Clamp and support for medical imaging

Abstract

In the invention, a cone beam mammary gland computed tomography (CBBCT) system will include a breast stabilization device for maintaining the position and stability of the breast during imaging.

Description

[0001] Related Applications

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

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

[0004] According to the National Cancer Institute, one in eight women will be diagnosed with breast cancer in her lifetime, and despite published reports showing a decrease in breast cancer mortality, the disease still kills 40,000 women each year.

[0005] The best breast imaging technology is able to detect tumors when they are small in mass, preferably less than 10 mm in diameter. The 16-year survival rate for women with invasive breast cancer (1-10 mm in diameter) detected on mammography is reported to be 93% and 16%. In addition, the probability of metastasis decreases dramatically as the diameter of the tumor decreases at the time of detection. If a breast tumor is detected when it is 10 mm in diameter or less, the probability of metastasis is 7.31%. If a cancer with a diameter of 4 mm is detected, the probability of metastasis is reduced to 0.617%, a decrease of more than 10 times.

[0006] Mammography (mammography) can detect cancers as small as about 12 mm on average and was the most effective tool for early detection of breast cancer until the advent of cone-beam computed tomography. Mammography has a relatively low sensitivity for small breast cancers (less than a few millimeters). The specificity and positive predictive value of mammography remain limited due to structural and tissue overlap. The limited sensitivity and specificity of mammography in breast cancer detection are primarily attributed to its poor contrast detectability, which is common to all types of projection imaging techniques (contrast detectability for projection imaging is only 10% at best), while mammography initially detected only 65-70% of breast cancers. For dense breasts, mammography sensitivity is further reduced to less than 30%. Digital mammography (DM) was developed in an attempt to overcome the limitations inherent in conventional screen-film mammography (SFM) by providing improved contrast resolution and digital image processing; however, a large clinical trial, the Digital Mammography Screening Trial (DMIST), showed that the false-positive rates of digital mammography and screen-film mammography were equivalent.

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

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

[0009] Results from phantom studies have shown that cone-beam breast computed tomography (CBBCT) is able to achieve a spatial resolution of approximately 2.8 lp / mm, which allows the detection of cancers of 2 mm in diameter and microcalcifications of approximately 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. This dose is lower than that of a single mammogram, assuming that two views are required for each breast. CBBCT has excellent image quality in visualizing breast tissue, breast tumors, and calcifications, and its ability to cover the breast (including the chest wall area) is at least equivalent to that of mammography. Major blood vessels can be visualized very well without the use of contrast agents.

[0010] Therefore, cone-beam breast computed tomography (CBBCT) offers significant improvements in the detection and biopsy of suspicious lesions. Furthermore, in many procedures using CBBCT, images can be obtained without the need for compression of breast tissue, which is commonly associated with mammography. The compression breast immobilization devices used in mammography are widely considered uncomfortable and are often cited as a factor that prevents patients from seeking ideal breast cancer screening. Further improvements in CBBCT imaging are expected to extend these benefits. Given the above factors, it would be highly desirable to be able to perform improved CBBCT imaging without the use of uncomfortable breast immobilization associated with mammography.

[0011] In current practice, patients undergoing cone-beam breast computed tomography (CBBCT) are positioned in the prone position on an examination table. The breast to be examined is lowered through an opening in the upper surface of the examination table, draped over the chest wall, into an imaging room located below the examination table. The position of the breast in the imaging room is maintained by keeping the patient still (i.e., keeping the patient motionless) as the patient's body lies on the examination table surface.

[0012] The imaging device is connected to a movable support, which is supported by a bearing device for rotation about a rotation axis. The rotation axis is placed in a generally vertical direction and passes through an opening in the upper surface of the examination bed. It is designed that the approximate center of mass of the breast to be imaged is arranged where the rotation axis passes.

[0013] During imaging, the mobile support rotates about the rotation axis and carries 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.

[0014] To avoid blurring during individual X-ray pulses and to keep the image consistent between pulses, the patient remains still during imaging. Even small changes in the spatial position of the breast can result in reduced image clarity.

[0015] In existing cone-beam breast computed tomography (CBBCT) systems, the breast hangs freely in the imaging room or is secured in a fixation system that compresses the breast tissue and / or provides spatial fixation to facilitate biopsy-related procedures. Compression systems can cause discomfort, while a freely hanging breast is susceptible to movement and vibration, which, as mentioned above, can adversely affect image quality.

[0016] Existing fixtures used for other applications of cone beam computed tomography (CBBCT), such as bite bars for dental tomosynthesis, are not suitable for the current problem. Summary of the invention

[0017] The inventors of the present invention have, after long and careful consideration, addressed the problems associated with cone beam computed tomography (CBBCT) imaging, particularly the need to stabilize CBBCT subjects for effective imaging, and have developed new and useful systems, devices and methods that represent significant improvements over previously known methods. The present invention includes devices for supporting and immobilizing tissue during tomographic imaging, and corresponding systems and methods, particularly for CBBCT.

[0018] In some embodiments, the present invention includes a breast support device. In some embodiments, the breast support device includes a stabilizer unit and a positioning device connected to the stabilizer unit to provide adjustable positioning of the stabilizer unit relative to a reference frame of a tomograph.

[0019] In some embodiments, the stabilizer unit includes a generally rigid body having a major surface area configured to contact a corresponding surface area of ​​the examined breast. In some selected embodiments, the generally rigid body includes a material having a desired transparency at an operating wavelength of imaging photon energy. Thus, in some embodiments, the generally rigid body includes one or more of the following materials: expanded polystyrene, polystyrene, polyethylene, acrylonitrile butadiene styrene (ABS), polypropylene, acrylates (e.g., polymethyl methacrylate), polyamides, polyamide aromatics, aerogels, ceramics, fiber reinforced composites, and polycarbonates (e.g., )wait.

[0020] The following description is intended to enable anyone familiar with the art to make and use the disclosed invention, and lists the best way the inventor currently implements his invention. In the following description, for illustration, many specific details are listed to provide a comprehensive understanding of the present invention. However, for those familiar with the art, it is apparent that the present invention can be implemented without these specific details. In other cases, known structures and devices are shown in block diagram form to avoid unnecessarily covering up the essence of the disclosed content. These and other advantages and features of the present invention will be more easily understood in the detailed description of the present invention provided together with the accompanying drawings.

[0021] 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. Instead, the figures collectively illustrate various aspects and principles of the invention. Therefore, it should not be assumed that any particular figure is only related to a single aspect or species of the invention. Instead, those skilled in the art will appreciate that the figures collectively reflect different aspects and embodiments of the invention.

[0022] Therefore, references throughout the specification to "one embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic associated with the embodiment is included in at least one embodiment of the present invention. Therefore, the phrases "in one embodiment" or "in an embodiment" that appear in different places in the specification do not necessarily all refer to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 A portion of a CBBCT breast imaging system is shown in schematic cross-sectional perspective view, including an exemplary breast stabilizer unit.

[0024] Figure 2 The structural relationships of certain aspects of an exemplary CBBCT breast imaging system prepared in accordance with the principles of the present invention are shown in block diagram form.

[0025] Figure 3A Certain aspects of an exemplary CBBCT breast imaging system prepared in accordance with the principles of the present invention are illustrated in schematic cross-section form, including a breast stabilizer unit in a first exemplary configuration.

[0026] Figure 3B Certain aspects of an exemplary CBBCT breast imaging system prepared in accordance with the principles of the present invention are illustrated in schematic cross-section form, including a breast stabilizer unit in a second exemplary configuration.

[0027] Figure 4A Certain aspects of an exemplary CBBCT breast imaging system prepared in accordance with the principles of the present invention, including a breast stabilizer unit, are illustrated in schematic perspective view.

[0028] Figure 4B Certain aspects of an exemplary CBBCT breast imaging system prepared in accordance with the principles of the present invention, including a breast stabilizer unit, are illustrated in schematic cross-sectional perspective view.

[0029] Figure 5 The structural relationships of certain aspects of an exemplary CBBCT breast imaging system prepared in accordance with the principles of the present invention are shown in block diagram form.

[0030] Figure 6 Certain aspects of an exemplary CBBCT breast imaging system prepared in accordance with the principles of the present invention are illustrated in schematic cross-sectional perspective views, including portions of coupling features of a breast stabilizer unit.

[0031] Figure 7 Further aspects of an exemplary CBBCT breast imaging system prepared in accordance with the principles of the present invention are illustrated in schematic cross-sectional perspective view, including portions of coupling features of a breast stabilizer unit.

[0032] Figure 8 Further aspects of an exemplary CBBCT breast imaging system prepared in accordance with the principles of the present invention are illustrated in schematic perspective views, including portions of coupling features of a breast stabilizer unit.

[0033] Fig. 9 Further aspects of an exemplary CBBCT breast imaging system prepared in accordance with the principles of the present invention are illustrated in schematic perspective views, including portions of coupling features of a breast stabilizer unit.

[0034] Fig.10 Certain aspects of an exemplary CBBCT breast imaging system prepared in accordance with the principles of the present invention are illustrated in schematic cutaway perspective views, including a receiving device and a portion for receiving a coupling feature of a breast stabilizer unit.

[0035] Fig.11A Certain aspects of an exemplary CBBCT breast imaging system prepared in accordance with the principles of the present invention, including certain aspects of an exemplary breast stabilizer unit, are illustrated in schematic cutaway perspective views.

[0036] Fig. 11B Other aspects of an exemplary CBBCT breast imaging system prepared in accordance with the principles of the present invention are illustrated in schematic cross-sectional detailed elevation views, including certain aspects of an exemplary breast stabilizer unit.

[0037] Fig.12 Certain features of an exemplary CBBCT imaging system prepared in accordance with the principles of the present invention, including a patient placement panel, are shown in schematic top view.

[0038] Fig.13 Additional features of an exemplary CBBCT imaging system prepared in accordance with the principles of the present invention are shown in schematic top view, including a patient placement panel.

[0039] Fig.14A Certain features of a CBBCT imaging system prepared in accordance with the principles of the present invention, including exemplary subpanel components, are shown in schematic top view.

[0040] Fig. 14B Other aspects of a CBBCT imaging system prepared in accordance with the principles of the present invention are shown in schematic top view, including exemplary sub-panel components.

[0041] Fig. 14C Further exemplary aspects of a CBBCT imaging system prepared in accordance with the principles of the present invention are shown in schematic top view, including exemplary sub-panel elements.

