Apparatus and method for integrating tissue sample imaging on radiographic imaging system

Abstract

A tissue imaging system (300) for use in conjunction with a radiographic imaging system (10) comprising a radiation source (16) and a detector (18) comprises a tissue imaging device (302) adapted to be positioned on a surface (50) of the detector (18) of the radiographic imaging system (10) between the radiation source (16) and the detector (18). The tissue imaging device (302) comprises: a housing (314) positionable on the surface (50) of the detector (18), the housing (314) defining an interior and a tissue support surface (319) opposite the surface (50) of the detector (18); and a photon counting energy discrimination (PCED) detector (316), the photon counting energy discrimination (PCED) detector being disposed in the interior of the housing (314). The PCED detector (316) is removably connected to the radiographic imaging system (10) and is operable to generate image data for forming one or more of a multi-energy material decomposition image, a material enhancement image, a 2D / 3D image tomographic reconstruction image, and a phase contrast image of imaged tissue positioned on the tissue support surface (319).

Description

Technical Field

[0001] The present disclosure relates generally to medical imaging systems, including mammography systems and apparatus, and more particularly to biopsy sample imaging systems for use with medical imaging systems. Background Art

[0002] Embodiments of the present invention relate generally to X-ray medical imaging, and more particularly to imaging systems or apparatus and methods for performing various imaging procedures, such as mammographic imaging procedures, including but not limited to spectral mammography (SM), such as 2D / 3D dual energy contrast enhanced (CE) mammography, full field digital mammography (FFDM), or digital breast fusion tomography (DBT) mammography.

[0003] Spectral mammography (SM) is an X-ray imaging modality used to scan the breast for screening, diagnosis and / or interventional examinations. The effectiveness of mammography is affected by many factors, one of which is the two-dimensional (2D) rendering of the images obtained using SM.

[0004] Alternative systems to SM are also known for breast imaging. Some examples include full-field digital mammography that captures images directly onto a flat-panel detector, computed radiography involving the use of a cassette containing imaging plates, or digital breast fusion tomography (DBT). A digital breast fusion tomography (DBT) or mammo-tomo system is a specialized mammography system that acquires several (e.g., dozens) of angularly offset projection X-ray images and reconstructs a three-dimensional (3D) image data set using the resulting X-ray image data.

[0005] The 3D image dataset is used to form various volumetric representations of the imaged breast, including the entire 3D volume of the breast, and various 3D segments of the 3D volume, such as slices or slabs of specified thickness constituting the 3D volume oriented to provide desired views of one or more regions of interest (ROIs) detected within the 3D image dataset.

[0006] Additionally, when a 3D image dataset of the breast has been generated, these 3D image datasets can be used to guide a biopsy device used with a DBT system into the breast to obtain a biopsy of a region of interest (ROI) identified within the 3D image dataset after use in a suitable imaging / diagnostic procedure. In a DBT system, the biopsy device is provided directly on the DBT system so that the 3D image dataset can be used to guide the biopsy device to the ROI to perform the biopsy. The mammographic imaging system provides high quality diagnostic mammographic images of breast tissue so that any ROI therein can be identified and sampled for further analysis in a biopsy procedure performed after the imaging / diagnostic procedure.

[0007] However, the quality of the images provided by the mammographic imaging system, while suitable for initial localization and diagnosis of the ROI, is not suitable for more accurate classification of tissue (e.g., microcalcifications) formed and / or present within the ROI. To this end, it is necessary to generate more detailed images of the biopsy sample obtained from the ROI. In many cases, the biopsy sample is transmitted to a histopathologist for use in a separate imaging system to obtain imaging information about the type of tissue present within the biopsy sample. The histopathology imaging system can be any of a variety of types of imaging systems, including a high-resolution optical system (i.e., a digital microscope) with a suitable contrast agent applied to the biopsy sample, or an X-ray-based imaging system similar to those previously discussed but configured to distinguish tissue types in the biopsy sample, a phase contrast X-ray imaging system, and / or an X-ray system including a photon counting energy discrimination (PCED) detector.

[0008] While being able to provide necessary information regarding the type of tissue present within the biopsy sample, the time required to transport the biopsy sample to the location of the histopathology imaging system and obtain images illustrating the type of tissue present in the biopsy sample is not ideal. More specifically, the delay caused by transporting the biopsy sample to a separate location and / or imaging system may present issues regarding the timeliness of providing the histopathology results to the physician and / or patient.

[0009] In one prior art that attempts to solve this problem, as shown in FIG1 , U.S. Patent No. 9,603,577 (the '577 patent), entitled X-Ray Imaging Apparatus And Control Method Thereof, discloses an X-ray imaging apparatus 1000, which includes an X-ray source 1100 and a pair of detectors 1200A, 1200B movably disposed relative to the X-ray source 1100, the entire contents of which are expressly incorporated herein for all purposes. The first detector 1200A is capable of lateral movement so as to selectively position the first detector 1200A below an object OB to be imaged and in the path of X-rays emitted from the X-ray source 1100 and passing through the object. The second detector 1200B is disposed below the first detector 1200A and is capable of vertical movement relative to the object and the X-ray source 110 to position a collimator 1300 attached to the second detector 1200B within the path of X-rays emitted from the source. When the first detector 1200A is laterally moved away from the object (e.g., retracted within the housing 1020 of the imaging device 1000), the first detector 1200A is arranged outside the path of the emitted X-rays, which can pass through the object and contact the second detector 1200B. With this configuration of the X-ray imaging device 1000, both an adsorption image and a phase contrast image of the object can be obtained.

[0010] However, operably integrating first detector 1200A and second detector 1200B into the structure of imaging device 1000 requires a high degree of complexity in the structure and operation of the imaging device of the '577 patent, making the imaging device 1000 disclosed therein less than ideal for the purpose of providing diagnostic and histopathological images using a single imaging system.

