System and method for identifying regions of interest in multiple imaging modalities - Patents.com

Abstract

A method for identifying the location of a region of interest within a breast utilizes compressed position coordinates for the region of interest recorded while the breast is under compression during an x-ray imaging procedure, such as mammography or tomosynthesis. The compressed position coordinates are converted to uncompressed position coordinates using a mathematical tissue deformation model. Breast volume and density affect the way the coordinates are converted for use by the ultrasound imaging system. A system including a computing system in communication with the ultrasound imaging system is utilized to perform the method. The resulting predicted position coordinates of the region of interest are used to guide a healthcare provider to potential lesions to be examined using ultrasound and that have previously been identified during a screening mammogram.

Description

[Technical field]

[0001] This application was filed as a PCT international patent application on March 23, 2021, and claims the benefit of priority to U.S. Provisional Patent Application Serial No. 63 / 000700, filed March 27, 2020, the disclosure of which is incorporated by reference in its entirety.

[0002] The present application relates to a system and method for identifying regions of interest in multiple imaging modalities. [Background technology]

[0003] Medical imaging provides a non-invasive method for visualizing the internal structures of a patient. Visualization methods can be used to screen and diagnose cancer in patients. For example, early screening can detect lesions in the breast that may be cancerous, so that treatment can be administered early for the disease.

[0004] Mammography and tomosynthesis utilize X-ray radiation to visualize the breast in a compressed position. These techniques are often used to screen patients for potentially cancerous lesions. A traditional mammogram involves taking two-dimensional images of the breast from various angles. Tomosynthesis produces multiple X-ray images of the breast, discrete layers or slices of it throughout its thickness. Tomosynthesis stitches together a three-dimensional visualization of the breast. Mammography and tomosynthesis are typically performed with the patient in an upright position and with the patient's breast tissue under compression.

[0005] Once a lesion is found, an ultrasound may be performed as the next step in determining whether the patient has a tumor. Ultrasound uses sound waves, typically generated by a piezoelectric transducer, to image the patient's tissue. An ultrasound probe focuses the sound waves by generating an arc of sound waves that propagate into the body and are partially reflected from layers between different tissues of the patient. The reflected sound waves are detected by the transducer and converted into electrical signals that can be processed by an ultrasound scanner to form an ultrasound image of the tissue. Ultrasound is typically performed with the patient in a supine position and with the patient's breast tissue not under compression. Summary of the Invention [Problem to be solved by the invention]

[0006] During ultrasound diagnostic imaging procedures, technicians and radiologists often struggle to navigate to and locate lesions that were previously identified during x-ray imaging. Correlating the location of a lesion from x-ray imaging to ultrasound imaging is challenging because x-ray imaging is performed while the patient is upright and the breast tissue is under compression, while ultrasound imaging is performed while the patient is in a decubitus position and the breast tissue is not under compression.

[0007] It is against this background that the present disclosure is made. Techniques and improvements are provided herein. [Means for solving the problem]

[0008] An embodiment of the present disclosure relates to a method for identifying a location of a region of interest within a breast: information indicative of a region of interest within the breast is received; if the breast is under compression, compressed position coordinates of the region of interest within the breast are received; if the breast is not under compression, a mathematical tissue deformation model is applied to the compressed position coordinates of the region of interest to predict uncompressed position coordinates of the region of interest within the breast; the predicted uncompressed position coordinates are stored in a data storage device.

[0009] In another embodiment, an ultrasound navigation system includes at least one data storage device, a processing device, and a memory storing instructions that, when executed by the processor, facilitate performance of predetermined operations including accessing compressed location coordinates of a region of interest within a breast under compression from the data storage device, calculating predicted uncompressed location coordinates of the region of interest within the breast when the breast is not under compression using a mathematical tissue deformation model, and saving the predicted uncompressed location coordinates in the data storage device.

[0010] In yet another aspect, a non-transitory machine-readable storage medium stores executable instructions that, when executed by a processor, facilitate performance of predetermined operations including recording an x-ray image of a breast, receiving information indicative of a region of interest in the x-ray image of the breast, recording one or more structural markers at or around the region of interest, determining compressed position coordinates of the region of interest within the breast if the breast is under compression, storing the compressed position coordinates and the one or more structural markers in a data storage device, predicting uncompressed position coordinates of the region of interest within the breast if the breast is not under compression by applying a mathematical tissue deformation model to the compressed position coordinates of the region of interest, storing the predicted uncompressed position coordinates in a data storage device, reporting the predicted uncompressed position coordinates and the structural markers to an optical tracking system in communication with the ultrasound system, and displaying the coordinate model and the structural markers on a display in communication with the ultrasound system. [Brief description of the drawings]