[0042] Fig.15 Certain further features of a CBBCT imaging system prepared in accordance with the principles of the present invention, including exemplary breast stabilization features, are illustrated in schematic distal perspective views. DETAILED DESCRIPTION

[0043] The following description is intended to enable anyone skilled in the art to make and use the disclosed invention and sets forth the best mode currently considered by the inventors to carry out their invention. In the following description, for the purpose of explanation, numerous specific details are set forth to provide a thorough understanding of the invention. However, it is apparent to those skilled in the art that the invention can be implemented without these specific details. In other instances, common structures and devices are shown in block diagram form to avoid unnecessarily obscuring the disclosed substance.

[0044] It should be noted that while any embodiments described below for illustrative purposes 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 assemblies where appropriate. In addition, when various aspects and features of specific elements described herein are disclosed as a whole, it should be understood that individual elements and assemblies that provide the same characteristics and / or functions are also disclosed.

[0045] Figure 1 A portion of an exemplary CBBCT imaging system 100 is shown in a cutaway perspective view, the system including a breast support device made 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 gantry 106. The rotating gantry 106 is supported by a bearing and is designed to rotate about an axis of rotation 108.

[0046] The X-ray source 102 is configured to emit a beam of X-rays 110. The beam of X-rays 110 defines a beam longitudinal axis 112 which, in the illustrated embodiment, intersects the axis of rotation 108 (at 114).

[0047] In some embodiments of the present invention, beam 110 is configured as a cone beam. In some configurations, a cross section of beam 110 taken along longitudinal axis 112 defines a disk having substantially uniform X-ray intensity and a substantially circular perimeter.

[0048] In other configurations of the invention, a cross section of the beam 110 taken transversely along the longitudinal axis 112 defines a region of substantially uniform x-ray intensity having a substantially circular perimeter except that a portion of the perimeter is located along a chord of the circular perimeter. As will be appreciated in further detail below, in certain embodiments, the chord will be substantially parallel to and spaced from the bottom surface of the examination couch.

[0049] In a further configuration of the present invention, a cross section of the beam 110 taken along the longitudinal axis 112 is defined as a region having substantially uniform X-ray intensity having a polygonal perimeter, wherein the polygonal perimeter may include any triangular perimeter, square perimeter, pentagonal perimeter, hexagonal perimeter, perimeter of higher geometry, or any arbitrary curve or combination of line segments and curves as required by a particular application in various embodiments and configurations. Furthermore, it should be understood that any of the above cross-sectional configurations may define a beam having non-uniform intensity, including but not limited to situations where the intensity drops to zero in certain cross-sectional regions.

[0050] An X-ray detector 116 is also mounted on the upper surface 104 of the rotating gantry 106. In an exemplary embodiment, the X-ray detector 116 includes a planar detector having a substantially planar receiving surface 118. The receiving surface 118 is generally located transverse to the longitudinal axis 112 and on the opposite side of the rotation axis 108 from the X-ray source 102.

[0051] Rotation of the rotating gantry 106 about the rotation axis 108 will cause the receiving surface 118 to move along a motion path along the rotation axis 108 during operation of the imaging system 100. In a typical configuration, the motion path will include at least a portion of a circle that is transverse to and centered on the rotation axis 108. However, it should be noted that other motion paths (however implemented) are considered to be within the scope of the present invention and will be disclosed herein.

[0052] In certain embodiments of the present invention, one or both of the X-ray source 102 and the X-ray detector 116 are arranged to be adjustable in their respective positions on the upper surface 104 of the gantry 106. For example, the X-ray source 102 and the X-ray detector 116 may be adjusted in a radial direction relative to the rotation axis 108, in a circumferential direction relative to the rotation axis 108, toward or away from the gantry surface 104, or in any other direction or manner deemed advantageous by a designer or user of a particular device.

[0053] The patient table 120, also referred to as a patient placement panel, has an upper surface 122 and a lower surface 124. A hole 126 connects the upper surface 122 and the lower surface 124 of the table. The upper surface 122 is designed to support a patient 128, who typically lies prone on the upper surface 122, as shown. In this arrangement, the breast 130 of the patient under the chest wall hangs downward through the hole 126.

[0054] In the illustrated embodiment, a breast immobilization device 132 (shown in cutaway view) is located at the aperture 126 and extends below the tabletop 124. Here, at least a portion of an outer surface area 134 of the breast 130 contacts an inner peripheral surface 136 of the immobilization device 132.

[0055] As will be discussed further below, the breast immobilization device 132 is coupled and supported in the imaging system 100 to maintain a substantially constant (i.e., stationary) position of the immobilization device relative to the rotation axis 108 while imaging the breast 130. In some applications, the breast immobilization device 132 is configured and adjusted to maintain the approximate geometric center of the breast intersecting the rotation axis 108.

[0056] In further implementations, the breast immobilization device 132 is configured and adjusted so that the approximate geometric center of the breast coincides with the intersection 114 of the rotation axis 108 and the longitudinal axis 112 of the x-ray beam. However, those skilled in the art will appreciate that there are many options for breast placement and configuration, depending on the particular patient, application, or imaging goal, and that this can be achieved by an appropriate shape, configuration, and position of the breast immobilization device 132.

[0057] Therefore, the breast immobilization device 132 is arranged, adjusted and configured to support, stabilize and keep at least a portion of the breast 130 in a fixed state relative to the motion path of the imaging plane 118 when the imaging system 100 images the breast.

[0058] As described below, a variety of different arrangements are well suited for maintaining stability and immobility of the breast stabilizer unit 132 relative to the imaging system 100 during imaging. For example, according to certain aspects of the present invention, the breast stabilizer unit 132 can be supported from above, below, laterally, or in any other manner deemed beneficial and / or consistent with the requirements of a particular system, application, patient, or imaging modality.

[0059] These different arrangements can be used alone and / or in combination, depending on the requirements of a particular application, and it should not be assumed that the use of one arrangement excludes the simultaneous use of another arrangement or imaging mode. Therefore, the configurations discussed below are merely examples of various devices and arrangements, including combinations of such devices and arrangements, that will be apparent to a person of ordinary skill in the art after reading this disclosure.

[0060] Figure 2 An exemplary immobilization subsystem 200 of a CBBCT imaging system (such as the imaging system 100 described above) prepared for breast support and immobilization according to the principles of the present invention is shown in schematic block diagram form. As shown, the subsystem 200 is supported by a base member 202 of the imaging system. In certain exemplary embodiments, the base member is connected to a frame member 203 of the breast imaging system (the frame member is a structural member that supports various components of the imaging system, such as a foundation member), or is directly supported on the floor of the room in which the breast imaging system is placed. Direct floor support provides certain advantages because, by being independently supported, the base member 202 can be relatively isolated from certain vibrations that may be present in the breast imaging system.

[0061] The base element 202 is operatively connected to an adjustment device 204. The design and configuration of the adjustment device 204 allows for adjustment of the spatial position of the breast stabilizer 212, as described below, for example, relative to an imaging region between an X-ray source and a detector of a breast imaging system. Thus, in certain embodiments, the adjustment device 204 is adapted to adjust the height of a portion of the breast relative to the base element, and thereby relative to the transmission path and the imaging region as described above.

[0062] As shown, the receiving device 206 is operatively connected to the adjustment device 204. The receiving device 206 includes a main body portion and / or a support member. In some embodiments, the receiving device 206 includes a receiving coupling feature 208.

[0063] The receiving coupling feature 208 includes at least one surface area that is geometrically complementary to a corresponding surface area of ​​the coupling feature 210 of the breast stabilizer unit 212. Thus, in certain embodiments, the coupling feature 210 of the breast stabilizer unit 212 can be operatively coupled to the coupling feature 208 of the receiving device. When such coupling is used, the breast stabilizer unit 212 can be maintained in a substantially fixed spatial relationship (i.e., does not move) relative to the receiving device 206.

[0064] Furthermore, the coupling between the breast stabilizer unit 212 and the receiving device 206 enables the subject's breast to maintain a determined relationship with the base element 202. Depending on the arrangement and configuration of the adjustment device 204, this determined relationship can be controlled by adjustment before imaging, and / or by actively adjusting the position and orientation of the receiving device relative to the base element during imaging.

[0065] As described below, the configuration of the breast stabilizer unit 212 is intended to support the patient's breast so that it is in a proper position and remains stable during imaging. Therefore, in certain embodiments of the present invention, the breast stabilizer unit 212 will include a support surface area 214. When in use, the surface area of ​​the patient's breast is directly or indirectly supported on the support surface area 214. In certain embodiments of the present invention, the support surface area includes a continuous circumferential surface area of ​​the breast stabilizer unit arranged around the longitudinal axis of the breast. In certain embodiments, the support surface area defines a substantially circumferentially continuous portion, which presents a surface area of ​​a cone (or cylindrical, elliptical, parabolic or other shape), so that the support surface area contacts a substantially continuous circumferential area of ​​the patient's breast.

[0066] In some embodiments, the support surface area forms a substantially closed surface area below the upper edge of the breast stabilizer unit 212, so that the breast is stabilized and supported from below by a lateral surface area of ​​the breast stabilizer unit 212, which is arranged transversely to the longitudinal axis of the breast. In some embodiments of the present invention, the lateral surface area is substantially continuous with the remaining inner surface area, so that the entire inner surface area of ​​the breast stabilizer unit 212 is also substantially continuous and / or coplanar. In some embodiments of the present invention, the inner surface area remains substantially stationary relative to the patient positioning plate, except for possible elastic compliance, for example, to improve patient comfort and / or conformity to breast geometry.

[0067] As described above, the adjustment device 204 is configured and adapted to adjust the height of the breast stabilizer unit 212 and the breast accommodated therein in at least one vertical degree of freedom. In other embodiments of the present invention, the adjustment device 204 can also be adjusted in other degrees of freedom, such as pitch, yaw, and roll relative to the longitudinal axis of the breast.

[0068] In certain embodiments of the invention, operation of the adjustment device 204 will be performed by manual adjustment, such as by a knob / screw combination or a ratchet jack mechanism. In other embodiments of the invention, the adjustment device is implemented by simple manual movement, thereby displacing the corresponding friction surfaces relative to each other. For example, a spirally wound "gooseneck" (or multiple goosenecks, such as three goosenecks in a tripod configuration) known in the industry can be used to provide the required manual / friction adjustment.

[0069] It is noted that in certain embodiments of the present invention, the breast stabilizer 212 will be placed in a desired position and orientation before the breast is brought into proximity with its inner surface area.

