Intraoperative sample imaging system and method, sample holding system

Abstract

The present invention is entitled "System and method for sample imaging using an existing mammographic imaging system". An intraoperative sample imaging system is provided herein. The intraoperative sample imaging system includes a mammographic imaging system configured to acquire imaging data. The intraoperative sample imaging system also includes a sample holding system configured to hold a tissue sample, wherein the sample holding system is retrofittedly coupled to the mammographic imaging system, wherein the intraoperative sample imaging system is configured to acquire imaging data to generate a three-dimensional (3D) image of the tissue sample.

Description

Technical Field

[0001] The subject matter disclosed herein relates to specimen imaging, and more particularly, to specimen imaging using existing mammographic imaging systems. Background Art

[0002] In breast lumpectomy surgery, the surgeon's goal is to remove the tumor while preserving as much healthy breast tissue as possible. In the process of striving to preserve healthy breast tissue, sometimes tumor tissue is left in the breast, or the distance between the tumor and the tumor resection sample boundary is too small (i.e., positive margin). In the case of positive margins, additional surgery (re-excision) is usually performed, which brings additional trauma and risk to the patient, as well as additional costs. The frequency of re-excision depends on the institution and the surgeon, ranging from 10% (for expert surgeons who perform many breast lumpectomies in the institution) to 50% or more (for surgeons with much less experience in smaller institutions). The current standard of care is to evaluate positive margins using histopathology, which takes more than a day to obtain results. In some institutions, various methods with various levels of effectiveness are used to perform intraoperative breast lumpectomy evaluation. For example, a two-dimensional (2D) sample evaluation can be performed using a commercial "cabinet" imaging system in the operating room or by sending the sample to the radiology department for imaging on a mammography imaging system. However, none of these solutions provide enough information to confidently detect or exclude positive margins. Additionally, sending samples to the radiology department causes delays and can create scheduling issues. If three-dimensional (3D) information is available during surgery to enable margin assessments that are as good or better than those provided using histopathology, re-excision rates could be reduced to zero. Ideally, the 3D assessment capability would be available in the operating room. Summary of the invention

[0003] The following shows an overview of certain embodiments disclosed herein. It should be understood that these aspects are provided only to provide the reader with a brief overview of these specific embodiments, and these aspects are not intended to limit the scope of the present disclosure. In fact, the present disclosure may cover various aspects that may not be shown below.

[0004] According to an embodiment, an intraoperative sample imaging system is provided. The intraoperative sample imaging system includes a mammographic imaging system configured to acquire imaging data. The intraoperative sample imaging system also includes a sample holding system configured to hold a tissue sample, wherein the sample holding system is retrofittedly coupled to the mammographic imaging system, wherein the intraoperative sample imaging system is configured to acquire imaging data to generate a three-dimensional (3D) image of the tissue sample.

[0005] According to another embodiment, a method for intraoperative sample imaging is provided. The method includes coupling a sample holding system to a mammographic imaging system, wherein the sample holding system includes a sample holder, an attachment for coupling the sample holder to the mammographic imaging system, and a motor configured to rotate the sample holder. The method also includes rotating the sample holder to rotate the tissue sample to different angular positions within a specific angular range, while emitting radiation from a radiation source of the mammographic imaging system to collect imaging data of the tissue sample at different angular positions. The method also includes generating a three-dimensional (3D) image of the tissue sample from the imaging data collected at different angular positions within the specific angular range.

