plane rack 304 and the patient support subsystem 330. The patient placement panel 338 has a first patient placement surface area 340 and a second distal surface area 342, wherein the distal surface area 342 is spaced apart from the patient placement 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 a columnar member 332. The seating device 344 includes a seat portion 346 having a structure 348 and a seat upper surface region 350. The seat upper surface region 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 the upper end of the exemplary seat post 352, which in the illustrated embodiment passes through an opening or slot 354 and enters the columnar member 332.

[0086] In some embodiments of the invention, the lower end of an exemplary seat column 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 upper surface region 350 of the seat is transferred through the seat structure 348 to the seat column 352, and then through the seat adjustment mechanism to the columnar member 332.

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

[0088] In an ideal aspect of certain embodiments of the invention, the seat 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 some embodiments, the seat adjustment mechanism also allows for additional degrees of freedom of pivotal rotation of the seat, namely yaw 362 and pitch 363. These different adjustments will improve patient comfort and optimal positioning.

[0089] In a further aspect of the invention, in some embodiments, the seat will be retractable (e.g., retracted 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 stands on the upper surface of the base member 336, or on a patient platform coupled to the base member 336 or the columnar member 332. Thus, the seat is available when needed, but may not be used in a support mode requiring the patient to stand.

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

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

[0092] Therefore, in various embodiments of the invention, the seat portion 346 and the patient back support portion 334 will be made of materials suitable for achieving these objectives. 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, acrylonitrile (acrylonitrile-butadiene) rubber, polyurethane, polybutadiene, polyisobutylene, chloroprene rubber, natural latex rubber, etc. Foam materials can be closed-cell or open-cell foams, and may include, but are not limited to, polyolefin foams such as polyethylene foam, polypropylene foam, and polybutene foam; polystyrene foam; polyurethane foam; any elastic foam made from the elastomers or rubber materials mentioned above; or any biodegradable or compostable polyester, such as polylactic acid resins (including L-lactic acid and D-lactic acid) and polyglycolic acid (PGA); polyhydroxyvalerate / hydroxybutyrate resin (PHBV) (a copolymer of 3-hydroxybutyric acid and 3-hydroxyvalerate) and polyhydroxyalkanoate (PHA) copolymers; and polyester / polyurethane resins. Those skilled in the art will understand that the above materials are merely some examples of suitable applications broadly applicable to the present invention.

[0093] Furthermore, certain aspects of the invention, in corresponding embodiments, will include an active back support mechanism coupled between the patient back support portion 334 and the columnar member 332. In some 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 orientation 364. In other embodiments, as will be further discussed below, the active back support mechanism will include a sac or expandable pad that, when activated, can push the patient toward the patient placement surface area 340 of the patient placement panel 338.

[0094] In a further aspect of the invention, the base component 336 includes a linear bearing device. This linear bearing device is coupled between the base component 316 of the vertical plane gantry subsystem 302 and the base component 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 direction 364.

[0095] This adjustability allows the patient to enter the patient support subsystem 330 and be positioned in the vertical plane gantry subsystem 302 at a location relatively far from the patient support subsystem 330 for scanning. Subsequently, as will be further described below, the vertical plane gantry subsystem 302 can be adjusted to be closer to the patient for effective scanning.

[0096] In some embodiments of the invention, this adjustment is achieved by manually moving the vertical plane rack subsystem 302. In other embodiments, the lateral adjustment of the position of the vertical plane rack subsystem 302 is controlled by a linear actuator.

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

[0098] Therefore, for example, in some embodiments of the invention, a 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 actuator assemblies with suitable functions known or likely to be known in the art in the future.

[0099] Figures 4A-4D The operation aspects and methods of a CBBCT imaging system 400, similar to the systems 200 and 300 described above, are demonstrated. Figure 4A and Figure 4B The loading and operation configuration of the imaging system 400 are shown respectively. Figure 4C An example of the operation of a vertical plane rack subsystem according to 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 CBBCT imaging system 400, a vertical plane gantry subsystem 402 and a patient support subsystem 404 are coupled to a base component 406.

[0101] In certain aspects of the invention, as an expression of 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 toward or away from the patient support subsystem 404 along direction (i.e., degree of freedom) 408.

[0102] The reader will understand that while this description relates to a patient support subsystem 404 substantially fixedly coupled to the base member 406, and the vertical plane gantry subsystem 402 relative to its movable system, in alternative embodiments the opposite is true. That is, in some embodiments, the vertical plane gantry subsystem 402 will be substantially fixedly coupled to the base member 406, while the patient support subsystem 404 is movable. In other embodiments, both the patient support subsystem 404 and the vertical plane gantry subsystem 402 can be movable—these examples demonstrate the adjustability of the distance between them in direction 408.

[0103] exist Figure 4A In the first state, the CBBCT system 400 is displayed, at which point the vertical plane gantry subsystem 402 is located at a distance from the patient support subsystem 404.

[0104] Figure 4B Further aspects of the exemplary CBBCT imaging system 400 are illustrated in a schematic perspective view. Figure 4B In the middle, the CBBCT system 400 is displayed in the second state, at which time the vertical plane gantry subsystem 402 is in a position closer to the patient support subsystem 404.

[0105] Refer 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 placement panel 412.

[0106] In typical operation, the CBBCT system 400 is in its initial first state (i.e., as shown in the image). Figure 4A (As shown), to prepare for receiving patients. The large distance between the vertical plane gantry subsystem 402 and the patient support subsystem 404 allows patients to easily approach and sit in the seat 410.

[0107] In some embodiments of the invention, the height and other positional parameters of the seat 410, as well as 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 adjustment of the seat 410 is performed after the patient is seated. In further aspects and embodiments of the invention, the parameters of the patient support subsystem are adjusted both 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 placement panel 412. Therefore, in some embodiments of the invention, the vertical plane rack subsystem 402 will move along dimension 408 toward the seated patient until the patient contact surface area 414 of the patient placement panel 412 approaches the patient.