[0070] In other embodiments of the present invention, the breast to be imaged will first be placed in the breast stabilizer, and then the position and orientation of the breast stabilizer 212 will be adjusted. In some embodiments, the breast will be placed in and coupled to the breast stabilizer, and then the breast stabilizer will be coupled to the receiving device, and then the adjustment device will be operated to finally determine the position of the breast, at which point the breast has been pre-positioned in the breast stabilizer.

[0071] It should be noted that in some embodiments of the present invention, the adjustment device may be adjusted at multiple times, including before and after the breast is placed on the breast stabilizer device 212, and in some embodiments, before and after the breast stabilizer device is coupled to the receiving device.

[0072] It should be noted that in some embodiments, the adjustment device 204 is omitted, and the receiving device 206 is directly coupled to the base element 202. In this arrangement, if the position of the breast needs to be adjusted, the desired breast position can be achieved by selecting a breast stabilizer unit 212 of a suitable size or other configuration. Therefore, in some embodiments of the present invention, the above-mentioned adjustment device 204 can be omitted, and other arrangements can be adopted to ensure that the breast is in an ideal position relative to the imaging device.

[0073] See also Figure 3A, a breast support subsystem 300 (which is an example of subsystem 200 described above) is supported by a base element 302 of the imaging system. In certain exemplary embodiments, the base element is connected to a frame (or frame element) of the breast imaging system, or is supported directly on the floor of a room in which the breast imaging system is placed. As described above, direct floor support provides certain advantages because, by being independently supported, the base element 302 can be relatively isolated from certain vibrations that may be present in the breast imaging system.

[0074] The base element 302 is operatively connected to the adjustment device 304. The design and configuration of the adjustment device 304 allows adjustment of the spatial position of the breast 305 relative to the imaging region (e.g., the region between the X-ray source and the detector in the breast imaging system). Therefore, in some embodiments, the adjustment device 304 is adapted to adjust the height 318 of a portion of the breast 305 relative to the base element 302 and the above-mentioned imaging region.

[0075] As shown, the receiving device 306 is operatively connected to the adjustment device 304. The receiving device 306 includes a body portion and / or a support member 307. In some embodiments, the receiving device 306 includes a receiving coupling feature 308. The receiving coupling feature 308 includes at least one surface area 309 that is geometrically complementary to the corresponding surface area 310 of the coupling feature 311 of the breast stabilizer unit 312.

[0076] Thus, in certain embodiments, the coupling feature 311 of the breast stabilizer unit 312 can be operatively coupled to the coupling feature 308 of the receiving device 306. Using this coupling, the breast stabilizer unit 312 can be held stationary relative to the receiving device 306 (i.e., maintained in a substantially fixed spatial relationship).

[0077] Furthermore, the coupling between the breast stabilizer unit 312 and the receiving device 306 enables the breast 305 to maintain a determined spatial relationship with the base element 302. Depending on the arrangement and configuration of the adjustment device 304, this determined relationship can be controlled by adjustment before imaging and / or by actively adjusting the position and orientation of the receiving device relative to the base element during imaging.

[0078] As described below, the breast stabilizer unit 312 is configured to support the patient's breast to keep it in place and stable during imaging. Therefore, in certain embodiments of the present invention, the breast stabilizer unit 312 will include a support surface area 314. In use, a surface area 316 of the patient's breast 305 will be supported directly or indirectly on the support surface area 314. As previously described, once the breast stabilizer unit is installed, the support surface area will remain substantially stationary relative to the patient positioning plate, ignoring any elastic compliance provided to improve patient comfort and / or conform to the breast geometry.

[0079] See also Figure 3B , it can be seen that the height of the breast stabilizer unit 312 relative to the base member 302 can be adjusted between a relatively lower retracted height 318 and a relatively higher extended height 320. Accordingly, the position of the breast 305 can also be adjusted to position the breast 305 for imaging as required by a particular imaging procedure, diagnosis, patient, or operation.

[0080] It should be noted that in some embodiments, the adjustment device 304 is omitted and the receiving device 306 is directly coupled to the base element 302. In this arrangement, if the position of the breast needs to be adjusted, the desired breast position can be achieved by selecting a breast stabilizer unit 312 of an appropriate size or other configuration.

[0081] In this case, the patient imaging kit may include a plurality of breast stabilizer units of different sizes. For example, in certain embodiments of the present invention, a method of using such a kit includes selecting a breast stabilizer unit 312 of an appropriate size from a plurality of breast stabilizer units included in the kit based on parameter measurements of the breast to be imaged.

[0082] In other embodiments, breast stabilizer units of various shapes and sizes may be provided in individually packaged form and received in bulk so that the appropriate breast stabilizer unit may be selected from local inventory as required for a particular imaging event or procedure.

[0083] Those skilled in the art will appreciate that in certain aspects of the present invention, it is beneficial to provide visual indications of the size, shape and / or other characteristics of the breast stabilizer unit. Thus, for example, the breast stabilizer unit may be color coded, marked with printed or molded size and shape indications, or labeled or printed with Arabic numerals, Roman numerals or other forms, and may also include machine readable identification, such as a barcode, QR code or RFID tag, etc. Of course, those skilled in the art will also appreciate that any combination of the above may also be used in appropriate applications of the present invention.

[0084] In certain embodiments of the present invention, a dispensing unit is provided, which includes a storage and dispensing device and is designed to provide a breast stabilizer unit of appropriate size and shape to a medical professional after appropriate information is input into a data interface of the dispensing device.

[0085] In certain embodiments of the invention, the data interface will be a human-machine interface, such as a keyboard, keyboard input device, and / or touch screen, in any configuration known or to become known in the art. In other embodiments of the invention, the automatic measurement device will determine the appropriate information required and provide it to the data interface. In further embodiments, the data interface will receive information from the patient record, whether paper or electronic, and use it to subsequently assign one or more breast stabilizer units.

[0086] In other embodiments, the personalized breast stabilizer unit will be manufactured in situ, such as using a mold forming process, a wrapping process, 3D printing or other additive process, laser processing or other subtractive process (or a combination thereof), according to the parameter measurement of the breast and the requirements of a specific imaging specification. Therefore, in some aspects, the present invention includes a breast stabilization method for CBBCT scanning, which forms a personalized breast stabilizer unit by using an additive process (such as a 3D printing laser sintering process, a 3D printing photopolymer curing process, a 3D printing thermoplastic polymer melting process, a 3D printing catalytic thermosetting process, and a combination thereof). Similarly, in other aspects, the present invention also includes a breast stabilization method for CBBCT scanning, which manufactures a personalized breast stabilizer unit by using a subtractive process (such as laser processing, mechanical milling, electric spark milling, chemical milling process, and a combination thereof).

[0087] Therefore, in some embodiments of the present invention, the above-mentioned adjustment device 304 can be omitted, and other arrangements can be used to achieve the ideal positioning of the breast relative to the imaging device.

[0088] like Figure 3A and 3BAs shown, the extension mechanism 322 within the adjustment device 304 provides the desired adjustment action. As will be appreciated by those skilled in the art, the extension mechanism 322 can be implemented by a variety of actuators. For example, in certain embodiments, the extension mechanism can include one or more of the following: a rack and pinion arrangement, a trapezoidal screw and a trapezoidal nut, a ball screw assembly, a linear stepper motor, a pair of lateral complementary ramps, a pneumatic cylinder, an air bag, a pneumatic bellows, a hydraulic cylinder, a hydraulic bag, a hydraulic bellows, a scissor linkage (including a scissor linkage operated by a screw, a cylinder or other actuator), a Sarus linkage, a thermoelectric actuator, a shape memory alloy actuator, a cable and pulley arrangement, a compression spring, a tension spring, a torsion spring, a coil spring, a leaf spring assembly, a spring including a plurality of Belleville washers, a ratchet lift jack arrangement, a folding mode deployment actuator, or any other linear actuator known or later known in the art suitable for a particular application and extension function.

[0089] Figure 4A Further aspects of a breast stabilizer unit 400 made in accordance with the principles of the present invention are shown in schematic perspective view. Those skilled in the art will appreciate that the illustrated breast stabilizer unit 400 may be used as an example of the aforementioned breast stabilizer units 132, 212, 312 in certain embodiments (and without limitation), or as an example of any other breast stabilizer unit described or suggested herein.

[0090] Figure 4B A schematic cross-sectional perspective view of a portion 402 of a breast stabilizer unit 400 is shown, further illustrating the shape and characteristics of the device. Figure 4A and 4B It is considered here at the same time for more clear description of the exemplary device in the present invention.

[0091] The exemplary breast stabilizer unit 400 includes a main body portion 404. The main body portion 404 has an outer surface region 406 and an inner surface region 408. In the illustrated embodiment, the outer surface region 406 and the inner surface region 408 intersect at an upper peripheral region 410 that is generally circular.

[0092] It should be noted that the peripheral region 410 is referred to as the "upper" peripheral region only for ease of discussion. In actual applications, the breast stabilizer unit 400 and any device described herein can take any orientation and position deemed appropriate according to the requirements of a specific application, function or mode of use.

[0093] Likewise, although the illustrated peripheral region 410 is described as being substantially circular, it should be understood that this is merely one example of a variety of geometric shapes that may be suitable for particular applications of the present invention, all of which are considered within the scope of the present disclosure. Thus, in certain embodiments, the peripheral region 410 may be substantially elliptical, generally elliptical, oblate, or polygonal, including (but not limited to) for example, substantially triangular, substantially rectangular (including but not limited to for example, substantially square), pentagonal, hexagonal, or any higher order polygon, or may be multi-arc, such as a circular arc intersected by two or more chords, or any combination of curves and / or line segments, which shapes may be selected as desired.

[0094] Likewise, the interior surface region 408 will have any shape deemed appropriate depending on the needs of a particular patient or procedure. Thus, by way of example, embodiments of the present invention will include interior surface regions (including partial features) having the following features: generally planar portions, generally cylindrical portions (cylinders may have any circular or other cross-section), generally annular portions, generally spherical portions (including hemispherical or any portion thereof), generally ellipsoidal portions, generally parabolic portions, generally hyperbolic portions, elliptical parabolic portions, parabolic portions of revolution, generally hyperbolic parabolic portions, generally conical portions, generally sinusoidal portions, generally co-curved portions, generally anti-curved portions, generally planar portions with any perimeter configuration, and any other geometric shapes that are deemed beneficial in improving imaging, enhancing patient comfort, or other aspects of the imaging procedure, or combinations of any of the above shapes that are or become known in the art.

