AU2017204458A1 - Integrated multi-mode mammography/tomosynthesis x-ray system and method - Google Patents

Abstract

A multi-mode breast x-ray imaging system comprises a tube arm assembly comprising an x-ray source, and a compression arm assembly. The compression arm assembly comprises a face shield and an x-ray receptor. The face shield is positioned generally between the x ray source and the x-ray receptor. The x-ray source and x-ray receptor are configured to generate images using at least two imaging modes. At least one imaging procedure is executed differently in each of the at least two imaging modes and the at least two imaging modes are temporally spaced. The x-ray source moves relative to the compression arm assembly in one of the at least two imaging modes.

Description

INTEGRATED MULTI-MODE MAMMOGRAPHY/TOMOSYNTHESIS X-RAY SYSTEM AND METHOD 2017204458 29 Jun2017 10001] The present application is a divisional application from Australian Patent

Application No. 2015224382, which is a divisional application from Australian Patent 5 Application No. 2009289574, the entire disclosure of which is incorporated herein by reference.

[0002] This application claims priority from U.S. Provisional Patent Application 61/094,320, fded September 4, 2008. The contents of that specification and the specifications of U.S. Patent 11/791,601 filed November 23, 2005, and U.S. provisional 10 application Serial No. 60/631,296, filed November 26, 2004 and entitled “INTEGRATED MULTI-MODE MAMMOGRAPHY/TOMOSYNTHESIS X-RAY SYSTEM AND METHOD”, are incorporated herein by reference.

FIELD

[0003] This patent specification pertains to x-ray mammography and, more 15 specifically, to an integrated system for selectively carrying out x-ray mammography and/or tomosynthesis imaging and a method of using such a system.

BACKGROUND |0004] X-ray mammography has long been a screening modality for breast cancer and other lesions, and also has been relied on for diagnostic and other purposes. For many 20 years, the breast image was recorded on x-ray film but more recently digital x-ray image receptors have come into use, as in the Selenia™ mammography system available from Hologic Inc. of Bedford, MA and its division Lorad Corporation of Danbury, CT. For mammograms, a cone-shaped or pyramid-shaped x-ray beam passes through the compressed breast and forms a two-dimensional projection image. Any one of a number 25 of orientations can be used, such as cranial-caudal (CC) or MLO (mediolateral-oblique) orientation. More recently, breast x-ray tomosynthesis has been proposed. The technology typically involves taking two-dimensional (2D) projection images of the immobilized breast at each of a number of angles of the x-ray beam relative to the breast and processing the resulting x-ray measurements to reconstruct images of breast slices that typically are in 30 planes transverse to the x-ray beam axis, such as parallel to the image plane of a 1 mammogram of the same breast. The range of angles is substantially less than in computerized tomography, i.e. substantially less than 180°, e.g. ±15°. Tomosynthesis technology is described in U.S. Patent Application Ser. No. 10/723,486 filed November 26, 2003; a prototype of a unit with at least some of the described features was shown at 5 the 2003 Radiological Society of North America meeting in Chicago, 111. Additional prototypes are in clinical testing in this country as of the filing of this patent specification. Other approaches to tomosynthesis also have been proposed: see, e.g., U.S. Patents Nos. 4,496,557, 5,051,904, 5,359,637, 6,289,235, and 6,647,092, published U.S. Patent Applications Nos. 2001/0038861, 2004/066882, 2004/0066884, and 2004/0066904, and 10 Digital Clinical Reports, Tomosynthesis (GE Brochure 98-5493, 11/98). How to reconstruct tomosynthesis images is discussed in DG Grant, "Tomosynthesis: a three-dimensional imaging technique", IEEE Trans. Biomed. Engineering, Vol BME-19, #1, (January 1972), pp 20-28. See, also, U.S. Provisional Application Serial No. 60/628,516, filed November 15, 2004, and entitled “Matching geometry generation and display of 15 mammograms and tomosynthesis images”. Mammography systems can also be used in interventional procedures, such as biopsy, by adding a biopsy station (for example, the StereoLoc IITM Upright Stereotactic Breast Biopsy System, which is available from Hologic, Inc.). The patents, applications, brochures, and article cited above are hereby incorporated by reference in this patent specification as though fully set forth herein. 2017204458 29 Jun2017 20 [0005] In clinical use, it can be desirable for a number of reasons to assess both tomosynthesis images and conventional mammograms of the patient’s breasts. For example, the decades of conventional mammograms have enabled medical professionals to develop valuable interpretation expertise. Mammograms may offer good visualization of microcalcifications, and can offer higher spatial resolution compared with 25 tomosynthesis. Tomosynthesis images may have different desirable characteristics - e.g., they may offer better visualization of structures that can be obscured by overlying or underlying tissue in a conventional mammogram.

[0006] While the existing and proposed systems for x-ray mammography and tomosynthesis offer many advantages, it is believed that a need still exists for further 30 improvements to make mammography/tomosynthesis more useful, and that it is particularly desirable to make it possible to use the same system in different modes of 2 operation and thereby reduce acquisition and operating costs and provide greater clinical value and convenience. 2017204458 29 Jun2017 [0007] A reference herein to a patent document or other matter which is given as prior art is not to be taken as an admission or a suggestion that the document or matter was 5 known or that the information it contains was part of the common general knowledge as at the priority date of any of the claims.

SUMMARY OF THE INVENTION

[000S] This patent specification describes examples of systems and methods for multi-mode breast x-ray imaging. A single system carries out breast imaging in modes 10 that include standard mammography, diagnostic mammography, dynamic imaging such as with a contrast agent and at different x-ray energies, tomosynthesis imaging, combined standard and tomosynthesis imaging during a single breast compression, needle localization, and stereotactic imaging with a biopsy station mounted to the system.