[0109] This brings the patient into contact with a portion of the patient contact surface area 414 of the patient placement panel 412, while the patient's breast to be imaged is placed vertically through the aperture 416.

[0110] As will be further discussed below, in various aspects and embodiments of the invention, the patient placement sub-panel will be located at the aperture (e.g., patient placement sub-panel 710 described below) such that the patient will be in contact with the surface area of ​​the sub-panel, and the breast to be imaged will be placed vertically through the aperture of the sub-panel.

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

[0112] Figure 4C The image shows an exemplary CBBCT imaging system 400 in progress. Figure 4B In the second state, the CBBCT system 400 is displayed, with the vertical plane gantry subsystem 402 positioned close to the patient support subsystem 404. Imaging is in progress, and the vertical plane gantry 418 is rotating 420 around the rotation axis 422.

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

[0114] Therefore, the CBBCT imaging system, in its various embodiments, will include interlocking devices and safety release / disconnection mechanisms. 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. Furthermore, in a typical system, an emergency stop / release subsystem 438 will be provided to stop the movement of the subsystem and release any applied pressure.

[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 rotary bearing 440, which is coupled to the vertical plane gantry 418 and supports its rotation about a rotational axis.

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

[0117] This movement is driven by a linear actuator 450. According to the current discussion, to ensure patient safety, the linear actuator 450 is coupled to the structural member (and therefore also to the patient placement panel) via 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 some embodiments of the 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 component 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, thereby enabling the patient placement panel 412 to move relative to the base member 406. However, if either the first force-limiting clutch 454 or the second force-limiting clutch 460 disengages, the structural member 430 and the remainder of the vertical plane frame subsystem 402 will be released from movement relative to the base member 406 in the 408 direction.

[0119] Therefore, if either force-limiting clutch 454 or 460 disengages, the patient placement panel 412 will no longer move toward the patient along the direction of 408, and the patient (and / or any medical / technician) will be able to push it away from the patient by pressing the patient placement panel 412.

[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 a base component 406.

[0121] It is evident that 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 408 direction is substantially fixed relative to the base member 406. When needed (i.e., to ensure patient comfort and safety), the clutch device 474 is released. This allows the column 470 and the patient back support portion 464 to move relative to the base member 406 toward the patient placement panel 412 in the 408 direction.

[0122] Therefore, if the force-limiting clutch device 474 disengages, the patient support subsystem 404 will no longer be fixedly coupled to the base component 406, thereby preventing the advancement of the patient placement panel 412 along the direction 408. Thus, the patient (and / or any medical / technician) will be able to push the patient support subsystem 404 away from the vertical plane rack subsystem 402 by, for example, pushing the patient placement panel 412.

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

[0124] In other embodiments of the invention, release of the force-limiting clutch device 474 will allow the patient support subsystem 404 to articulate relative to the base component 406 and away from the vertical plane frame 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 means suitable for the desired articulation movement.

[0125] In some embodiments of the 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 plane gantry subsystem 402 in the 408 direction. In this way, the patient is protected even if they lack sufficient strength to separate the two subsystems upon release of the force-limiting clutch device 474. Similarly, in some embodiments, an auxiliary mechanism will be provided to assist movement of the vertical plane gantry subsystem 402 away from the patient support subsystem 404 in the 408 direction.

[0126] In view of the foregoing, those skilled in the art will understand that the present invention includes various passive or active auxiliary mechanisms suitable for the requirements of a particular embodiment and can be implemented with minimal experimentation. Therefore, in some embodiments of the invention, the auxiliary 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 tension spring, helical spring, torsion spring, any of the aforementioned linear actuators and related components, whether used alone or in combination, and any other suitable mechanisms known or to be known in the art.

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

[0128] Those skilled in the art will also recognize that any force-limiting clutch described above may include, for example, one or more mechanical friction clutches, magnetic clutches, pressure relief safety valves coupled to cylinders or airbags, fragile components (such as fragile metal components, fragile polymer components, fragile glass components), compressible components (such as compressible foam polymer components), malleable or ductile metal bellows or other malleable or ductile metal components in compressed or stretched form, ratchet and pawl assemblies, or any other means or device configured and adapted to release under predictable force, whether for single-use or reusable release. It should be understood that, in various embodiments, the force-limiting clutch may include both single-use and non-single-use (i.e., reusable) components. For example, the fragile component may be a single-use / disposable component that needs to be replaced upon clutch release.

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

[0130] Therefore, for example, the mechanical limiting device 486 is operatively coupled to the base component 406. The mechanical limiting device 486 is positioned to restrict movement of the vertical plane gantry subsystem 402 relative to the base component 406 in the 408 direction, and thus also restricts movement relative to the patient support subsystem 404.

[0131] In some embodiments of the invention, the mechanical limiting device 486 is substantially permanently coupled to the base component 406. In other embodiments of the invention, the mechanical limiting device 486 is substantially fixedly coupled to the base component 406, but can be released. Therefore, the position of the mechanical limiting device 486 relative to the base component 406 can be adjusted according to the requirements of a particular patient or procedure.

[0132] In a further aspect or embodiment of the invention, a further mechanical restraint device 490 is operatively coupled to the patient placement panel 412. Similar to mechanical restraint device 486, mechanical restraint device 490 is capable of limiting the distance between the vertical plane gantry subsystem 402 and the patient support subsystem 404 to a minimum distance. Similar to mechanical restraint device 486, mechanical restraint device 490 can be substantially permanent or removable and / or replaceable, and can be of various lengths. Therefore, the length of some mechanical restraint devices 490 will be selected or adjusted according to the requirements of a particular patient or procedure. A set of mechanical restraint devices 490 of different sizes may be provided with specific embodiments of the invention.

[0133] In some embodiments of the invention, the safety features of the CBBCT imaging system 400 will include one or more emergency stop / release subsystems 438 to stop movement of the vertical plane gantry and patient support subsystem and release 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 rack subsystem 402 and / or the patient support subsystem 404. The patient-accessible stop buttons are signal-coupled to the control system 496. Those skilled in the art will understand that the control system may be, for example, a pneumatic control system, an electronic control system (including microcontrollers 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, which are known or will be known.