[0095] Also note that Figure 4B yes Figure 4A Cross-sectional view of the breast stabilizer unit. Figure 4A From the perspective of the embodiment of the present invention, in some embodiments of the present invention, the main body portion 404 forms an integral body having a permanent continuous interior surface region 408. In some embodiments of the present invention, the continuous interior surface region 408 forms a single circumferential surface region surrounding the portion of the breast to be imaged. In further embodiments, the continuous lateral interior surface region forms a single circumferential surface surrounding the continuous lateral surface portion of the breast and also includes a lower concave surface region surrounding the entire breast below the upper peripheral surface region 410. That is, in some embodiments, the entire interior surface region 408 forms a single, generally concave continuous surface region (but not necessarily monotonous or partially concave) that is connected at the upper peripheral surface region 410 and surrounds a depression (or hole, cavity; see the description of element 428 below) for placing the breast to be imaged.

[0096] In addition, it should be noted that although in the illustrated embodiment 400, the peripheral area 410 is substantially located in the same plane, those skilled in the art will appreciate that the peripheral area 410 can occupy any curve in three-dimensional space. Therefore, the aforementioned exemplary shapes and curves (as well as other shapes and curves reasonably inferred therefrom by those skilled in the art) will have corresponding three-dimensional corresponding forms in the corresponding embodiments of the present invention.

[0097] Those skilled in the art will appreciate that in certain embodiments, a particular curve, whether planar or three-dimensional, is particularly advantageous in that it can conform to the shape of a corresponding area of ​​the breast to be imaged, or an adjacent area of ​​the patient's chest wall, or both. This design can provide better fit and support during imaging.

[0098] In addition, it can be noted that in different embodiments of the present invention, the peripheral region 410 may include a relatively obvious rounded edge, or form a three-dimensional smooth curve between the outer surface region 406 and the inner surface region 408, and the two are not mutually exclusive. Figure 4B Region 412 in FIG. 4 shows a relatively smooth curve between the outer surface region 406 and the inner surface region 408 , while region 416 in the same figure includes a relatively sharp or distinct edge 418 .

[0099] It should also be noted that any particular device or component prepared within the scope of the present invention may include one or more of these features, in any effective combination to enhance the speed, clarity, or other results of the imaging process, while increasing user comfort or improving other aspects of the invention.

[0100] A lower peripheral region 420 is also shown in the breast stabilizer unit 400. Similar to the upper peripheral region 410, the lower peripheral region 420 is also shown as a generally circular shape. In addition, as shown in the figure, the circle describing the upper peripheral region and another circle describing the lower peripheral region are generally parallel and spaced apart, and are concentrically distributed around the longitudinal axis 422 of the breast stabilizer unit 400.

[0101] However, it should be understood that the lower peripheral region can take on any of the same shapes or features as the upper peripheral region 410 discussed above. In addition, if the upper and lower peripheral regions define two-dimensional or multi-dimensional curves, these curves can be parallel or arranged in any suitable orientation as required by a particular design or implementation. This flexibility allows for adjustments based on imaging requirements or patient comfort.

[0102] It should also be noted that the upper peripheral region 410 defines an upper opening 424 of the breast stabilizer unit 400, while the lower peripheral region 420 defines a lower opening 426. Thus, the interior surface region 408 defines an interior hole or cavity 428 around the longitudinal axis 422 at its maximum extent. However, in certain embodiments of the present invention, the interior surface region 408 is continuous below the upper opening 424, and thus the lower opening 426 of the breast stabilizer 400 will be closed. Accordingly, the interior cavity 428 will form a recess, which is closed at its lower end and has a lower surface region that is connected to the rest of the interior surface region 408 and constitutes a portion of the interior surface region.

[0103] Those skilled in the art will appreciate that the lower surface area can take any form to optimize the performance of the breast stabilizer unit 400 in terms of imaging function or patient comfort. The shape and design of this lower surface area will be adjusted according to specific needs to ensure optimal support and comfort during imaging.

[0104] As can be seen from the figure, the exemplary outer surface area 406 and the inner surface area 408 define a cross-section 430 having a generally arc-shaped outer portion 432 and an inner portion 434. However, it should be understood that these curves are only examples of a variety of geometric forms, including linear, arc-shaped, and any combination thereof, that can achieve the purpose of the present invention in a particular application. In addition, in some embodiments, the specific curvature, planarity, texture, or other characteristics of a local area of ​​the outer surface area 406 or the inner surface area 408 may vary from location to location to better suit imaging needs or patient comfort.

[0105] Thus, in certain aspects or embodiments of the present invention, the breast stabilizer unit 400 may include openings, through-holes, and / or other features located in any portion of the outer surface region 406 and the inner surface region 408 as deemed beneficial by the designer of a particular embodiment. Additionally, in certain embodiments of the present invention, the region located between the surface regions 406 and 408 may include localized openings, porosity, embedded structural or indicator elements, or any other features that may help enhance the functionality, comfort, or aesthetics of the breast stabilizer unit.

[0106] Those skilled in the art will appreciate that in many embodiments, one or more materials will be selected and included in the breast stabilizer unit 400 to enhance its functionality. Thus, in certain embodiments, the breast stabilizer unit 400 will include a material that is relatively transparent to X-rays. In other embodiments of the present invention, relatively radiopaque materials will be used in all or part of the breast stabilizer unit 400. These materials will provide reference points or alignment points in respective embodiments for locating and aligning specific areas of the physical breast with corresponding areas in an image or data set during CBBCT imaging.

[0107] Furthermore, those skilled in the art will appreciate that in certain embodiments, depending on the material of the breast stabilizer unit, holes, grooves or openings in the breast stabilizer unit will be visible in subsequent CBBCT images. Therefore, appropriately arranging holes, grooves and openings around the breast stabilizer unit can also be used to locate and align specific areas of the physical breast with corresponding areas in an image or dataset.

[0108] In other embodiments, one or more material layers (e.g., metal or other materials) may be deposited within the body of the cross-section 430, or in surface layers of one or both of the exterior surface region 406 and the interior surface region 408. Such metallic or other materials will be selected to help filter and / or adjust the spectrum of incident X-rays to facilitate a particular imaging procedure. Thus, in certain embodiments of the present invention, the breast stabilizer unit 400 will include a metallic material that is capable of generating a relatively narrow spectrum of X-rays that penetrate the breast, suitable for applications such as multi-spectral CBBCT.

[0109] In certain embodiments of the present invention, the thickness of the surface layer of the breast stabilizer unit will vary between different regions in order to adjust the filtering and / or intensity control of the X-rays reaching the breast. In further embodiments, the material in or on the body of the breast stabilizer unit 400 will contain local openings to focus the imaging of specific regions of interest, and / or contain radiation (e.g., X-ray) shielding materials for areas of the breast that do not need to be imaged. This design can effectively optimize imaging quality and reduce unnecessary radiation exposure.

[0110] The reader will understand that in certain aspects and embodiments of the present invention, certain materials will be selected for inclusion in or adjacent to the inner surface area 408. These materials will be selected to improve the patient's comfort and / or health when the skin contacts the surface area. Therefore, in certain embodiments, materials with lower hardness will be selected. In some embodiments, materials with hygroscopic properties will be selected to avoid sweat accumulation. Therefore, in certain embodiments, woven and / or non-woven textiles will be selected for use in or adjacent to the inner surface area 408. Of course, in many embodiments, materials with excellent biocompatibility properties will be ideal. It should be understood that these are just some examples of various properties, and more relevant properties will become apparent as the overall content of this disclosure.

[0111] In view of the above, it can be understood that in certain embodiments of the present invention, the use of any of the following materials will be considered an ideal choice.

[0112] Suitable polymers include polyethylene, polypropylene, polybutylene, polystyrene, polyester, acrylic polymers, polyvinyl chloride, polyamide or the like. Polyetherimides; polymer alloys, such as Resin, which is a composite of polycarbonate and polybutylene terephthalate, or Plastics, which are copolymers of polycarbonate and isophthalic acid resin (both provided by GE Plastics), liquid crystal polymers, such as liquid crystal polymers containing aromatic polyesters or aromatic polyester amide components, containing at least one of the following components: aromatic hydroxycarboxylic acids (such as hydroxybenzoic acid (rigid monomer), hydroxynaphthoic acid (flexible monomer), aromatic hydroxylamine and aromatic diamine, polyester imide anhydride, with terminal anhydride groups or pendant anhydride groups, or a combination thereof.

[0113] In addition, any polymer composite material, such as an engineered prepreg or composite material (polymer filled with pigments, carbon particles, silica, glass fibers, conductive particles, such as metal particles or conductive polymers, or mixtures thereof) can also be used. For example, a mixture of polycarbonate and ABS (acrylonitrile-butadiene-styrene copolymer) can be used.

[0114] If a surface film or bulk inclusions are desired, one or more metals or metal alloys such as stainless steel, aluminum, nickel titanium, and any amorphous metal are suitable.

[0115] In addition, natural polymers and natural materials such as felted or woven textiles including one or more of cotton, bamboo, linen, wool, leather, cork and other tree products, paper, and clay will be included in certain embodiments. It should be understood that these materials can be used alone or in any combination and spatial arrangement, including in layers, particles, pulp, gel, or other physical forms.

[0116] Other features of the breast stabilizer unit 400 will be described below in conjunction with further embodiments, particularly with respect to coupling features (e.g., 208, 210), as described in Figure 2 As briefly mentioned in the context of

[0117] Figure 5 A portion of another exemplary subsystem 500 prepared in accordance with the principles of the present invention is shown in block diagram form, the subsystem being used for breast support and fixation. Unlike the system 200 described above, the subsystem 500 is comprised of an examination couch or patient placement panel (e.g., Figure 1 As will be discussed further below, in some embodiments of the present invention, the couch coupling device 502 is operatively connected to or located between an upper surface or lower surface area of ​​the patient couch portion. Thus, during operation, the patient lies prone on an upper surface area (e.g., 122) of the patient couch portion, and the breast to be imaged is connected to the subsystem 500 through an opening of the couch portion. In some embodiments of the present invention, the couch coupling portion is integrally formed as a part of the patient couch portion.

[0118] In some embodiments of the present invention, the couch coupling device 502 is connected to an adjustment device 504. The adjustment device 504 is designed and configured to allow adjustment of the spatial position of the breast relative to the imaging device of the breast imaging system. For example, in some embodiments, the adjustment device 504 is adapted to adjust the height of a portion of the breast relative to the patient couch, thereby adjusting the height relative to the imaging area of ​​the imaging device.

