Ergonomic improvements in cone beam breast computed tomography

Abstract

In the present invention, a cone beam mammary computed tomography (CBBCT) system includes a rotatable patient support panel such that a patient can access the panel in an upright position, and then the panel can be rotated to image the patient in a generally prostrate position. This design facilitates patient positioning and comfort while ensuring stability and accuracy during imaging.

Description

[0001] Related Applications

[0002] This application claims the benefit of the following provisional patent applications: Comprehensive Disclosure described in U.S. Provisional Application No. 63 / 331,153, filed on April 14, 2022, and Fixture and Support for Medical Imaging described in U.S. Provisional Application No. 63 / 401,475, filed on August 26, 2022, and Ergonomic Improvements in Cone Beam Breast Computed Tomography described in U.S. Provisional Application No. 63 / 401,493, filed on August 26, 2022, and Static Detail Imaging in Cone Beam Breast Computed Tomography described in U.S. Provisional Application No. 63 / 401,513, filed on August 26, 2022, and U.S. Provisional Application No. 63 / 401,514, filed on August 26, 2022. No. 63 / 401,546, filed on August 26, 2022, “Cone Beam Breast Computed Tomography with a Patient Support Subsystem”, and U.S. Provisional Application No. 63 / 401,548, filed on August 26, 2022, “Cone Beam Breast Computed Tomography with a Pivotable Frame System”, and U.S. Provisional Application No. 63 / 430,571, filed on December 6, 2022, “Ultrasound Hybrid Imaging in Cone Beam Breast Computed Tomography”, and U.S. Provisional Application No. ___________, filed on _________________, all of the above contents are fully incorporated herein by reference. Technical Field

[0003] The present invention relates to the field of cone beam tomography, and in particular to the field of patient ergonomics in cone beam breast tomography. Background Art

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

[0005] The best breast imaging technology is able to detect tumors when they are less than 10 mm in diameter. Reports show that 93% of women with invasive breast cancer (between 1-10 mm in diameter) found on mammography have a 16-year survival rate. In addition, as the diameter of the tumor decreases when it is detected, the probability of metastasis decreases dramatically. If a breast tumor is detected when it is 10 mm or smaller, the probability of metastasis will be 7.31%. If a 4 mm cancer is detected, the probability of metastasis will decrease by more than 10 times, to 0.617%.

[0006] Although mammography was previously the most effective early breast cancer detection tool available, detecting cancers about 12 mm in size on average, its sensitivity for small breast cancers (under a few millimeters) is relatively low. The specificity and positive predictive value of mammography remain limited due to structural and tissue overlap.

[0007] Mammography has limited sensitivity and specificity in breast cancer detection, primarily due to poor contrast detectability, which is common to all types of projection imaging techniques (projection imaging has a contrast detectability of only 10% at best). In addition, mammography initially detects only 65-70% of breast cancers.

[0008] In dense breasts, the sensitivity of mammography is further reduced to as low as 30%. Digital mammography (DM) aims to overcome the inherent limitations of conventional film mammography (SFM) by providing better contrast resolution and digital image processing. However, a large-scale clinical trial, the Digital Mammography Screening Trial (DMIST), showed that the false positive rates of digital mammography and film mammography were the same.

[0009] The relatively low specificity of mammography results in biopsies being performed in indeterminate cases despite the additional expense and stress this imposes on patients. Nearly 80% of the more than one million breast biopsies performed annually in the United States to evaluate suspicious mammographic findings are benign, causing undue anxiety for patients and significant costs to the healthcare system. Therefore, more accurate characterization of breast lesions is needed to reduce biopsy rates and false-positive rates of pre-biopsy mammography.

[0010] To address the limitations of mammography described above, one of the inventors previously developed a cone beam breast computed tomography (CBBCT) system. In brief, the key features of the existing CBBCT include: a horizontal, ergonomically designed patient table with modular support trays to optimize coverage of the uncompressed breast (including the chest wall); 1-meter-wide openings on both sides of the patient table to facilitate positioning of the breast and possible imaging-guided biopsies and other procedures without significantly changing the basic platform; and slip-ring technology to facilitate efficient dynamic contrast imaging studies and future angiogenesis imaging.

[0011] Results from phantom studies have shown that CBBCT is able to achieve a spatial resolution of up to approximately 2.8 lp / mm, allowing detection of cancers as small as 2 mm in diameter and microcalcifications as small as 0.2 mm in size, for an average-sized breast (chest wall diameter of approximately 13 cm) with a total dose of approximately 5 mGy, which is lower than the dose of a single mammogram, assuming that two views are required for each mammogram.

[0012] CBBCT has excellent image quality in visualizing breast tissue, breast tumors, and calcifications, and coverage of the breast (including the chest wall area) is at least equivalent to that of mammography. Visualization of major blood vessels is excellent, even without the use of contrast agents. Thus, CBBCT provides a significant improvement in the detection and biopsy of suspicious lesions.

[0013] While the imaging benefits of CBBCT are significant, in many ways the ergonomic benefits of this technology are equally important. For example, in many CBBCT procedures, images can be acquired without the intense compression of breast tissue that occurs with mammography. This pressure-reducing design improves patient comfort while still enabling effective imaging, further enhancing the patient experience.

[0014] For example, a feature of mammography is that the patient's breast is inserted into a clamping device prior to breast imaging that significantly compresses the breast tissue perpendicular to the longitudinal axis of the breast. Patients commonly report physical and psychological discomfort associated with the degree of compression required for routine mammography, and research suggests that this discomfort is a contributing factor to low rates of screening and diagnostic mammography among patients in general and among certain ethnic and cultural groups.

[0015] Additionally, breast compression associated with mammography can cause displacement of breast tissue, making it more difficult to subsequently locate features such as lesions and calcifications, which is particularly important for procedures such as biopsies and lumpectomies. This displacement not only affects the accuracy of imaging, but can also increase the difficulty patients face during subsequent treatment.

[0016] The additional improvements to CBBCT imaging presented here are expected to further extend its imaging benefits and provide equally beneficial ergonomic improvements. These improvements include technical advances, as well as methods and devices that facilitate patient acceptance of CBBCT systems. These improvements include loading devices, patient seating facilities, and equipment layout and configuration that improve patient comfort and convenience, with the goal of making the use of the equipment easier for patients and technical and medical staff.

[0017] In current practice, patients undergoing CBBCT lie prone on an examination table. The breast to be examined is lowered through an opening above the examination table, suspended below the chest wall into an imaging room located below the table. The position of the breast in the imaging room is maintained by the patient remaining still as they lie on the examination table.

[0018] The imaging device is connected to a movable rotating frame which is supported by a bearing assembly for rotation about an axis of rotation. The axis of rotation is generally vertical and passes through an opening in the examination bed. The center of the breast to be imaged is designed to be placed on the axis of rotation.

[0019] During imaging, the movable rotating frame rotates about the rotation axis to carry the imaging device through at least a portion of a circular path. As it moves along this path, the imaging device emits a series of X-ray pulses and captures corresponding image data, which are processed to prepare a tomographic model of the breast.

[0020] Despite the many benefits and advantages of CBBCT, for some patients, it is difficult or impossible to perform the examination in the prone position on the patient table. These patients may not be able to properly position themselves on the tabletop or to insert the breast to be imaged through the opening. The elderly, obese, pregnant women, disabled people, and those who suffer from other medical conditions such as paralysis or amputation are among those patients who find it extremely difficult to climb onto the tabletop and lie in a specific prone position. Summary of the invention

[0021] The inventors of the present invention, after long and careful consideration of the issues related to breast imaging, CBBCT imaging, and particularly CBBCT ergonomics, have developed new and useful systems, apparatus, and methods that represent substantial improvements over previously known methods. The present invention includes apparatus and corresponding systems and methods for positioning a patient in a CBBCT system and supporting the patient during tomographic imaging.