[0135] As shown in the figure, additional stop buttons, such as 497, will also be provided in locations accessible to technicians and / or medical personnel. These buttons are operatively coupled to the control system 496 to ensure that patients and technicians and / or medical personnel can immediately stop the movement of the subsystem and release the patient from the CBBCT imaging system 400. Similarly, a general technician will immediately understand that the control system 496 will be operatively coupled to one or more linear actuators 450, the 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 a schematic perspective view, including a vertical plane 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 invention. The vertical plane gantry subsystem 502 includes a vertical plane gantry 506 configured to rotate about a generally horizontal axis of rotation 508.

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

[0138] It should be noted that the horizontal structural members 512 and 514 shown are configured as cantilever structures, supported by the vertical column structural member 510. However, those skilled in the art will recognize that in the various embodiments of the invention, any combination of support arrangements can effectively achieve the objective of at least supporting the horizontal structural members 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 many arrangements, such as configurations including a single structural member, a solid member (including an I-beam) or any other solid member, a tubular beam (including a cylindrical tubular beam), a box girder, and a truss composed of multiple solid or tubular members, etc. All of the foregoing (and any comparable components known or to be known) is intended to be included in the present disclosure.

[0140] According to the exemplary embodiment of the present 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 structural members 510 and 512, respectively, and are coupled to each other to the coupling device 524.

[0141] In various aspects and embodiments of the invention, the coaxial support subsystem 504 will support a variety of auxiliary devices, 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, an auxiliary camera and other imaging devices, or other known or to be known auxiliary devices that can work in conjunction with the rest of the CBBCT imaging system.

[0142] Therefore, any of the aforementioned auxiliary devices will be coupled to coupling device 524, and thus operably supported by horizontal structures 512 and 514. Those skilled in the art will understand that the presence of linear bearings 526 and 528 allows the auxiliary devices to be displaced in a manner that allows them to move from a storage configuration located at the distal ends (e.g., 520 and 522) of horizontal structures 512 and 514 to an operating configuration located at the proximal ends (516 and 518) of horizontal structures.

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

[0144] In some 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] Those skilled in the art will understand that the linear actuators described herein (and any linear actuators mentioned herein) can employ a variety of actuators available in the art. For example, in some embodiments, a linear actuator may include one or more gear carriers and gear assemblies, Acme screws and Acme nuts; ball screw assemblies; linear stepper motors; lateral complementary ramps; pneumatic cylinders; pneumatic airbags; pneumatic bellows; hydraulic cylinders; hydraulic airbags; hydraulic bellows; scissor linkage mechanisms, including, for example, scissor linkage mechanisms driven by a screw, cylinder, or any other actuator discussed herein, or any other suitable actuator; Salus linkage mechanisms; thermoelectric actuators; shape memory alloy actuators; rope and pulley arrangements; and any combination of manual actuators, such as hand cranks and / or ratchet levers; compression springs; tension springs; torsion springs; combinations of leaf springs; springs comprising multiple Belleville washers; or any other linear actuator currently known or to be known, suited to the requirements of a particular application and providing the required telescopic functionality.

[0146] Therefore, for example, in some embodiments of the invention, a linear actuator may include one or more solenoid valves, pneumatic cylinders, hydraulic cylinders, pneumatic air bladders, hydraulic air bladders, linear motors, linear stepper motors, rotary actuators, and: Acme screws and nuts, lead screws, ball screws, ropes, pulleys, timing belts, timing pulleys, worm gear reducers of suitable size, gear carriers and gear assemblies, gear carriers and worm gear assemblies, piezoelectric actuators, piezoelectric actuators combined with ratchet and pawl drivers, spring-driven actuators, and actuators including shape memory alloys, as well as any other actuator assemblies with suitable functions known or to be known in the art.

[0147] In some embodiments, one or more assistive device units are detachably coupled to the coupling device to allow for the installation of specific assistive device units onto the coupling device according to the requirements of a particular patient and a particular imaging / diagnostic protocol. Furthermore, in various embodiments of the invention, the installation and removal of the assistive device from the coupling device is performed manually or automatically by a corresponding motion control system.

[0148] In some embodiments of the invention, one or more diagnostic device units are stored in a storage space adapted to be permanently or temporarily fixed to the CBBCT imaging system 500. Therefore, the aforementioned motion control system will retrieve the required auxiliary device unit from the storage space and mount it onto the coupling device according to the requirements of a specific patient or imaging / diagnostic protocol.

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

[0150] therefore, Figure 6A The steps are demonstrated as follows: 602. Arranging the CBBCT imaging system to its initial (distal) state; 604. Capturing patient measurements (i.e., body dimensions and characteristics); 606. Installing and configuring the patient placement sub-panel; 608. Making initial adjustments to the patient support system parameters; 610. Introducing the patient into the imaging system; 612. Seating the patient in the saddle; 614. Further adjusting the patient support system parameters to ensure patient comfort and optimal imaging position; 616. Advancing the imaging sub-system towards the patient, so that the imaging sub-system (i.e., the vertical plane gantry sub-system) moves to the aforementioned secondary (proximal) state; 618. Adjusting the configuration of the patient placement sub-panel, including, for example, optionally installing a breast stabilization unit; 620. Completing the configuration of the patient placement sub-panel; 622. Further adjusting the patient support system parameters to improve patient comfort and imaging positioning; 623. Advancing the patient back support pad towards the patient's back to facilitate the patient's rest against the patient placement panel and stabilize the patient to prevent accidental movement; 626. Activating the X-ray source; 628. Rotating the gantry around the rotation axis; and 630. Initiating the CBBCT scan.