[0119] As shown, the receiving device 506 is operatively connected to the adjustment device. The receiving device 506 includes a main body portion and / or a support member. In some embodiments, the receiving device 506 includes a receiving coupling feature 508. The receiving coupling feature 508 includes at least one surface area corresponding to the coupling feature 510 of the breast stabilizer unit 512, and these surface areas are operatively matched.

[0120] As described below, the configuration of the breast stabilizer unit 512 is intended to support the patient's breast so that it is in a proper position and remains stable during imaging. Therefore, in certain embodiments of the present invention, the breast stabilizer unit 512 will include a support surface area. When in use, the surface area of ​​the patient's breast will be directly or indirectly supported on the support surface area.

[0121] It should be noted that in some embodiments, the adjustment device 504 is omitted and the receiving device 506 is directly connected to the coupling device 502. In this arrangement, if the position of the breast needs to be adjusted, the size or other configuration of the breast stabilizer unit 512 can be selected to provide the desired breast positioning (as described above). Therefore, in some embodiments of the present invention, the adjustment device 504 can be omitted and other arrangements can be used to achieve the ideal positioning of the breast relative to the imaging device.

[0122] According to the above disclosure, Figure 6 A portion 600 of a breast imaging system is shown in a cross-sectional perspective schematic diagram, including certain aspects of the interface between a receiving device and a breast stabilizer unit. Specifically, Figure 6 A portion of a receiving device 602 is shown, including a receiving coupling feature 604 , and a breast stabilizer unit 606 , wherein the breast stabilizer unit includes a corresponding coupling feature 608 .

[0123] exist Figure 6 In the example device of the embodiment of the present invention, the receiving coupling feature 604 and the breast stabilizer coupling feature 608 include matching serrated surface areas 610, 612, respectively. It will be readily understood by those skilled in the art that the generally rectangular protrusions, such as 614, of the receiving coupling feature 604 will be designed and configured to fit tightly into the corresponding generally rectangular grooves 616 in the breast stabilizer coupling feature 608, and vice versa. This design ensures a secure connection and stability of the two.

[0124] In addition, those skilled in the art will appreciate that, in some embodiments, if the sizes of the various saw teeth are substantially uniform, the breast stabilizer unit can be placed in a variety of symmetrical ways relative to the receiving device. Therefore, it is easier to rotate the breast stabilizer unit around the longitudinal axis of the receiving device (i.e., around the rotation axis 108 of the rotating frame 104 in some embodiments). This design provides flexibility, allowing fine-tuning and optimized positioning according to imaging requirements.

[0125] This design is particularly useful in embodiments where the breast stabilizer unit has asymmetric features to match the corresponding asymmetry of the patient's breast. Thus, the breast support unit can be rotated (as shown at 618) until it is properly aligned with the patient's breast while the patient lies prone on the support table. This rotational adjustment can better accommodate the shape of the breast, ensuring more accurate imaging and better patient comfort.

[0126] Figure 7 A portion 700 of a breast imaging system is shown in a cross-sectional perspective schematic diagram, including certain aspects of the interface between a receiving device and a breast stabilizer unit. Specifically, Figure 7 A further portion of a receiving device 702 is shown, the receiving device comprising a receiving coupling feature 704, and a breast stabilizer unit 706 comprising a corresponding breast stabilizer unit coupling feature 708. This design shows how a stable and secure connection can be achieved between the receiving device and the breast stabilizer unit, ensuring correct positioning and function of the breast stabilizer during imaging.

[0127] exist Figure 7 In the example device of , the receiving coupling feature 704 and the breast stabilizer coupling feature 708 include matching substantially triangular and truncated triangular features. Figure 6 As described above, those skilled in the art will readily appreciate that the truncated triangular protrusion portion (e.g., 714) of the receiving coupling feature 704 will be designed and configured to fit tightly into the corresponding truncated triangular groove 716 in the breast stabilizer coupling feature 708. Similarly, the generally triangular protrusion 718 of the breast stabilizer coupling feature 708 will fit into the generally triangular groove 720 of the receiving coupling feature 704. This design ensures a tight docking and stable connection between the two.

[0128] Similar to the case of area 600, a plurality of staggered protrusions and grooves allow the breast stabilizer unit 706 to be rotationally adjusted (as shown at 722) about the longitudinal axis 724 to meet imaging requirements, improve patient comfort, or optimize other characteristics of the system. This design provides flexible adjustment capabilities, allowing the breast stabilizer unit to be precisely positioned according to specific needs, ensuring better imaging results and patient experience.

[0129] Those skilled in the art will clearly understand that the specific configurations of the coupling features described above are only examples of a variety of geometric shapes, including polygons, arcs, and any other geometric shapes (e.g., see the geometric shapes mentioned above in other contexts.) These geometric configurations provide a wide range of design flexibility and can be customized according to specific imaging requirements or patient comfort needs.

[0130] Additionally, in certain applications of the present invention, the breast stabilizer unit will include a coupling feature with a fixed or variable rotation interface. Figure 8 The schematic perspective view shows another exemplary arrangement of a breast stabilizer unit 800 prepared according to the principles of the present invention. This design provides more flexible adjustment capabilities, allowing the breast stabilizer to be rotated or fixed as needed, thereby optimizing imaging effects and patient comfort.

[0131] The breast stabilizer unit 800 includes a body portion 802. The body portion 802 has an inner surface area 804 and an outer surface area 806. In the illustrated embodiment, the inner surface area 804 and the outer surface area 806 intersect at a generally circular upper peripheral area 808. This design helps provide stable breast support while ensuring a smooth transition between the outer and inner surface areas to accommodate patient comfort and imaging needs.

[0132] In the illustrated example, the breast stabilizer unit 800 includes a coupling feature in the form of a surface region 810 defining a groove or keyway 812 adjacent to the generally circular upper peripheral region 808. Based on the above disclosure, one skilled in the art will appreciate that the groove or keyway 812 is adapted to receive a corresponding protrusion or key of the receiving portion. In most cases, the geometry of the key will conform to the keyway 812 (although this is not the case in every embodiment). This design ensures a secure connection while allowing for flexibility in adjustment based on specific needs.

[0133] Fig. 9 Another exemplary arrangement of a breast stabilizer unit 900 prepared according to the principles of the present invention is shown in a schematic perspective view. This arrangement shows the design of the breast stabilizer unit 900, and further shows how the principles of the present invention can be used to support optimal positioning and stability for breast imaging. This design can be adjusted and customized according to specific imaging needs and patient comfort.

[0134] The breast stabilizer unit 900 includes a main body portion 902. The main body portion 902 has an inner surface area 904 and an outer surface area 906. In the illustrated embodiment, the inner surface area 904 and the outer surface area 906 intersect at a generally circular upper peripheral area 908. This design ensures stability and support of the breast stabilizer unit while providing the desired geometry for imaging.

[0135] In the illustrated example, the breast stabilizer unit 900 includes a coupling feature in the form of a surface region 910 defining a protrusion or key 912 adjacent to the generally circular upper peripheral region 908. Based on the above disclosure, one skilled in the art will appreciate that the protrusion or key 912 is adapted to be inserted into a corresponding recess or keyway of the receiving portion to form an interlocking element. In most cases, the geometry of the keyway will coincide with the key 912 (although this is not the case in every embodiment). This design ensures stability and reliability of the connection while allowing for flexible adjustment to meet specific imaging needs.

[0136] It should also be noted that the breast stabilizer unit 900 illustrates one of many possible arrangements and configurations, wherein the lower end 914 of the breast stabilizer is closed. Thus, the recess 916 of the breast stabilizer unit 900 is adapted to receive and fully contain the breast to be imaged. Other advantages of this configuration include enabling the breast stabilizer unit 900 to serve as a safe enclosure for the breast to avoid the possibility of any mechanical interference between the breast and the rotating imaging device (i.e., X-ray source, X-ray detector, rotating frame, etc.).

[0137] In addition, it can be appreciated that a fully enclosed breast stabilizer unit (such as shown in breast stabilizer unit 900) can confine the breast to a uniform spatial range. This has particular benefits in various imaging operations and other procedures of the imaging system associated with the present invention (for example, when using a bow-tie filter, the uniform symmetrical shape of the supported breast will match the contour of the bow-tie filter). This design not only improves the accuracy of imaging, but also optimizes the efficiency of the entire imaging process.

[0138] Fig.10 The arrangement of another exemplary receiving device 1000 prepared according to the principles of the present invention is shown in the form of a schematic perspective cross-sectional view. The receiving device 1000 includes a receiving body component 1002. In the illustrated embodiment, the receiving device body component 1002 is generally annular. Although the annular body shown has a generally rectangular cross-section, those skilled in the art will understand that this is only an example, and in fact, a variety of different cross-sectional shapes can be used according to the requirements of a specific application.

[0139] In the exemplary embodiment shown, the receiving body 1002 includes a coupling feature including an inner generally circumferential engagement surface 1004 and a keyway 1006. This design enables the receiving device to be effectively connected to other components and provides stable support to ensure smooth imaging process.

[0140] Those skilled in the art will appreciate that the keyway is optional, as some embodiments of the breast stabilizer may have neither a key nor a keyway, but rather be held in place by friction between the circumferential engagement surface 1004 and a corresponding engagement surface of the breast stabilizer. In other embodiments and applications of the present invention, it is considered advantageous to allow the breast stabilizer to rotate relatively freely rather than maintain a relatively fixed relationship with the patient couch. This flexibility facilitates fine-tuning based on imaging needs, improving imaging results and patient comfort.

[0141] In the illustrated embodiment, the receiving device 1000 is designed to receive e.g. Fig. 9 1000. Therefore, the key 912 is adapted to be inserted into the key slot 1006 to achieve a stable connection. This design ensures a firm connection between the breast stabilizer unit and the receiving device, thereby improving the reliability and efficiency of the imaging process.

[0142] In certain embodiments, as shown, the receiving device 1000 includes an actuator 1008. The actuator 1008 includes an engagement mechanism that couples with corresponding elements of the receiving body 1002. In operation, before or after the coupling features of the breast stabilizer unit are coupled with the coupling features of the receiving device 1000, the rotational position 1010 of the receiving body 1002 can be adjusted based on the comfort of the patient and other requirements for using the imaging system. In the exemplary embodiment shown, this rotation is powered by manual rotation of a drive shaft 1012 of the actuator 1008. The drive shaft is coupled to a worm gear that engages with a corresponding rack of the receiving device 1000. However, those skilled in the art will readily appreciate that a variety of other actuators, including manually and automatically activated actuators, will be used in various embodiments of the present invention.