[0011] Therefore, in view of the aforementioned shortcomings of prior art imaging systems in the ability to obtain both diagnostic images for biopsy procedures and histopathological images of the obtained biopsy samples, it is desirable to develop an improved imaging system and method for obtaining both diagnostic images and histopathological images on a single imaging system. Summary of the invention

[0012] According to one aspect of an exemplary embodiment of the present disclosure, a tissue imaging system for use in conjunction with a radiographic imaging system including a radiation source and a detector includes a tissue imaging device adapted to be positioned on a surface of the detector of the radiographic imaging system between the radiation source and the detector, the tissue imaging device having: a housing capable of being positioned on the surface of the detector, the housing defining an interior and a tissue support surface opposite to the surface of the detector; and a photon counting energy discrimination (PCED) detector disposed in the interior of the housing, the PCED detector adapted to generate image data for forming one or more of a multi-energy material decomposition image, a material enhancement image, a 2D / 3D image tomographic reconstruction image, and a phase contrast image of the imaged tissue.

[0013] According to another aspect of an exemplary embodiment of the present disclosure, a radiographic imaging system includes: a radiation source; a detector capable of receiving radiation from the radiation source and defining a surface; a controller capable of operating to control operation and movement of the radiation source and the detector to generate image data, the controller including a central processing unit and interconnected memories for processing the image data from the detector; a display operably connected to the controller to present information to a user; a user interface operably connected to the controller to enable user input to the controller; and a tissue imaging system having: a housing removably positionable on the surface of the detector, the housing defining an interior and a tissue support surface opposite to the surface of the detector; and a photon counting energy discrimination (PCED) detector disposed in the interior of the housing, the PCED detector removably connected to the controller and adapted to generate image data of the imaged tissue to form one or more of a multi-energy material decomposition image, a material enhancement image, a 2D / 3D image tomographic reconstruction image, and a phase contrast image of the imaged tissue.

[0014] According to yet another aspect of an exemplary embodiment of the present disclosure, a method for generating image data of an imaged tissue to produce one or more of a multi-energy material decomposition image, a material enhancement image, a 2D / 3D image tomographic reconstruction image, and a phase contrast image of the imaged tissue on a radiographic imaging system comprises the following steps: providing a radiographic imaging system, the radiographic imaging system comprising a radiation source, a detector capable of receiving radiation from the radiation source and defining a surface, a controller operable to control operation and movement of the radiation source and the detector to generate image data, the controller comprising a central processing unit for processing the image data from the detector, a memory operably connected to the controller, and interconnecting the memory. a display for presenting information to a user, and a user interface operably connected to the controller to enable user input to the controller; positioning a tissue imaging device on the surface of the detector, the tissue imaging device having a housing defining an interior and a tissue support surface opposite the surface of the detector, and a photon counting energy discrimination (PCED) detector disposed in the interior of the housing and removably connected to the controller; positioning imaged tissue on the tissue support surface between the radiation source and the PCED detector; and operating the radiation source to direct radiation through the imaged tissue into contact with the PCED detector and generate image data of the imaged tissue.

[0015] These and other exemplary aspects, features and advantages of the present invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The drawings illustrate the best mode presently contemplated of practicing the invention.

[0017] In the attached picture:

[0018] FIG. 1 is an isometric view of a prior art phase contrast mammographic imaging system.

[0019] Figure 2 is a perspective view of an exemplary mammographic imaging system according to one embodiment of the present disclosure.

[0020] Figure 3 yes Figure 2 0014] Figure 2 is a diagram of a mammographic imaging system showing a radiation source of the system in a scanning position according to one embodiment of the present disclosure.

[0021] Figure 4 is a device according to one embodiment of the present disclosure including a biopsy system thereon Figure 2 Side elevation view of a mammographic imaging system.

[0022] Figure 5A biopsy imaging system is included thereon according to one embodiment of the present disclosure Figure 4 Side elevation view of a mammographic imaging system.

[0023] Figure 6 According to one embodiment of the present disclosure Figure 5 Schematic diagram of a mammography imaging system and a biopsy imaging system.

[0024] Figure 7 According to another embodiment of the present disclosure Figure 5 Schematic diagram of a mammography imaging system and a biopsy imaging system.

[0025] Figure 8 According to another embodiment of the present disclosure Figure 5 Side elevation view of a mammography imaging system and a biopsy imaging system.

[0026] Fig. 9 According to another embodiment of the present disclosure Figure 5 Schematic diagram of a mammography imaging system and a biopsy imaging system.

[0027] Fig.10 According to another embodiment of the present disclosure Figure 5 Schematic diagram of images displayed by a mammography imaging system and a biopsy imaging system. DETAILED DESCRIPTION

[0028] One or more specific embodiments will be described below. In order to provide a concise description of these embodiments, all features of an actual implementation may not be described in the specification. It should be understood that, as in any engineering or design project, in the development of any such actual implementation, numerous implementation-specific decisions must be made to achieve the developer's specific goals, such as complying with system-related and business-related constraints that may differ between implementations. In addition, it should be understood that such development efforts may be complex and time-consuming, but are still routine tasks of design, fabrication, and manufacturing for ordinary technicians who benefit from this disclosure.

[0029] When introducing elements of various embodiments of the present invention, the articles "a," "an," "the," and "said" are intended to mean that there are one or more of such elements. The terms "comprising," "including," and "having" are intended to be inclusive, and mean that there may be additional elements in addition to the listed elements. Furthermore, any numerical examples in the following discussion are intended to be non-limiting, and thus the additional numerical values, ranges, and percentages are within the scope of the disclosed embodiments.