[0011] [Figure 1] 1 illustrates an exemplary system for locating a region of interest in a breast. [Diagram 2] 1 shows a schematic diagram of an exemplary system for managing healthcare data including imaging data. [Diagram 3] 1 is a schematic diagram of an exemplary X-ray imaging system. [Figure 4]FIG. 4 is a perspective view of the X-ray imaging system of FIG. [Diagram 5] 1 shows an X-ray imaging system in breast positioning for a left lateral oblique (LMLO) imaging orientation. [Figure 6] 1 illustrates an exemplary ultrasound imaging system. [Figure 7] 7 illustrates an example of the ultrasound imaging system of FIG. 6 being used on a patient's breast. [Figure 8] 1 is a flow diagram illustrating an exemplary method for identifying a region of interest in a breast. [Figure 9] 2 illustrates an exemplary display of the graphical user interface of FIG. 1; [Figure 10] FIG. 1 is a schematic diagram of an example computing system that can be used to implement one or more aspects of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] The details of one or more technologies are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of these technologies will become apparent from the description, drawings, and claims.

[0013] The present disclosure relates to systems and methods for navigating to a region of interest in a breast using an imaging device. In particular, a computing system uses a tissue deformation model to calculate predicted coordinates of a region of interest in the breast. The region of interest may be identified during visualization of the breast using a first imaging modality, such as mammography or tomosynthesis. In some embodiments, the region of interest may require further imaging to determine whether a lesion within the region of interest is potentially cancerous. In such embodiments, an ultrasound imaging procedure may be performed on the breast.

[0014] Technologists and radiologists may find it difficult to locate the same region of interest due to the fact that the position of the breast is different in an ultrasound procedure compared to an X-ray imaging procedure (e.g., mammography or tomosynthesis). Typically, during X-ray imaging, the patient is in an upright position and the breast is under compression, whereas during an ultrasound examination, the patient is typically in a supine position and the breast is not under compression. This shift in position may make it difficult to correlate lesions found in the X-ray image to the image produced by ultrasound. Technologists typically use different coordinate systems and other means to identify the location of the region of interest in the breast in an ultrasound examination compared to X-ray imaging.

[0015] A computational system running the tissue deformation model may convert coordinates used during an x-ray imaging procedure into predicted coordinates usable during an ultrasound imaging procedure. The predicted coordinates can provide the ultrasound technician with greater confidence that he or she is seeing the same region of interest identified during the x-ray imaging procedure.

[0016] 1 illustrates an exemplary system 100 for locating a region of interest in a breast. System 100 includes a computing system 102, an X-ray imaging system 104, and an ultrasound imaging system 106. In some embodiments, system 100 operates to guide a technician to a location of interest in the breast during ultrasound imaging based on data collected during an X-ray imaging procedure that initially identified the location of the interest.

[0017] The computing system 102 operates to process and store information received from the x-ray imaging system 104 and to provide processed information to the ultrasound imaging system 106. In the example of Figure 1, the computing system 102 includes a tissue deformation model 110 and a data store 112. In some embodiments, the tissue deformation model 110 and the data store 112 are contained within memory of the computing system 102. In some embodiments, the computing system 102 accesses the tissue deformation model 110 and the data store 112 from a remote server, such as a cloud computing environment.

[0018] The tissue deformation model 110 is utilized to analyze information obtained regarding a region of interest in the breast during x-ray imaging and convert that information into location identification information that can be used to navigate to the same region of interest during ultrasound imaging. Coordinates of the region of interest determined during the x-ray imaging procedure when the breast tissue is under compression are converted into a different set of coordinates that are used to position the region of interest during ultrasound imaging of uncompressed breast tissue.

[0019] The tissue deformation model 110 predicts ultrasound coordinates based on the density and volume of the breast being imaged. In some embodiments, the tissue deformation model 110 is based on a deformation curve determined based on the amount of diffusion of breast tissue recorded in a mammography paddle. The tissue deformation model 110 is calculated for each patient using the known compression force of the paddle and the density determined by x-ray.

[0020] The data storage device 112 operates to store information received from the X-ray imaging system 104 and after it has been processed by the tissue deformation model. In some embodiments, the data storage device 112 is actually two or more separate data storage devices. For example, one data storage device may be a remote data storage device that stores coordinates of compressed locations for the region of interest from one or more X-ray imaging systems. The other data storage device may be housed locally within the computing system 102 and may store coordinates of predicted uncompressed locations for the region of interest. In some embodiments, the data storage device 112 may be part of an electronic medical record (EMR) system.

[0021] The X-ray imaging system 104 is operative to capture images of breast tissue using X-ray radiation. The X-ray imaging system 104 includes an X-ray imaging device 114 and an X-ray computing device 116 in communication with the X-ray imaging device 114. The X-ray imaging device 114 is described in further detail with reference to Figures 3-5. The X-ray computing device 116 is operative to receive input from a healthcare provider H to operate the X-ray imaging device 114 and to view images received from the X-ray imaging device 114.