[0151] In addition to the steps described above, method and process 600 may optionally include one or more of the following steps: optionally initiating a secondary hybrid scan 632, such as, but not limited to, CBBCT / ultrasound hybrid scan, CBBCT / PET hybrid scan, CBBCT / terahertz hybrid scan, and CBBCT / optical hybrid scan; optionally configuring a fixed scanning subsystem 634 and initiating a fixed scan 636, and optionally deconfiguring a fixed scanning subsystem 638; optionally configuring a biopsy guidance subsystem 640 to guide a manual biopsy procedure, optionally performing a biopsy procedure 642, and optionally deconfiguring a biopsy guidance subsystem 644 (or performing the same operation for an automated biopsy procedure). Of course, those skilled in the art, upon reviewing the benefits of this disclosure, will recognize that combining available auxiliary equipment and methods with other optional steps of this method would be desirable and readily implementable. Therefore, all of the above is intended to be covered within the scope of this disclosure.

[0152] The disclosed methods and processes further include the following steps: retracting the back support pad for patient 646; retracting the imaging subsystem 648 from the patient to its initial (distal) state; and removing patient 650 from the imaging system.

[0153] See also Figure 2 The illustrated embodiment shows a patient placement panel 238 located between the rotating 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.

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

[0155] As described above, the arrangement of the patient placement surface area 240 is designed to isolate the patient from the remainder of the vertical gantry subsystem 206, with the patient's breast extending through the aperture 246. In various embodiments and aspects of the invention, a patient placement sub-panel is located at the aperture 246. In various aspects, this sub-panel will provide an aperture designed and positioned according to the characteristics of a particular patient and the breast being imaged, protecting areas of the patient that may be exposed to scattered X-ray photons, supporting fixation features for auxiliary equipment, and other features such as support and stability for the breast being imaged. Further aspects and details of the sub-panel will be provided below.

[0156] Figure 7 A schematic proximal elevation view illustrates certain aspects of an exemplary CBBCT imaging system 700 prepared according to the principles of the present invention, including a vertical plane gantry subsystem 702. It will be understood that the vertical plane gantry subsystem 702 is similar in features to the subsystems discussed above and illustrates 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 placement panel 704 includes a patient placement surface region 706 adapted to support a patient during scanning. In various embodiments of the invention, the patient placement surface region 706 includes an inner peripheral edge 708 defining an aperture through the patient placement surface region of the patient placement panel. In some embodiments, this aperture is adapted to receive a patient's breast passing through. In other embodiments, it includes... Figure 7 As shown, the aperture is adapted to receive a patient placement sub-panel 710 passing through the peripheral edge 708. The patient placement sub-panel 710 is coupled to and / or supported by the patient placement panel 704.

[0158] When comparing the inner perimeter edges, for example 244 ( Figure 2As can be clearly seen in 708 and 708, the peripheral edges of a particular shape will be selected in the corresponding embodiments to optimize considerations such as functionality and ease of manufacture. Therefore, the geometries shown are merely examples of various configurations that will immediately become apparent to those skilled in the art when taken into account the full scope of this disclosure.

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

[0160] Please refer to the above for further details. Figure 7 and Figure 3 In some embodiments of the invention, the patient support subsystem 330 will include an exemplary seat assembly 344. As described above, the exemplary seat assembly 344 is coupled to and supported by the column 332. The seat assembly 344 includes a saddle-shaped portion 346 having a structural body 348 and a saddle-shaped upper surface region 350.

[0161] As described above, the seat adjustment mechanism allows the saddle-shaped portion 346 to be adjusted vertically 356 and laterally 358 relative to the longitudinal axis 360 of the base component 336. In some embodiments, the seat adjustment mechanism also allows the saddle-shaped portion to have additional rotational degrees of freedom about the longitudinal axis of the seat post 352, namely 362 (yaw) and 363 (pitch) rotation about the lateral axis 358.

[0162] Therefore, the seat adjustment mechanism is suitable for adjusting the lateral position of the patient relative to the patient placement panel 704. In other degrees of freedom, this system will allow adjustment of the patient's position in dimension 720, laterally to the centerline 718 of the table. This adjustment will, in advantageous applications, move the patient's breast along one direction (i.e., degree of freedom 722) toward the centerline of the CBBCT imaging system (i.e., toward the rotation axis, such as the rotating gantry 306 described above).

[0163] Those skilled in the art will understand that, in some embodiments of the invention, multiple sub-panels will be provided, these sub-panels including holes of different sizes. For example, a sub-panel will be provided with an inner peripheral edge 724 that defines a hole of a smaller diameter (compared to the hole 716 defined by the inner peripheral edge 714). Thus, those skilled in the art or in the medical field will be able to select and install a sub-panel with holes appropriate for the size and location of a particular patient's breast.

[0164] In other embodiments of the invention, the aperture size is adjusted via an operational adjustment mechanism, such as an iris leaf aperture mechanism (see below). Figure 10D-10F In some embodiments, the adjustment mechanism will be substantially permanently coupled to the patient placement panel 704 of the vertical plane gantry subsystem 702. In other embodiments of the invention, the adjustment mechanism will be coupled to the sub-panel 710 described above.

[0165] In some embodiments of the invention, the aperture for receiving the breast to be imaged is typically aligned with the centerline of the patient placement panel. In such embodiments, the patient is positioned so that the breast to be imaged is aligned with the centerline of the table. Therefore, no additional lateral mechanism is required to align the breast with the axis of rotation of the gantry. Those skilled in the art will understand that this alignment of the breast aperture can be achieved by providing the aperture directly on the patient placement panel, or alternatively, on a sub-panel configured to be connected to or coupled to the patient placement panel.

[0166] therefore, Figure 8 A schematic near-end elevation view illustrates certain aspects of the exemplary CBBCT imaging system 800, including the vertical plane gantry subsystem 802, which is typically associated with... Figure 7 The vertical plane gantry subsystem 702 is similar to the one in the previous system. The vertical plane gantry subsystem 802 includes a patient placement panel 804.