[0022] Therefore, in certain embodiments of the present invention, a CBBCT system is provided that is designed to facilitate the positioning of a patient in an upright position and then automatically reposition the patient in a scanning orientation. In certain embodiments of the present invention, a saddle is provided to the patient to provide support when in an upright position and is used before the patient is repositioned. In certain embodiments of the present invention, the patient support panel is arranged to rotate between a vertical orientation and a horizontal orientation to facilitate the positioning of the patient. In certain embodiments of the present invention, the patient support panel is adapted to pivot from a vertical orientation to a horizontal orientation, at which point it serves as a patient examination couch to facilitate positioning of the patient for scanning. In certain embodiments of the present invention, the patient stands on a patient footrest supported by the patient support panel.

[0023] The following description is intended to enable anyone skilled in the art to make and use the disclosed invention and to illustrate the best mode currently presented by the inventors for carrying out their invention. In the following description, for ease of explanation, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be apparent to those skilled in the art that the invention can be implemented without relying on these specific details. In other cases, known structures and devices are shown in block diagram form to avoid unnecessarily obscuring the substance of the disclosure. These and other advantages and features of the present invention will be described in detail below and in conjunction with the accompanying drawings. Figure 1 It is easier to understand from the detailed description provided.

[0024] It should be noted that although the various figures illustrate different aspects of the invention, no single figure is intended to illustrate the entire invention. Rather, the figures collectively illustrate various aspects and principles of the invention. Therefore, it should not be assumed that any particular figure is only related to a single aspect or feature of the invention. Instead, those skilled in the art will recognize that the figures taken together reflect various aspects and embodiments that embody the invention.

[0025] Therefore, the reference to "one embodiment" or "an embodiment" in the specification means that the specific features, structures, or characteristics associated with the embodiment are included in at least one embodiment of the present invention. Therefore, the phrases "in one embodiment" or "in an embodiment" that appear in multiple places in the specification do not necessarily refer to the same embodiment. In addition, specific features, structures, or characteristics can be combined in one or more embodiments in any suitable manner. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 A portion of an exemplary CBBCT imaging system is shown in a cutaway perspective view;

[0027] Figure 2 Certain aspects of an exemplary CBBCT imaging system are shown in schematic side view, including a rotatable patient support panel prepared in accordance with the principles of the present invention;

[0028] Figure 3 Other aspects and features of an exemplary CBBCT imaging system are illustrated in schematic side view, including a patient footplate for a rotatable patient support panel, the footplate being prepared in accordance with the principles of the present invention;

[0029] Figure 4 Other aspects and configurations of an exemplary CBBCT imaging system prepared in accordance with the principles of the present invention are illustrated in schematic side view;

[0030] Figure 5 Other aspects and configurations of an exemplary CBBCT imaging system prepared in accordance with the principles of the present invention are illustrated in schematic side view;

[0031] Fig. 6A Certain processes and methods of a CBBCT imaging system prepared according to the principles of the present invention are illustrated in the form of a functional block diagram;

[0032] Figure 6B Other processes and methods of a CBBCT imaging system prepared according to the principles of the present invention are presented in the form of a functional block diagram;

[0033] Figure 7Other aspects and configurations of an exemplary CBBCT imaging system are illustrated in schematic proximal view, including patient support panel features prepared in accordance with the principles of the present invention;

[0034] Figure 8 Further aspects and configurations of an exemplary CBBCT imaging system are illustrated in schematic proximal view, including patient support panel features prepared in accordance with the principles of the present invention;

[0035] Fig. 9A Certain features of a CBBCT imaging system prepared in accordance with the principles of the present invention are illustrated in schematic perspective view, including an exemplary handle;

[0036] Fig. 9B Other features of a CBBCT imaging system prepared in accordance with the principles of the present invention are shown in schematic perspective views, including an exemplary handle;

[0037] Fig. 9C Further features of a CBBCT imaging system prepared in accordance with the principles of the present invention are shown in schematic perspective views, including an exemplary handle;

[0038] Fig.9D Other features of a CBBCT imaging system prepared in accordance with the principles of the present invention are shown in schematic perspective views, including an exemplary handle;

[0039] Fig.9E Further aspects and features of a CBBCT imaging system prepared in accordance with the principles of the present invention are illustrated in schematic perspective views, including an exemplary handle;

[0040] Fig. 10A Certain features of a CBBCT imaging system prepared in accordance with the principles of the present invention are illustrated in schematic proximal side views, including an exemplary secondary panel element;

[0041] Fig. 10B Other aspects of a CBBCT imaging system prepared in accordance with the principles of the present invention are shown in schematic proximal side views, including exemplary secondary panel elements;

[0042] Fig. 10C Further exemplary aspects of a CBBCT imaging system prepared in accordance with the principles of the present invention are illustrated in schematic proximal side views, including an exemplary secondary panel element;

[0043] Fig. 10D Certain features of a CBBCT imaging system prepared in accordance with the principles of the present invention are illustrated in schematic proximal side views, including an exemplary adjustable sub-panel element;

[0044] Fig.10EFurther details and configurations of a CBBCT imaging system prepared in accordance with the principles of the present invention are shown in schematic proximal side views, including exemplary adjustable sub-panel elements;

[0045] Fig.10F Other configurations of CBBCT imaging systems prepared in accordance with the principles of the present invention are shown in schematic proximal side views, including exemplary adjustable sub-panel elements;

[0046] Fig.11 Certain further features of a CBBCT imaging system prepared in accordance with the principles of the present invention are illustrated in schematic perspective views, including exemplary breast stabilization features;

[0047] Fig.12 Other aspects and features of an exemplary CBBCT imaging system are shown in schematic side view, including a patient saddle prepared in accordance with the principles of the present invention;

[0048] Fig.13A Certain aspects of an exemplary CBBCT imaging system including certain security features prepared in accordance with the principles of the present invention are shown in an elevated schematic perspective view;

[0049] Fig. 13B Certain aspects of an exemplary CBBCT imaging system, including additional security features prepared in accordance with the principles of the present invention, are shown in an elevated schematic perspective view. DETAILED DESCRIPTION

[0050] The following description is intended to enable anyone familiar with the art to make and use the disclosed invention and to illustrate the best mode currently used by the inventor to implement his invention. In the following description, for the sake of explanation, many specific details are listed in order to provide a comprehensive understanding of the invention. However, it will be apparent to those familiar with the art that the present invention can be implemented without relying on these specific details. In other cases, known structures and devices are shown in block diagram form to avoid unnecessarily obscuring the substance disclosed.

[0051] It should be noted that although any exemplary embodiments described below will identify specific elements and combinations of elements, these examples are not intended to be definitive. Instead, discrete elements will be combined into integral elements and / or components where appropriate. In addition, certain aspects and features of specific elements described herein are considered as a whole and should be understood to also include disclosure of individual elements and components having the same features and / or functions.

[0052] Figure 1A portion of an exemplary CBBCT imaging system 100 is shown in cutaway perspective view, which is prepared according to the principles of the present invention. The system 100 includes an X-ray source 102. The X-ray source 102 is mounted on an upper surface 104 of a rotating frame 106. The rotating frame 106 is supported by a bearing and is designed to rotate around a rotation axis 108.

[0053] The 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 that intersects the rotation axis 108 (at 114) in the illustrated embodiment.

[0054] In some embodiments of the present invention, beam 110 is configured as a cone beam. In some configurations, when taken in cross section, the cross section of beam 110 defines a disk having substantially uniform X-ray intensity in a direction perpendicular to longitudinal axis 112 and having a substantially circular perimeter.

[0055] In other configurations within the scope of the present invention, when taken in cross section, the cross section of the beam 104 defines a region of substantially uniform x-ray intensity in a direction perpendicular to the longitudinal axis 112, with a substantially circular perimeter, except for a chord of the circular perimeter. As will be understood from further disclosure below, in certain embodiments, the chord will be substantially parallel to and spaced apart from the lower surface of the patient couch.