[0030] As used herein, "electrically coupled," "electrically connected," and "electrically communicating" means that the referenced elements are directly or indirectly connected such that current can flow from one to the other. The connection may include a direct conductive connection (i.e., without intervening capacitors, inductors, or active elements), an inductive connection, a capacitive connection, and / or any other suitable electrical connection. There may be intervening components.

[0031] Furthermore, although the embodiments disclosed herein are described with respect to mammographic apparatus for 2-dimensional imaging of breast tissue, it should be understood that embodiments of the present invention may be applicable to other types of imaging systems for both 2-dimensional and 3-dimensional imaging, including, for example, fluoroscopy, full-field digital mammography, digital breast fusion tomography (DBT), and spectral mammography (mono- or multi-energy), as well as other types of imaging systems for imaging procedures of tissues other than breast tissue. Still further, embodiments of the present invention may be used to analyze tissues generally, and are not limited to analyzing human tissues.

[0032] Reference now Figure 2 and Figure 3 , showing the main components of an exemplary radiographic imaging system 10 formed as a mammographic imaging system 12 for imaging breast tissue according to one embodiment of the present disclosure. The radiographic imaging system 10 includes a radiation source / X-ray source 16, a radiation detector 18, and a collimator 20, such as the system disclosed in U.S. Patent Application Publication No. US20200060632, entitled Apparatus And Method For Mammographic Breast Compression, the entire contents of which are expressly incorporated herein by reference for all purposes. The radiation source 16 is movable between multiple imaging positions relative to the detector 18 and is operable to emit radiation rays 22 ( Figure 2), which radiation rays are received by the radiation detector 18 to provide an image of an object such as a breast 52. The radiation source 16 can be operated to emit X-rays at one or more energy spectra (e.g., at low energy (source operating voltage of about 60 kVp-80 kVp) and high energy (source operating voltage of about 120 kVp-140 kVp)), and in other embodiments can emit at multiple spectrums (i.e., spectra including a specific kVp range) localized around energy levels different from those listed herein, and / or at more than two emission spectra for a given examination. The selection of the respective energy levels for emission can be based at least in part on the anatomical structure being imaged and the material of interest for tissue characterization. In an embodiment, the radiographic imaging system 10 can include a patient shield 24 mounted to the radiation source 16 via a face shield rail 26 to prevent the patient's head from obstructing the radiation rays and to protect the patient from the radiation rays 22.

[0033] Still further reference Figure 2 and Figure 3 , the radiographic imaging system 10 also includes a compression paddle or plate 28 and a support structure 30 to which one or more of the radiation source 16, the radiation detector 18 and / or the compression plate 28 may be mounted. In an embodiment, the radiographic imaging system 10 may also include a controller 32. The controller 32 may be a workstation having at least one processor / central processing unit / computer and a memory device / database storing information and / or instructions used by the controller 32 for the operation of the radiographic system 10, such as Figure 2 As shown, or in other embodiments, the controller 32 may be embedded / integrated into one or more of the various components of the system 10 disclosed above. In an embodiment, the controller 32 may be electrically connected to the radiation source 16, the radiation detector 18, and / or the compression plate 28 via a cable 34. As will be appreciated, in an embodiment, the connection 34 may be a wireless connection. In an embodiment, the controller 32 may include a radiation shield 36 that protects an operator of the radiographic imaging system 10 from the radiation rays 22 emitted by the radiation source 16. The controller 32 may also include a display 38, a keyboard 40, a mouse 42, and / or other appropriate user input devices that facilitate control of the radiographic imaging system 10 via a user interface 44.

[0034] like Figure 2 and Figure 3As further shown, the radiation source 16, together with the radiation detector 18, forms part of an X-ray system that provides X-ray images for the purpose of imaging a body part of a patient, such as a breast 52. As described above, the radiation source 16 emits radiation rays 22 such that the radiation rays 22 travel from the radiation source 16 to the radiation detector 18. Although the radiation rays 22 are discussed herein as X-rays, it should be understood that the radiation source 16 may emit other types of electromagnetic rays that can be used to image a patient. The radiation source 16 may be mounted to the support structure 30 so that the radiation source can rotate relative to the radiation detector 18 about an axis 46, but movement of the radiation source 16 in a path other than rotation about a fixed axis, such as during digital breast fusion tomography (DBT), is also contemplated. In an embodiment, the radiation detector 18 may be configured to rotate or translate within its housing, such as in the directions indicated by arrows 53 and 55.

[0035] exist Figure 2 In the illustrated exemplary embodiment of the present invention, the radiation source 16 and the detector 18 are mounted to a gantry 90 that is secured to the support structure 30. The support structure 30 houses a translation mechanism 92 that is operably connected to the gantry 90. The translation mechanism 92 is operable to vertically move the gantry 90 relative to the support structure 30 so as to position the gantry 90 at an appropriate height to accommodate the size of the patient on which the radiography imaging system 10 is utilized. The translation mechanism 92 is also operable to rotate the gantry 90 about the horizontal axis 46 relative to the support structure 30 so as to rotationally position the gantry 90 relative to the patient as desired.

[0036] The gantry 90 includes a generally C-shaped body 94 with the radiation source 16 at one end and the detector 18 at the opposite end. In this configuration, the radiation source 16 is disposed in alignment with the detector 18 regardless of the vertical and / or rotational orientation of the gantry 90, such as to position the radiation source 16 and the detector 18 relative to the patient's breast 52 to obtain X-ray images in various orientations, such as for craniocaudal (CC) or mediolateral oblique (MLO) views, etc. In this position, the detector 18 is capable of receiving X-rays 22 emitted from the radiation source 16 that pass through the portion of the patient (i.e., the patient's breast 52) ​​located between the radiation source 16 and the detector 18 to generate image data to be sent to the control system 32 of the radiographic imaging system 10 to create a 3D image data set for viewing by a physician (such as by using DBT), as well as other known methods.