[0009] Viewed from one aspect, there is provided a multi-mode breast x-ray 15 imaging system comprising: an x-ray source, an x-ray receptor, a compression arm assembly configured to immobilize a patient’s breast between the x-ray source and the x-ray receptor, and wherein the x-ray source and the x-ray receptor are configured to be angled differently relative to each other for two or more modes of operation of the x-ray imaging system in which each mode is temporally spaced from another mode of operation, 20 the two or more modes of operation being performed under a same breast compression, and wherein an automatic exposure control (AEC) varies during the two or more modes of operation, in which the receptor count varies during the two or more modes of operation to compensate for radiographic scatter.

[0010] Also described herein is there is provided a multi-mode breast x-ray 25 imaging system comprising: an x-ray tube assembly comprising an x-ray source for imaging a breast, an x-ray receptor, a compression arm assembly configured to immobilize a patient’s breast between the x-ray tube assembly and the x-ray receptor, a patient shield secured to the compression arm assembly and positioned generally parallel to but outside the path of x-ray beams from the x-ray source, wherein the x-ray tube assembly and the x-30 ray receptor are configured to be angled differently relative to each other for at least two 3 modes of operation of the x-ray imaging system in which each mode is temporally spaced from another mode of operation, a first mode of operation comprising mammography imaging, a second mode of operation comprising tomosynthesis imaging, the two or more modes of operation being performed under a same breast compression, wherein the x-ray 5 tube assembly rotates relative to the compression arm assembly in the second mode of operation, and wherein an automatic exposure control (AEC) varies during the two or more modes of operation, in which the receptor count varies during the two or more modes of operation to compensate for radiographic scatter. 2017204458 29 Jun2017 [0011] A system for multi-mode breast x-ray imaging may be provided which 10 supports imaging using at least two imaging modes. At least one imaging mode differs from at least one other imaging mode by at least one imaging procedure selected from a group including, but not limited to, receptor motion, anti-scatter grid use, exposure control and patient shielding. Breast imaging using each of the different modes may occur during a single compression and image scan of the breast or for temporally spaced compressions 15 and scans.

[0012] Also described is a multi-mode breast x-ray imaging system comprising: an x-ray source; and an x-ray receptor, wherein the x-ray source and x-ray receptor are configured to operate using at least two different imaging modes and wherein at least one imaging procedure is executed differently in each of the at least two different imaging 20 modes during the single scan.

[0013] The system supports a combination imaging mode wherein images are captured using at least two imaging modes (either during a single image scan or during different image scans) and wherein each of the at least two imaging modes uses at least one different imaging procedure. For dual mode capture using a single scan, such an 25 arrangement facilitates fast capture of a plurality of images of different types without decompression of a patient’s breast. As a result, the quantity and quality of information available for screening and diagnosis is substantially increased without concomitant increase in examination time, or patient discomfort. For dual mode capture using different image scans, such an arrangement allows different imaging protocols to be implemented 30 using a single imaging system. As a result, the quantity and quality of information 4 available for screening and diagnosis is substantially increased without concomitant increase in examination equipment cost. 2017204458 29 Jun2017 [0014] In an example of a system using the teachings of this patent specification, a compression arm assembly for compressing and immobilizing the breast for x-ray 5 imaging, an x-ray tube assembly, and an x-ray image receptor can be angled differently relative to each other for different imaging protocols and modes. For example, in first 4a mode such as a mammography mode the receptor may be positioned generally normal to the plane of the x-ray tube assembly. In second mode, such as a tomosynthesis mode, as the x-ray tube assembly rotates through a first angular range the receptor rocks through a second angular range that is less than the first angular range such that the relative position 5 of the x-ray tube assembly and x-ray receptor is offset from normal. In a preferred embodiment, the x-ray tube assembly and the x-ray receptor rotate and rock with different angular displacements. As described above, the system supports a combination imaging mode wherein a plurality of images are captured during either during a single scan of the x-ray tube assembly or during multiple, temporally spaced scans, using at least two 10 different imaging modes (where ‘temporally spaced’ may mean a different scan during the same compression of the breast or a different scan using a later compression of the same breast). In such an arrangement, the receptor moves into a plurality of positions relative to the x-ray assembly, at least one different position for each of the modes of imaging that are performed during the single scan. 2017204458 29 Jun2017 15 [0015] A patient shield can be removably mounted to the compression arm assembly to provide a mechanical interlock against patient contact with the rotating x-ray tube assembly. In one embodiment, the patient shield may move to different positions for at least two different imaging modes of the multi-mode system. In an alternate embodiment, the patient shield may be removed and/or replaced for each of the different imaging modes 20 of the multi-mode system.

[0016] A removable anti-scatter grid can be used that can cover the imaging area of the x-ray receptor in some modes but be removed for other modes. In a preferred embodiment, the anti-scatter grid is positioned parallel to and above the receptor in a first mode, and retracted in a second mode. However, as will be described in more detail 25 below, other methods in addition to retraction may be used to remove the anti-scatter grid and the present invention is not limited to any particular method of grid removal.

[0017] In some embodiments, Automatic Exposure Controls (AECs) are varied in accordance with at least one of an imaging mode and a breast density.

[0018] The exemplary system further includes a breast compression paddle that is 30 laterally movable, under manual control or when motorized and operating under software control. The compression paddle can shift automatically depending on the view to be acquired. For example, the paddle can be centered on the x-ray receptor for a CC view, 5 shifted to one lateral side of the receptor for an MLO view of one breast and to the other lateral side of the receptor for an MLO view of the other breast. The paddle can be automatically recognized by the system when mounted so that the shifts can be adjusted to the type of paddle. 2017204458 29 Jun2017 5 [0019] The compression paddle can be easily removable from a support that has a mechanism for laterally moving the paddle and for allowing the paddle to tilt for better conformance with the breast for selected image modes but locking the paddle against tilt for other modes. With the movement mechanism in the support and not integral with the paddle, the paddle can be simple and inexpensive, and easy to mount to and remove from 10 the support. A number of relatively inexpensive paddles of different sizes and shapes can be provided and conveniently interchanged to suit different procedures and patients.