[0056] Thus, in some configurations, when taken in cross section, the cross section of beam 110 defines a truncated disk of substantially uniform x-ray intensity in a direction perpendicular to longitudinal axis 112, with a substantially truncated circular perimeter (i.e., circular in perimeter except for a horizontal chord at its upper edge). This configuration optimizes imaging of the breast while minimizing exposure to chest wall tissue above the breast. In some embodiments, this is achieved by placing an x-ray opaque collimator plate over a portion of the otherwise circular cross-sectional beam produced by the x-ray source.

[0057] In further configurations within the scope of the present invention, when the cross section is taken, the cross section of the beam 110 defines a region having substantially uniform X-ray intensity in a direction perpendicular to the longitudinal axis 112, and the perimeter is a polygon. In various embodiments and configurations, the polygonal perimeter may include a triangular perimeter, a rectangular perimeter (including but not limited to a square perimeter), a pentagonal perimeter, a hexagonal perimeter, a perimeter of any higher order geometry, or a perimeter having any arbitrary curve or combination of line segments and curves as required by a particular application. In addition, it should be understood that any of the above cross-sectional configurations may define a beam having non-uniform intensity, including but not limited to having an intensity drop to zero in a certain region or certain regions of the cross section.

[0058] An X-ray detector 116 is also mounted on the upper surface 104 of the rotating frame 106. In an exemplary embodiment, the X-ray detector 116 includes a flat panel detector having a generally planar receiving surface 118. The receiving surface 118 is generally perpendicular to the longitudinal axis 112 and is located on the other side of the rotation axis 108, opposite the X-ray source 102. Those skilled in the art will appreciate that the described configuration is only an example of many possible arrangements, wherein the X-ray source, X-ray detector, and any other components of the system may be supported from above, from the side, or in any other manner suitable for achieving the desired functions, and the shape and configuration of the rotating frame and the X-ray detector may also take any form in various embodiments of the present invention.

[0059] During operation of the imaging system 100, rotation of the rotating frame 106 about the rotation axis 108 will cause the receiving surface 118 to move along a trajectory of the rotation axis 108. In a typical configuration, the trajectory will include a portion of a circle centered at and perpendicular to the rotation axis 108. However, it should be noted that other trajectories are also considered to be within the scope of the present invention and will be disclosed herein.

[0060] In some embodiments of the present invention, one or both of the X-ray source 102 and the X-ray detector 116 are arranged to be adjustable in position on the upper surface 104 of the rotating frame 106. For example, the X-ray source 102 and the X-ray detector 116 can be adjusted together or independently in a radial direction with respect to the rotation axis 108, in a circumferential direction along the rotation axis 108, in a direction toward or away from the rotating frame surface 104, or in other ways that a designer or user deems advantageous.

[0061] The patient couch (or patient support panel) 120 includes an upper surface 122 and a lower surface 124. An opening 126 communicates between the upper surface 122 and the lower surface 124 of the couch. The upper surface 122 is arranged to support a patient 128, typically, the patient is lying prone on the surface 122, as shown. In this arrangement, the patient's breast 130 is suspended from the patient's chest wall and extends downward from the opening 126.

[0062] During operation, the rotating frame rotates around the rotation axis 108, carrying the X-ray source 102 and the X-ray detector 116 along a path around the patient's breast. During this process, the X-ray detector 116 captures X-ray image data through corresponding interface electronics and computer systems. The X-ray image data corresponds to a plurality of X-ray images taken at various angular positions around the rotation axis 108. These X-ray image data or a subset thereof are processed to provide information about the internal state and condition of the breast.

[0063] Figure 2A portion of an exemplary CBBCT imaging system 200 is shown in schematic side view, including an ergonomic assistance subsystem 202. Similar to the system 100 described above, the system 200 includes an x-ray source 204. The x-ray source 204 is mounted on an upper surface 206 of a rotating frame 208. The rotating frame 208 is supported by bearings 210 and is arranged to rotate about a rotation axis 212. The bearings 210 are supported on a base 214 of the imaging system 200.

[0064] The X-ray source 204 is configured to emit a beam of X-rays 216. The X-ray beam 216 defines a beam longitudinal axis 218, which, in the illustrated embodiment, intersects the rotation axis 212 (at 220).

[0065] In this exemplary embodiment, the ergonomic assistance subsystem 202 includes a structural column 222 having a lower end 224 connected to an upper surface area 226 of the base 214. The upper end 228 of the structural column 222 includes a first hinge flange 230 of a hinge feature 232. The second hinge flange 234 of the hinge feature 232 is hingedly connected to the first hinge flange 230 via a hinge pin 236.

[0066] The ergonomic assistance subsystem 202 includes a patient couch (or patient support panel) 238. The patient couch 238 is connected and supported thereto by a hinge flange 234, allowing articulated movement 240 about the longitudinal axis of a hinge pin 236. A linear actuator 242 is connected at a lower end 244 to the base 214 and at an upper end 246 to the patient couch 238. In operation, the length of the linear actuator 242 is controllable between the lower end 244 and the upper end 246, so that shortening the linear actuator 242 causes the couch 238 to rotate downward 250, while lengthening the linear actuator 242 causes the couch 238 to rotate upward 252.

[0067] In the illustrated embodiment, the linear actuator includes a motor 254, through the operation of which the above-described shortening and lengthening of the linear actuator 242 can be achieved. However, those skilled in the art will appreciate that any number of linear actuators, rotary actuators, or other operating mechanisms and arrangements may be used in corresponding embodiments of the present invention.

[0068] Thus, for example, in certain embodiments of the present invention, the linear actuator may include one or more electromagnets, pneumatic cylinders, hydraulic cylinders, pneumatic bladders, hydraulic bladders, linear motors, rotary motors, Acme screws and nuts, lead screws, ball screws, ropes, pulleys, timing belts, synchronous pulleys, appropriately sized worm gear reducers, rack and pinion gear sets, rack and worm gear sets, and any other appropriately functional actuator components known or that may appear in the future.

[0069] The ergonomic assistance subsystem 202 also includes a patient pedal assembly 256. In the illustrated embodiment, the patient pedal assembly 256 is connected to and supported by a patient couch 238. The patient couch 238 includes an upper surface area 258. A lower surface area 260 of the patient couch 238 is spaced apart from the upper surface area 258 in a substantially parallel relationship. As will be discussed further below, in operation of the ergonomic assistance subsystem 202, the patient couch 238 and the patient pedal assembly 256 cooperate to support a patient and position the patient for CBBCT imaging.

[0070] Figure 3 Additional details of an exemplary patient pedal assembly 300 are shown in schematic side view, similar to Figure 2 Component 256 associated with ergonomic assistance subsystem 202. Patient pedal assembly 300 includes a pedal member 302 having an upper surface area 304 and a lower surface area 306. In the illustrated embodiment, upper surface 304 and lower surface 306 are spaced apart in a generally parallel relationship. However, other configurations are possible and the present disclosure is intended to teach such configurations.

[0071] In one configuration, as shown, the upper surface 304 is in a generally horizontal orientation. However, as will be discussed further below, this orientation may be modified during operation of the CBBCT system, particularly during operation of the ergonomic assistance subsystem.

[0072] In the exemplary embodiment shown, the patient pedal assembly 300 includes a flange portion 308. The flange portion 308 is hingedly connected to a linear bearing assembly 312 via a bearing member 310. The flange portion 308 is also substantially fixedly connected to the pedal member 302, so that the pedal member 302 is supported by the linear bearing assembly 312.

[0073] Depending on the requirements of a particular application or embodiment of the present invention, the bearing member 310 may be a hinge pin, a shaft, a rotary bearing assembly, a flexible living hinge, or any known or yet to be discovered device that allows for adjustable hinged motion 314 of the flange portion 308. Thus, the hinged combination of the flange portion 308 through the bearing member 310 and the linear bearing assembly 312 enables the upper surface 304 of the pedal member 302 to be adjustable in position through motion 314, as will be further described below.