[0143] Fig.11A Further aspects and features of an exemplary imaging system 1100 prepared in accordance with the principles of the present invention are illustrated in schematic perspective cross-sectional view. As shown, the imaging system includes a patient table 1102 having an upper surface 1104 and a lower surface 1106. The imaging system 1100 exhibits certain particularly desirable features, including a breast stabilizer unit 1108 that is carefully designed and configured to allow imaging of the entire breast to be imaged and, in some cases, corresponding portions of the chest wall. This design ensures that extensive and detailed image information is obtained during the imaging process.

[0144] Unlike a conventional separate receiving device, the illustrated embodiment shows a surface area 1110 of a patient examination bed 1102, which serves as a receiving device coupling area 1112. This design integrates the receiving function into the patient examination bed, helps to simplify the device structure, and ensures that the breast stabilizer unit can be firmly combined with the imaging system to achieve an efficient imaging process.

[0145] Now combine Fig.11A and Fig. 11B Make a reference; Fig. 11B Further details of the exemplary imaging system 1100 are shown in the form of a schematic cross-sectional view. As described above, the patient couch 1102 includes an upper surface area 1104 and a lower surface area 1106. This design provides detailed information about the structure of the imaging system, helping to understand how the various components interact to optimize imaging results and patient comfort.

[0146] In operation, the x-ray beam 1114 fills the spatial region below the surface 1106 and spans 1116 a cross-sectional area designed and configured to illuminate the target area of ​​the breast to be imaged, up to and including the entire breast. This design ensures that the imaging system can capture comprehensive details of the breast, thereby providing high-quality imaging results.

[0147] It should be understood that in certain applications of the imaging system 1100, the upper boundary 1118 of the x-ray beam 1114 should be as close as possible to the lower surface 1106 of the patient couch 1102 (i.e., minimize or optimize the distance 1120) so as to image the relationship between the breast and the patient's chest wall as closely or practically as possible. In fact, in certain embodiments of the present invention, the use of the imaging system 1100 will enable the imaging of a partial area of ​​the chest wall. This design optimizes the range and clarity of the imaging, and helps to provide more comprehensive diagnostic information.

[0148] In the illustrated embodiment, the breast stabilizer unit 1108 includes a first body member 1122 and a second edge member 1124. The first body member 1122 will, in certain embodiments, comprise a structural material having sufficient mechanical properties to support the patient's breast, while also comprising a material that is relatively transparent to x-rays. In certain embodiments of the invention, a single material will have both of these properties. This design ensures that support is provided without impeding the clarity and quality of x-ray imaging.

[0149] In certain embodiments of the present invention, the first body element 1122 will be fixedly coupled to the second edge element 1124 at respective interface surface areas 1126 and 1128. In various embodiments, such coupling can be achieved by using chemical adhesives, physical bonding, mechanical fasteners, mechanical extrusion, welding (e.g., heat welding, ultrasonic welding, laser welding, or chemical welding) or any other coupling mechanism suitable for application requirements, including any combination of the above methods. This flexibility ensures the firmness and stability of the connection to meet specific usage requirements.

[0150] In the illustrated example, the second edge element 1124 includes an edge coupling surface area 1130. The edge coupling surface area 1130 is designed and configured to interface with a corresponding coupling surface area 1132 of the patient couch to form a secure coupling between the patient table 1102 and the breast stabilizer unit 1108. This design ensures a secure positioning of the breast stabilizer, thereby improving the accuracy and reliability of imaging.

[0151] According to the illustrated example, the properties of the selected materials and the configuration of these materials enable the patient examination couch 1102 to support the breast stabilizer unit 1108 without significantly interfering with the upper boundary 1118 of the X-ray beam 1114. Therefore, the material of the second edge element 1124 will be selected accordingly and in various embodiments include metal materials, synthetic polymer materials, glass materials, natural polymer materials, or any other structural materials suitable for the requirements of a specific embodiment, including combinations thereof. This flexible material selection ensures the strength and functionality of the stabilizer while optimizing imaging quality.

[0152] In the illustrated example, the second edge element 1124 is coupled to the patient table 1102 via keys 1134 and 1136 to limit rotation 1138 of the breast stabilizer unit 1108 about its longitudinal axis. However, as described above, in other embodiments of the present invention, the design, material, and configuration of the second edge element 1124 and the corresponding coupling surface area 1132 of the patient table 1102 will be selected and configured to allow frictional rotation or substantially free rotation of the breast stabilizer unit 1108. This flexibility enables the imaging system to be tailored to specific imaging needs and patient comfort.

[0153] It should also be understood that the second edge element 1124 will have respective radial dimensions in various embodiments so that a single opening of substantially fixed dimensions on the patient couch 1102 can accommodate breast stabilizer units (e.g., 1108) of various different diameters and other configurations and parameters. In this case, the respective radial widths of the second edge element 1124 will adapt these different dimensions to each other. This design provides greater flexibility, allowing different breast stabilizer units to be effectively combined with the imaging system to meet diverse imaging needs.

[0154] Those skilled in the art will appreciate that the presence of separate edge elements is optional, and in certain embodiments of the present invention, a single uniform material will comprise the first body portion 1122 and the second edge element 1124 of the breast stabilizer unit 1108, forming an integral, single component. In other embodiments of the present invention, internal reinforcement materials, such as reinforcing fibers of glass, carbon, polymer, or other materials, may be present in certain regions of the breast stabilizer unit 1108. It should be appreciated that the material transition between these regions may be abrupt or gradual, depending on the requirements of a particular model or application.

[0155] Finally, in conjunction with the overall content of the present disclosure, it can be understood that the exemplary features of the opening and interface surface area 1132 of the established patient examination couch 1102 will form a standard interface on which any of a variety of breast stabilizer units can be prepared and coupled. Therefore, in certain embodiments of the present invention, the breast stabilizer unit will have a standard interface at its upper radial edge and be customized in size according to the requirements and / or parameters (e.g., size) of a specific patient, procedure, diagnosis, or operating mode. As described above, in certain embodiments, the breast stabilizer unit will be prepared using locally available (i.e., within the imaging facility) additive or subtractive manufacturing equipment and processes.

[0156] Fig.12 Certain aspects of an exemplary CBBCT imaging system 1200 are shown in a schematic top view, including a patient placement panel (or patient table) 1204. This design shows the overall layout of the imaging system, highlighting the relationship between the patient and the imaging equipment, and how to optimize the imaging process to ensure patient comfort and imaging results.

[0157] The patient placement panel 1204 includes a patient placement surface area 1206 that is intended to support the patient during the scanning process. In various embodiments of the present invention, the patient placement surface area 1206 includes an inner peripheral edge 1208 that defines an opening in the patient placement surface area. In some embodiments, the opening is adapted to receive a patient's breast therethrough. In other embodiments, the opening includes a Fig.12In the illustrated embodiment, the opening is adapted to receive a patient support subpanel 1210 extending through the peripheral edge 1208. The patient support subpanel 1210 is coupled to and / or supported by the patient couch 1204.

[0158] When considering the inner peripheral edge, it is apparent that the specific shape of the peripheral edge will be selected in the respective embodiments to optimize functionality, ease of manufacturing, etc. Therefore, the geometric shapes shown are merely examples of various configurations, and those skilled in the art will be able to immediately understand other possible designs based on the overall content of this disclosure.

[0159] The patient support subpanel 1210 includes a subpanel surface area 1212. Further inner peripheral edge 1214 defines a subpanel opening 1216 through the subpanel. In the illustrated configuration, the subpanel opening 1216 is located to the right of the longitudinal centerline 1218 of the patient placement panel 1204. Thus, in typical operation of the CBBCT imaging system, the patient's right breast will pass through the subpanel opening 1216 during imaging. This design ensures effective imaging of the right breast while providing the support and comfort required by the patient.

[0160] Those skilled in the art will appreciate that in certain embodiments of the present invention, multiple sub-panels will be provided that include openings of different sizes. For example, a sub-panel will be provided having an inner peripheral edge 1224 that defines an opening 1225 of smaller diameter (compared to the illustrated opening diameter 1215 defined by the inner peripheral edge 1214). Thus, a technician or medical staff will be able to select and install a sub-panel having an opening that is appropriate for the size of the breast of a particular patient to be imaged. This flexibility ensures that the imaging system can meet the needs of different patients, thereby improving the accuracy and effectiveness of imaging.

[0161] In other embodiments of the invention, adjustment of the opening size will be achieved through operation of an adjustment mechanism, such as an iris blade aperture mechanism. In some embodiments, the adjustment mechanism will be substantially permanently connected to the patient table 1204. In other embodiments, the adjustment mechanism will be connected to a removable sub-panel (such as the sub-panel 1210 described above). This design provides flexibility, allowing for quick and convenient adjustments based on specific imaging needs while ensuring compatibility with imaging systems.

[0162] In certain embodiments of the present invention, the opening for receiving the breast to be imaged generally coincides 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 table. Thus, no additional lateral mechanism is required to align the breast with the axis of rotation of the rotating frame. Those skilled in the art will appreciate that such alignment of the breast opening can be achieved by providing the opening directly on the patient table, or alternatively, the opening can be provided in a sub-panel configured to be connected or coupled to the patient table.

[0163] therefore, Fig.13 Certain aspects of an exemplary CBBCT imaging system 1300 are shown in a schematic top view, including a patient placement panel (or patient table) 1304. This design highlights the overall layout of the imaging system, emphasizing the relationship between the patient and the imaging equipment, and how to optimize the imaging process to ensure patient comfort and imaging results.

[0164] The patient positioning panel 1304 includes a patient support surface area 1306, which is intended to support the patient during scanning, and a sub-panel 1310 that passes through the inner peripheral edge 1308 of the patient support surface area 1306. The sub-panel 1310 is connected to and / or supported by the patient positioning panel 1304. This design ensures stable support during imaging while allowing the breast or other parts to be effectively interfaced with the imaging device through the sub-panel.

[0165] The subpanel 1310 includes a subpanel surface area 1312. Further, an inner peripheral edge 1314 defines a subpanel opening 1316 through the subpanel. In the illustrated configuration, the subpanel opening 1316 coincides with the longitudinal centerline 1318 of the patient table 1304. Therefore, in a typical operation of the CBBCT imaging system, either breast of the patient can be imaged through the subpanel opening 1316, and the patient is accordingly arranged on the patient support surface area 1306 of the patient placement panel 1304. This design provides a convenient imaging method, ensuring flexibility and patient comfort during imaging.