[0037] Additionally, in another embodiment, the radiation source 16 may be attached to the gantry 90 to rotate and / or move independently of the gantry 90 and the detector 18 to enable the radiation source 16 to capture X-ray images of the patient's breast at various angles (e.g., between + / - 60°) relative to the detector 18. The images obtained by the radiation source 16 between these angles may be used to create stereoscopic images during a biopsy procedure using the system 10 or for DBT when the radiography imaging system 10 is operated in an imaging mode.

[0038] As described above, radiation detector 18 receives radiation rays 22 emitted by radiation source 16. In an embodiment, data regarding radiation rays 22 received by radiation detector 18 may be electronically transmitted from radiation detector 18 to controller 32 via cable / electronic connection 34, so that controller 32 generates one or more images that may be displayed on display 38 and stored in a memory device.

[0039] The compression plate 28 is operable to move toward and away from the radiation detector 18, as indicated by the arrow / compression axis 48, in response to instructions from the controller 32 or in response to instructions from a controller or switch controller 80 on or near the radiographic imaging system 10, so that the compression plate 28 flattens and holds a body part (e.g., a breast 52) ​​against the surface 50 of the radiation detector 18. In this regard, the radiation detector 18 and its surface 50 are referred to herein as a "compression surface or support plate" that cooperates with the compression plate 28 to compress and clamp the patient's breast therebetween.

[0040] In one exemplary embodiment, to maintain the position of the patient's breast 52 stationary during an imaging and / or biopsy procedure, the compression plate 28 is attached to a plate or paddle support mechanism 45 located on and / or within the gantry 90 that positions the compression plate 28 directly above and aligned with the detector 18 / compression surface 50 and is operably connected to the controller 32. The plate support mechanism 45 is operable within the gantry 90 at any rotational or vertical position of the gantry 90 to move the plate 28 in a line toward or away from the detector 18 / compression surface 50. The mechanism 45 can have any of a variety of different configurations, but in one exemplary embodiment takes the form of a compression screw mechanism that is operable to move the plate 28 into engagement with the patient's breast 52 to apply a predetermined pressure / compression on the breast 52 to maintain the breast 52 in a stationary position between the plate 28 and the detector 18 / compression surface 50 during an imaging and / or biopsy procedure.

[0041] In operation, according to an embodiment, a patient's breast 52 may be placed on the compression surface 50 of the radiation detector 18. Under control of the controller 32 on the plate support mechanism 45, the compression plate 28 moves toward the detector 18 to compress the breast 52 against the surface 50 of the detector 18 so that the breast 52 is immobilized. The compression plate 28 moves toward the detector 18 to press the breast 52 against the detector 18 / compression surface 50 for the compression phase of the radiographic imaging system 10. Once the target compression is achieved, the movement of the compression plate 28 is stopped, and the compression plate 28 and the detector 18 / compression surface 50 are maintained in a fixed position to clamp the breast 52 therebetween (referred to herein as the clamping phase) so that imaging or a procedure, such as a biopsy, may be started. During the imaging procedure, the radiation source 16 is selectively adjusted so that it moves / rotates to a first scanning position and scans the breast 52. The radiation detector 18 receives the radiation rays 22 that pass through the breast 52 and transmits data to the controller 32, which then generates one or more X-ray images of the breast 52. Once imaging is complete, the controller 32 moves the compression paddle 28 away from the detector 18 / compression surface 50 to release the breast 52 .

[0042] Still further reference Figure 2 In one embodiment, the radiographic imaging system 10 may include one or more physiological monitoring or sensor devices 54, 56, 58, 60 communicatively coupled to the controller 32 for monitoring one or more physiological parameters of the patient (and for transmitting physiological parameter data to the controller 32). Figure 2 The sensor devices 54, 56, 58 are illustrated as being connected to the controller 32, but in some embodiments, one or more of the sensor devices may be communicatively coupled to the mammography apparatus without departing from the broader aspects of the invention. The sensor devices may be selected to monitor and / or measure any desired physiological information of the patient, including but not limited to diastolic blood pressure, systolic blood pressure, body temperature, blood oxygen level, patient weight, skin conductance, pulse rate, etc. Figure 2 As shown, one or more of the sensor devices (e.g., sensor device 60) may be physically integrated with the compression plate 28 and / or the detector 18 / compression surface 50. By incorporating the sensor devices into the detector 18 / compression surface 50 or the compression plate 28, physiological parameter data of the patient may be acquired and sent to the controller 32 without any additional intervention by a system operator.

[0043] In an embodiment, the sensor device 60 may be a force sensor for measuring the amount of pressure or compressive force applied to the breast 52. Additional sensors for measuring physiological parameters may be configured to directly measure or allow calculation of variables such as force, pressure, temperature, stiffness, elasticity, breast size and / or volume, and / or tissue density, and may be embedded in the compression plate 28 or detector 18 / compression surface 50 or attached as part of the radiographic imaging system 10.

[0044] Refer again Figure 2 In one embodiment, the operation of the radiographic imaging system 10 during the compression phase and the clamping phase can be controlled by the patient using a switch control 80 (e.g., a foot switch control). The switch control 80 is typically connected to the radiographic imaging system 10 via a cable / wire 82. The controls are also typically mirrored on the opposite side of the radiographic imaging system 10 (not shown). Other controls (not shown) may be present on a special attachment placed in the paddle / breast support area. In an embodiment, the switch control can be a handheld control unit 84 with a wired, wireless, Bluetooth or other connection to the radiographic imaging system 10, rather than a foot switch control.

[0045] Now refer to Figure 4 , the radiographic imaging system 10 may further or alternatively include a biopsy system 200 that is selectively removable from the radiographic imaging system 10. In such an embodiment, the radiation source 16 together with the radiation detector 18 form part of an X-ray system that provides X-ray images for guiding the biopsy system 200 to a suspicious location within a body part of a patient. Figure 4 As shown, in an embodiment, biopsy system 200 may be disposed on support structure 30 such that it also rotates about axis 46 in a manner similar to radiation source 16 and / or moves vertically and / or horizontally in a manner similar to compression plate 28 .