[0074] The linear bearing assembly 312 can also be adjusted upwardly 316 and downwardly 318 along its longitudinal axis 320 to provide corresponding adjustment of the flange portion 308, the pedal member 302, and ultimately the upper surface 304 of the pedal member 302. As described below, this adjustability is advantageous for the operative positioning of the patient relative to the CBBCT system.

[0075] It should be understood that in certain embodiments, the linear bearing assembly 312 will include a variety of actuators and actuation mechanisms, such as electric, mechanical, pneumatic or hydraulically operated linear actuators, similar to any of the actuators described above, and various manual actuators, such as a hand crank and / or a ratchet lever. Likewise, the bearing member 310 will also be operated by a variety of actuators and actuation mechanisms in exemplary embodiments, such as electric, mechanical, pneumatic or hydraulically operated linear actuators, similar to any of the actuators described above, and various manual actuators, such as a hand crank and / or a ratchet lever.

[0076] Figure 4 A portion of an exemplary CBBCT imaging system 400 is shown in schematic side view, including a Figure 2 The ergonomics assisting subsystem 402 is similar to the subsystem 202 in FIG. In the figure, the ergonomics assisting subsystem 402 is shown in a fully raised state, i.e., in the extreme position in the direction 404.

[0077] Patient 406 is shown on ergonomic assist subsystem 402. The assist subsystem 402 has been adjusted to achieve comfort and proper positioning of patient 406. Thus, pedal member 408 has been articulated upwardly (or downwardly) about bearing member 410.

[0078] Additionally, pedal member 408 is raised or lowered 412 via operation of linear bearing assembly 414 to adjust the position of patient 406 so that the patient's breast 416 is properly positioned within opening 418 of patient couch (or patient support panel) 420 for imaging.

[0079] Those familiar with the art will appreciate that in the various aspects and operating modes of the present invention of the example system 400, adjustments to the various controllable degrees of freedom of the system can be made before, after, or both after and before the patient 406 steps on the pedal assembly 408, thereby being arranged on the ergonomic assistance subsystem 402.

[0080] In certain embodiments of the present invention, various devices will be provided to ensure the safety and convenience of the patient, such as grip handles (such as 422), safety belts (such as 424), safety bars (not shown), and with or without positive adjustment functions (not shown) to ensure that the patient does not accidentally fall out of the system after being installed on the ergonomic assistance subsystem 402.

[0081] After positioning the patient 406 on the ergonomic assistance subsystem 402 , the linear actuator 426 is operated to shorten the effective length 428 of the linear actuator and cause the patient couch 420 to move 430 about the hinge or bearing 432 .

[0082] In typical operation of the ergonomic assistance subsystem 402, operation of the linear actuator 426 continues and the patient couch 420 continues to approach 430 until the patient is positioned in a generally horizontal orientation, such as Figure 5 shown.

[0083] therefore, Figure 5 A portion of an exemplary CBBCT imaging system 500 is shown in schematic side view, including a Figure 4 The ergonomic assistance subsystem 502 is similar to the subsystem 402 in FIG. In the figure, the ergonomic assistance subsystem 502 is shown in a fully lowered state, that is, in the extreme position in the direction 504.

[0084] Consistent with this state, the linear actuator assembly 506 (connected between the patient couch (or patient support panel) 508 and the base 510 of the imaging system 500 ) is in a minimum length state 512 .

[0085] A patient 514 lies in a prone position on an upper surface 516 of a patient couch 508 (shown in a lowered position). The patient couch 508 includes an opening 518 between the upper surface 516 and a lower surface 520.

[0086] The breast 522 of the patient 514 is suspended from the patient's chest wall, through the opening 518, and is thus positioned for imaging. Therefore, the approximate center of gravity of the breast 522 coincides with the rotation axis 524 of the rotating frame 530 of the CBBCT imaging system 500.

[0087] The reader will appreciate that the details of the CBBCT system 500 will vary depending on the configuration and requirements of a particular embodiment. In the example system 500 provided herein, the breast is positioned to advantageously place it within the operating position of the x-ray beam 526 generated by the x-ray source 528. The x-ray source 528 is connected to and supported on a rotating frame 530 for controlled rotation about the rotation axis 524.

[0088] Likewise, an x-ray imager 532 is also coupled to and supported on the rotating frame 530 and is positioned effectively to capture images of the breast 522. Those skilled in the art will readily appreciate that the specific arrangement of imaging components may vary in different embodiments, and any aspect of the described systems 100-400 is intended to be incorporated into the present disclosure as appropriate.

[0089] After imaging of the breast 522 is complete, further operation of the linear actuator assembly 506 in response to the technician's input will cause the linear actuator to resume its extended length, returning the patient couch 508 to a fully raised position, such as Figure 4 shown.

[0090] Fig. 6A and 6B Considering the same, a method 600 of operating a CBBCT imaging system, including an ergonomic assistance subsystem, is shown. Figures 2 to 5 Thus, prior to operation of the ergonomic assistance subsystem, the subsystem is configured in a fully raised state 602 .

[0091] Patient parameters (e.g., breast height relative to the patient's feet, etc.) are acquired 604, which can be achieved by manually measuring the patient, extracting from the patient's medical records, or by automatic measurement. The parameter values ​​are optionally used to set the position of the patient's footboard after acquisition, adjusting its height 606 and direction 608 (one, both, or neither) as described above. The patient then steps onto the footboard 610 and leans over the examination tabletop facing the patient.

[0092] Alternatively, in some embodiments, the patient stands directly on the patient pedal. Then, while the patient remains in position, the height and direction of the patient pedal are adjusted, and the necessary positioning (i.e., patient parameters) is obtained by manually observing or automatically sensing the position of the patient's body relative to the system. In other words, the patient pedal is adjusted until the patient's breast is correctly located in the opening of the examination couch.

[0093] Before or after adjustment, the patient may choose to secure themselves to the couch using one or more safety features 612. Safety features include, for example, straps or belts, locking bars behind the patient's back, and hook and loop (e.g., Velcro) between the couch and one or more straps or garments pre-worn by the patient. TM ) are connected, the latter including corresponding hook and loop elements. Those familiar with the technology will appreciate that in some embodiments, once the patient steps on the pedal, one or more safety features will be enabled. In other embodiments, the safety features will be enabled after the patient is positioned.

[0094] Where advantageous, the position and orientation of the patient's breast to be imaged is then adjusted 614 to achieve optimal imaging. In certain embodiments, a breast stabilization device is applied to the breast 616 to support and stabilize the breast during imaging.

[0095] Where advantageous, a safety shield will be installed 618 around the breast to ensure that the breast to be imaged is effectively isolated from the rotating mechanical equipment of the CBBCT imaging system.

[0096] Once the patient is positioned and prepared, the patient couch is rotated 620 to a fully lowered position. The imaging device is then operated 622 to acquire CBBCT image data.

[0097] In some embodiments, the image data is immediately processed and used to identify features of the breast, including, for example, calcifications and lesions. In some cases, these represent newly identified breast features. In other cases, the CBBCT image data is used to pinpoint previously discovered features and, in some cases, guide supplemental procedures 624, such as aspiration needle biopsy or other procedures.

[0098] These procedures are, of course, optional and should only be applied when relevant to a particular patient. It should be further noted that in some cases, in-situ breast marking or pre-alignment marking is performed to allow for supplemental procedures to be performed after the table has been returned to a partially or fully raised configuration, or even after the patient has been removed from the system.

[0099] In other embodiments, once the imaging and supplemental procedures are complete, the couch will rotate to the fully raised position 626. Subsequently, the safety shield will be removed 628 and the breast stabilization device will also be removed 630, if appropriate.

[0100] The patient safety feature is then disengaged 632 and the patient removed from the system 634. Any image post-processing and diagnostic procedures may then be performed 636 on the stored data.