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

[0168] Sub-panel 810 includes a sub-panel surface region 812. A further inner peripheral edge 814 defines an aperture 816 through the sub-panel. In the illustrated configuration, the sub-panel aperture 816 coincides with the longitudinal centerline 818 of the patient placement panel 804. Therefore, in typical operation of the CBBCT imaging system, either breast of the patient can be imaged through the sub-panel aperture 816, and the seat adjustment mechanism (e.g., as described above) can be adjusted accordingly. Figure 3 The relevant mechanism is configured to align the breast to be imaged with the subpanel aperture 816, and the patient will be placed accordingly on the upper surface 806 of the patient placement panel 804.

[0169] Although the inner peripheral edges (e.g., 714, 724, 814) shown and discussed above exhibit a generally circular characteristic, those skilled in the art will understand that, according to the requirements of a particular application of the invention, the peripheral edges can take any shape deemed advantageous. Therefore, in some embodiments of the invention, the peripheral edges may be generally elliptical, or may be generally triangular, or any other regular or irregular polygonal shape, or any arcuate shape, or a combination of arcuate and linear segments, or any combination of the foregoing, all of which should be considered within the scope of this disclosure.

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

[0171] In various embodiments of the invention, handles 730 and 732 can rotate in one or more dimensions of the centerline 718, the lateral dimension 720, and about their respective vertical axes passing through their respective handles and substantially perpendicular to the patient placement surface 706 of the patient placement panel 704. The reader will understand that the exemplary handle positions and configurations shown herein are only one of many possible configurations.

[0172] Furthermore, in corresponding embodiments of the invention, the position of any handle can be reconfigured to be located at any suitable position on the patient placement surface 706 of the patient placement panel 704. Therefore, in some embodiments of the invention, the handle (e.g., 730) can be coupled to the patient placement surface 706 by a detachable magnetic device, hook and loop fastener, quick-release fastener, protrusion and groove device, resilient 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 An exemplary handle that will be used in various embodiments of the invention is illustrated in a schematic perspective view. Those skilled in the art will readily understand the advantages of the particular handle shown, as well as other handles suggested in this disclosure, which are considered to be within its scope. For example, Figure 9A A handle 900 is shown, suitable for being gripped primarily around the transverse longitudinal axis 902, and substantially fixedly coupled to the patient placement panel at its first end 904 and second end 906, directly or via an adjustment device. It should be noted that... Figure 9A The handle and Figure 7 The handles shown in parts 730 and 732 are somewhat similar.

[0174] Figure 9B An alternative handle 910 is shown, designed for gripping around a longitudinal axis 912 that is substantially perpendicular to the surface of the patient placement panel. The radius of the flange portion 914 of the handle 910 is generally larger than the radius 918 of the grip portion 919. This extended flange effectively couples to the patient placement panel and improves the stability and rigidity of the handle 910.

[0175] Figure 9C A further alternative handle 920 is shown, designed for gripping around a longitudinal axis 922 that is generally perpendicular to the surface of the patient placement panel. The radius of the lower flange portion 924 of the handle 920 is generally larger than the radius 928 of the grip portion 929. The upper flange portion 930 extends in an arc shape away from the longitudinal axis 922 and slopes downwards to couple with the patient placement panel at its lower edge 932. The extended upper and lower flanges effectively couple the handle 920 to the patient placement panel and improve the stability and rigidity of the handle.

[0176] Figure 9D A further alternative handle 934 is shown, designed for gripping primarily around a raised upper surface 936, which is generally parallel to the surface of the patient placement panel and transverse to the 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 during 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. The lower flange portion 942 of the handle 934 effectively couples the handle 934 to the patient placement panel and improves the stability and rigidity of the handle.

[0177] Figure 9E A further alternative handle 944 is shown, designed for gripping around a longitudinal axis 946 that is generally perpendicular to the surface of the patient placement panel. The radius of the lower flange portion 948 of the handle 944 is generally larger than the lateral dimension 952 of the grip portion 954. A vertical surface area 956 of the handle 944 is generally convex in shape, designed for contact with the patient's palm.

[0178] The opposite vertical surface area 958 includes multiple concave grooves, such as 960, 962, and 964, each groove 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 rotary bearing and is adapted to rotate substantially freely in the circumferential direction 966, or be adjusted and rotatably released into place as required by a specific application. This articulated movement allows adjustment of the positions of surfaces 956 and 958 to achieve optimal comfort when the patient grips the handle.

[0179] In the context of the above discussion, Figure 10A-10F Various exemplary sub-panel configurations are illustrated in an illustrative manner. These configurations fall within the scope of the present invention and are related to the above. Figure 7 and 8 The related sub-panels 710 and 810 are similar.

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

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

[0182] Figure 10B A sub-panel 1012 is shown, similar to sub-panel 1000. Like sub-panel 1000, sub-panel 1012 has an inner peripheral edge 1014 that defines a hole 1016 passing through sub-panel 1012. Similar to hole 1006, hole 1016 is located to the left of the longitudinal centerline 1018 of sub-panel 1012. However, the diameter 1020 of hole 1006 is relatively small, smaller than the corresponding diameter 1022 of hole 1016.

[0183] Figure 10CA sub-panel 1026 is shown, similar to sub-panels 1000 and 1012. Like sub-panel 1000, sub-panel 1026 has an inner peripheral edge 1028 defining an aperture 1030 passing through it. The diameter 1032 of aperture 1030 is substantially equal to the corresponding diameter 1022 of aperture 1016. However, the centroid of aperture 1030 roughly coincides with the centerline 1034 of sub-panel 1026. Therefore, while apertures 1006 and 1016 are primarily configured to receive images of a patient's left breast, aperture 1030 is suitable for receiving images of either the left or right breast.

[0184] Those skilled in the art will also understand that, with appropriate peripheral configuration and coupling features provided, the symmetry of the illustrated panel will be used for imaging in various embodiments of the invention, for example, to image the left or right breast by symmetrically rotating the sub-panels 1000 or 1012 about center lines 1008 and 1018, respectively.