[0020] Also described is a method of acquiring both 2D and 3D images of a patients breast using a multi-mode imaging system which comprises an x-ray tube assembly and an x-ray receptor, wherein the patient’s breast is compressed between the x-ray tube 15 assembly and the x-ray receptor and wherein the 2D and 3D images are acquired without decompressing the breast includes the steps of: moving the x-ray tube assembly to a plurality of positions associated with 2D and 3D imaging modes; and executing at least one imaging procedure differently for each of the 2D and 3D modes during the single scan. 20

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Embodiments of the invention will now be described with reference to the accompanying drawings. It is to be understood however that the drawings are examples only and do not limit the scope of the invention as it is defined in the claims appended 25 hereto.

[0022] Fig. 1 is a perspective view of a gantry and an acquisition workstation in accordance with an example of the disclosed system.

[0023] Fig. 2 is an enlarged view of a portion of the system of Fig. 1, with a tube arm assembly in a rotated position. 30 [0024] Fig. 3 is a front elevation of the apparatus of Fig. 2. 6 Γ0025] Fig. 4 is a side view of a gantry with a biopsy station and a spacer, with schematic illustration of other mechanisms. 2017204458 29 Jun2017 [0026] Fig. 5 is an enlarged view of a portion of Fig. 1. Γ0027] Fig. 6 is a block diagram of the disclosed system when connected to other 5 systems.

[0028] Fig. 7 is a flow chart illustrating a general work flow for the disclosed system.

[0029] Fig. 8 is a flow chart illustrating one of several examples of work flow for a standard mammography mode.

[0030] Fig 9 is a flow chart illustrating one of several examples of work flow for an 10 image detector subsystem in the standard mammography mode.

[0031] Fig. 10 is a perspective view of the structure of Fig. 4.

[0032] Fig. 11 is similar to Fig. 2 but shows a tube arm assembly angled differently.

[0033] Fig. 12 is a front elevation of the structure of Fig. 11.

[0034] Fig. 13 is a flow chart illustrating one of several examples of work flow for a 15 tomosynthesis mode.

[0035] Fig. 14 is a flow chart illustrating one of several examples of work flow for an image detector subsystem in the tomosynthesis mode.

[0036] Fig. 15 is a flow chart illustrating one of several examples of work flow for a combination mode. 20 [0037] Fig. 16 is a flow chart illustrating one of several examples of work flow for an image detector subsystem in the combination mode.

[0038] Fig. 17 is an enlarged side view of a structure for removably mounting a breast compression paddle.

[0039] Figure 18 is a graph illustrating a relationship between target count and breast 25 thickness.

[0040] Figure 19A is a flow diagram illustrating exemplary steps for varying target count using breast density information. 7 [0041] Figure 19B is a graph illustrating various relationships between target count and breast density. 2017204458 29 Jun2017