[0022] Ultrasound imaging system 106 is operative to capture images of breast tissue using ultrasound. Ultrasound imaging system 106 is described in further detail with reference to Figures 6-7. Ultrasound imaging system 106 includes an ultrasound computing device 118 and an ultrasound imaging device 120. Ultrasound computing device 118 is operative to receive input from a healthcare provider H to operate ultrasound imaging device 120 and to view images received from ultrasound imaging device 120.

[0023] FIG. 1 illustrates how information obtained from an X-ray imaging system 104 can be utilized by an ultrasound imaging system 106. A healthcare provider H operates an X-ray computing device 116 to capture an X-ray image of a patient P's breast using an X-ray imaging device 114. The X-ray image may be taken as part of a routine health screening or a follow-up diagnostic screening. The image is reviewed by a radiologist, who may identify one or more regions of interest in the patient P's breast that require further analysis to determine whether lesions within those regions of interest are potentially cancerous and require a biopsy. The radiologist may mark the regions of interest, and the computing system (102 or other system) may determine the coordinates based on the radiologist's selection and store the coordinates in DICOM format associated with the X-ray image. In another embodiment, the coordinates may be stored in association with the patient by patient ID. In some embodiments, the coordinates are stored in a database with a unique identifier linked to the patient's electronic medical record registration number.

[0024] In one embodiment, the coordinates of the region of interest may be determined using a computer-aided detection system stored on the computing device 116 and communicated to the computing system 102. In some embodiments, the computer-aided detection system utilizes artificial intelligence or machine learning techniques to determine the coordinates. The coordinates recorded by either the radiologist or the computing device 116 are analyzed using the tissue deformation model 110. The output of the analysis is a set of predicted coordinates, which may be communicated to the ultrasound computing device 118, for use at a later appointment, typically at a location that is often different than the location at which the imaging procedure was performed.

[0025] A healthcare provider H operating an ultrasound computing device 118 navigates to a region of interest in a breast of a patient P with an ultrasound imaging device 120 using the predicted coordinates. In some embodiments, the predicted coordinates of the ROI are used in conjunction with an image representation of the breast on the display of the ultrasound computing device 118. The predicted coordinates are used to generate a visual indicator in the image of the breast of the location of the region of interest. In some embodiments, this is represented such that the ROI is illustrated as a clock position relative to the nipple of the image representation of the breast. Additionally, a different visual indicator may be displayed to indicate the current position of the ultrasound probe. In some embodiments, a dot may be used to indicate the location of the ROI while a rectangle indicates the location of the ultrasound probe. In some embodiments, the orientation of the probe may be indicated by a rectangle and updated in real time. When the ultrasound probe is located over the region of interest, the visual indicators are illustrated to converge on the display of the ultrasound computing device 118. This visual guide makes it much easier for the healthcare provider to verify that the same lesion identified by the x-ray imaging system 104 is being examined using the ultrasound imaging system 106. FIG. 10 provides an example of such a display.

[0026] 2 shows a schematic diagram of an exemplary system 150 for managing healthcare data, including imaging data. System 150 includes multiple computing components in communication with each other via a communications network 152. The computing components may include a tracking system 154, a navigation system 156, an EMR system 158, and a display system 160, in addition to the computing system 102, the X-ray imaging system 104, and the ultrasound imaging system 106 described in FIG.

[0027] It should be noted that although the "system" is shown as multiple functional blocks in FIG. 1, different systems may be integrated into a common device and communication links may be connected between some but not all of the systems. For example, the tracking system 154, the navigation system 156, and the display system 160 may be included in an acquisition workstation or technician workstation that may control the acquisition of images in a radiology suite. Alternatively, the navigation system 156 and the tracking system 154 may be integrated into the ultrasound imaging system 106 or may be provided as stand-alone modules with separate communication links to the display 160, the x-ray imaging system 104, and the ultrasound system 106. Similarly, one skilled in the art will further recognize that the communication network 152 may be a local area network, a wide area network, a wireless network, the Internet, an intranet, or other similar communication network.

[0028] In one embodiment, the X-ray imaging system 104 is a tomosynthesis acquisition system that captures a set of projection images of the patient's breast as an X-ray tube scans over a path over the breast. The set of projection images is then reconstructed into a three-dimensional volume, which may be viewed as slices or slabs along any plane. The three-dimensional volume may be stored locally at the X-ray imaging system 104 (either the X-ray imaging device 114 or the X-ray computing device 116) or may be stored in a data storage device, such as the data storage device 112, which communicates with the X-ray imaging system 104 via a communications network 152. In some embodiments, the three-dimensional volume may be stored in the patient's file in an electronic medical record (EMR) system 158. Additional details regarding an exemplary X-ray imaging system are described with reference to FIGS. 3-5.