[0006] According to another embodiment, a sample holding system is provided. The sample holding system includes a sample holder configured to hold a tissue sample, an attachment configured to couple the sample holder to a mammographic imaging system, and a motor configured to rotate the sample holder. The sample holding system is configured to be retrofitted to the mammographic imaging system to form an intraoperative sample imaging system, which is configured to acquire imaging data of the tissue sample at different angular positions within an angular range of up to at least 360 degrees to generate a three-dimensional (3D) image of the tissue sample. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] These and other features, aspects and advantages of the present invention will be better understood when the following detailed description is read with reference to the accompanying drawings, in which like characters refer to like parts throughout the several views, and in which:

[0008] Figure 1 is an embodiment of a digital X-ray system (e.g., a mammographic imaging system) according to aspects of the present disclosure;

[0009] Figure 2 An embodiment of an intraoperative imaging system according to aspects of the present disclosure is shown;

[0010] Figure 3 A flow chart illustrating an embodiment of a method for intraoperative imaging of a tissue sample according to aspects of the present disclosure;

[0011] Figure 4 A flow chart illustrating an embodiment of another method for intraoperative imaging of a tissue sample according to aspects of the present disclosure;

[0012] Figure 5A and Figure 5B An embodiment of a digital breast tomosynthesis imaging system is shown that is modified to operate in a magnified mode for specimen imaging (eg, at high magnification); and

[0013] Fig. 6A and Figure 6B An embodiment of a digital breast tomosynthesis imaging system is shown that is modified to operate in a magnification mode for specimen imaging (eg, at low magnification). DETAILED DESCRIPTION

[0014] One or more specific embodiments will be described below. In order to provide a concise description of these embodiments, not all features of an actual implementation are described in the specification. It should be understood that in the development of any such actual implementation, as in any engineering or design project, many 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 vary from implementation to implementation. In addition, it should be understood that such development efforts may be complex and time-consuming, but are still routine tasks for design, fabrication, and manufacturing for ordinary technicians who benefit from this disclosure.

[0015] 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 the 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.

[0016] The present disclosure provides a system and method for sample imaging (e.g., intraoperative sample imaging), which utilizes an existing mammography imaging system for sample imaging. Specifically, the intraoperative sample imaging system includes a sample holding system configured to hold a tissue sample, wherein the sample holding system is retrofitted to an existing mammography imaging system, wherein the intraoperative sample imaging system is configured to acquire imaging data to generate a 3D image of the tissue sample. In certain embodiments, the sample holding system includes a sample holder and a motor coupled to the sample holder, which rotates the sample holder with the tissue sample between exposures. In certain embodiments, the sample can rotate continuously. In certain embodiments, the existing mammography imaging system includes a full-field digital mammography imaging system configured to acquire 2D imaging data. In certain embodiments, the existing mammography imaging system includes a digital breast tomosynthesis imaging system, which is configured to acquire 2D imaging data (e.g., projection data) within a limited angular range (e.g., 60 degrees or less) to generate 3D imaging data. The intraoperative sample imaging system can acquire imaging data over an angular range of up to 360 degrees plus an additional angular range to ensure data integrity. In addition, because imaging is performed in a magnified mode, imaging data can be acquired at a higher resolution. The intraoperative sample imaging system can be used during surgery (e.g., breast lumpectomy, mastectomy, etc.) on a patient in an operating room to obtain a tissue sample from the patient in order to provide improved intraoperative imaging (e.g., high-resolution 3D images) at a lower cost to institutions (which may not normally have intraoperative sample imaging available).

[0017] Turning now to the accompanying drawings, Figure 1An imaging system 10 (e.g., a mammographic imaging system) for acquiring and processing discrete pixel image data is schematically shown. In the illustrated embodiment, the system 10 is a digital X-ray system designed to both acquire raw image data and process the image data for display in accordance with the present technology. The imaging system 10 can be a fixed system or a mobile X-ray system disposed in a fixed X-ray imaging room. The imaging system 10 is a mammographic imaging system. In some embodiments, the imaging system 10 is a full-field digital mammographic imaging system configured to acquire 2D imaging data. In some embodiments, the imaging system 10 is a digital breast tomosynthesis imaging system that is configured to acquire 2D imaging data (e.g., projection data) within a limited angular range (e.g., 60 degrees or less) to generate 3D imaging data. In particular, the imaging system 10 is an existing mammographic imaging system retrofitted with a sample holding system that enables acquisition of 2D imaging data of a tissue sample (breast or any other tissue type) over an angular range of up to 360 degrees plus an additional angular range to ensure the integrity of the data, thereby enabling generation of a 3D image, as described in more detail below.