[0101] Figure 7 Certain aspects of an exemplary CBBCT imaging system 700 are shown in schematic proximal elevation, including an ergonomic assistance subsystem 702 prepared in accordance with the principles of the present invention. It will be appreciated that the ergonomic assistance subsystem 702 is similar in nature to the systems discussed above, and illustrates further aspects and details of the same invention. Thus, the ergonomic assistance subsystem 702 includes a patient couch (or patient support panel) 704. The patient couch 704 is shown in a fully raised position, similar to the above Figure 2 and Figure 4 The configuration is consistent with that shown in .

[0102] The patient couch 704 includes an upper surface area 706 adapted to support the patient during scanning. In various embodiments of the present invention, the upper surface area 706 includes an inner peripheral edge 708 defining a hole in the upper surface area of ​​the patient couch. In some embodiments, the hole is adapted to receive a breast of the patient therethrough. In other embodiments, the upper surface area 706 includes an inner peripheral edge 708 defining a hole in the upper surface area of ​​the patient couch. In some embodiments, the hole is adapted to receive a breast of the patient therethrough. Figure 7 In the embodiment shown in FIG. 704 , the aperture is adapted to receive a secondary panel 710 that spans the peripheral edge 708 . The secondary panel 710 is connected to or supported by the patient couch 704 .

[0103] The secondary panel 710 includes a secondary panel surface area 712. A further inner peripheral edge 714 defines a secondary panel aperture 716 extending through the secondary panel. In the illustrated configuration, the secondary panel aperture 716 is located to the right of a longitudinal centerline 718 of the patient couch 704. Thus, in typical operation of the CBBCT imaging system, the patient's right breast will pass through the secondary panel aperture 716 during imaging.

[0104] In certain embodiments of the present invention, the ergonomic assistance subsystem 702 will include a lateral bearing and actuator assembly. The lateral bearing and actuator assembly is intended to adjust the lateral position of the patient couch 704. In operation, the system will allow the position of the couch 704 to be adjusted in a dimension 720 that is transverse to the centerline 718 of the couch. This adjustment will, in advantageous applications, align the patient's breast toward the centerline of the CBBCT imaging system (i.e., toward the axis of rotation of the rotating frame, e.g., Figure 2 The axis 212 in the middle moves.

[0105] In certain embodiments of the present invention, a technician or medical staff will be able to select and install a sub-panel having an aperture that is appropriate for a particular patient's breast size. For example, a sub-panel will be provided having an inner peripheral edge 724 that defines an aperture of a smaller diameter (compared to the aperture defined by the inner peripheral edge 714). Thus, multiple sub-panels may be provided that have different aperture sizes so as to be able to meet the needs of different patients.

[0106] In other embodiments of the present invention, the aperture size adjustment will be achieved by operation of an adjustment mechanism, such as an aperture blade adjustment mechanism. In some embodiments, the adjustment mechanism will be substantially permanently connected to the patient couch 704 of the human assistance subsystem 702. In other embodiments of the present invention, the adjustment mechanism will be connected to the secondary panel 710 as described above.

[0107] In certain embodiments of the present invention, the aperture for receiving the breast to be imaged is substantially coincident with the centerline of the patient table. In such embodiments, the patient will be positioned so that the breast to be imaged is aligned with the centerline of the examination couch. Thus, no additional lateral mechanism is required to align the breast with the rotation axis of the rotating frame. A skilled artisan will appreciate that such alignment of the breast aperture can be achieved by providing the aperture directly in the patient examination couch, or alternatively providing the aperture in a secondary panel configured to be connected or coupled to the patient examination couch.

[0108] therefore, Figure 8 Certain aspects of an exemplary CBBCT imaging system 800 are shown in schematic front perspective view, including a Figure 7The ergonomic assistance subsystem 802 is substantially similar to the ergonomic assistance subsystem 702 in FIG. The ergonomic assistance subsystem 802 includes a patient examination bed (or patient support panel) 804. The patient examination bed 804 is shown in a fully raised position, similar to the above Figure 7 The configuration is consistent with that shown in .

[0109] The patient couch 804 includes an upper surface area 806 that is intended to support the patient during scanning. In various embodiments of the present invention, the upper surface area 806 includes an inner perimeter 808 that defines a hole in the upper surface area of ​​the patient couch. In some embodiments, the hole is adapted to receive a breast of a patient passing therethrough. In other embodiments, the hole includes a Figure 7 The hole shown in FIG. 804 is adapted to receive a secondary panel 810 that spans the perimeter 808. The secondary panel 810 is connected to and / or supported by the patient couch 804.

[0110] The secondary panel 810 includes a secondary panel surface area 812. Further, the inner periphery 814 defines an aperture 816 on the secondary panel. In the illustrated configuration, the secondary panel aperture 816 coincides with the longitudinal centerline 818 of the patient couch 804. In typical operation of the CBBCT imaging system, either breast of the patient can be imaged through the secondary panel aperture 816, and the patient is accordingly arranged on the upper surface 806 of the patient couch 804.

[0111] Although the inner periphery 714, 724, 814 shown and discussed above presents a substantially circular feature, it will be appreciated by the skilled person that the periphery may have any shape deemed advantageous according to the requirements of a particular application of the present invention. Thus, in certain embodiments of the present invention, the periphery may be generally elliptical, or may be generally triangular, or any other regular or irregular polygonal shape, or any arc shape, or any combination of arcs and linear segments, or all of the above, which are considered within the scope of the present disclosure.

[0112] Reference again Figure 7 , the exemplary patient examination couch 704 includes handles 730 and 732. The position and configuration of the handles 730 and 732 enable the patient to hold the handles when entering and operating the ergonomic assistance subsystem 702. This improves the patient's body positioning ability on the patient examination couch 704 and provides stability for the patient during the transition of the ergonomic assistance system from a fully raised state to a fully lowered state. In addition, holding the handles will prevent the patient from moving during imaging, thereby improving data / image quality.

[0113] In various embodiments of the present invention, handles 730 and 732 will be adjustable in one or more dimensions of centerline 718, lateral dimension 720, and in a manner of rotation about respective vertical axes. The vertical axis passes through the respective handles and is generally perpendicular to the surface 706 of the patient couch 704. Please realize that the handle positions and configurations shown here are only examples of many possible configurations. Other examples will be provided below.

[0114] Figures 9A-9E Schematic perspective views of exemplary handles are shown that may be used in various embodiments of the present invention. A skilled artisan will readily appreciate the advantages of the particular handles shown, as well as other handles suggested by the present disclosure, and consider them to be within the scope of the present invention. For example, Fig. 9A A handle 900 is shown, which is mainly suitable for grasping along a transverse longitudinal axis 902 and is fixedly connected to the patient examination bed at its first end 904 and second end 906, directly or through an adjustment device. It should be noted that Fig. 9A The handle and Figure 7 The handles shown in elements 730 and 732 have some similarities.

[0115] Fig. 9B An alternative handle 910 is shown, adapted to be grasped primarily about a longitudinal axis 912, which is generally perpendicular to the surface of the patient couch. The flange portion 914 of the handle 910 has a generally larger radius 916, compared to a smaller radius 918 of the gripping portion 919. This extended flange provides an effective connection to the couch subassembly while increasing the stability and rigidity of the handle 910.

[0116] Fig. 9C Another alternative handle 920 is shown, adapted to be grasped primarily about a longitudinal axis 922, which is generally perpendicular to the surface of the patient couch. A lower flange portion 924 of the handle 920 has a generally larger radius 926, compared to a smaller radius 928 of a gripping portion 929. An upper flange portion 930 extends outwardly from the longitudinal axis 922 in an arcuate manner, sloping downwardly toward the couch subassembly to which it is connected at its lower edge 932. The extended upper and lower flanges effectively connect the handle 920 to the couch subassembly while increasing the stability and rigidity of the handle.