[0029] The X-ray imaging system 104 may transmit three-dimensional X-ray image volumes via the communications network 152 to the navigation system 156, where such X-ray images may be stored and viewed. The navigation system 156 displays the X-ray images acquired by the X-ray imaging system. Once reconstructed for display in the navigation system 156, the X-ray images may be reformatted and repositioned to view the images in any plane and at any slice position or orientation. In some embodiments, the navigation system 156 displays multiple frames or windows on the same screen showing alternative positions or orientations of the X-ray image slices.

[0030] Those skilled in the art will appreciate that the x-ray image volume acquired by the x-ray imaging system 104 may be transmitted to the navigation system 156 at any time, not necessarily immediately after acquiring the x-ray image volume, but instead upon request of the navigation system 156. In alternative embodiments, the x-ray image volume is sent to the navigation system 156 by a transportable media device, such as a flash drive, CD-ROM, and DVD-ROM diskette, or other such transportable media device.

[0031] The ultrasound imaging system 106 acquires ultrasound images of the patient's tissue, typically using an ultrasound probe. The ultrasound probe is used to image a portion of the patient's tissue within the field of view of the ultrasound probe. For example, the ultrasound imaging system 106 may be used to image the breast, and more specifically, the breast ducts. The ultrasound imaging system 106 acquires and displays ultrasound images of the patient's anatomical structures within the field of view of the ultrasound probe, typically displaying the images in real time as the patient is being imaged. In some embodiments, the ultrasound images may also be stored on a storage medium, such as a hard drive, CD-ROM, flash drive, or diskette, for later reconstruction or playback. Additional details regarding the ultrasound imaging system are described with reference to FIGS. 6-7.

[0032] In some embodiments, the navigation system 156 may access the ultrasound images, and in such embodiments, the ultrasound imaging system 106 may be further connected to a communications network 152, and copies of the ultrasound images acquired by the ultrasound imaging system 106 may be transmitted to the navigation system 156 via the communications network 152. In other embodiments, the navigation system 156 may access and copy the ultrasound images remotely via the communications network 152. In alternative embodiments, copies of the ultrasound images may be stored in the data storage device 112 or an EMR system 158 in communication with the navigation system 156 via the communications network 152, and accessed remotely by the navigation system 156.

[0033] The tracking system 154 may communicate with the navigation system 156 via the communication network 152 to track the physical location where the ultrasound imaging system 106 is imaging the patient's tissue. In some embodiments, the tracking system 154 may be directly connected to the navigation system 156 via a direct or wireless communication link. The tracking system 154 tracks the location of transmitters connected to the ultrasound imaging system 106 and provides data to the navigation system 156 representing their coordinates in the tracker coordinate space. In some embodiments, the tracking system 154 may be an optical tracking system comprising an optical camera and an optical transmitter, although one skilled in the art will appreciate that any device or system capable of tracking the location of an object in space may be used. For example, one skilled in the art will appreciate that in some embodiments, an RF tracking system comprising an RF receiver and an RF transmitter may be used.

[0034] The ultrasound imaging system 106 may be configured for use with a navigation system 156 through a calibration process using the tracking system 154. Transmitters connected to an ultrasound probe of the ultrasound imaging system 106 may transmit their position in the tracker coordinate space to the tracking system 154, which then provides this information to the navigation system 156. For example, transmitters may be located on the probe of the ultrasound imaging system 106 such that the tracking system 154 can monitor the position and orientation of the ultrasound probe and provide this information in the tracker coordinate space to the navigation system 156. The navigation system 156 may use this tracked position to determine the position and orientation of the ultrasound probe relative to the tracked position of the transmitters.

[0035] In some embodiments, configuration is performed using a configuration tool. In such embodiments, the position and orientation of the configuration tool may be further tracked by the tracking system 154. During configuration, the configuration tool contacts a transducer face of an ultrasound probe of the ultrasound imaging system 106, and the tracking system 154 transmits information representing the position and orientation of the configuration tool in the tracker coordinate space to the navigation system 156. The navigation system 156 may determine a configuration matrix that can be used to determine the position and orientation of the field of view of the ultrasound probe in the tracker coordinate space based on the tracked position of a transmitter connected to the ultrasound probe. In an alternative embodiment, a database having configuration data for multiple brands or models of various ultrasound probes may be used to preload field of view configurations into the navigation system 156 during configuration.

[0036] Once the ultrasound imaging system 106 is configured with the navigation system 156, the patient's tissue may be imaged by the ultrasound imaging system 106. During ultrasound imaging, the tracking system 154 monitors the position and orientation of the ultrasound probe of the ultrasound imaging system 106 and provides this information in tracker coordinate space to the navigation system 156. Because the ultrasound imaging system 106 is configured for use with the navigation system 156, the navigation system 156 can determine the position and orientation of the field of view of the ultrasound probe of the ultrasound imaging system 106.