[0018] exist Figure 1 In the illustrated embodiment, the imaging system 10 includes an X-ray radiation source 12 positioned adjacent a collimator 14. The collimator 14 allows a stream of radiation 16 to penetrate into an area in which an object 18 (e.g., a tissue or biopsy sample) is positioned. A portion of the radiation 20 passes through or around the subject and strikes a digital X-ray detector, generally indicated by the reference numeral 22. In certain embodiments, the detector 22 may convert X-ray photons incident on its surface into lower energy photons and subsequently into electrical signals that are collected and processed to reconstruct an image of features within the object or within the subject. In other embodiments, such as in a direct conversion implementation, the incident radiation itself may be measured without an intermediate conversion process.

[0019] The source 12 is controlled by a power supply / control circuit 24, which provides power and control signals for the inspection sequence. In addition, the detector 22 includes a detector controller 26 (e.g., a control circuit) that commands the acquisition of signals generated in the detector 22. The detector controller 26 may also perform various signal processing and filtering functions, such as initial adjustment for dynamic range, interleaving of digital image data, etc. Both the power supply / control circuit 24 and the detector controller 26 are responsive to signals from a system controller 28. In general, the system controller 28 commands the operation of the imaging system to execute the inspection protocol and process the acquired image data. In the present case, the system controller 28 also includes signal processing circuitry and associated articles of manufacture such as optical memory devices, magnetic memory devices, or solid-state memory devices for storing programs and routines executed by the processor to perform various functions (e.g., acquiring imaging data in a magnified mode; reconstructing imaging data via cone beam computed tomography (CT) reconstruction (such as back-projection, iterative reconstruction, or other reconstruction methods); a computer-aided detection (CAD) module for automatically detecting calcifications, markers, and / or masses within a tissue sample; rotating a tissue sample or sample synchronously with exposure via a sample holding system; adding an electronic grid or other fiducial or indicator to the image after imaging to indicate the distance and position of the tissue sample relative to the patient from which the sample was obtained; and storing configuration parameters and image data; interface protocols; etc.). In one embodiment, a programmed computer system may be provided with hardware, circuitry, firmware, and / or software for performing the functions attributed to one or more of the power / control circuitry 24, the detector controller 26, and / or the system controller 28 as described herein.

[0020] In certain embodiments where the imaging system 10 is a digital breast tomosynthesis imaging system, the system controller 28 is coupled to the rotation subsystem. The rotation subsystem enables the X-ray source 12 and the collimator 14 to rotate within a limited angular range (e.g., 60 degrees or less) around the object 18, such as primarily in the xy plane around the object 18. It should be noted that the rotation subsystem may include a gantry on which the corresponding X-ray emission and detection components are disposed. Thus, in such embodiments, the system controller 28 may be used to operate the gantry.

[0021] exist Figure 1In the illustrated embodiment, the system controller 28 is linked to at least one output device, such as a display or printer as indicated by reference numeral 30. In some embodiments, the images can be displayed on the display in a video loop (e.g., movie mode) for viewing by a radiologist or surgeon during surgery (e.g., in an operating room). The output device may include a standard monitor or a dedicated monitor and associated processing circuitry. In some embodiments, one or more operator workstations 32 may be further linked in the system for outputting system parameters, requesting exams, viewing images, and the like. Generally speaking, the displays, printers, workstations, and similar devices provided within the system may be local to the data acquisition components, or may be remote from these components, such as elsewhere within an institution or hospital, or located at an entirely different location, linked to the image acquisition system via one or more configurable networks (such as the Internet, a virtual private network, etc.).

[0022] It should also be noted that the operator workstation 32 may also be coupled to a picture archiving and communication system (PACS) 34 or other examination workstation. The PACS 34 may run a digital imaging and communications in medicine (DICOM) server to generate DICOM images of tissue samples. The PACS 34 may in turn be coupled to a remote client 36, a radiology department information system (RIS), a hospital information system (HIS), or to an internal or external network so that others at different locations may access the raw or processed image data.