[0046] Watch now Figures 5 to 7In an exemplary embodiment of the present invention, the radiographic imaging system 10, with or without the biopsy system 200, includes a tissue or biopsy imaging system 300 operably disposed on the radiographic imaging system 10. The biopsy imaging system 300 includes a tissue or biopsy imaging device 302 positioned on the surface 50 directly above the detector 18, and a control device 304 operably connected to the biopsy imaging device 302. The biopsy imaging device 302 is also operably connected to the radiographic imaging system 10, such as to the gantry 90 using a direct wired connection 303 for communication between the radiographic imaging system 10 and the biopsy imaging device 302, with the biopsy imaging device disposed on the surface 50 above the detector 18, with the compression paddle 28 and the biopsy system 200 optionally removed from the radiographic imaging system 10.

[0047] exist Figure 5 and Figure 6 In the illustrated exemplary embodiment, the control device 304 is separate from the controller 32 and is shown as including a control processor 306, an electronic memory 308 for storing operating instructions for the control processor 306 and other information, a user interface 310, and a display 312, which is operably connected to the biopsy imaging device 302, such as by a wired or wireless connection. However, embodiments in which the control device 304 and / or the control processor 306 function in conjunction with other control devices (e.g., the controller 32 or other control circuitry local or remote to the radiographic imaging system 10) are also encompassed by the present disclosure, such that the functions of the control device 304 may be optionally performed in part or in whole by the controller 32, such that the control device 304 need not be coupled to the biopsy imaging device 302, and the biopsy imaging device 302 may be operably connected directly to the controller 32.

[0048] The control processor 306 commands the operation of the radiography imaging system 10 and the biopsy imaging device 302 to perform filtering, inspection and / or calibration protocols, and may process the acquired data. With respect to the radiation source 16, the control device 304, optionally in cooperation with the controller 32, provides power, focus position, control signals, etc. for the X-ray inspection sequence. According to some embodiments, the control device 304 may control the filter assembly 328 ( Figure 7 ), operation of the gantry 90 (or other structural support to which the radiation source 16 and detector 316 are attached), and / or translation and / or tilting of the patient support during the examination.

[0049] In addition, if Figure 7In the illustrated embodiment, the control processor 306, via the motor controller 336, can control the operation of the linear positioning subsystem 332 and / or the rotation subsystem 334 for moving components of the radiographic imaging system 10, the biopsy imaging device 302, and / or the tissue sample 320. The control processor 306 can include signal processing circuitry and associated memory circuitry, such as electronic memory 308. In such embodiments, the memory circuitry can store programs, routines, and / or coded algorithms executed by the control processor 306 to operate the radiographic imaging system 10 and the biopsy imaging device 302 (including the x-ray source 16 and / or the filter assembly 328) and process the digital measurements acquired by the detector 316 according to the steps and processes discussed herein. In one embodiment, the control processor 306 can be implemented as all or part of a processor-based system.

[0050] The radiation source 16 may be controlled by an X-ray controller 338 included within the control processor 306. The X-ray controller 338 may be configured to provide power, timing signals, and / or focal spot size and focal spot position to the radiation source 16. Additionally, in some embodiments, the X-ray controller 338 may be configured to selectively activate the radiation source 16 so that tubes or emitters at different locations within the radiographic imaging system 10 may operate synchronously with or independently of each other, or to switch the source between different energy profiles during an imaging session.

[0051] The control processor 306 may include a data acquisition system (DAS) 340. The DAS 340 receives data collected by the readout electronics of the detector 316, such as a digital signal from the detector 316. The DAS 340 may then convert and / or process the data for subsequent processing by a processor-based system, such as a computer 342 operably connected to the control processor 306. In certain implementations discussed herein, circuitry within the detector 316 may convert the detector's analog signal to a digital signal before being sent to the data acquisition system 340. The computer 342 may include or communicate with one or more non-transitory memory devices 308 capable of storing data processed by the computer 342, data to be processed by the computer 342, or instructions to be executed by the image processing circuitry 344 of the computer 342. For example, a processor of the computer 342 may execute one or more sets of instructions stored on a memory 308, which may be a memory of the control device 304 or the computer 342, other memory of the processor, firmware, or the like, to perform image acquisition and reconstruction techniques and / or processes.

[0052] The computer 342 may also be adapted to control features (i.e., scanning operations and data acquisition) enabled by the control processor 306, such as in response to commands and scanning parameters provided by an operator via the user interface 310 and / or the operator workstation 348. In addition, a display 312 / 350 and / or printer 352 coupled to the control device 304 and the user interface 310 allows the operator to view relevant system data, imaging parameters, raw imaging data, reconstruction data (e.g., soft tissue images, bone images, segmented vessel trees, etc.), material base images, and / or material decomposition results, etc. Further, the control processor 306 may include or be coupled to a picture archiving and communication system (PACS) 354. The PACS 354 may be coupled to a remote system or client 356, a radiology department information system (RIS), a hospital information system (HIS), or an internal or external network, so that others at different locations can access the image data.