[0037] The navigation system 156 may be configured to register the ultrasound image with the X-ray image. In some embodiments, the navigation system 156 may be configured to transform the position and orientation of the field of view of the ultrasound probe from the tracker coordinate space to a position and orientation in the X-ray image, for example to X-ray system coordinates. This may be accomplished by tracking the position and orientation of the ultrasound probe and transmitting this position information in the tracker coordinate space to the navigation system 156, which then relates this position information to the X-ray coordinate system.

[0038] For example, a user may select an anatomical plane in an x-ray image, and then the user may manipulate the position and orientation of the tracked ultrasound probe to align the ultrasound probe's field of view with the selected anatomical plane. Once alignment is achieved, the associated tracker space coordinates of the ultrasound image can be captured. Registration of the anatomical axes (superior-inferior (SI), left-right (LR), and anterior-posterior (AP)) between the x-ray image and the tracker coordinate space may be determined from the relative rotational difference between the tracked ultrasound field of view direction and the selected anatomical plane, using techniques known to those skilled in the art.

[0039] The configuration may further include selecting a landmark in the X-ray image, for example using an interface that allows the user to select an anatomical landmark. In some embodiments, the landmark may be an internal tissue landmark such as a vein or artery, while in other embodiments, the landmark may be an external landmark such as a fiducial skin marker or an external landmark such as a nipple. The same landmark selected in the X-ray image may be positioned relative to the ultrasound probe, and upon positioning, a mechanism may be provided to capture the coordinates of the representation of the target in the tracker coordinate space. The relative difference between the coordinates of the target in the X-ray image and the coordinates of the target in the tracker coordinate space is used to determine the transformation parameters required to align the two coordinate spaces. Previously acquired plane orientation information may be combined with the transformation parameters to provide a complete 4×4 transformation matrix that can register the two coordinate spaces together.

[0040] The navigation system 156 may then reformat the displayed x-ray image using a transformation matrix so that the slice of tissue displayed is in the same plane and orientation as the field of view of the ultrasound probe of the ultrasound imaging system 106. The matched ultrasound and x-ray images may then be displayed side-by-side or directly superimposed in a single image viewing frame. In some embodiments, the navigation system 156 may display an additional x-ray image in a separate frame or location on the display screen. For example, the x-ray image may be displayed along with a graphical representation of the field of view of the ultrasound imaging system 106, where the graphical representation of the field of view is displayed slicing through a 3D representation of the x-ray image. In other embodiments, annotations may also be displayed, which represent the location of an instrument imaged by the ultrasound imaging system 106, such as a biopsy needle, a guidance wire, an imaging probe, or other similar device.

[0041] In other examples, the ultrasound image displayed by the ultrasound imaging system 106 may be superimposed on a slice of the x-ray image displayed by the navigation system 156, allowing a user to simultaneously view both the x-ray and ultrasound images superimposed on the same display. In some examples, the navigation system 156 may enhance certain aspects of the superimposed ultrasound or x-ray images to improve the quality of the resulting combined image.

[0042] 1, the computing system 102 operates to predict coordinates of uncompressed locations of a region of interest using the tissue deformation model 110. The predicted uncompressed location coordinates may be used by the navigation system 156 to assist a user in locating the region of interest while operating the ultrasound imaging system 106.

[0043] The electronic medical record system 158 stores multiple electronic medical records (EMRs). Each EMR contains a patient's medical and treatment history. Examples of electronic medical record systems 158 include those developed and maintained by Epic Systems Corporation, Cerner Corporation, Allscripts, and Medical Information Technology, Inc. (Meditech).

[0044] FIG. 3 is a schematic diagram of an exemplary X-ray imaging system 104. FIG. 4 is a perspective view of the imaging system 104. Referring simultaneously to FIGS. 3 and 4, the X-ray imaging system 104 immobilizes a patient's breast 202 for X-ray imaging (mammography and / or tomosynthesis) using a breast compression immobilizer device 204 including a static breast support platform 206 and a movable compression paddle 208. The breast support platform 206 and the compression paddle 208 each have compression surfaces 210 and 212, respectively, that move toward one another to compress and immobilize the breast 202. In known systems, the compression surfaces 210 and 212 are exposed for direct contact with the breast 202. The platform 206 also houses an image receptor 216, optionally a tilt mechanism 218, and optionally an anti-scatter grid. The immobilizer device 204 is in the path of an imaging beam 220 emanating from an X-ray source 222 such that the beam 220 is incident on the image receptor 216 .