[0185] Similarly, rotating the panel around an axis transverse to the center line can be used to adjust the position of the indicated holes to be relatively higher or lower, depending on the needs of taller or shorter patients.

[0186] In light of the foregoing discussion, the reader will understand that in some embodiments of the present invention, multiple sub-panels and imaging systems will be provided to allow selection of sub-panels with appropriate apertures based on the patient’s height, weight, breast size, and other parameters.

[0187] In another embodiment of the invention, individual reusable sub-panels will be purchased so that they are available when needed. In other embodiments of the invention, disposable sub-panels will be used for each patient and discarded after a single use.

[0188] Figure 10D-10F A schematic representation of a further sub-panel 1050 prepared according to the principles of the present invention is shown. The sub-panel 1050 is shown in cross-sectional view, showing the adjustment mechanism 1052 included in the sub-panel 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 components, 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 the iris mechanism used in photographic cameras. Therefore, by operating links 1060 and 1062, blade components 1056 and 1058 will be actuated to rotate to adjust the diameter of the aperture 1064 to a value required for breast imaging of a particular patient.

[0190] With further explanation, in Figure 10EIn this example, the iris mechanism 1070 is adjusted and configured to present an aperture 1072 with a relatively small diameter 1074. Figure 10F In this example, the iris mechanism 1070 is adjusted and configured to present the same aperture 1072, but with a relatively larger diameter 1076.

[0191] In a further aspect of the invention, Figure 11 A subpanel 1100 is shown in a schematic distal cross-sectional 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 via a hole 1104 on the distal surface 1106.

[0192] Experts in the technical field will readily understand the various benefits and ways of using exemplary stabilizer units like those shown here when reviewing the aforementioned applications.

[0193] Figure 12 A portion of an exemplary CBBCT imaging system 1200, similar to system 200, is shown in a schematic side elevation view, including a vertical plane gantry subsystem 1202. The vertical plane gantry subsystem 1202 includes a vertical plane gantry 1204 configured to rotate about a generally horizontal axis of rotation 1206.

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

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

[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... Figure 2 The patient placement panel in the image is similar to 238.

[0197] Therefore, see Figure 2 and Figure 12The patient placement panel includes an inner peripheral edge of a patient placement surface area. The inner peripheral edge surrounds an aperture 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 patient placement surface area 1240 is arranged to isolate the patient from the remainder of the vertical gantry subsystem 1202, with the patient's breast extending through aperture 1246. In various embodiments and aspects of the invention, the patient placement subsystem (as shown above) is positioned at aperture 1246. In various aspects, the patient placement subsystem will provide an aperture designed and positioned according to the characteristics of the specific patient and the breast to be imaged, protect areas of the patient that may be exposed to scattered X-ray photons, and provide support and stability to the breast to be imaged, among other features.

[0199] The CBBCT imaging system 1200 also includes an exemplary seat assembly 1276. In the illustrated embodiment, the exemplary seat assembly 1276 is coupled to and supported by a corresponding portion 1278 of the patient placement surface region 1240. In other embodiments of the invention, the exemplary seat assembly 1276 is coupled to and supported by a base component 1230 and / or a patient step 1250, or coupled to any other location, feature, or aspect of the CBBCT imaging system, or a combination thereof, as suited to 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 region 1284. The saddle-shaped upper surface region 1284 is adapted to position and support a patient sitting on the saddle-shaped portion 1280 during imaging and during optional supplementary examinations.

[0201] In the illustrated embodiment, the structural body 1282 is substantially fixedly coupled to the upper end of an exemplary seat column 1286, which is coupled to the CBBCT imaging system 1200 as described above, directly or via a suitable positioning adjustment device. The seat column is optional; in some embodiments of the invention, the saddle-shaped structural body is directly coupled to the CBBCT imaging system 1200.

[0202] Therefore, in some embodiments of the invention, the lower end of the exemplary seat column 1286 is operatively coupled to a seat adjustment mechanism. The seat adjustment mechanism is directly or indirectly coupled to the base component 1230 to provide support. Thus, the weight of a patient sitting on the saddle-shaped upper surface region 1284 is transferred through the saddle-shaped structural body 1282 to the seat column 1286, and then through the seat adjustment mechanism to the base component 1230.

[0203] In an ideal aspect of certain embodiments of the invention, the seat adjustment mechanism allows the saddle portion 1280 to be positioned in the vertical direction 1288, i.e., laterally relative to the upper surface 1290 of the base member 1230. In some embodiments, the seat adjustment mechanism also allows for hinged rotation in additional degrees of freedom, i.e., deflection of the saddle portion about the longitudinal axis of the seat post 1286, as well as pitch and roll about their respective axes.

[0204] Furthermore, in some embodiments of the invention, the rolling of the saddle-shaped portion 1280 can also be adjusted to ensure patient comfort and optimal positioning on the vertical plane gantry subsystem 1202.

[0205] In a further aspect of the invention, in some embodiments, the saddle portion may be detachable, foldable, or otherwise displaceable so that the patient to be imaged does not sit on the saddle portion, but rather stands, for example, on the upper surface 1254 of the step portion 1250. Thus, the saddle portion can be used when needed, but is unnecessary in cases where patient support in a standing position is more suitable.

[0206] Those skilled in the art will understand that the saddle-shaped portion 1276 will be shaped and configured to promote optimal patient comfort and positioning on the vertical plane gantry subsystem 1202. In some embodiments, the saddle-shaped portion 1276 will comprise a material that is biocompatible and has desirable rheological and elastic stiffness properties.

[0207] Therefore, in various embodiments of the invention, the saddle-shaped portion 1276 will include suitable materials to achieve these objectives. Figure 3 The related description provides a variety of exemplary materials corresponding to the various embodiments.

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

[0209] Figure 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] Figure 13AA seatbelt 1300 of the CBBCT imaging system is shown. The seatbelt 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, a knitted textile, a felted textile, or a chain link textile. In other embodiments of the 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 aforementioned objectives and functions.