[0117] Fig.9DAnother alternative handle 934 is shown, adapted to be grasped primarily about a raised upper surface 936, which is generally parallel to the surface of the patient couch and transversely intersecting a longitudinal axis 938 of the handle 934. The longitudinal axis 938 is generally perpendicular to the surface of the patient couch and generally passes through the patient's palm and / or finger joints when in use. An annular groove 940 located below the raised upper surface 936 is generally transverse to the longitudinal axis 938 and is adapted to fit the tips of the patient's fingers, thereby enhancing the patient's grip. A lower flange portion 942 of the handle 934 effectively connects the handle 934 to the couch subassembly while increasing the stability and rigidity of the handle.

[0118] Fig.9E Another alternative handle 944 is shown, adapted to be grasped primarily about a longitudinal axis 946, which is generally perpendicular to the surface of the patient couch. The radius 950 of the lower flange portion 948 of the handle 944 is generally greater than the transverse dimension 952 of the gripping portion 954. A vertical surface area 956 of the handle 944 is generally convex and adapted to contact the palm of the patient's hand. The opposing vertical surface area 958 includes a plurality of concave grooves, such as 960, 962, 964, each groove being adapted to fit a corresponding finger of the patient. In some embodiments, the handle 944 is fixedly connected to the couch subassembly of the patient couch. In other embodiments, the handle is connected to the couch subassembly via a swivel bearing and is adapted to be rotated 966 circumferentially in an almost free manner, or to be adjusted by rotating 966 circumferentially and then released to be fixed in place, depending on the requirements of the particular application. This circumferentially rotatable movement allows the position of the surfaces 956 and 958 to be adjusted to optimize the comfort of the patient grasping the handle.

[0119] In the context of the above discussion, Figures 10A-10F A series of exemplary secondary panel configurations are schematically shown, which are within the scope of the present invention and are related to Figure 7 and Figure 8 The secondary panels 710 and 810 described in are similar.

[0120] Figures 10A-10C Exemplary secondary panels with various opening locations and sizes are shown in schematic proximal stereoscopic views, respectively.

[0121] exist Fig. 10A 1000. In the embodiment of the present invention, the secondary panel 1000 includes a secondary panel surface area 1002. The inner peripheral edge 1004 defines a secondary panel opening 1006 through the secondary panel. Consistent with the above discussion, the opening 1006 is adapted to receive a patient's breast to be imaged. In the illustrated configuration, the secondary panel opening 1006 is located to the left of the longitudinal centerline 1008 of the secondary panel 1000. Thus, in typical operation of the CBBCT imaging system, the patient's left breast will be imaged through the secondary panel opening 1006.

[0122] Fig. 10B A subpanel 1012 is shown, similar to subpanel 1000. Like subpanel 1000, subpanel 1012 has an inner peripheral edge 1014 that defines a subpanel opening 1016 through subpanel 1012. Like opening 1006, opening 1016 is located to the left of a longitudinal centerline 1018 of subpanel 1012. However, a diameter 1020 of opening 1006 is relatively small, while a corresponding diameter 1022 of opening 1016 is larger.

[0123] Fig. 10C A secondary panel 1026 is shown, similar to secondary panels 1000 and 1012. As with secondary panel 1000, secondary panel 1026 has an inner peripheral edge 1028 that defines a secondary panel opening 1030 through secondary panel 1026. The diameter 1032 of opening 1030 is substantially equal to the corresponding diameter 1022 of opening 1016. However, the center of opening 1030 is substantially coincident with a centerline 1034 of secondary panel 1026. Thus, while openings 1006 and 1016 are primarily configured to receive a patient's left breast for imaging, opening 1030 is well suited to receive either a left or right breast.

[0124] Skilled technicians will also understand that the symmetry of the panels shown will be used in various embodiments of the present invention to image, for example, a left breast or a right breast by symmetrically rotating the sub-panel 1000 or 1012 about the center lines 1008 and 1018, provided that appropriate peripheral configuration and coupling characteristics are provided.

[0125] Likewise, rotating the panels about axes lateral to their respective centerlines may position the illustrated openings relatively higher or lower as desired for taller or shorter patients, respectively.

[0126] In view of the above discussion, the reader will understand that in some embodiments, the imaging system will provide multiple sub-panels so that the sub-panel with the appropriate opening can be selected based on the patient's height, weight, breast size and other parameters.

[0127] In another aspect or embodiment of the present invention, a reusable sub-panel will be purchased separately so that it can be provided when needed. In other embodiments of the present invention, a disposable sub-panel will be used for a single use with a specific patient and then discarded after use.

[0128] Figures 10D-10F A schematic diagram of a further sub-panel 1050 prepared in accordance with the principles of the present invention is shown. The sub-panel 1050 is shown in a cut-away view illustrating an adjustment mechanism 1052 included in the sub-panel 1050.

[0129] In the exemplary embodiment shown, the adjustment mechanism 1052 includes an adjustable mechanical aperture mechanism 1054. The adjustable aperture mechanism 1054 includes a plurality of blade elements, e.g., 1056 and 1058, coupled to corresponding operative links 1060 and 1062, respectively. A skilled artisan will recognize that the form and function of the adjustable aperture mechanism 1054 is similar to the aperture mechanism used in a photographic camera. Thus, by operating the links 1060 and 1062, the blade elements 1056 and 1058 will passively rotate, thereby adjusting the diameter of the opening 1064 to a desired value as required for imaging a particular patient's breast.

[0130] By further explanation, in Fig.10E In the example aperture mechanism 1070 is adjusted and configured to present an opening 1072 of a relatively small diameter 1074. Fig.10F , the exemplary aperture mechanism 1070 is adjusted and configured to present the same opening 1072 , but with a relatively larger diameter 1076 .

[0131] In another aspect of the present invention, Fig.11 A secondary panel 1100 is shown including a breast stabilization device 1102 adapted to support and stabilize a patient's breast during imaging. As shown, the breast stabilization device 1102 is attached to the distal surface region 1106 of the secondary panel 1100 at an opening 1104 .

[0132] A skilled artisan, after reviewing the above-mentioned related applications, will readily appreciate the various benefits and ways of employing a breast stabilization device similar to that exemplified herein.

[0133] Fig.12 A partially schematic side view of an exemplary CBBCT imaging system 1200 is shown, which is similar to system 200 and includes an attachable patient support panel 1202. CBBCT imaging system 1200 includes a CBBCT rotating frame 1204 configured to rotate about, for example, a generally vertical rotation axis 1206.

[0134] Similar to the above-described systems 100 and 200, the system 1200 includes an x-ray source 1208. The exemplary x-ray source 1208 is mounted and supported on a mounting surface 1210 of a CBBCT rotating frame 1204. The CBBCT rotating frame 1204 is supported by a bearing 1212 and is arranged to rotate about a rotation axis 1206. The bearing 1212 is in turn connected to and supported by a base assembly (or base element) 1214. The patient support panel 1202 is hingedly connected to the base assembly 1214 at a hinge element 1216.

[0135] The patient support panel 1202 has a first patient support surface area 1218 and a second distal surface area 1220, wherein the distal surface area 1220 is spaced apart from the patient support surface area 1218. The exemplary patient support panel 1202 is similar in form and function to the Figure 2 Similar to the patient support panel 238 in FIG.

[0136] Similar to the above description, the patient support surface area 1218 is intended to isolate the patient from the CBBCT rotating frame 1204 and the mobile device connected thereto. In the illustrated embodiment, the exemplary seating device 1222 is connected to and supported by a corresponding portion 1224 of the patient support surface area 1218. In other embodiments of the present invention, the exemplary seating device 1222 may be connected to and supported by the base assembly 1214, the patient footrest 1226, or any other location, feature, or aspect of the CBBCT imaging system, or a combination of these elements to meet the requirements of a particular application and embodiment.