[0045] The immobilizer device 204 is supported on a first support arm 224 and the x-ray source 222 is supported on a second support arm 226. For mammography, the support arms 224 and 226 may rotate as a device about an axis 228 between different imaging orientations, such as CC and MLO, so that the system 104 may take mammogram projection images in each orientation. In operation, the image receptor 216 remains in the same position relative to the platform 206 while taking images. The immobilizer device 204 releases the breast 202 for movement of the arms 224 and 226 to different imaging orientations. For tomosynthesis, the support arm 224 remains in the same position and the breast 202 is fixed and remains in the same position, while at least the second support arm 226 rotates the x-ray source 222 relative to the immobilizer device 204 and compressed breast 202 about the axis 228. The system 104 captures multiple tomosynthesis projection images of the breast 202 at each angle of the beam 220 relative to the breast 202 .

[0046] At the same time, and optionally, the image receptor 216 may be tilted relative to the breast support platform 206 in synchronization with the rotation of the second support arm 226. The tilt may be through the same angle as the rotation of the x-ray source 222, or through a different angle selected such that the beam 220 remains at substantially the same location on the image receptor 216 for each of the multiple images. The tilt may be about an axis 230, which may not be in the image plane of the image receptor 216. A tilt mechanism 218 connected to the image receptor 216 may drive the image receptor 216 in a tilting motion.

[0047] For tomosynthesis and / or CT imaging, the breast support platform 206 may be horizontal or at an angle to the horizontal, e.g., in an orientation similar to that for prior art MLO imaging in mammography. The X-ray imaging system 104 may simply be a mammography system, a CT system, or a tomosynthesis system, or may be a "combo" system capable of performing multiple forms of imaging. One example of such a combo system is offered by the assignee of the present application under the trademark Selenia Dimensions.

[0048] When the system is operated, the image receptor 216 generates imaging information in response to illumination by the imaging beam 220 and supplies it to an image processor 232 for processing and generating a mammogram. A system control and workstation device 238, including software, controls the operation of the system and interacts with an operator to receive commands and transmit information including processed light images.

[0049] 5 shows an exemplary X-ray imaging system 106 in breast positioning for a left mediolateral oblique (MLO) imaging orientation. The tube head 258 of the system 104 is oriented generally parallel to the gantry 256 of the system 104, but not otherwise perpendicular to the flat portion of the support arm 260 on which the breast is placed. In this position, the technician may more easily position the breast without having to bow or squat below the tube head 258.

[0050] The X-ray imaging system 104 includes a floor mount or base 254 for supporting the X-ray imaging system 104 above a floor. A gantry 256 extends upwardly from the floor mount 252 and rotatably supports both a tube head 258 and a support arm 260. The tube head 258 and the support arm 260 are configured to rotate independently of one another and may be raised and lowered along a gantry face 262 to accommodate patients of different heights. An X-ray source, referred to elsewhere in this application but not shown, is disposed within the tube head 258. The support arm 260 includes a support platform 264 that includes an X-ray receptor and other components (not shown) therein. A compression arm 266 extends from the support arm 260 and is configured to linearly raise and lower (relative to the support arm 260) a compression paddle 268 to compress the patient's breast during an imaging procedure. Together, the tube head 258 and the support arm 260 may be referred to as a C-arm.

[0051] A number of interfaces and display screens are located on the X-ray imaging system 104. These include a leg display screen 270, a gantry interface 272, a support arm interface 274, and a compression arm interface 276. In general, the various interfaces 272, 274, and 276 may include one or more tactile buttons, knobs, switches, and may also include one or more display screens, including capacitive touch screens with graphic user interfaces (GUIs) to allow user interaction and control of the X-ray imaging system 104. In an embodiment, the interfaces 272, 274, 276 may include control functions that may be available in system controls and workstations, such as the X-ray computing device 116 of FIG. 1. Any individual interface 272, 274, 276 may include functions available in the other interfaces 272, 274, 276, sequentially or selectively, based at least in part on predefined settings, user preferences, or operating requirements. Generally, as described below, leg display screen 270 is the primary display screen, while a capacitive touch screen may be utilized if necessary or desired.

[0052] In an embodiment, gantry interface 272 may allow functions such as selection of imaging orientation, display of patient information, adjustment of support arm height or support arm angle (tilt or rotation), safety features, etc. In an embodiment, support arm interface 274 may allow functions such as adjustment of support arm height or support arm angle (tilt or rotation), adjustment of compression arm height, safety features, etc. In an embodiment, compression arm interface 276 may allow functions such as adjustment of compression arm height, safety features, etc. Additionally, one or more displays associated with compression arm interface 276 may display more detailed information such as the applied compression arm force, selected imaging orientation, patient information, support arm height or angle settings, etc. Leg display screen 270 may also display information as displayed by one or more displays of compression arm interface 276, or may display additional or different information as needed or desired for a particular application.