[0023] Figure 2 An imaging system 38 is shown. The imaging system 38 includes an apparatus for mammographic imaging 40 (e.g., an existing mammographic imaging system). The apparatus 40 includes an arm 42 having a radiation source 44, such as an x-ray tube, at one end of the arm and an x-ray detector 48 at the other end of the arm. The end of the arm 42 having the x-ray detector 48 may also include a support device 46, such as a breast support plate for supporting a breast for mammographic imaging, which support device may be removable if desired. The arm 42 is mounted on a frame 50. In some embodiments (e.g., for example, for a conventional mammographic imaging system), the radiation source and / or the x-ray detector 46 may be directly coupled to the frame 50. In some embodiments (e.g., for example, Figure 5A , Figure 5B and Fig. 6A , Figure 6B In the digital breast tomosynthesis imaging system shown in FIG. 4 , the X-ray tube 44 may be pivoted or rotated within a limited angular range (eg, 60 degrees or less), for example, particularly around a horizontal axis, while the X-ray detector 46 remains stationary.

[0024] As depicted, a sample holding system 52 is coupled to the apparatus 40. The sample holding system 52 includes an attachment 54 for coupling the system 52 to the apparatus 40, a sample holder 56 for holding a tissue sample 58, and a motor drive mechanism 60 for rotating the sample holder 56 about an axis 64 (e.g., a horizontal axis) as indicated by arrow 62 up to 360 degrees plus an additional angular range to ensure data integrity. The sample holding system 52 provides a greater angular range for acquiring imaging data than a digital breast tomosynthesis imaging system. In certain embodiments utilizing a digital breast tomosynthesis imaging system (e.g., such as Figure 5A , Figure 5B and Fig. 6A , Figure 6B ), the sample holding system 52 may not include a motor drive mechanism, but may include a mechanism to couple the sample holder 56 to a gantry that enables the sample holder 56 to remain stationary while the radiation source 44 moves. In some embodiments, the sample holder 56 may move as the radiation source 44 moves to maintain the projection of the X-ray source and sample on the X-ray detector 46 and avoid edge effects and cutoff. This enables the digital breast tomosynthesis imaging system to be used in a magnified mode when imaging a sample.

[0025] The accessory 54 can be inserted into a receiver 66, which is generally configured to receive a compression paddle or a magnifying support. In some embodiments, inserting the accessory 54 into the receiver 66 will cause (or deceive) the device 40 to operate in a magnified mode (e.g., geometric magnification>1), which is opposite to the contact mode (i.e., this mode is used if the breast is placed in contact with the support device 46). In the magnified mode, the object (e.g., a tissue sample) will be closer to the x-ray source and farther away from the detector. In the magnified mode, the geometric magnification may be limited by the system configuration to 1.5× to 2×. In some embodiments, the geometric magnification can be as high as 5× or even 10×. In addition, the field of view of the object can be reduced in the magnified mode (e.g., for 2×, 300mm to 150mm), and the effective pixel size of the object will be proportionally reduced (e.g., for 2×, 100μm to 50μm). It should be noted that for the magnified mode, the focal spot size of the x-ray source may need to be reduced to achieve the desired spatial resolution. This can reduce the maximum power of the X-ray source and therefore require longer scan times and higher radiation doses than the non-amplified mode; however, since this is a sample scanner, these are acceptable tradeoffs. This, combined with no restrictions on radiation dose, enables high-resolution images of the tissue sample 58. It should be noted that the sample remains in the field of view during image acquisition (regardless of whether the sample is rotated).