DETAILED DESCRIPTION 5 [0042] In describing examples and preferred embodiments illustrated in the drawings, specific terminology is employed for the sake of clarity. However, the disclosure of this patent specification is not intended to be limited to the specific terminology so selected and it is to be understood that each specific element includes all technical equivalents that operate in a similar manner. 10 [0043] Figs. 1-6 illustrate a non-limiting example of a multi-mode mammography/ tomosynthesis system comprising a gantry 100 and a data acquisition work-station 102. Gantry 100 includes a housing 104 supporting a tube arm assembly 106 rotatably mounted thereon to pivot about a horizontal axis 402 (Fig. 4) and carrying an x-ray tube assembly 108. X-ray tube assembly 108 includes (1) an x-ray tube generating x-ray energy in a 15 selected range, such as 20-50 kV, at mAs such as in the range 3-400 mAs, with focal spots such as a nominal size 0.3 mm large spot and nominal size 0.1 mm small spot (2) supports for multiple filters such as molybdenum, rhodium, aluminum, copper, and tin filters, and (3) an adjustable collimation assembly selectively collimating the x-ray beam from the focal spol in a range such as from 7x8 cm to 24x29 when measured at the image plane of 20 an x-ray image receptor included in the system, at a maximum source-image distance such as 75 cm. Also mounted on housing 104, for rotation about the same axis 402, is a compression arm assembly 110 that comprises a compression plate 122 and a receptor housing 114 having an upper surface 116 serving as a breast plate and enclosing a detector subsystem system 117 comprising a flat panel x-ray receptor 502 (Fig. 5), a retractable 25 anti-scatter grid 504 and a mechanism 506 for driving and retracting anti-scatter grid 504. Housing 104 also encloses the following components schematically illustrated in Fig. 4: a vertical travel assembly 404 for moving tube arm assembly 106 and compression arm assembly 110 up and down to accommodate a particular patient or imaging position, a tube arm assembly rotation mechanism 406 to rotate tube arm assembly 106 about axis 30 402 for different imaging positions, a detector subsystem rotation mechanism 408 for rotating components of detector subsystem 117 (such as x-ray receptor 502) about axis 402 to accommodate different operations modes, and couple/uncouple mechanism 410 to 8 selectively couple or uncouple tube arm assembly 106 and compression arm assembly 110 to and from each other, and tube arm assembly 106 and detector subsystem 117 to and from each other. Housing 104 also encloses suitable motors and electrical and mechanical components and connections to implement the functions discussed here. 2017204458 29 Jun2017 5 [0044] A patient shield 200, schematically illustrated in Fig. 2, can be secured to compression arm assembly 110 to provide a mechanical interlock against patient contact with the rotating x-ray tube arm assembly 106 and reduce patient interference with the x-ray image capture. One exemplary patient shield is a shifting patient shield that is positioned generally parallel to but outside the path of x-ray beams from source 108. The 10 shifting face shield is supported by an extension arm that extends laterally from the compression arm assembly and permits movement of the face shield along a z axis (indicated by line 202) between a patient access position and a patient shielding position as described in U.S. Provisional application 61/075,226, incorporated herein by reference. In various embodiments the patient shield may be removably secured either to the 15 extension arm, compression arm assembly or the x-ray source assembly 108 to facilitate removal and/or replacement of shields for different imaging modes. In various embodiments, the face shield may be of fixed size, or may be adjustably sized. An example of an adjustable face shield is disclosed in U.S. 7,315,607, incorporated herein by reference, where the face shield is positioned to slide vertically along a y-axis, as indicated 20 by arrow 201, up into the x-ray assembly. The vertical movement removes the face shield to allow for patient positioning as well as allows the shield to be selectively positioned to provide shields of different sizes for different imaging modes. Alternate embodiments are also envisioned wherein the face shield is programmed to shift laterally along an x-axis in response to a selection of a particular imaging mode. Such an embodiment is described in 25 U.S. patent 7,245,694 issued July 17, 2007 to Hologic Inc., and incorporated herein by reference. In summary, it is anticipated that different shields or shield arrangements may be used in a system of the present invention which supports a combination imaging mode, wherein the shield is removable or moves, either automatically or manually, between at least two positions for at least two different imaging modes. 30 [0045] Work-station 102 comprises components similar to those in the Selenia™ mammography system, including a display screen (typically a flat panel display that may include touch-screen functionality), user interface devices such as a keyboard, possibly a 9 touch-screen, and a mouse or trackball, and various switches and indicator lights and/or displays. Work-station 102 also includes computer facilities similar to those of the Selenia™ system (but adapted through hardware, firmware and software differences) for controlling gantry 100 and for processing, storing and displaying data received from 5 gantry 100. A power generation facility for x-ray tube assembly 108 may be included in housing 104 or in work-station 102. A power source 118 powers work-station 102. Gantry 100 and work-station 102 exchange data and controls over a schematically illustrated connection 120. 2017204458 29 Jun2017 [00461 As illustrated in Fig. 6, additional storage facilities 602 can be connected to 10 work-station 102, such as one or more optical disc drives for storing information such as images and/or for providing information to work-station 102 such as previously obtained images and software, or a local printer (not shown). In addition, the disclosed system can be connected to a hospital or local area or other network 604, and through the network to other systems such as a soft copy workstation 606, a CAD (Computer Aided Detection) 15 station 608 for computer- processing mammography and/or tomosynthesis images to identify likely abnormalities, an image printer 610 for printing images, a technologist workstation 612, other imaging systems 614 such as other mammography systems or systems for other modalities for exchange of images and/or other information, and to a PACS (Picture Archiving) systems 616 for archiving images and other information and/or 20 retrieving images and other information.

[0047] The illustrated system has several modes of operation. An example of typical workflow generally applicable for each mode is illustrated in Fig. 7, and several examples of operational modes are discussed below. Of course, this is only one example and workflow steps may be arranged differently. In all modes, the operator can perform x-ray 25 exposure using manual setting of technic factors such as mA and mSec, or can use an Automatic Exposure Control (AEC) method as known in the art to set the exposure time, kV and filter modes for an image, for example by using a short, low-x-ray dose preexposure. Work-station 102 is set up to record the exposure technic information and associate it with the breast image for later review. 30 [0048] During an exemplary Automatic Exposure Control (AEC) method, a short (e.g., ~5 msec) an x-ray is taken (either at a low dose, or full dose) and the image receptor’s image is read by a computer process. This initial x-ray is often referred to as a ‘scout’ 10 image. The computer process uses information from the scout image to identify the breast’s radio-density and to calculate the correct final x-ray tube exposure voltage kVp, current mAs, and exposure time for delivering a desired x-ray dose be obtained prior to performing mammography or tomosynthesis. 2017204458 29 Jun2017 5 [0049] In an alternate embodiment described in U.S. Patent 7,245,694, in a combination mammography/tomosynthesis system when a tomosynthesis scan follows a mammogram, the mammogram exposure data may be used to estimate tomosynthesis exposure techniques, hi still another alternate embodiment, a first tomosynthesis image may be used to as the ‘scout’ image to estimate the appropriate exposure factors for the 10 remaining images in the tomosynthesis sequence.

[0050] Lookup tables have historically been used to identify appropriate kVp and mAs for desired exposures using scout or mammogram images. Look-up tables are reliable in 2D mammography systems which position the x-ray source normal to the detector and utilize anti-scatter grids to minimize radiographic scatter. In such systems the detector 15 count rate may be fixed, with exposure dosing being controlled by varying the kVp and mAs.