[0053] In general, the various interfaces and display screens located on the X-ray imaging system 104 may be used by a technician during various imaging procedures performed on a patient. The techniques described herein improve workflow efficiency, which may be advantageous for a number of reasons. For example, an efficient workflow may reduce the length of time of an imaging procedure. This helps reduce stress on the patient and allows a technician to see more patients in a given time frame. Utilizing the techniques described herein may also improve technician performance; that is, the technician may work more comfortably as he or she works to position the patient and control the imaging system during an imaging procedure, and may avoid unnecessary or excessive bending, twisting, and pulling during an imaging procedure. This helps reduce repetitive stress on the technician and may reduce fatigue.

[0054] 6 illustrates an example of an ultrasound imaging system 106. The ultrasound imaging system 106 includes an ultrasound probe 302 that includes an ultrasound transducer 304. The ultrasound transducer 304 is configured to emit an array of ultrasound waves 306. The ultrasound transducer 304 converts electrical signals into ultrasound waves 306. The ultrasound transducer 304 may be configured to detect ultrasound waves, such as ultrasound reflected from an interior of the patient, such as a breast duct. In some embodiments, the ultrasound transducer 304 may incorporate a capacitive transducer and / or a piezoelectric transducer, or may incorporate other suitable transduction technologies.

[0055] The ultrasound transducer 304 is also operatively connected (e.g., wired or wirelessly) to a display 310. The display 310 may be part of a computing system, such as the ultrasound computing device 118 of Figure 2, that includes a processor and memory configured to generate and analyze ultrasound images. The display 310 is configured to display ultrasound images based on ultrasound imaging of a patient.

[0056] The ultrasound imaging performed in ultrasound imaging system 106 is primarily B-mode imaging, which produces a two-dimensional ultrasound image of a cross-section of a portion of the patient's interior. The brightness of pixels in the resulting image generally corresponds to the amplitude or intensity of the reflected ultrasound waves.

[0057] Other ultrasound imaging modes may be utilized, for example, the ultrasound probe may operate in a 3D ultrasound mode in which ultrasound image data is acquired from multiple angles relative to the breast to build a 3D model of the breast.

[0058] In some embodiments, the ultrasound image may not be displayed during the acquisition process, rather, the ultrasound data is acquired and a 3D model of the breast is generated without displaying the B-mode image.

[0059] The ultrasonic probe 302 may include a probe positioning transceiver 308. The probe positioning transceiver 308 is a transceiver that emits signals that provide positioning information for the ultrasonic probe 302. The probe positioning transceiver 308 may include a radio frequency identification (RFID) chip or device for transmitting and receiving information, and may also include an accelerometer, a gyroscopic device, or other sensor that can provide directional information. For example, the signal emitted by the probe positioning transceiver 308 may be processed to determine the orientation or position of the ultrasonic probe 302. The orientation and position of the ultrasonic probe 302 may be determined or provided as three-dimensional components, such as Cartesian or spherical coordinates. The orientation and position of the ultrasonic probe 302 may be determined or provided relative to other objects, such as a cutting instrument, a marker, a magnetic direction, a normal to gravity, and the like. Using the orientation and position of the ultrasonic probe 302, additional information may be generated and provided to the surgeon to assist in guiding the surgeon to a lesion within the patient, as will be described in more detail below. Although the term transceiver is used in this application, this term is intended to cover both transmitters and receivers, transceivers, and any combination thereof.

[0060] FIG. 7 illustrates an example of an ultrasound imaging system 106 used on a patient's breast 312. An ultrasound probe 302 is in contact with a portion of the breast 312. In the position illustrated in FIG. 7, the ultrasound probe 302 is used to image a duct 314 of the breast 312. To image the duct 314, an ultrasound transducer 304 emits an array of ultrasound waves 306 into the interior of the breast 312. Some of the ultrasound waves 306 are reflected from internal components of the breast, such as a duct if the duct 314 is in the field of view, and return to the ultrasound probe 302 as reflected ultrasound waves 316. The reflected ultrasound waves 316 may be detected by the ultrasound transducer 304. For example, the ultrasound transducer 304 receives the reflected ultrasound waves 316 and converts the reflected ultrasound waves 316 into electrical signals. The electrical signals may be processed and analyzed to generate ultrasound image data on a display 310.

[0061] The depth of the vessel 314 or other object in the imaging plane may be determined from the time between the pulse of ultrasound 306 being emitted from the ultrasound probe 302 and the reflected ultrasound 316 being detected by the ultrasound probe 302. For example, the speed of sound is known and the effect of the speed of sound due to soft tissue can also be determined. Thus, based on the propagation time of the ultrasound 306 (more specifically, half the propagation time), the depth of the object in the ultrasound image may be determined. Other corrections or methods for determining the depth of the object may be implemented, such as compensating for the refraction and change speed of the wave through tissue. Those skilled in the art will appreciate further details of depth measurement in medical ultrasound imaging techniques. Such depth measurements and determinations may be used to construct a 3D model of the breast 312, and more specifically, a 3D model of the vessel 314 of the breast 312.