[0026] In some embodiments, the sample holding system 52 may include a hardware identifier 68 (e.g., a bar code or other readable indicia) configured to be scanned or read by the device 40. In some embodiments, the device 40 may include an optical reader to scan or read the indicia 68. In some embodiments, assuming that the system is capable of introducing new compression paddles and software, the scanning or reading of the indicia 68 will cause the device 40 (e.g., from a memory) to access or obtain a special program for intraoperative imaging of the tissue sample 58 (e.g., in a magnified mode). Specifically, the device 40 responds to reading the indicia 68 so that the device 40 (e.g., automatically) acquires imaging data at different angular positions (over an angular range of up to at least 360 degrees), wherein the motor drive mechanism 60 rotates the sample holder 56 (and the tissue sample 58). If in a step-by-step shooting mode, the motor drive mechanism 60 rotates the tissue sample 58 in synchronization with the exposure.

[0027] In some embodiments, the system may not be turned on, and the mark 68 utilized may be a mark typically used for a spot compression paddle. In some systems where controls are not accessible, the user utilizes a manual mode to set the acquisition sequence or exposure. In this case, a lookup table of suggested exposures may be provided to the user.

[0028] As described above, the motor drive mechanism 60 can rotate the tissue sample 58 within an angle range of up to 360 degrees plus an additional angle range to ensure data integrity. For the image acquisition sequence, between each exposure, the motor drive mechanism 60 rotates the tissue sample about 90 degrees or less. The angular rotation of the tissue sample 58 between exposures can be in the range of about 0.1 degrees to 90 degrees. Therefore, the number of angular positions at which imaging data can be collected (and therefore the number of images collected) can be in the range of 4 to 3600. In a preferred embodiment, the tissue sample will rotate 1 degree / image. In systems that allow modification of the control software, it may only be necessary to press (and hold) the X-ray trigger once to perform the image acquisition sequence. In other systems, it may be necessary to press the X-ray trigger multiple times during the image acquisition sequence. It should be noted that in some embodiments, the sample can rotate continuously.

[0029] In certain embodiments, the sample holder 56 may include a fiducial 70 (e.g., a radiopaque grid, an electronic grid, or any other type of fiducial). The fiducial 70 provides (e.g., via an alphanumeric grid) the distance and position of the tissue sample 58 in the subject or patient from which the tissue sample 58 was obtained. The fiducial 70 appears on the acquired image. In certain embodiments, via processing circuitry, an electronic fiducial may be added as a reference after exposure. Information from the fiducial 70 (e.g., distance and position), if provided to the system, enables an image of the tissue sample 58 to be displayed relative to its pre-resection orientation and position in the patient's body during examination. In certain embodiments, the surgeon may place the tissue sample 58 on the positioning fiducial in the operating room.

[0030] Figure 3 A flow chart of an embodiment of a method 72 for intraoperative imaging of a tissue sample is shown. Figure 1 and Figure 2 The component of the intraoperative imaging system or the processor-based system in the present invention performs one or more steps of method 72. Method 72 includes coupling the sample holding system to an existing mammographic imaging system (e.g., a digital breast tomosynthesis imaging system or a full-field digital mammographic imaging system) (block 74). For example, an accessory of the sample holding system can be inserted into a receiver that is generally configured to receive a compression paddle or a magnification support of an existing mammographic imaging system.

[0031] The method 72 also includes setting or obtaining an image acquisition sequence (block 76). In an open system, a tag may be read or scanned on a sample holding system (e.g., when the sample holding system is coupled) that obtains a specific program for intraoperative imaging of a tissue sample that has been stored in a memory of the mammographic imaging system. In other systems, a user may have to manually set up the imaging system (e.g., using a lookup table that provides a suggested exposure).

[0032] The method 72 also includes starting an image acquisition sequence (frame 78) (e.g., via pressing an X-ray trigger). The method 72 even includes rotating the tissue sample synchronously with the exposure (frame 80). In some embodiments (e.g., in an open system), the system automatically alternates between exposing and rotating the tissue sample to different angular positions within an angular range (e.g., up to 360 degrees). In other embodiments, the user may have to manually trigger the exposure between each rotation of the tissue sample. It should be noted that in some embodiments, the sample can be rotated continuously.