[0053] Watch now Figure 5 and Figure 6In an exemplary embodiment of the present invention, the biopsy imaging device 302 includes a housing 314 formed of an X-ray transparent material and a photon counting energy discrimination (PCED) detector 316 disposed within the housing, which is operably connected to a control processor 306 of the control device 304 and / or a controller 32 of the radiography system 10 via a wired connection 303. The housing 314 is sized to support a biopsy sample holder 318 thereon aligned with the PCED detector 316. The housing 314 is shaped as a box 315, which includes a plurality of side panels 317 extending upwardly from a surface 50 and a top panel 319 that connects the side panels 317 opposite the surface 50 and forms a tissue support surface for the biopsy sample holder 318. The housing 314 may also include a bottom plate 321 opposite the top plate 319, and one or more of the side plates 317, the top plate 319, and / or the bottom plate 312 may be selectively removable to allow access to the PCED 316 and other components inside the housing 314. The positioning of the housing 314 on the surface 50 of the detector 18 enables the detector 18 to be moved relative to the source 16 to additionally move the housing 314 so as to properly position the sample holder 318 and the detector 316 to properly magnify the image to be produced of the sample 320 disposed in the sample holder 318. In addition, in an optional exemplary embodiment of the present disclosure, the top plate 319 may be formed with the sample holder 318 integrated into the top plate 319, or with a suitable attachment structure (not shown) suitable for engaging and retaining the sample holder 318 on the top plate 319 during operation of the biopsy imaging system 300. In yet another alternative exemplary embodiment, the housing 314 can be deployed on the surface 50 while the patient's breast 52 is still compressed on the radiography system 10 (such as between the compression plate 28 and the top plate 319 of the housing 314), and while the breast 52 is not compressed on the radiography system 10.

[0054] The PCED detector 316 present within the biopsy imaging device 302 provides image data to the control device 304 and / or the controller 32 for high resolution image generation compared to a standard embedded detector (i.e., the detector 18 used primarily for generating diagnostic images). The PCED detector 316 may be additionally optimized for biopsy specimen imaging, i.e., may be configured to be application and / or subject or tissue specific. The PCED detector 316 provides enhanced resolution images (i.e., with reduced noise) and is used in conjunction with the radiation source 16 to provide image data for forming multi-energy material decomposition images, material enhancement images, 2D / 3D image reconstruction images (tomographic images), and phase contrast images.

[0055] The PCED detector 316 can have any desired configuration, such as the configuration disclosed in U.S. Patent No. 10,827,992, entitled Energy-Discriminating Photon-Counting Detector And The Use Thereof, the entire contents of which are expressly incorporated herein by reference for all purposes, and provides the radiographic imaging system 10 with greatly improved image resolution capabilities for producing high-resolution images of a biopsy sample 320 disposed in a sample holder 318, which sample holder can have any suitable X-ray transparent form, such as a plastic container, e.g., a Petri dish, which can be positioned on the housing 314 between the source 16 and the PCED detector 316. Utilizing the ability of the PCED detector 316 to detect or measure spectral information of the intensity or energy of photons / X-ray radiation contacting the PCED detector 316 during energy discrimination imaging (e.g., classifying incident photons / X-ray radiation into two or more energy bins based on energy signals generated by the photons / X-ray radiation and measured by the PCED 316), the biopsy imaging device 302 in combination with the radiography imaging system 10 can generate various high-resolution images and / or related information of the constituent tissues in the biopsy sample 320, including, but not limited to, molecular decomposition images of the biopsy sample 320 and real-time information about the characteristics of the tissue within the biopsy sample 320, malignant tumors, material-specific images, etc.

[0056] The PCED detector 316 may be movably positioned or supported within the housing 314 such that the PCED detector 316 is movable relative to the housing 314. Figure 7 In the illustrated exemplary embodiment, the PCED detector 316 is operably connected to a motor 324 that is capable of displacing the PCED detector 316 within the housing 314. The motor 324 is operably connected to the control device 304 and / or the controller 32 to control the movement of the PCED detector 316 within the housing 314, optionally in conjunction with the movement of the radiation source 16, for operation of the biopsy imaging device 302 during a tomographic imaging procedure, such as a photon counting computed tomography (PCCT) procedure.

[0057] In addition, if Figure 5 and Figure 7As shown in the exemplary embodiment of FIG. 1 , the biopsy imaging system 300 may include a camera 370 disposed in a room (not shown) in which the radiographic imaging system 10 is located, and in one embodiment, disposed on or in a gantry 90 spaced apart from the radiation source 16. The camera 370 is operably connected to the control device 304 and / or the controller 32, and provides a visual indication of the position of the sample holder 318 and the sample 320 disposed on the top plate 319 of the housing 314 on the housing 314, which visual indication can be used with reference information, including but not limited to the dimensions of the housing 314 and the known position of the surface 50, to accurately determine the distance of the radiation source 16 relative to the sample 320. In the event that the breast 52 is still compressed on the radiographic system 10 (e.g., compressed between the compression plate 28 and the top plate 319 of the housing 314) when the biopsy imaging system 300 is operated, the camera 370 can additionally provide information related to the position of the breast 52. Using information about the position of the sample 320 provided by the camera 370, the control device 304 can configure components of the radiographic imaging system 10 (such as the radiation source 16 and / or the collimator 20) and / or the biopsy imaging device 302 (such as the detector 316 and / or the magnetic frame 322) to obtain a desired image of the sample 320.

[0058] In addition, Figure 7 In the illustrated exemplary embodiment, the grid 326 can be positioned within the housing 314 in a location spaced apart from the PCED detector 316, and in an exemplary embodiment can be formed as a 1D slit grid or a 2D matrix grid. The grid 326 can be present to reduce scatter in the X-rays generated by the source 16 and directed through the sample 320 to the PCED detector 316. In addition, optionally in conjunction with the motor 324 (when present), the grid 326 can enable the biopsy imaging device 302 to operate in a slit scanning mode for imaging the biopsy sample 320.

[0059] In addition, if Figure 8 As shown in the exemplary embodiment illustrated in , in alternative embodiments, the housing 314 can be disposed on or alternatively below the magnetic rack 322 to further elevate the sample holder 318 to a desired magnification position relative to the source 16. The magnetic rack 322 can be a separate structure from the housing 314, or can be integrated into the form of the housing 314, such as an extendable upper portion (not shown) of the housing 314 that is operably connected to a lower portion (not shown) in which the detector 316 is positioned.