[0211] The illustrated seatbelt 1300 includes a coupling mechanism (e.g., 1304, 1306) adapted to detachably couple the seatbelt 1300 to the patient placement panel 1238. In various embodiments of the invention, coupling mechanisms 1304, 1306 will include one or more fasteners, buttons, hook and loop fasteners, mechanical quick-release buckles, magnetic quick-release buckles, adhesive quick-release buckles, or any other known or to be known fasteners suitable for the purposes of this disclosure, as well as combinations thereof.

[0212] In some embodiments of the invention, the seatbelt 1300 will include a cushioning component 1308. In some embodiments, the cushioning component will include a generally resilient component for dispersing 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 invention, the cushioning assembly 1308 will include an expansion assembly, such as an airbag, a liquid bladder, or a mechanical actuator. In some embodiments of the invention, the expansion assembly is adapted to expand in a controllable manner after the seatbelt is coupled to the patient placement panel 1238, thereby pressing the patient against the patient placement surface 1240.

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

[0215] The flexible component 1312 has a first end 1314 and a second end 1316, both ports being adapted for coupling with respective regions of the patient placement panel 1238. In some 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, ports 1314 and 1316 are detachably and / or adjustably coupled to the patient placement panel 1238.

[0216] In the illustrated embodiment, the flexible component 1312 has a third end 1318 and a fourth end 1320, these two internal ports being adapted to be releasably coupled to each other. Therefore, internal ports 1318 and 1320 will include respective complementary coupling features. Thus, for example, internal ports 1318 and 1320 will include respective complementary portions of fasteners, buttons, hook and loop fasteners, mechanical quick-release fasteners, magnetic quick-release fasteners, or any other known or to be known fasteners suitable for the purposes of this disclosure, as well as combinations thereof.

[0217] In some embodiments of the invention, seat belts 1300 and 1310 will comprise, for example, polymeric materials, such as polyamide or polyaramid.

[0218] In other embodiments of the invention, seat belts 1300 and 1310 (including their components) will comprise one or more of polyethylene, polypropylene, polybutene, polystyrene, polyester, acrylic polymers, 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 isoquinone terephthalate resin (both available from GE Plastics); liquid crystal polymers, such as aromatic polyesters or aromatic polyesteramides containing at least one compound selected from the group consisting of aromatics.

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

[0220] Cone-beam computed tomography (CBBCT) equipment acquires two-dimensional projection data. The acquired geometry can be a single-circle geometry, a double-circle geometry (suitable for large breasts), a circle plus a straight line geometry, a semi-circle plus a cone angle geometry, or a spiral cone-beam geometry. One or more of these geometries are then used to construct a three-dimensional CBBCT image from the two-dimensional projection data. Reconstruction methods can include filtered backprojection, iterative algorithms, and / or AI deep learning algorithms. Rapid reconstruction and imaging processing can be performed using a dedicated imaging processor.

[0221] In some embodiments, the CBBCT scanning system includes a base component comprising a vertical plane gantry subsystem coupled to and supported therefrom. The vertical plane gantry subsystem includes a CBBCT gantry adapted and configured to rotate about a generally horizontal axis of rotation; the vertical plane gantry subsystem includes a patient placement panel having a patient placement surface area with a through-hole; the vertical plane gantry subsystem includes a patient support sub-panel disposed within the through-hole of the patient placement panel; and a patient support subsystem coupled to and supported therefrom. The patient support system includes a saddle-shaped portion and a back portion. The saddle-shaped portion has a saddle-shaped upper surface area adapted to support a patient seated thereon, adjacent to the patient placement surface area. The back portion includes an active back support mechanism adapted, when activated, to push the patient toward the patient placement surface area and to position and stabilize the patient's breast during 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 patient-controlled release mechanism.

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

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

[0225] In some embodiments, the seat adjustment mechanism of the CBBCT scanning system is adapted to adjust the upper saddle surface area of ​​the saddle portion in the pitch degree of freedom, while in other embodiments, the seat adjustment mechanism is adapted to adjust the upper saddle surface area of ​​the saddle portion in the roll degree of freedom; in a further embodiment, the seat adjustment mechanism is adapted to adjust the upper saddle surface area of ​​the saddle portion in the yaw degree of freedom.

[0226] In some embodiments of the invention, a method of performing a CBBCT scan includes providing an imaging system comprising a base component, a vertical plane gantry subsystem coupled to the base component, a patient support subsystem coupled to the base component, configuring the imaging system in a first distal configuration relative to the distance between the patient support subsystem and the vertical plane gantry subsystem, adjusting parameters of the patient support subsystem for patient positioning, seating the patient on a saddle portion of the patient support subsystem, configuring the imaging system in a second proximal configuration relative to the distance between the patient support subsystem and the vertical plane gantry subsystem, placing the patient's breast within the vertical plane gantry subsystem, activating a back support mechanism of the patient support subsystem, pushing the patient toward the vertical plane gantry subsystem, performing a CBBCT scan of the patient's breast using the vertical plane gantry subsystem, releasing the back support mechanism of the patient support subsystem, restoring 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 invention, the method of performing a CBBCT scan further includes providing a patient placement panel having a through hole, mounting 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 patient parameter values ​​and selecting a patient support sub-panel based on the patient parameter values.

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

[0230] In a further embodiment of the invention, selecting a patient support sub-panel based on patient parameter values ​​includes selecting a patient support sub-panel such that its breast opening is advantageously located on one side of the centerline of the patient placement panel.

[0231] In some embodiments of the present invention, the 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 some embodiments of the invention, the method of performing a CBBCT scan includes adjusting the diameter of the breast aperture on the patient support subpanel.

[0233] In some embodiments of the invention, placing the patient's breast in the breast hole 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 some embodiments of the invention, the back support mechanism for activating the patient support subsystem involves a pneumatic airbag assembly of an inflatable back support mechanism.