[0033] The method 72 also includes generating a 3D image (box 82) from imaging data collected within an angular range greater than 2 degrees (and up to 360 degrees plus an additional angular range to ensure data integrity). The imaging data can be reconstructed into a 3D image via cone beam computed tomography (CT) reconstruction, such as back projection, iterative reconstruction, and deep learning-based reconstruction methods or other reconstruction methods. The imaging data can be sent to a process-based system running a DICOM server for reconstruction. In certain embodiments, the method 72 includes detecting an object within an image of a tissue sample (box 84). For example, a CAD module can automatically detect calcifications, markers, and / or masses within an image.

[0034] The method 72 also includes displaying the 3D image (block 86). For example, the image may be displayed on a display in the operating room (e.g., on a workstation) for viewing by a surgeon or radiologist. In some embodiments, the image may be displayed on a PACS system in the operating room. In some embodiments, the image may be displayed in a video loop (e.g., movie mode) on a display in the operating room. The image may include a grid or other reference information related to distance and position relative to the position and orientation of the sample before it was removed from the patient. As described above, this information may be provided to the system to enable a sketch of the patient and the orientation of the sample image to be displayed in the examination.

[0035] Figure 4 A flow chart of an embodiment of a method 88 for intraoperative imaging of a tissue sample is shown. Figure 1 and Figure 2 A component of an intraoperative imaging system or a processor-based system in the present invention performs one or more steps of method 88. One or more steps in method 88 may be performed in a different order or simultaneously. Method 88 includes reading or scanning a marker associated with a sample holding system when coupling the sample holding system to an existing mammographic imaging system (e.g., a digital breast tomosynthesis imaging system or a full-field digital mammographic imaging system) (box 90). For example, an accessory of the sample holding system may be inserted into a receiver that is generally configured to receive a compression paddle or a magnification support of an existing mammographic imaging system. Method 88 includes entering a magnification mode (box 92) and a sample imaging mode (e.g., intraoperative imaging mode) (box 94) when reading or scanning the marker. In the magnification mode, a geometric magnification of typically up to 1.5× to 2× may be utilized during an image acquisition sequence. Entering the sample imaging mode includes obtaining a special program for intraoperative imaging of a tissue sample from a memory of the mammographic imaging system, the special program including a specific image acquisition sequence. In some embodiments, a user is able to select a desired number of images and / or angle ranges to acquire imaging data, or is able to select from different specific image acquisition sequences.

[0036] The method 88 also includes starting an image acquisition sequence (block 96) (e.g., via pressing an X-ray trigger). The method 88 even includes rotating the tissue sample synchronously with the exposure (block 100). The system automatically alternates between exposing and rotating the tissue sample to different angular positions within an angular range (e.g., up to at least 360 degrees). It should be noted that in some embodiments, the sample can be continuously rotated.

[0037] The method 88 also includes generating a 3D image from imaging data collected within an angular range greater than 60 degrees (and up to 360 degrees) (box 102). The imaging data can be reconstructed into a 3D image via cone beam computed tomography (CT) reconstruction, such as back projection, iterative reconstruction, or other reconstruction methods. The imaging data can be sent to a process-based system running a DICOM server for reconstruction. In certain embodiments, the method 88 includes detecting an object within an image of a tissue sample (box 104). For example, a CAD module can automatically detect calcifications, markers, and / or masses within an image.

[0038] Method 88 also includes displaying the 3D image (block 106). For example, the image may be displayed on a display in the operating room (e.g., on a workstation) for viewing by a surgeon or radiologist. In some embodiments, the image may be displayed on a PACS system in the operating room. In some embodiments, the image may be displayed in a video loop (e.g., movie mode) on a display in the operating room. The image may include reference information related to distance and location within the patient's body. As described above, this information may be provided to the system to enable a sketch of the patient and the orientation of the sample image to be displayed in the examination.