[0051] However tomosynthesis systems which do not maintain a constant perpendicular relationship between the receptor and the x-ray source are not able to use an anti-scatter grid. The present invention recognizes that such systems may benefit from 20 improved exposure control techniques having the ability to vary the target detector count to compensate for radiographic scatter, where the detector count relates a count of photons to a desired x-ray dose. In a preferred embodiment the detector count is varied in accordance with a thickness of the imaged breast. Thus thicker breasts, which experience a higher radiographic scatter, have a higher detector target count. Varying the detector 25 count in accordance with breast thickness ensures that image quality of the breasts is maintained despite increased scatter. Accordingly, in one embodiment the present invention compensates for the increased scatter by varying the target count in response to at least one of a breast thickness or a breast density. Image exposure is controlled by reducing the detector target counts for compressed breasts having a thickness that is below 30 the lower breast thickness threshold, and increasing detector target counts for compressed breasts having a thickness that is above the upper breast thickness threshold as shown in Figure 18. 11 [0052] According to a further aspect of the invention and as shown in Figures 19A and 19B,_target counts are varied in response to breast density rather than breast thickness. Figure 19A is a flow diagram illustrating a process 1900 according to the present invention which suggests a method of varying target count based on breast density. At step 2017204458 29 Jun2017 5 1910 the breast is compressed and at step 1912 a low voltage scout pulse is emitted from the x-ray source. At step 1914 the x-ray detector values are quickly read and evaluated to locate the portion of the breast associated with the highest signal attenuation, i.e., the ‘target’. At step 1916 a target count associated with this attenuation is then selected, for example from a previously populated lookup table. In general, as is known in the art, the 10 higher the attenuation at the target, the higher the target counts. Figure 19B is a graph that illustrates several exemplary functions for varying the target count in response to breast density, for example where the target count increases linearly (as shown by line 1920), stepwise (1922) or according to a predetermined function (1924).

[0053] Thus, when a multi-mode imaging system is used in combination mode, several 15 different AEC techniques and/or parameters may be used during a single sweep of the x- ray tube assembly arm (or between different sweeps of the x-ray tube assembly).

[0054] In addition, although the table illustrates that a common kV, mA and count is provided for a given thickness, it is also envisioned that the AEC values may be customized for different imaging positions along the tomosynthesis path to accommodate 20 for different types of radiographic scatter resulting from different x-ray source/receptor angular relationships, whether the imaging positions be associated with different imaging modes (such as mammography and tomosynthesis) or within the same imaging mode (i.e., different tomosynthesis imaging angles).

[0055] In standard mammography mode, typically used for screening mammography, 25 tube arm assembly 106 and compression arm assembly 110 are coupled and locked

together by 410 in a relative position such as seen in Fig. 1, such that an x-ray beam from x-ray tube assembly 108 illuminates x-ray receptor 502 when the patient’s breast is compressed by compression device 112. In this mode, the system operates in a manner similar to said Selenia™ system to take a mammogram. Vertical travel assembly 404 and 30 tube arm rotation mechanism 406 can make vertical adjustments to accommodate a patient, and can rotate tube arm assembly 106 and compression arm assembly 110 together as a unit about axis 402 for different image orientations such as for CC and for MLO 12 images. For example, lube arm assembly 106 and compression arm assembly 110 can rotate between (-195°) and (+150°) about axis 402. As in the Selenia™ system, compression device 112 includes a compression paddle 122 that can move laterally, in a direction along the chest wall of a patient, to adjust for different imaging orientations. 2017204458 29 Jun2017 5 However, as described further below, the mechanism for supporting and moving compression paddle 122 is different. Typically, anti-scatter grid 504 is over x-ray receptor 502 in the standard mammography mode to reduce the effect of x-ray scatter. Fig. 8 illustrates a typical workflow for an exposure in standard mammography mode, and Fig. 10 illustrates an example of the operation of detector subsystem 117 in standard 10 mammography. Of course, these are only examples; other workflow steps or orders of steps can be used instead. Γ0056] In a diagnostic mode, the patient’s breast can be spaced from upper surface 116, for example by an x-ray translucent spacer gantry 1002 (Fig. 10), with the system otherwise similar to Fig. 1, for a magnification of up to 1.8, for example. In this mode, as 15 in standard mammography, tube arm assembly 106 and compression arm assembly 110 are locked to each other and can move up or down and rotate about axis 402 for different image orientation. A different spacer 1002 can be used for a different degree of magnification. Also, differently shaped or dimensioned compression paddles 122 can be used for different breast compression effects. The x-ray tube in x-ray tube assembly 108 20 can be set to a smaller focal spot size to improve a diagnostic image. In this mode, anti-scatter grid 504 typically is retracted or otherwise removed when magnification is used such that grid 504 is completely out of the image. The user can elect not to use a spacer 1002 in diagnostic imaging, in which case anti-scatter grid 504 can be used over the entire image. 25 [0057] In a dynamic imaging mode, a number of breast images are taken while the patient’s breast remains compressed. In one technique, an agent such as iodine is injected into the patient and after a suitable waiting time such as about one minute for a maximum uptake, two images breast are taken in rapid succession, for example one at an x-ray energy just above the K-edge of iodine and one at an energy just below the K-edge. 30 Alternatively, a succession of breast images can be taken at a single x-ray energy band or bands just above and below the K-edge, or at another x-ray energy range, to track the uptake of agent over time. Another technique adds taking a baseline breast image before 13 or soon after injecting the agent and using it together with later breast images to generate subtraction images that provide better visualization of anatomy that may be of interest. Still another dynamic imaging mode technique comprises injecting a contrast agent and taking a succession of images over a period such as 5-7 minutes, for example one image 5 every minute, and processing the image data to generate for each pixel, or at least for each pixel of interest, a histogram of the change in the pixel value, to thereby use the manner in which pixel values change to differential abnormal tissue. For this mode, work-station 102 can store preset data that commands gantry 100 and work-station 102 to take a desired sequence of images for the dynamic mode technique selected by the operator, such that the 10 command data sets the appropriate parameters such as x-ray energy, dose, timing of images, etc. Alternatively, such processing to assess changes in pixel values can be done for a region of interest rather than over individual pixels, to produce information such as a measure of changes in the average pixel values in the region of interest. 2017204458 29 Jun2017 [0058] In tomosynthesis mode, tube arm assembly 106 and compression arm assembly 15 110 are decoupled by unit 410 such that compression arm assembly 110 stays in one position, compressing the patient’s breast, while tube arm assembly 106 rotates about axis 402, for example between the position illustrated in Fig. 2 to that illustrated in Fig. 11, or +15° relative to compression arm assembly 110. In one embodiment, during tomosynthesis mode the x-ray tube assembly rotates in an arc shaped path within a plane 20 although this is not a requirement of the invention. Other tomosynthesis embodiments wherein the x-ray tube moves in a non-arc shaped path, for example through movement of the source outside of the plane of the x-ray assembly, or alternatively movement of the x-ray source vertically within the plane, are also envisioned.