[0137] The seating device 1222 includes a saddle member 1228 having a structural body 1230 and a saddle upper surface area 1232. The saddle upper surface area 1232 is intended to position and support a patient seated on the saddle member 1228 during imaging procedures and during optional supplemental procedures.

[0138] In the illustrated embodiment, the structural body 1230 is substantially fixedly connected to the upper end of the seat post 1234, and the seat post is connected to the above-mentioned CBBCT imaging system 1200, directly or through an appropriate position adjustment device. The seat post is optional, and in some embodiments, the structural body of the saddle component is directly connected to the CBBCT imaging system 1200.

[0139] Thus, in certain embodiments, the lower end of the exemplary seat post 1234 is operatively connected to a seat adjustment mechanism. The seat adjustment mechanism is directly or indirectly connected to the patient support panel 1202 to provide support. Thus, the weight of a patient seated on the saddle upper surface area 1232 is transferred through the structural body 1230 of the saddle to the seat post 1234, and then to the patient support panel 1202 through the seat adjustment mechanism.

[0140] In a preferred aspect of certain embodiments, the seat adjustment mechanism allows the saddle portion 1228 to be positionally adjusted in a vertical direction, i.e., vertically along the upper surface 1238 of the patient step 1226. In certain embodiments, the seat adjustment mechanism also allows the saddle to be rotated in yaw about the longitudinal axis of the seat post 1234, and in pitch about the transverse axis.

[0141] Additionally, in certain embodiments, the roll of the saddle portion 1228 may also be adjusted to ensure that the patient remains comfortably and optimally positioned on the rotatable patient support panel 1202 .

[0142] In further aspects of the invention, in certain embodiments, the saddle may be removable, foldable, or otherwise movable so that the patient does not have to sit on the saddle during imaging, but can stand on the upper surface 1238 of the step portion 1226. Thus, the saddle may be used for sitting support when desired, but may not be used in more appropriate circumstances, allowing the patient to remain standing.

[0143] As will be appreciated by those skilled in the art, the shape and configuration of the structural body 1230 and the saddle upper surface area 1232 will help promote optimal comfort and positioning between the patient and the rotatable patient support panel 1202. In certain embodiments, the saddle portion 1228 will comprise a material that is biocompatible and exhibits good rheological and elasto-hardness properties.

[0144] Therefore, in various embodiments of the present invention, the saddle will include appropriate materials to achieve these objectives. Fig.13A and 13B A variety of example materials are provided, applicable to the invention of various embodiments

[0145] Fig.13A and 13B Security elements are shown in schematic perspective view, which are examples of security features 424 in the CBBCT imaging system 400. Referring again to Figure 7 , example safety elements would include a seat belt 734 and a buckle 736 .

[0146] Fig.13A A safety belt 1300 of a CBBCT imaging system is shown. The safety belt 1300 includes a generally flexible member 1302. In the illustrated embodiment, the flexible member 1302 includes, for example, a textile material, such as a woven textile material, a knitted textile material, a felt textile material, or a chain-link textile material. In other embodiments of the invention, the flexible member 1302 may include one or more molded elastic polymers, spray-coated elastic polymers, ropes or cables, natural materials such as natural polymers, leather, plant materials, or other materials or combinations of materials suitable for the purposes and functions described herein.

[0147] The safety belt 1300 shown includes a coupling mechanism, such as 1304, 1306, suitable for removably coupling the safety belt 1300 to a Figure 7Patient support panel 704. According to various embodiments of the present invention, coupling mechanisms, such as 1304, 1306, can include one or more buckles, buttons, hook and loop fasteners, mechanical snaps, magnetic fasteners, adhesive fasteners, or any other fasteners suitable for the purposes of the present invention, as well as combinations thereof.

[0148] In certain embodiments of the present invention, the safety belt 1300 will include a cushioning element 1308. In certain embodiments, the cushioning element will include a generally elastic element designed to distribute the force on the inner surface of the flexible element 1302 to avoid excessive pressure at the point of contact with the patient's back.

[0149] In some embodiments of the present invention, the cushioning element 1308 will include an expansion element, such as an air bag, a liquid bag, or a mechanical actuator. In some embodiments of the present invention, the expansion element is designed to expand in a controlled manner after the safety belt is connected to the patient support panel, thereby pushing the patient toward the patient support surface.

[0150] Fig. 13B An alternative safety belt 1310 for use with a CBBCT imaging system is shown. Similar to safety belt 1300, safety belt 1310 also includes a generally flexible member 1312. In the illustrated embodiment, flexible member 1312 comprises, for example, a textile material and / or any of the material examples provided above.

[0151] Flexible member 1312 has a first end 1314 and a second end 1316, which are adapted to be connected to respective areas of the patient support panel. In some embodiments, respective ends 1314 and 1316 are substantially permanently connected to the patient support panel. In other embodiments, ends 1314 and 1316 are removably and / or adjustably connected to the patient support panel.

[0152] In the illustrated embodiment, the flexible member 1312 has a third end 1318 and a fourth end 1320 that are adapted to be releasably connected to each other. Thus, the inner ends 1318 and 1320 will include respective interlocking connection features. For example, the inner ends 1318 and 1320 may include respective interlocking buckles, buttons, Velcro, mechanical snap fasteners, magnetic snap fasteners, or any other connector suitable for the above purpose, which connectors and combinations thereof are known or may become known in the context of the present invention.

[0153] In certain embodiments, elements of the seat belts 1300, 1310 and their components will include one or more materials, such as polyethylene, polypropylene, polybutylene, polystyrene, polyester, acrylic polymer, polyvinyl chloride, polyamide or polyetherimide (such as ULTEM.RTM.); polymer alloys, such as Xenoy.RTM. resin, which is a composite of polycarbonate and polybutylene terephthalate, or Lexan.RTM. plastic, which is a copolymer of polycarbonate and isophthalate phenolic resin (both available from GE Plastics); liquid crystal polymers, such as aromatic polyesters or aromatic polyester amides, which contain at least one compound selected from the following group: aromatic hydroxycarboxylic acids (such as hydroxybenzoic acid (rigid monomer), hydroxynaphthoic acid (flexible monomer), aromatic hydroxylamine and aromatic diamine), and polyesterimide anhydrides having terminal anhydride groups or lateral anhydride groups.

[0154] In addition, any polymer composite material, such as an engineering prepreg or composite material, in which the polymer is filled with pigments, carbon particles, silica, glass fibers, conductive particles (e.g., 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.

[0155] A CBBCT scanning system includes a base assembly and a CBBCT rotating frame system, wherein the CBBCT rotating frame system is connected to and supported by the base assembly. The CBBCT rotating frame system includes a CBBCT rotating frame adapted and configured to rotate around a rotation axis, and a patient support panel.

[0156] The patient support panel has a patient support surface having a height axis. The patient support panel is hingedly connected to the base assembly by a hinge. The patient support panel is capable of pivoting about the hinge. The patient support panel pivots between a first patient loading configuration and a second patient imaging configuration, wherein the height axis of the first configuration is generally aligned with the rotation axis and the height axis of the second configuration is generally transversely aligned with the rotation axis.

[0157] In some embodiments, the CBBCT scanning system includes an actuator connected between the base assembly and the patient support panel. The actuator is designed to push the patient support panel to pivot around the hinge to convert between a first patient loading configuration and a second patient imaging configuration.

[0158] In some embodiments, the CBBCT scanning system includes a linear actuator. In some embodiments, the CBBCT scanning system includes a rotary actuator.

[0159] In some embodiments, the CBBCT scanning system includes a patient support panel having an opening. In some embodiments, the patient support sub-panel is disposed within the opening.

[0160] In some embodiments, the CBBCT scanning system includes a patient support sub-panel with a breast opening adapted to receive a patient's breast for imaging.

[0161] In certain embodiments, the CBBCT scanning system includes a patient support sub-panel having a breast stabilization device that is intended to support the patient's breast during imaging.