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

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

[0237] Some embodiments include having the patient sit on the saddle-shaped portion of the patient support subsystem and activating the safety features of the patient support subsystem.

[0238] In some embodiments of the invention, activating the safety feature includes fastening the seatbelt of the patient support subsystem.

[0239] Some embodiments of the invention include manually advancing the vertical plane rack subsystem from a remote configuration to a near configuration, while other embodiments automatically advance the vertical plane rack subsystem from a remote configuration to a near configuration.

[0240] Some embodiments of the present invention include a fixed scanning subsystem that operates a vertical plane gantry subsystem to capture a fixed scan of a patient's breast.

[0241] Some embodiments of the present invention include a biopsy guidance subsystem for operating a vertical plane gantry subsystem to guide a manual biopsy procedure on a patient's breast.

[0242] In some embodiments of the invention, the CBBCT scanning system includes a base component, a vertical plane gantry subsystem coupled to and supported thereon, the vertical plane 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 thereon, the patient support subsystem including a saddle-shaped portion adapted to support a patient seated thereon during CBBCT scanning of a patient's breast, adjacent to the patient placement surface area, wherein the base component is adapted to support horizontal movement between the vertical plane gantry subsystem and the patient support subsystem.

[0243] While the exemplary embodiments described above are primarily from the field of devices and systems and methods related to the operation of CBBCT imaging systems, including systems and methods with ergonomic improvements, those skilled in the art will understand that the principles of the invention are equally applicable to other imaging technologies, and the benefits of the invention can also be achieved in a wide range of other imaging technologies, such as imaging of other body parts and imaging of industrial and technical products. Furthermore, although the invention has been described in detail in association with the present preferred embodiments, it should be clearly understood that the invention is not limited to the disclosed embodiments. Rather, the invention can be modified to incorporate any number of variations, adjustments, substitutions, or equivalent arrangements not yet described, all of which are consistent with the spirit and scope of the invention. Therefore, the invention should not be considered as limited by the foregoing description, but only by the scope of the appended claims.

Claims

1. A CBBCT scanning system, comprising: A basic component; A vertical plane rack subsystem, coupled to and supported by the base member, the vertical plane rack subsystem including a CBBCT rack designed and configured to rotate about a generally horizontal axis of rotation; The vertical plane rack subsystem includes a patient placement panel with a placement surface area and a through opening; The vertical plane gantry subsystem also includes a patient support sub-panel located within the opening of the patient placement panel; A patient support subsystem, coupled to and supported by the base component, includes a seat and a backrest. The seat has a seat surface area designed and configured to support a patient seated thereon, bringing them close to a patient placement surface area. The backrest includes an active back support mechanism that, when activated, propels the patient toward the patient placement surface area and is used to position and stabilize the patient's breast during CBBCT breast imaging.

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

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

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

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

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

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

11. A method for performing a CBBCT scan, comprising the following steps: Provide an imaging system that includes basic components; A vertical planar rack subsystem coupled to the base component is provided; A patient support subsystem coupled to the basic component is provided; The imaging system is positioned in a first remote configuration relative to the distance between the patient support subsystem and the vertical plane gantry subsystem; Adjust the parameters of the patient support subsystem to locate the patient; Position the patient in the seat of the patient support subsystem; The imaging system is positioned in a second close proximity configuration relative to the distance between the patient support subsystem and the vertical plane gantry subsystem; Position the patient's breast within the vertical plane gantry subsystem; Activate the back support mechanism of the patient support subsystem; Prop the patient toward the vertical plane gantry subsystem; The patient's breast was scanned using the vertical plane gantry subsystem described above; Release the back support mechanism of the patient's support subsystem; Return the imaging system to the first remote configuration; Remove the patient from the seat of the patient support subsystem.

12. The CBBCT scanning method as defined in claim 11, further comprising the following steps: A patient placement panel is provided, the patient placement panel having a through sub-panel opening; A patient support sub-panel is installed at the opening of the sub-panel; The patient's breast is placed through the breast opening in the patient support sub-panel.

13. The CBBCT scanning method as defined in claim 12, further comprising the following steps: Received a patient parameter value; Select the corresponding patient support sub-panel based on the patient parameter values.

14. The CBBCT scanning method as defined in claim 13, wherein the step of selecting the patient support sub-panel based on the patient parameter values ​​includes: Select a patient support sub-panel with a breast aperture diameter that corresponds to the patient's breast diameter value.

15. The CBBCT scanning method as defined in claim 13, wherein the step of selecting the patient support sub-panel based on the patient parameter values ​​includes: Choose a patient support subpanel with the breast aperture advantageously located on one side of the centerline of the patient placement panel.

16. The CBBCT scanning method as defined in claim 12, further comprising the following steps: Receives a patient parameter value; The step of installing the patient support sub-panel also includes: Select the corresponding patient support sub-panel based on the patient parameter values.

17. The CBBCT scanning method as defined in claim 12, further comprising the following steps: Adjust the diameter of the breast aperture on 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 subpanel comprises: Position the patient's breast within the breast stabilization device of the patient support sub-panel.

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

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

21. The CBBCT scanning method as defined in claim 11, wherein the step of adjusting the parameters of the patient support subsystem for patient localization includes: Adjust the height of the seat relative to the upper surface of the base component.

22. The CBBCT scanning method as defined in claim 11, wherein the step of adjusting the parameters of the patient support subsystem for patient localization includes: Adjust the pitch angle of the seat relative to the upper surface of the base component.

23. The CBBCT scanning method as defined in claim 11, wherein the step of accommodating the patient in the seat of the patient support subsystem further comprises: Activate the security functions of the patient support subsystem.

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

25. The CBBCT scanning method as defined in claim 11, further comprising the following steps: The vertical plane rack subsystem is manually moved from a distant configuration to a closer configuration.

26. The CBBCT scanning method as defined in claim 11, further comprising the following steps: The vertical plane rack subsystem is automatically moved from a distant configuration to a closer configuration.

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

Images