[0059] Tomosynthesis can be carried out for different image orientations, so that 25 compression arm assembly 110 can be rotated about axis 402 (alone or together with assembly 106) for a desired image orientation and locked in place, and then tube arm assembly 106 can be rotated relative to that position of compression arm assembly 110 for tomosynthesis imaging over ±15° or some other desired angular range. In one example, 11 images are taken during an angular sweep of tube arm assembly 106, one every 30 approximately 3°. However, a different number of images can be taken, for example up to 21 during a single sweep. For tomosynthesis images, the x-ray tube in x-ray tube assembly 108 continuously rotates and the x-ray tube is pulsed for each image, for 14 example, for x-ray energy pulses each lasting approximately 100 mSec, although pulses of different duration can be selected. Alternatively, the rotational motion can stop for taking each image, or continuous motion without pulsing can be used (and the timing of data measurements relied to define pixel values). As seen in Figs. 2, 3, 5, 11 and 12, in this 5 mode mechanism 506 fully retracts anti-scatter grid 504 away from x-ray receptor 502 so grid 504 is out of the image. Alternate methods of removing the anti-scatter grid from the image, such as ejecting the grid out of a side of the receptor housing 114 or otherwise accessing and removing the grid are also contemplated by this invention. 2017204458 29 Jun2017 [0060] Also as seen in these Figs., while the breast remains immobilized in 10 compression arm assembly 110 during the angular sweep of tube arm assembly 106, in one embodiment the x-ray receptor 502 rocks within receptor housing 114. In this rocking motion, controlled by unit 408 (Fig. 4), a line normal to the image face of x-ray receptor 502 may keep pointing to the focal spot of the x-ray tube in x-ray tube assembly 108. Alternatively, the rotation of tube arm assembly 106 and rocking of x-ray receptor 502 can 15 be through different angles; for example, tube arm assembly 106 can rotate through 15° while x-ray receptor 502 rocks through 5°, i.e. the rocking angle can be an amount one-third that of assembly 108. In general, the receptor 502 rocks in concert with, but with a smaller angular displacement, from the x-ray tube assembly. Although a one-third relationship has been described, the present invention is not limited to any particular 20 fractional angular relationship between the assembly and the receptor, and the present invention envisions systems wherein the detector is stationary during imaging.

[0061] Synchronous rotation of tube arm assembly 106 and rocking of x-ray receptor 502 can be achieved by controlling separate motors for each or, alternatively, through using a motor to drive tube arm assembly 106 and a mechanical coupling between the 25 rotation of lube arm assembly 106 and rocking of x-ray receptor 502. Image data can be obtained and processed into tomosynthesis images for display and/or storage as described in the material incorporated by reference, for example in co-pending patent application Ser. No. 10/723,486 or in U.S Provisional Application No. 60/628,516, filed November 15, 2004. Fig. 13 illustrates a typical workflow for tomosynthesis mode operation, and 30 Fig. 14 illustrates an example of the operation of detector subsystem 117 in that mode. Again, these are only examples, and other steps or orders of steps can be used instead. 15 Γ0062] It should be noted that although in preferred embodiments the receptor rocks such that it is positioned offset from normal to the x-ray source, this is not a requirement of the invention. Alternate embodiments where the receptor rotates along the same angular displacement and synchronous to the x-ray source are also contemplated. In 5 addition, embodiments where the x-ray receptor moves linearly or laterally in a plane, rather than rocking, are within the scope of the present invention. In addition, in embodiments wherein the x-ray source assumes a non-arc shaped path, systems wherein the receptor rotates or tilts in a manner related to the x-ray source movement are contemplated by the present invention. Of course other embodiments wherein the detector 10 remains stationary are also contemplated by this invention. 2017204458 29 Jun2017 [00631 hi a combination mode, during a single compression of the patient’s breast the system takes a conventional mammogram and tomosynthesis images. In this mode, while the breast remains compressed in compression arm assembly 110, (1) tube arm assembly 106 sweeps and x-ray receptor 502 rocks, each through an appropriate angle, and 15 exposures are taken for tomosynthesis images, and (2) a standard mammogram is taken. The standard mammogram can be taken at a 0° relative angle between tube arm assembly 106 and a normal to the imaging plane of x-ray receptor 502, and can be taken before or after the tomosynthesis images are taken or between the taking of two successive tomosynthesis images. Typically, each tomosynthesis image utilizes substantially lower 20 x-ray dose than the standard mammogram. For example, the total x-ray dosage for tomosynthesis imaging in one sweep of tube arm assembly 106 can be approximately the same as that for a single standard mammogram, or up to approximately three times that dosage. The relationship between the two dosages can be user-selected. Figure 15 illustrates an example of workflow for the combination mode, and Fig. 16 illustrates an 25 example of the operation of detector subsystem 117 in that mode. Again, these are examples, and different steps or orders of steps can be used instead. For example, a preferred approach may be to take the standard mammogram first, then move arm 106 to one end of its rotational range for tomosynthesis and take the tomosynthesis images. The order in which the two types of images are taken may be optimized such that the overall 30 imaging time is minimized, and an order that achieves such minimization can be the preferred order. 16 [0064] The exposure (tube current mA, tube voltage kVp, and exposure length msec) techniques for the standard mammogram and the tomosynthesis exposures can be set manually, by using automatic methods or using the methods described above. If the standard mammogram is taken first, its exposure techniques can be used to set an optimal 2017204458 29 Jun2017 5 technique for the subsequent tomosynthesis images, and vice versa. The exposure technique can be modified dynamically, if the software senses that the signal reaching the image receptor is either too low or too high and adjust subsequent exposures as needed.