[0060] Reference now Fig. 9In the exemplary embodiment illustrated in FIG. 1 , the biopsy device 302 can be configured to include a plurality (i.e., two or more) of grids 360, 362 to obtain a phase contrast image of the sample 320 using the biopsy imaging device 302 and the combined PCED detector 316 in a structure and method similar to that disclosed in U.S. Pat. No. 11,389,124, entitled X-ray Phase Contrast Detector, the entire contents of which are expressly incorporated herein by reference for all purposes. In this embodiment of the biopsy imaging device 302, the first grid 360 is positioned between the radiation source 16 and the sample 320, and the second grid 362 is positioned between the sample 320 and the PCED detector 316. The second grid 362 can be formed by the grid 326 disposed within the housing 314, as discussed in the previous embodiment, or can be a separate grid 362 located outside the housing 314, such as a grid 362 located within a magnetic frame 322 positioned between the housing 314 and the sample 320. With the configuration of grids 360, 362 located on either side of the sample 320 and between the radiation source 16 and the PCED detector 316, the control device 304 can operate the radiographic imaging system 10 to obtain phase contrast images, thereby providing enhanced differentiation of soft tissue within the sample 320 for accurate characterization of the tissue for histopathological purposes. Such phase contrast information from the PCED 316 and / or spectral information about the sample 320 provided by the PCED detector 316 enables the biopsy imaging device 302 on the radiographic imaging system 10 to identify the composition of the tissue within the sample 320 and classify those tissues into, for example, microcalcifications, cysts, solid masses, etc.

[0061] Watch now Figure 7 and Fig.10In an exemplary embodiment, to enhance the output of the biopsy imaging system 300 regarding the classification of tissue present within the imaged sample 320 based on the PCED and / or phase contrast images of the sample 320, the controller 32, the control processor 306, and / or the image processing circuitry 344 in the computer 342 may include an artificial intelligence AI and / or machine learning ML algorithm or module 380 that is trained to analyze the multi-energy and phase contrast images 382 provided by the PCED detector 316 to identify the type of tissue present within the sample 320, and enhance the visualization of suspicious tissue or regions of interest (ROIs) 384 within the imaged sample 320, and provide summary information regarding the characteristics of the ROI 384 (e.g., the probability of malignancy). In an exemplary embodiment, after the image 382 is created by the control processor 306 and / or the image processing circuitry 344 for presentation on the display 312 / 350, the AI / ML model 380 analyzes the image 382 and the spectral information provided by the PCED 316 to determine the type of tissue present in the image 382. This in turn enables the AI / ML module 380 to use known recognition processes and / or algorithms for image generation of X-ray imaging systems to locate ROIs 384 within the image 382 (which include, but are not limited to, various tissue types and / or structures that constitute abnormalities 386, such as microcalcifications, cysts, solid masses, etc.) or other areas of clinical relevance present within the image 382. For example, traditional image processing techniques or artificial intelligence (AI)-based methods (including machine learning (ML) and deep learning (DL), etc.) or a combination of both can be used to identify / classify and locate these ROIs 384 and abnormalities 386 within the image 382. For AI-based recognition methods, the ultimate goal of identifying and locating these ROIs 384 and abnormalities 386 can be formulated as an image segmentation or object localization problem. Although ML-based methods (such as support vector machines (SVM), random forests (RF), etc.) can be used to solve these problems, convolutional neural networks (CNNs), a class of DL-based models, are best suited for such tasks, resulting in better accuracy and adaptability under various imaging conditions. Additionally, where tissue present within biopsy sample 320 is identified and classified by AI / ML module 380, AI / ML module 380 may output these results along with on-the-spot recommendations for further examination based on the results illustrating the presence of malignant tissue in biopsy sample 320, such as by providing a visual indication 388 of the AI / ML module 380 assessment results associated with image 382 of sample 320.

[0062] Regarding an exemplary form of the AI / ML module 380, a typical mammography image detection and classification algorithm may be configured as follows:

[0063] 1. Examples of inputs to the AI / ML module 380: raw / processed images (one view or all views), multi-energy X-ray acquisitions, molecular decomposition and phase contrast images, previous images, patient data (age, risk factors, history, etc.).

[0064] 2. Examples of outputs of the AI* / ML module 380: lesion location, malignancy, tissue prognostic tumor markers (such as estrogen and triple negative receptor status), histological classification, microcalcification analysis.

[0065] 3. Examples of AI / ML / DL models: CNN / encoder + dense classification layer for feature extraction, radiomics feature extraction, and / or a combination of both, e.g., modules presented and described in:

[0066] https: / / www.nature.com / articles / s41598-018-22437-z, for malignant tumor analysis,

[0067] https: / / link.springer.com / article / 10.1007 / s00330-022-08538-4, tissue prognosis for tumors,

[0068] https: / / link.springer.com / article / 10.1007 / s10278-021-00508-4 for histological classification analysis, and

[0069] https: / / www.mdpi.com / 1660-4601 / 19 / 4 / 2159 for microcalcification analysis, the contents of each of which are expressly incorporated herein by reference for all purposes. In addition, with respect to the training of the AI / ML module 380 for one or more of these analyses, the ground truth for training (output) is typically provided by radiology and histopathology reports associated with the input images and patient data.