[0039] Figure 5A and Figure 5BAn embodiment of a digital breast imaging system 108 is shown that is modified to operate in a magnified mode for sample imaging (e.g., at high magnification). As shown, a sample holding system 110 includes a non-motorized mechanical device 112 (e.g., a non-motorized mechanical device that utilizes passive mechanical sample positioning) that is attached between an X-ray source 114 (e.g., an X-ray tube) and a detector 116 of the digital breast tomosynthesis imaging system 108. The sample holding system 100 also includes a sample holder 118 attached to the device that holds a sample 120 (which includes a feature 121 (e.g., a tumor)) at a distance from the detector 116 to achieve magnification. As the X-ray source 114 is automatically moved to different angular positions 122 between X-ray exposures, projections (e.g., projections 124 of the sample 120 and projections 126 of the feature 121) are acquired within an angular range suitable for digital tomosynthesis. In doing so, the attached non-motorized device 112 moves to the same angle as the x-ray source 114, thereby positioning the sample 120 between the x-ray source 114 and the detector 116 in a consistent alignment, i.e., a consistent lateral position relative to the x-ray source and detector, a consistent rotational orientation relative to the detector, and a consistent geometric magnification. Figure 5A In FIG. 1 , the position 122 of the X-ray source 114 is the center position 128. Figure 5B In FIG. 1 , the position 122 of the X-ray source 114 is the end position 130. In conjunction with the use of the sample holding system 110, appropriate geometric calibration and reconstruction are used to acquire imaging data of the sample 120. Typically, the DBT imaging system 108 cannot be operated in a magnified mode because the projection will miss the detector. However, Figure 5A and Figure 5B The sample holding system 110 in enables the DBT imaging system 108 to operate in a magnified mode. Fig. 6A and Figure 6B A DBT imaging system 108 is shown, which is modified to operate in a magnified mode for imaging similar to Figure 5A and Figure 5B The sample is imaged, except that the sample holding system 100 is configured for a lower constant magnification and for holding a larger sample.

[0040] By retrofitting existing mammographic imaging systems that are unable to acquire 3D images over a wider range of angles (greater than 25 degrees and up to 360 degrees), the techniques described above will provide a moderate level of 3D assessment capability to the operating room. These high-resolution images can provide enough information to detect or exclude positive margins in a timely and confident manner, which can result in margin assessments that are as good or better than those performed using histopathology and reduce the need for additional surgery (e.g., re-excision). In certain embodiments, the disclosed techniques can help locate tumor tissue, calcifications, or markers within a breast lumpectomy specimen during surgery or during a mastectomy.

[0041] Technical effects of the disclosed subject matter include providing systems and methods for sample imaging (e.g., intraoperative sample imaging), which utilize existing mammographic imaging systems for sample imaging. Specifically, the intraoperative sample imaging system includes a sample holding system configured to hold a tissue sample, wherein the sample holding system is retrofittedly coupled to an existing mammographic imaging system, wherein the intraoperative sample imaging system is configured to acquire imaging data to generate a 3D image of the tissue sample. The intraoperative sample imaging system can be used during surgery (e.g., breast tumor removal surgery, mastectomy, etc.) performed on a patient in an operating room to obtain a tissue sample from the patient, so as to provide improved intraoperative imaging (e.g., high-resolution 3D images) at a lower cost to institutions (which may not normally have available intraoperative sample imaging).

[0042] The technology presented and claimed herein is referred to and applied to physical and specific examples of a practical nature that clearly improves upon the present state of the art and, therefore, is not abstract, intangible, or purely theoretical. In addition, if any claim appended to the end of this specification contains one or more elements designated as "means for [performing] the function of ..." or "steps for [performing] the function of ...," it is intended that such elements be interpreted under 35 USC § 112(f). However, for any claim containing elements designated in any other manner, it is not intended that such elements be interpreted under 35 USC § 112(f).

[0043] This written description uses examples to disclose the subject matter, including the best mode, and also to enable those skilled in the art to practice the subject matter, including making and using any devices or systems and performing any included methods. The patentable scope of the subject matter is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to fall within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements that have minor differences from the literal language of the claims.