[0166] Although the inner peripheral edges 1214, 1224, 1314 discussed above present generally circular features, it will be appreciated by those skilled in the art that the peripheral edge may take any form that is deemed advantageous under the requirements of a particular application. Thus, in certain embodiments of the present invention, the peripheral edge may be generally elliptical, triangular, or any other regular or irregular polygonal shape, or any arc, or a combination of an arc and a line segment, or any combination of the above shapes, all of which are considered within the scope of the present disclosure.

[0167] Figures 14A to 14CExemplary subpanels with different opening locations and sizes are shown in schematic top view. These examples demonstrate the flexibility of subpanel design, which can be customized to specific imaging needs and patient anatomy to ensure optimal imaging and patient comfort.

[0168] First reference Fig.14A , the subpanel 1400 includes a subpanel surface area 1402. The inner peripheral edge 1404 defines a subpanel opening 1406 through the subpanel. Consistent with the above discussion, the opening 1406 is adapted to receive a patient's breast to be imaged therethrough. In the illustrated configuration, the subpanel opening 1406 is located to the left of the longitudinal centerline 1408 of the subpanel 1400. Thus, in typical operation of the CBBCT imaging system, the patient's left breast will pass through the subpanel opening 1406 during imaging. This design ensures effective imaging of the left breast while providing the patient with the desired support and comfort.

[0169] Fig. 14B A subpanel 1412 is shown, similar to subpanel 1400. Like subpanel 1400, subpanel 1412 also has an inner peripheral edge 1414 that defines a subpanel opening 1416 through subpanel 1412. Similar to opening 1406, opening 1416 is located to the left of a longitudinal centerline 1418 of subpanel 1412. However, a diameter 1420 of opening 1406 is relatively small and smaller than a corresponding diameter 1422 of opening 1416. This design provides options for different opening sizes to accommodate different patient needs and imaging requirements.

[0170] Fig. 14C A subpanel 1426 is shown, similar to subpanels 1400 and 1412. Similar to subpanel 1400, subpanel 1426 also has an inner peripheral edge 1428 that defines a subpanel opening 1430 through subpanel 1426. The diameter 1432 of opening 1430 is substantially equal to the corresponding diameter 1422 of opening 1416. However, the center point of opening 1430 is located on the centerline 1434 of subpanel 1426. Therefore, while openings 1406 and 1416 are primarily configured to receive a patient's left breast for imaging, opening 1430 is suitable for receiving either a left or right breast. This design flexibility ensures that the imaging system can meet the needs of different patients.

[0171] Those skilled in the art will appreciate that, provided that appropriate peripheral configurations and coupling features are provided, the symmetry of the illustrated panel will be used for imaging in various embodiments of the present invention, for example, by symmetrically rotating the sub-panels 1400 or 1412 about the centerline 1408 or 1418, or by rotating about the center point of the panel (e.g., 180° in the plane of the panel). That is, rotation of the panel about an axis perpendicular to the centerline can be used to relatively raise or lower the position of the illustrated opening as required by taller or shorter patients. This flexibility ensures that the imaging system can adapt to different patient sizes, thereby providing more accurate imaging results.

[0172] In conjunction with the above discussion, the reader will understand that in certain embodiments of the present invention, multiple sub-panels will be provided for use with the imaging system so that a sub-panel with a suitable opening can be selected according to the patient's height, weight, breast size, and any other parameters. This design ensures that the imaging system can be customized according to the specific needs of each patient, thereby improving the accuracy of imaging and the comfort of the patient.

[0173] In another aspect or embodiment of the invention, a single reusable sub-panel will be purchased so that it is available when needed. In other embodiments of the invention, a disposable sub-panel will be used for a single use with the respective patient and then discarded after use. This design provides flexibility and convenience to meet different clinical environments and patient needs while ensuring hygiene and safety.

[0174] In another aspect or embodiment of the invention, a disposable liner, such as a woven or felted textile material or a polymer film, is provided to fit the reusable subpanel. This design can improve hygiene by ensuring a clean contact surface for the patient at each use while allowing the reusable subpanel to remain in good condition.

[0175] In a further aspect of the invention, Fig.15 A subpanel 1500 is shown in a schematic distal cutaway perspective view, including a breast stabilizer unit 1502 designed and configured to support and stabilize a patient's breast during imaging. As shown, the breast stabilizer unit 1502 is coupled to an opening 1504 of a distal surface 1506. This design ensures stability and proper positioning of the breast during imaging, thereby improving imaging quality and patient comfort.

[0176] In some applications, the breast stabilizer unit 1502 is designed and adjusted so that the geometric center of the breast is approximately coincident with the rotation axis of the CBBCT rotating frame and the longitudinal axis 222 of the X-ray beam. However, those skilled in the art will appreciate that a variety of breast placements and configurations are ideal for specific patients, applications, or imaging goals, which will be achieved through appropriate configuration, shape, and placement of the breast stabilizer unit 1502. This flexibility ensures that the imaging system can meet different clinical needs and improve imaging effects and patient comfort.

[0177] In certain embodiments of the present invention, a breast stabilizer for a cone-beam breast tomography system includes a main body portion having an inner surface region and a coupling surface portion. The inner surface region remains substantially stationary relative to the coupling surface portion, and the inner surface region includes a breast contact portion, which is adapted to support a corresponding surface region of a patient's breast during operation of the cone-beam breast tomography system. The coupling surface portion is adapted to connect the main body portion to a receiving device of the cone-beam breast tomography system. This design ensures effective support and stabilization of the breast while facilitating integration with the imaging system.

[0178] In some embodiments of the present invention, the breast contact portion forms a substantially continuous circumferential surface area of ​​the inner surface area. This design provides uniform support and can better adapt to the shape of the patient's breast, thereby improving imaging accuracy and patient comfort.

[0179] In certain embodiments of the present invention, the breast stabilizer of the cone-beam breast tomography system is directly connected to the patient placement panel of the cone-beam breast tomography system. This design simplifies the system structure, ensures the stable positioning of the breast stabilizer, and optimizes the imaging process, thereby improving the patient's comfort and the imaging effect.

[0180] In some embodiments of the present invention, the breast stabilizer of the cone-beam breast tomography system is integrally formed with the patient placement panel of the cone-beam breast tomography system. This design enhances the integrity and stability of the system, reduces the connection points between components, and thus improves the efficiency of the imaging process and the comfort of the patient.

[0181] In some embodiments of the present invention, a breast stabilizer of a cone-beam breast tomography system is connected to a patient placement panel of the cone-beam breast tomography system through an adjustment mechanism. This design allows the position of the breast stabilizer to be flexibly adjusted during imaging to meet the needs and imaging requirements of different patients, thereby improving imaging accuracy and patient comfort.

[0182] In some embodiments of the present invention, the receiving device of the breast stabilizer of the cone-beam breast tomography system is directly connected to the frame element of the cone-beam breast tomography system. In other embodiments of the present invention, the receiving device of the breast stabilizer is connected to the frame element of the cone-beam breast tomography system through an adjustment mechanism. This design provides different connection options, allowing for flexible adjustment according to specific imaging needs and patient comfort, while ensuring effective integration of the stabilizer with the imaging system.

[0183] In certain embodiments of the present invention, a breast stabilizer of a cone-beam breast tomography system has a receiving device, and the receiving device has a further coupling surface portion. In this case, coupling of the body portion to the receiving device of the cone-beam breast tomography system comprises placing the coupling surface portion in rotational friction contact with the further coupling surface portion. This design allows flexible rotational adjustment while ensuring a secure connection of the stabilizer, providing a reliable support for efficient imaging.

[0184] In certain embodiments of the present invention, the coupling surface portion of the breast stabilizer of the cone-beam breast tomosynthesis system has a further coupling surface portion having respective complementary interlocking elements. Furthermore, the respective interlocking elements are adapted to control the rotation of the main body portion about its longitudinal axis with the receiving device. This design ensures a secure positioning of the breast stabilizer and allows precise rotational adjustment to meet imaging requirements.

[0185] The present invention also includes some embodiments in which the inner surface area includes a portion of a substantially parabola. This design helps provide uniform support and stability during imaging, thereby optimizing image quality and patient comfort. The shape of the parabola can effectively adapt to the natural contours of the breast, helping to improve the accuracy of imaging.

[0186] The present invention also includes some embodiments in which the inner surface area includes a substantially hyperboloidal portion. This design can provide different support characteristics to adapt to the shape of the breast to optimize stability and comfort during imaging. The shape of the hyperboloid helps improve the geometric characteristics of the imaging, ensuring better results during imaging.

[0187] The present invention also includes some embodiments in which the inner surface area includes a substantially hemispherical portion. This design can provide good support and stability, adapt to the shape of the breast, and ensure comfort during imaging. The hemispherical shape helps to evenly distribute pressure, thereby improving the quality and effect of imaging.

[0188] In certain embodiments of the present invention, a method for stabilizing a breast for CBBCT scanning includes the following steps: providing a CBBCT system including a CBBCT rotating frame and a frame element; providing a patient placement panel supported by the frame element and having a first patient placement surface area having an opening; providing a receiving device having a first coupling portion and a first coupling surface area and maintaining a substantially fixed spatial relationship with the opening; determining a parameter of the breast and identifying a size of a breast stabilizer unit based on the parameter; providing the identified breast stabilizer unit having an inner surface area corresponding to the breast parameter; the breast stabilizer unit having a second coupling portion and a second coupling surface area, the inner surface area being substantially stationary with the coupling surface portion; contacting the first coupling surface area with the second coupling surface area, thereby supporting the breast stabilizer unit through the receiving device; contacting the breast with the inner surface area, thereby supporting the breast through the breast stabilizer unit; and finally scanning the breast using the CBBCT system. This method ensures stability and accuracy of the breast during imaging.

[0189] In some embodiments of the present invention, the process of providing a breast stabilizer unit includes selecting a suitable unit from a plurality of breast stabilizer units, while in other embodiments, the process of providing a breast stabilizer unit includes making a personalized breast stabilizer unit using an additive manufacturing process. In some embodiments, the process of making a personalized breast stabilizer unit includes forming the breast stabilizer unit by a mold process, while in further embodiments, the process of making a personalized breast stabilizer unit includes forming the breast stabilizer unit by a coating process. These flexible manufacturing methods ensure that the specific needs and imaging requirements of different patients can be met.