[0065] In a stereotactic mode, during a single compression of the patient’s breast at least two images of taken, for example one at (+15)° angle and one at (-15°) angle of tube 10 arm assembly 106 relative to compression arm assembly 110, although other angles can be used and more images can be taken. X-ray receptor 502 can remain in place for this procedure, or can be rocked through a selected angle, for example through an angle sufficient to maintain the same orientation of the imaging surface of receptor 502 relative to tube arm assembly 106. A spacer 1002 can be used for magnification. If x-ray receptor 15 502 remains in place despite rotation of arm 106, or if spacer 1002 is used, anti-scatter grid 504 is fully retracted; if x-ray receptor 502 maintains its orientation relative to tube arm assembly 106 and not spacer 1002 is used, anti-scatter grid 504 need not be retracted. As is known in the art, the two or more images can be used to identify the location of a lesion, so that needle biopsy can be used, for example with an upright needle biopsy 20 station 412 (Fig. 4) in a manner similar to that used with the commercially available Selenia™ system and StereoLoc II™. A compression paddle 122 appropriate for needle biopsy typically is used when taking the stereotactic images. Alternatively, some or all of the images taken in the tomosynthesis mode and/or in the combined mode can be used to identify the location of a lesion for biopsy, in which case a compression paddle 122 25 appropriate for the purpose typically is used when taking the images.

[0066] In needle localization mode, x-ray images can be taken after a biopsy or other needle is inserted into the compressed breast. For this purpose, imaging such as in the stereotactic mode, the tomosynthesis mode, or the combined mode can be used.

[0067] In the disclosed system, compression paddle 122 is movable laterally, as 30 generally described in co-pending U.S. Patent Application Publication No. 2005/0063509

Al, hereby incorporated by reference herein. In addition, compression paddle 122 can pivot about an axis along the patient’s chest wall to conform the breast shape in certain 17 procedures, as discussed in said U.S. Patent 5,706,327. However, in the system of this patent specification compression paddle 122 is mounted differently and moves in a different manner. 2017204458 29 Jun2017 [0068] As illustrated in Figs. 5 and 17, compression paddle 122 is removably mounted 5 to a support 510 that moves up and down compression arm assembly 110 as needed for breast compression. To mount compression paddle 122 onto 510, a projection compression paddle 122a of the paddle engages a projection 510a of the support, and a projection 122b of the paddle latches onto projection 510b of the support. Projection 510a is spring-loaded, such as by a spring schematically illustrates at 510c to allow for pivoting 10 compression paddle 122 about an axis where it latches onto 510, as illustrated by arrow A, for better conformance with the compressed breast in some imaging protocols. Other imaging protocols may require compression paddle 122 not to pivot, in which case projection 510a is locked in place by a locking mechanism in 510 (not shown) to keep compression paddle 122 in place relative to support 510. The locking mechanism can be 15 manually set to a lock position, and manually unlocked by the operator. Alternatively, the locking mechanism can be controlled through an operator input at gantry 100 or workstation 102. A sensing mechanism can be included to sense whether compression paddle 122 is locked against pivoting, to provide information that work-station 102 can use for setting imaging protocols such as for automated breast compression and automated 20 exposure methods. Two knobs 510d, one on each lateral side of support 510, can be manually rotated to move projection 510b and thus compression paddle 122 laterally such that it compress a breast that is not centered laterally on upper surface 116, for example for MLO imaging. Each knob 510d can operate a mechanism such as an endless screw rotating in a nut secured to projection 510b. Alternatively, or in addition, projection 510b 25 and thus compression paddle 122 can be driven laterally by a motor, under control of operator switches or other interface at gantry 100 or at work-station 102, or automatically positioned laterally under computer control.

[0069] Importantly, compression paddle 122 is driven for lateral movement by components that are a part of support 510. Thus, compression paddle 122 can be simple 30 structure, and can even be disposable, with a new one used for each patient or for only a few patients. This can simplify and reduce the cost of using the system, because an imaging facility usually stocks a number of different paddles for different purposes. If the 18 lateral movement mechanism is integral with a compression paddle, the paddle assembly is considerably larger, heavier and more expensive. But with a compression paddle 122 that relies for lateral movement on support 510, and is easily mounted by hand and without tools to support 510, by sliding compression paddle 122a into projection 510a and 5 latching projection paddle 122b onto projection 510b, and is easily removed by reversing the process, the expense of keeping a number of different compression paddles in stock or replacing paddles with new ones is greatly reduced, as are the time and convenience when changing from one type of compression paddle to another. Compression paddle 122 can include a bar code that is automatically read by a bar code reader in support 510, to keep 10 work-station 102 informed of the paddle currently mounted to support 510, for use in automating imaging protocols. For example, the bar code information can be checked to ensure through computer processing that the type of paddle that is currently mounted on support 510 matches the imaging that will be commanded, and the information from the sensor for whether compression paddle 122 is locked in non-tilting mode can be used to 15 automatically make adjustments for compression height to ensure accurate automatic x-ray exposure operation. Further, the bar code information identifying the paddle can be used to automatically set collimation in x-ray lube assembly 108 so that the x-ray beam matches the size and shape of the currently installed compression paddle 122. 2017204458 29 Jun2017 [0070] Thus a system for multi-mode breast x-ray imaging that supports at least two 20 imaging modes has been shown and described. Multiple different imaging modes may be used in a single breast compression or alternatively using temporally spaced compressions. The imaging modalities include, but are not limited to, mammography, dynamic imaging mode, diagnosis mode, tomosynthesis, combination mode and stereotactic mode. The system facilitates imaging protocols wherein at least one imaging mode differs from at 25 least one other imaging mode for at least one imaging capture procedure selected from a group including, but are not limited to receptor motion, x-ray source location, anti-scatter grid use, exposure control and patient shielding.