[0162] In some embodiments, the CBBCT scanning system includes a patient support panel having a patient support pedal assembly. In some embodiments, the pedal assembly is connected to a chair adjustment mechanism.

[0163] In some embodiments, the CBBCT scanning system includes a seat adjustment mechanism adapted to adjust the saddle upper surface of the saddle component in a vertical degree of freedom. The seat adjustment mechanism is also adapted to adjust the saddle upper surface of the saddle component in a horizontal direction.

[0164] The method for performing a CBBCT scan includes providing a base and a CBBCT rotating frame. The CBBCT rotating frame is rotationally coupled to the base to rotate around a rotation axis. The rotation axis is substantially stationary on the base. In addition, a patient support panel coupled to the base is provided. The patient support panel is in a generally upright posture. Then, a patient is introduced into the patient support panel. Thereafter, the patient support panel is placed in a second scanning direction. Next, the CBBCT rotating frame is operated to perform a CBBCT scan, and then the patient support panel is returned to the first generally upright posture.

[0165] In certain embodiments, a method of performing a CBBCT scan further includes providing a patient footrest having an upper surface area adapted to support a patient during imaging, and adjusting the patient footrest to position the patient.

[0166] In certain embodiments, the first generally upright orientation comprises an orientation between about 80° and 90° relative to horizontal.

[0167] In some embodiments, the first generally upright orientation includes an orientation between about 70° and 80° relative to the horizontal plane, while in some embodiments, the first generally upright orientation includes an orientation between about 50° and 70° relative to the horizontal plane.

[0168] In certain embodiments, the method of performing a CBBCT scan includes a second scanning direction that is between about 0° and 20° relative to the horizontal plane.

[0169] In some embodiments, the second scanning direction is between about 20° and 45° relative to the horizontal plane, while in other embodiments, the second scanning direction is between about 45° and 70° relative to the horizontal plane.

[0170] In certain embodiments, a method of performing a CBBCT scan includes connecting a patient support sub-panel to a patient support panel; and in certain embodiments, the method further includes connecting the patient to the patient support panel via a safety device.

[0171] In certain embodiments, a method of performing a CBBCT scan includes activating a safety device and advancing a patient toward a patient support panel using the safety device.

[0172] In certain embodiments, a method of performing a CBBCT scan includes connecting a breast stabilization unit to a patient support sub-panel.

[0173] In certain embodiments, a method of performing a CBBCT scan includes determining patient parameters, and selecting a breast stabilization device based on the patient parameters.

[0174] In certain embodiments, a method of performing a CBBCT scan includes connecting a handle to a patient support panel.

[0175] Although the above-described example embodiments are primarily derived from the operation of the apparatus of the CBBCT imaging system and its corresponding systems and methods, including its ergonomically improved systems and methods, those skilled in the art will appreciate that the principles of the present invention are equally applicable to a variety of other imaging techniques, such as imaging of other body parts and imaging of industrial and technological products. In addition, although the present invention has described the present preferred embodiments in detail, it should be clearly understood that the present invention is not limited to these disclosed embodiments. On the contrary, the present invention can be modified to incorporate any number of changes, modifications, substitutions or equivalent arrangements not described, which are consistent with the spirit and scope of the present invention. Therefore, the present invention should not be construed as being limited to the foregoing description, but should be limited only by the scope of the appended claims.

Claims

1. Cone beam breast computed tomography system, comprising: a base assembly; a CBBCT rotating frame system coupled to and supported by the base assembly, the CBBCT rotating frame system comprising a CBBCT rotating frame designed and configured to rotate about a rotation axis; as well as A patient support panel having a patient support surface having an elevation axis, the patient support panel being pivotally connected to the base assembly via a hinge pivot, the patient support panel being designed to rotate about the hinge pivot between a first patient loading configuration and a second patient imaging configuration, wherein in the first configuration the elevation axis is substantially aligned with the rotation axis and in the second configuration the elevation axis is substantially perpendicular to the rotation axis.

2. The CBBCT scanning system defined in claim 1 further comprises an actuator connected between the base assembly and the patient support panel, the actuator being designed to drive the support panel to rotate about the hinge pivot between a first patient loading configuration and a second patient imaging configuration.

3. A CBBCT scanning system as defined in claim 2, wherein the actuator comprises a linear actuator.

4. The CBBCT scanning system as defined in claim 2, wherein the actuator comprises a rotary actuator.

5. The CBBCT scanning system as defined in claim 1, wherein the patient support panel includes a patient support surface area having an opening.

6. The CBBCT scanning system defined in claim 5, further comprising a patient support sub-panel disposed within the opening.

7. The CBBCT scanning system defined in claim 6, wherein the patient support sub-panel includes a breast opening designed to receive a patient's breast to be imaged.

8. The CBBCT scanning system as defined in claim 6, wherein the patient support sub-panel includes a breast stabilizer unit designed to support the patient's breast during imaging.

9. The CBBCT scanning system as defined in claim 1, wherein the patient support panel comprises a patient support footrest assembly.

10. The CBBCT scanning system as defined in claim 9, wherein the pedal assembly is connected to a seat adjustment mechanism.

11. The CBBCT scanning system as defined in claim 10, wherein the seat adjustment mechanism is adapted to adjust an upper surface of a saddle surface of the saddle in a vertical degree of freedom.

12. The CBBCT scanning system as defined in claim 10, wherein the seat adjustment mechanism is adapted to adjust an upper surface of a saddle surface of the saddle in a horizontal direction.

13. Methods for performing CBBCT scanning, including: providing a base assembly; providing a CBBCT rotating frame rotationally coupled to the base assembly for rotation about a rotation axis, the rotation axis remaining substantially stationary in relation to the base assembly; Provide a patient support panel; pivotally connecting the patient support panel to the base assembly; placing the patient support panel in a first generally upright orientation; introducing a patient into the patient support panel; Thereafter, placing the patient support panel in a second scanning direction; Afterwards, the CBBCT rotating frame is operated to perform CBBCT scanning; Finally, the patient support panel is positioned in the first generally upright orientation.

14. The method for performing CBBCT scanning as defined in claim 13, further comprising: providing a patient pedal having a patient pedal upper surface area, the patient pedal upper surface area being designed to support a patient during an imaging procedure; Adjust the patient footrest for patient positioning.

15. A method of performing CBBCT scanning as defined in claim 13, wherein the first generally upright orientation is an orientation between about 80° and 90° relative to a horizontal plane.

16. A method of performing CBBCT scanning as defined in claim 13, wherein the first generally upright orientation is an orientation between about 70° and 80° relative to a horizontal plane.

17. A method of performing CBBCT scanning as defined in claim 13, wherein the first generally upright orientation is an orientation between about 50° and 70° relative to a horizontal plane.

18. The method for performing CBBCT scanning as defined in claim 13, wherein the second scanning direction is a direction between about 0° and 20° relative to a horizontal plane.

19. The method for performing CBBCT scanning as defined in claim 13, wherein the second scanning direction is a direction between about 20° and 45° relative to a horizontal plane.

20. The method for performing CBBCT scanning as defined in claim 13, wherein the second scanning direction is a direction between about 45° and 70° relative to a horizontal plane.

21. The method for performing CBBCT scanning as defined in claim 13, further comprising: A patient support sub-panel is coupled to the patient support panel.

22. The method for performing CBBCT scanning as defined in claim 21, further comprising: A breast stabilizer unit is coupled to the patient support sub-panel.

23. The method for performing CBBCT scanning as defined in claim 22, further comprising: Determine a patient parameter; The breast stabilizer device is selected according to the patient parameters.

24. The method for performing CBBCT scanning as defined in claim 13, further comprising: The patient is coupled to the patient support panel using a safety device.

25. The method for performing CBBCT scanning as defined in claim 24, further comprising: activating the safety device; The patient is pushed toward the patient support panel by the safety device.

26. The method for performing CBBCT scanning as defined in claim 13, further comprising: A handle is coupled to the patient support panel.

Images