[0190] In certain embodiments of the present invention, the process of making a personalized breast stabilizer unit includes forming the breast stabilizer unit using an additive manufacturing process, which includes one or more of the following methods: 3D printing laser sintering process, 3D printing photopolymer curing process, 3D printing molten thermoplastic polymer process, 3D printing catalytic thermal curing process, and combinations thereof. These advanced manufacturing technologies allow for precise control of the shape and properties of the breast stabilizer to better suit the needs of a specific patient.

[0191] In certain embodiments of the present invention, the process of making a personalized breast stabilizer unit includes forming the breast stabilizer unit using a subtractive process, the process including one or more of the following methods: laser machining process, mechanical milling process, electrical discharge milling process, chemical milling process, and combinations thereof. These subtractive manufacturing technologies provide high-precision machining capabilities, allowing the breast stabilizer unit to be customized according to specific design requirements, thereby improving imaging effects and patient comfort.

[0192] In some embodiments of the present invention, placing the receiving device in a substantially fixed spatial relationship with the opening includes coupling the receiving device to the patient placement panel. This design ensures the stability of the receiving device, enabling it to effectively support the breast stabilizer unit, thereby improving the accuracy and reliability of the imaging process.

[0193] In certain embodiments of the present invention, a method for stabilizing a breast for CBBCT scanning includes providing an adjustment device, coupling the adjustment device to a patient placement panel, and coupling a receiving device to the adjustment device. This design allows the position of the breast stabilizer unit to be flexibly adjusted to meet the needs and imaging requirements of different patients, thereby improving the accuracy of imaging and the comfort of the patient.

[0194] In some embodiments of the present invention, an adjustment device is provided, which is coupled to the frame element, and the receiving device is coupled to the adjustment device. This design ensures the stable positioning of the receiving device while allowing flexible adjustment to adapt to the needs and imaging requirements of different patients, thereby improving the imaging effect and the comfort of the patient.

[0195] In certain embodiments of the present invention, the adjustment device includes a linear actuator.

[0196] In certain embodiments of the present invention, the linear actuator includes a linear stepper motor.

[0197] In certain embodiments of the present invention, the linear actuator includes a ball screw assembly.

[0198] In certain embodiments of the present invention, a method for stabilizing a breast for CBBCT scanning includes the following steps: providing a CBBCT system including a CBBCT rotating frame and a CBBCT frame element; providing a patient placement panel supported by the frame element and having a first patient placement surface area having an opening; providing a receiving device, the receiving device being maintained in a substantially fixed spatial relationship with the opening, the receiving device having a first coupling portion with a coupling surface area; determining the spatial size of the breast and preparing a breast stabilizer unit according to the size of the breast; the breast stabilizer unit having an inner surface area and a second coupling portion with a second coupling surface area, the inner surface area being substantially stationary with the second coupling surface area; contacting the first coupling surface area with the second coupling surface area, thereby supporting the breast stabilizer unit through the receiving device; contacting the breast with the inner surface area, thereby supporting the breast through the breast stabilizer unit; and finally, scanning the breast using the CBBCT system. This method ensures breast stability and accurate imaging, thereby improving imaging quality and patient comfort.

[0199] Although the above exemplary embodiments are mainly selected from the equipment field of CBBCT imaging systems, and breast stabilization systems and operating methods thereof, those skilled in the art will understand that the principles of the present invention are equally applicable to other wide-ranging imaging technologies, and the advantages of the present invention can also be fully reflected in the imaging of other parts of the body and the imaging of other subjects (such as industrial and technical products). In addition, although the present invention has described the currently preferred embodiments in detail, it should be understood that the present invention is not limited to the disclosed embodiments. On the contrary, the present invention may be modified to incorporate any number of variations, substitutions, or equivalent arrangements that have not been described heretofore but are consistent with the spirit and scope of the invention disclosed herein. Therefore, the present invention should not be construed as limited to the above description, but only to the scope of the appended claims.

Claims

1. A breast stabilizer for a cone beam breast tomosynthesis system (CBBCT), comprising: A body portion having an inner surface region and a coupling surface portion, the inner surface region being substantially fixed relative to the coupling surface portion, the inner surface region including a breast contact portion adapted to support a corresponding surface region of a patient's breast during operation of the cone-beam tomography system, the coupling surface portion adapted to couple the body portion to a receiving device of the cone-beam tomography system.

2. A breast stabilizer for CBBCT as defined in claim 1, wherein the breast contacting portion forms a substantially continuous annular surface area of ​​the inner surface area.

3. A breast stabilizer for CBBCT as defined in claim 1, wherein the receiving device is directly connected to a patient placement panel of the cone beam tomography system.

4. A breast stabilizer for CBBCT as defined in claim 1, wherein the receiving device is integrally formed with a patient placement panel of the cone beam tomography system.

5. A breast stabilizer for CBBCT as defined in claim 1, wherein the receiving device is connected to a patient placement panel of the cone beam tomography system through an adjustment mechanism.

6. A breast stabilizer for CBBCT as defined in claim 1, wherein the receiving device is directly connected to a frame element of the cone beam tomography system.

7. A breast stabilizer for CBBCT as defined in claim 1, wherein the receiving device is connected to a frame element of the cone beam tomography system through an adjustment mechanism.

8. A breast stabilizer for CBBCT as defined in claim 1, wherein the receiving device includes a further coupling surface portion, and the main body portion is coupled to the receiving device of the cone beam tomography system in such a manner that the coupling surface portion is configured in a rotational frictional contact with the further coupling surface portion.

9. A breast stabilizer for CBBCT as defined in claim 1, wherein the coupling surface portion and the further coupling surface portion have respective complementary locking elements, and the respective complementary locking elements are adapted to control rotation of the main body portion relative to the receiving device around a longitudinal axis of the main body portion.

10. A breast stabilizer for CBBCT as defined in claim 1, wherein the interior surface area includes a portion having a substantially parabolic surface area.

11. A breast stabilizer for CBBCT as defined in claim 1, wherein the interior surface region includes a portion that is a substantially hyperbolic surface region.

12. A breast stabilizer for CBBCT as defined in claim 1, wherein the interior surface area includes a portion of a substantially hemispherical surface area.

13. A breast stabilization method for CBBCT scanning, comprising: A CBBCT system is provided, wherein the CBBCT system comprises a CBBCT frame and a frame element; providing a patient positioning panel, wherein the patient positioning panel is supported by the frame member, the patient positioning panel having a first patient positioning surface area, the first patient positioning surface area having an aperture therethrough; providing a receiving device, wherein the receiving device has a first coupling portion and a first coupling surface area; disposing the receiving device in a substantially fixed spatial relationship proximate the aperture; determining a parameter of the breast; determining the size of the breast stabilizer unit according to the parameters of the breast; providing the identified breast stabilizer unit, wherein the breast stabilizer unit has an interior surface area corresponding to the breast parameter, the breast stabilizer unit having a second coupling portion and a second coupling surface area; the interior surface area being substantially fixed relative to the coupling surface portion; subsequently, bringing the first coupling surface area into contact with the second coupling surface area, thereby supporting the breast stabilizer unit with the receiving device; contacting the breast with the interior surface area, thereby supporting the breast with the breast stabilizer unit; The breast is scanned using the CBBCT system.

14. A method for breast stabilization for CBBCT scanning as defined in claim 13, wherein providing a breast stabilizer unit comprises: The breast stabilizer unit is selected from a plurality of breast stabilizer units.

15. A breast stabilization method for CBBCT scanning as defined in claim 13, wherein providing a breast stabilizer unit comprises: The breast stabilizer unit is prepared using additive manufacturing technology for individualization.

16. A method for breast stabilization for CBBCT scanning as defined in claim 15, wherein the step of preparing a breast stabilizer unit for individualization comprises: The breast stabilizer unit is formed by a molding process.

17. A method for breast stabilization for CBBCT scanning as defined in claim 15, wherein the step of preparing a breast stabilizer unit for individualization comprises: The breast stabilizer unit is formed by a coating process.

18. A method for breast stabilization for CBBCT scanning as defined in claim 15, wherein the step of preparing a breast stabilizer unit for individualization comprises: The breast stabilizer unit is formed by an additive manufacturing process, including one or more 3D printing laser sintering processes, 3D printing photopolymer curing processes, 3D printing molten thermal polymer processes, 3D printing catalytic thermosetting processes and combinations thereof.

19. A method for breast stabilization for CBBCT scanning as defined in claim 15, wherein the step of preparing a breast stabilizer unit for individualization comprises: The breast stabilizer unit is formed by a subtractive process, including one or more laser processing processes, mechanical milling processes, electrical discharge milling processes, chemical milling processes, and combinations thereof.

20. A method for breast stabilization for CBBCT scanning as defined in claim 13, wherein said arranging said receiving device in a substantially fixed spatial relationship proximate said aperture comprises: The receiving device is coupled to the patient placement panel.

21. A method of breast stabilization for CBBCT scanning as defined in claim 13, further comprising: providing an adjustment device; coupling the adjustment device to the patient positioning panel; and coupling the receiving device to the regulating device.

22. A method of breast stabilization for CBBCT scanning as defined in claim 13, further comprising: providing an adjustment device; coupling the adjustment device to the frame member; and coupling the receiving device to the regulating device.

23. A method of breast stabilization for CBBCT scanning as defined in claim 22, wherein the adjustment device comprises a linear actuator.

24. A method of breast stabilization for CBBCT scanning as defined in claim 23, wherein the linear actuator comprises a linear stepper motor.

25. A method for breast stabilization for CBBCT scanning as defined in claim 23, wherein the linear actuator comprises a ball screw assembly.

26. A breast stabilization method for CBBCT scanning, comprising: A CBBCT system is provided, wherein the CBBCT system comprises a CBBCT rack and a CBBCT frame element; providing a patient positioning panel, wherein the patient positioning panel is supported by the frame member, the patient positioning panel having a first patient positioning surface area, the first patient positioning surface area having an aperture therethrough; providing a receiving device, wherein the receiving device is coupled to the aperture in a substantially fixed spatial relationship, the receiving device having a coupling portion and a coupling surface area; determining the spatial dimensions of the breast; preparing a unit for breast stabilization according to the dimensions, the breast stabilizer unit having an inner surface area and a second coupling portion and second coupling surface area, the inner surface area being substantially fixed relative to the second coupling surface area; bringing the first coupling surface area into contact with the second coupling surface area, thereby supporting the breast stabilizer unit with the receiving device; contacting the breast with the interior surface area, thereby supporting the breast with the breast stabilizer unit; The breast is scanned by CBBCT using the CBBCT system.

Images