[0070] In other alternative and exemplary embodiments, the radiography imaging system 10 is not limited to the mammography imaging system 12, but can be any X-ray imaging system employed in the context of medical imaging, where it is desired to obtain improved visualization of the ROI 384 in the imaged tissue / biopsy sample 320 using the existing radiology imaging system 10 in combination with on-site characterization of the imaged tissue characteristics and probability of malignancy and associated classification or recommendation for further imaging, testing or treatment, without having to wait for off-site histopathology results. However, it should be understood that the present technology is not limited to such medical contexts. Indeed, the examples and explanations provided in such medical contexts are merely for the purpose of facilitating explanation by providing examples of realistic specific implementations and applications. However, the present method can also be used in other contexts, such as non-destructive inspection of manufactured parts or goods (i.e., quality control or quality audit applications), and / or non-invasive inspection of packages, boxes, luggage, etc. (i.e., security or screening applications). In general, the present method can be desirable in any imaging or screening context where energy discrimination in a photon counting context is desired.

[0071] Furthermore, while the above description illustrates the use of the biopsy imaging system 300 to provide high resolution images, composition information, and classification for the biopsy sample 320, the biopsy imaging system 300 can be used to image other materials and body components, including but not limited to an entire breast (not shown) or other body part of a patient, which can be positioned in a known manner on the radiographic imaging system 10 in conjunction with the biopsy imaging device 302 for imaging the breast or other body part in one or more of the previously described manners.

[0072] It should be understood that the aforementioned compositions, devices and methods of the present disclosure are not limited to specific embodiments and methods, as these may vary. It should also be understood that the terms used herein are only for the purpose of describing specific exemplary embodiments, and are not intended to limit the scope of the present disclosure, which will only be limited by the appended claims.

Claims

1. A tissue imaging system (300) for use in conjunction with a radiographic imaging system (12), the radiographic imaging system comprising a radiation source (16) and a detector (18), the tissue imaging system (300) comprising: A tissue imaging device (302) adapted to be positioned on a surface (50) of the detector (18) of the radiographic imaging system (12) between the radiation source (16) and the detector (18), the tissue imaging device (302) comprising: a. a housing (314) capable of being positioned on the surface (50) of the detector (18), the housing (314) defining an interior and a portion of the detector a tissue support surface (319) opposite to said surface (50) of the device (18); and b. A photon counting energy discrimination (PCED) detector (316), wherein the photon counting energy discrimination (PCED) detector is disposed within the housing (314). The PCED detector (316) is adapted to generate image data for forming one or more of a multi-energy material decomposition image, a material enhancement image, a 2D / 3D image tomographic reconstruction image, and a phase contrast image of the imaged tissue.

2. The tissue imaging system (300) of claim 1, further comprising a control device (304) operably connected to the PCED detector (316).

3. The tissue imaging system (300) of claim 2, wherein the control device (304) comprises an artificial intelligence module (380) configured to classify a tissue type detected within the image data of the imaged tissue.

4. The tissue imaging system (300) of claim 1, wherein the PCED detector (316) is adapted to be operably connected to the radiography imaging system (10).

5. The tissue imaging system (300) of claim 1, wherein the tissue imaging device (302) further comprises a motor (324) disposed within the housing (314) and operably connected to the PCED detector (316) to move the PCED detector (316) within the interior of the housing (314).

6. The tissue imaging system (300) of claim 1, wherein the tissue imaging device (302) further comprises at least one grid (326) spaced apart from the PCED detector (316).

7. The tissue imaging system (300) of claim 6, wherein the at least one grid (326) is disposed within the interior of the housing (314) between the tissue support surface (319) and the PCED detector (316).

8. The tissue imaging system (300) according to claim 6, further comprising: a. A first grid (360) adapted to be positioned on the sample support surface (319) and said radiation source (16); and b. A second grid (362) positioned on the sample support surface (319) and the detector (18).

9. According to claim 1, the tissue imaging system (300) further comprises a camera (370) adapted to obtain an image of the tissue support surface (319) for providing positioning information of the tissue support surface (319) and the PCED detector (316) relative to the radiation source (16).

10. A radiographic imaging system (10), comprising: a. Radiation source (16); b. a detector (18) capable of receiving radiation from the radiation source (16) and defining a surface (50); c. a controller (32) operable to control the operation and movement of the radiation source (16) and the detector (18) to generate image data, the controller (32) comprising a central processing unit and interconnected memory for processing the image data from the detector (18); d. a display (38) operably connected to the controller (32) for presenting information to a user; e. a user interface (44) operably connected to the controller (32) to enable user input to the controller (32); and f. A tissue imaging system (300), comprising: i. a housing (314) removably positionable on the surface (50) of the detector (18), the housing (314) defining an interior and a tissue support surface (319) opposite the surface (50) of the detector (18); and ii. A photon counting energy discrimination (PCED) detector (316), which is disposed in the interior of the housing (314), the PCED detector (316) being removably connected to the controller (32) and suitable for generating image data of the imaged tissue to form one or more of a multi-energy material decomposition image, a material enhancement image, a 2D / 3D image tomography reconstruction image and a phase contrast image of the imaged tissue.

11. The radiographic imaging system (10) of claim 10, further comprising a control device (304) operably connected to the PCED detector (316) and comprising an artificial intelligence module (380) configured to classify a tissue type detected within the image data of the imaged tissue.

12. The radiographic imaging system (10) of claim 10, wherein the tissue imaging device (300) further comprises a motor (324) disposed within the housing (314) and operably connected to the PCED detector (316) to move the PCED detector (316) within the interior of the housing (314).

13. The radiographic imaging system (10) of claim 10, wherein the tissue imaging device (300) further comprises at least one grid (326) spaced apart from the PCED detector (316).

14. The radiographic imaging system (10) of claim 10, further comprising a magnetic frame (322) coupled to the housing (314) to change a position of the tissue support surface (319) relative to the surface (50) of the detector (18).

15. The radiographic imaging system (10) according to claim 10 further comprises a camera (370) operably adapted to obtain an image of the tissue support surface (319) for providing positioning information of the tissue support surface (319) and the PCED detector (316) relative to the radiation source (16).

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