Claims

1. An intraoperative sample imaging system, comprising: A mammographic imaging system comprising a radiation source configured to emit radiation; and a sample holding system comprising a sample holder configured to hold a tissue sample, wherein the sample holding system is retrofitted to the mammographic imaging system, wherein the sample holder is rotatable to rotate the tissue sample in the sample holder to different angular positions within a specific angular range, Wherein, the mammographic imaging system is configured to acquire imaging data at the different angular positions within the specific angular range to generate a three-dimensional image of the tissue sample when the radiation source emits radiation while the tissue sample in the sample holder is rotated to the different angular positions.

2. The intraoperative specimen imaging system of claim 1, wherein the mammographic imaging system is configured to acquire the imaging data within an angular range greater than 2 degrees.

3. The intraoperative sample imaging system of claim 2, wherein the angular range extends up to at least 360 degrees.

4. The intraoperative specimen imaging system of claim 1, wherein the mammographic imaging system comprises a full-field digital mammographic imaging system configured to acquire two-dimensional imaging data.

5. The intraoperative specimen imaging system of claim 1, wherein the mammographic imaging system comprises a digital breast tomosynthesis imaging system configured to acquire projection data while operating in a magnified mode.

6. The intraoperative sample imaging system of claim 1, wherein the sample holding system comprises a sample holder and an accessory configured to couple the sample holder to the mammographic imaging system.

7. The intraoperative sample imaging system of claim 6, wherein the sample holding system comprises a motor configured to rotate the sample holder.

8. The intraoperative sample imaging system according to claim 7, wherein: The attachment includes a marker configured to be scanned or read by the mammographic imaging system, wherein the scanning or reading of the marker is configured to cause the mammographic imaging system to automatically acquire imaging data at the different angular positions, wherein the motor rotates the tissue sample between each angular position.

9. The intraoperative sample imaging system of claim 6, wherein the accessory is configured to couple the sample holding system to a portion of the mammographic imaging system, wherein the compression paddle or magnification support is configured to couple to the mammographic imaging system.

10. The intraoperative sample imaging system according to claim 9, wherein: When the accessory is coupled to the portion of the mammographic imaging system, the mammographic imaging system is configured to enter a magnified mode.

11. The intraoperative sample imaging system of claim 6, wherein the sample holder includes a radiopaque fiducial for providing a distance and position of the tissue sample in a subject from which the tissue sample was obtained.

12. The intraoperative sample imaging system of claim 1, wherein the intraoperative sample imaging system is configured to add an electronic fiducial to the image of the tissue sample after acquiring the imaging data.

13. A method for intraoperative sample imaging, the method comprising: coupling a sample holding system to a mammographic imaging system, wherein the sample holding system comprises a sample holder, an attachment for coupling the sample holder to the mammographic imaging system, and a motor configured to rotate the sample holder; Rotating the sample holder to rotate the tissue sample in the sample holder to different angular positions within a specific angular range, emitting radiation from a radiation source of the mammographic imaging system to acquire imaging data of the tissue sample at the different angular positions; as well as A three-dimensional image of the tissue sample is generated from the imaging data acquired at the different angular positions within the specific angular range.

14. The method of claim 13, comprising alternating between the following operations within the specific angle range: emitting said radiation from said radiation source to acquire said imaging data; and The sample holder is rotated after emitting the radiation to rotate the tissue sample to the different angular position, wherein alternating between emitting the radiation and rotating the sample holder occurs automatically in a synchronized manner.

15. A sample holding system, the sample holding system comprising: a sample holder configured to hold a tissue sample; an accessory configured to couple the sample holder to a mammographic imaging system; and a motor configured to rotate the sample holder to rotate the tissue sample in the sample holder to different angular positions within a specific angular range; The sample holding system is configured to be retrofittedly coupled to the mammographic imaging system to form an intraoperative sample imaging system, wherein the intraoperative sample imaging system is configured to acquire imaging data of the tissue sample at different angular positions within an angular range of up to at least 360 degrees to generate a three-dimensional image of the tissue sample.

Images