[0071] The system further supports a combination imaging mode wherein images are captured using at least two imaging modes during a single image scan and wherein each of 30 the at least two imaging modes differs by at least one image capture procedure during the single scan. Such an arrangement facilitates fast capture of a plurality of images of different types without decompression of a patient’s breast. As a result, the quantity and 19 quality of information available for screening and diagnosis is substantially increased without concomitant increase in examination time or patient discomfort. 2017204458 29 Jun2017 [0072] The above specific examples and embodiments are illustrative, and many variations can be introduced on these examples and embodiments without departing from 5 the spirit of the disclosure or from the scope of the appended claims. For example, elements and/or features of different illustrative embodiments may be combined with each other and/or substituted for each other within the scope of this disclosure and appended claims.

[0073] Where the terms “comprise”, “comprises”, “comprised” or “comprising” are 10 used in this specification (including the claims) they arc to be interpreted as specifying the presence of the stated features, integers, steps or components, but not precluding the presence of one or more other feature, integer, step, component or group thereof. 20

Claims (17)

1. The claims defining the invention are as follows:

   1. A multi-mode breast x-ray imaging system comprising: an x-ray source, an x-ray receptor, a compression arm assembly configured to immobilize a patient’s breast between the x-ray source and the x-ray receptor, and wherein the x-ray source and the x-ray receptor are configured to be angled differently relative to each other for two or more modes of operation of the x-ray imaging system in which each mode is temporally spaced from another mode of operation, the two or more modes of operation being performed under a same breast compression, and wherein an automatic exposure control (AEC) varies during the two or more modes of operation, in which the receptor count varies during the two or more modes of operation to compensate for radiographic scatter.
2. 2. The multi-mode breast x-ray imaging system of claim 1, wherein the AEC varies during the second mode of operation, a tomosynthesis mode of imaging.
3. 3. The multi-mode breast x-ray imaging system of any of the foregoing claims, wherein the receptor count varies in accordance with a thickness of the patient’s breast.
4. 4. The multi-mode breast x-ray imaging system of any of the foregoing claims further comprising a removable anti-scatter grid configured to be positioned between the x-ray source and the x-ray receptor, wherein the removable anti-scatter grid is positioned between the x-ray source and the x-ray receptor for the first mode of operation and removed for the second mode of operation.
5. 5. The multi-mode breast x-ray imaging system of any of the foregoing claims, wherein the x-ray receptor rocks in at least one of the modes of operation.
6. 6. A multi-mode breast x-ray imaging system comprising: an x-ray tube assembly comprising an x-ray source for imaging a breast, an x-ray receptor, a compression arm assembly configured to immobilize a patient’s breast between the x-ray tube assembly and the x-ray receptor, a patient shield secured to the compression arm assembly and positioned generally parallel to but outside the path of x-ray beams from the x-ray source, wherein the x-ray tube assembly and the x-ray receptor are configured to be angled differently relative to each other for at least two modes of operation of the x-ray imaging system in which each mode is temporally spaced from another mode of operation, a first mode of operation comprising mammography imaging, a second mode of operation comprising tomosynthesis imaging, the two or more modes of operation being performed under a same breast compression, wherein the x-ray tube assembly rotates relative to the compression arm assembly in the second mode of operation, and wherein an automatic exposure control (AEC) varies during the two or more modes of operation, in which the receptor count varies during the two or more modes of operation to compensate for radiographic scatter.
7. 7. The multi-mode breast x-ray imaging system of claim 6, wherein the patient shield is supported by an extension arm that extends laterally from the compression arm assembly.
8. 8. The multi-mode breast x-ray imaging system of claim 7, wherein the extension arm is removably secured to the compression arm assembly.
9. 9. The multi-mode breast x-ray imaging system of any of claims 6-8, wherein the patient shield is removably secured to the compression arm assembly.
10. 10. The multi-mode breast x-ray imaging system of any of claims 6-9, wherein the patient shield is configured to shift laterally, generally along the same direction of movement as the x-ray tube assembly relative to the compression arm assembly in the second mode of operation.
11. 11. The multi-mode breast x-ray imaging system of claim 10, wherein the patient shield is shifted automatically between at least two positions.
12. 12. The multi-mode breast x-ray imaging system of claim 10, wherein the patient shield is positioned differently for at least two modes of operation.
13. 13. The multi-mode breast x-ray imaging system of any of claims 6-11 further comprising a removable anti-scatter grid configured to be positioned between the x-ray source and the x-ray receptor, wherein the removable anti-scatter grid is positioned between the x-ray source and the x-ray receptor for the first mode of operation and removed for the second mode of operation.
14. 14. The multi-mode breast x-ray imaging system of any of claims 6-13, wherein a size of a patient shield differs for at least two modes of operation.
15. 15. The multi-mode breast x-ray imaging system of any of claims 6-14, wherein the x-ray receptor rocks in at least one mode of operation.
16. 16. The multi-mode breast x-ray imaging system of any of claims 6-15, wherein the AEC varies during the second mode of operation, a tomosynthesis mode of imaging.
17. 17. The multi-mode breast x-ray imaging system of any of claims 6-16, wherein the receptor count varies in accordance with a thickness of the patient’s breast.