[0062] Additionally, multiple frequencies or modes of ultrasound techniques may be utilized. For example, real-time and simultaneous transmit and receive multiplexing of positioning frequencies and imaging and acquisition frequencies may be implemented. These capabilities may be utilized to provide information to register or fuse together multiple data sets from ultrasound techniques, thereby allowing vessel 164 and other medical images to be visualized on display 310. Imaging frequencies and acquisition sequences may include B-mode imaging (with or without compounding), Doppler modes (e.g., color, duplex), harmonic modes, shear wave and other elastography modes, contrast enhanced ultrasound, among other imaging modes and techniques.

[0063] An exemplary method 500 for identifying the location of a region of interest within a breast will now be described with reference to Figure 8. In some embodiments, the systems and devices described in Figures 1-7 can be used to perform the method 500. In particular, the computing system 102 of Figures 1-2 operates to perform the steps of the method 500 to assist a healthcare provider in navigating to a region of interest within a breast during an imaging procedure.

[0064] In operation 502, an x-ray image of a breast is recorded. In some embodiments, x-ray imaging device 114 of x-ray imaging system 104 of FIGS. 1-2 operates to record the x-ray image as a result of input provided by healthcare provider H in x-ray computing device 116. In some embodiments, the x-ray image is acquired using digital breast tomosynthesis. In some embodiments, the x-ray image may be acquired from a remote data storage device. In such embodiments, the x-ray images may be recorded at different times and locations and then stored in an EMR or other data storage device.

[0065] In operation 503, a deformation curve for the breast is determined. While x-ray images are being acquired during a mammogram, the breast is compressed with a paddle with a known amount of force. Marks on the paddle indicate the distance, and the distance the breast tissue spreads under compression is recorded. The known force versus distance is used to determine a deformation curve that approximates the volume and density of the breast.

[0066] In operation 504, information is received indicating a region of interest in the X-ray image. In some embodiments, the information is received from a healthcare provider H. In some embodiments, the healthcare provider H may be a radiologist located at a different location than the X-ray imaging system 104. The healthcare provider H may operate a computing device to display a user interface, thereby allowing the healthcare provider H to easily interact with the X-ray image to highlight the region of interest with input provided using an input device in communication with the X-ray computing device 116, such as a mouse, touch screen, or stylus. The region of interest may include one or more lesions identified by the healthcare provider H that require further analysis. In other embodiments, the information is received from a computer-aided detection system that uses a computer algorithm to determine the region of interest.

[0067] In operation 506, structural marks are recorded in and around the region of interest. In some embodiments, this step is optional. However, in some instances, it may be useful to record structural marks or biomarkers to aid in navigating in the region of interest in future imaging procedures. Such biomarkers may include naturally occurring marks (e.g., ducts, scar tissue, etc.) or may include artificial marks (e.g., features of biopsy implants, breast implants, etc.). While the breast is under compression, structural marks, biomarkers, or landmarks are recorded.

[0068] In operation 508, coordinates of the compressed location of the region of interest are determined. The coordinates of the region of interest are recorded during the X-ray imaging process using the X-ray imaging system 104. In some embodiments, the uncompressed location coordinates include at least two of the clock location relative to the nipple, the depth from the surface of the breast, and the distance from the nipple. Having all three coordinates improves the accuracy of the location coordinates. In some embodiments, the coordinates may be Cartesian or polar. In some embodiments, the region of interest may be identified within a particular slice in the tomosynthesis image stack (z coordinate) and its location may be further identified by x and y coordinates within that image slice.

[0069] In operation 509, a tissue deformation model is generated for the breast based on the x-ray images and the deformation curves. The volume and density of the breast are used to calculate the tissue deformation model. In some embodiments, machine learning techniques are used to calculate the tissue deformation model based on a large dataset of information about breast tissue.

[0070] In operation 510, the coordinates of the compressed locations, the structural markers (if recorded), and the tissue deformation model are stored in a data store. In some embodiments, this information is stored in data store 112 of FIG. 1. In other embodiments, the information may be stored in the patient's medical record in EMR system 158. In some embodiments, the coordinates of the compressed locations and any recorded structural or biomarkers are communicated directly to a tracking system in communication with the ultrasound system.

[0071] A mathematical tissue deformation model is applied to the coordinates of the compressed locations to predict coordinates of the uncompressed locations of the region of interest in operation 512. The tissue deformation model predicts the coordinates of the uncompressed locations based on the volume and density of breast tissue.

[0072] In operation 514, the coordinates of the predicted non-compression location are stored in a data store. In some embodiments, the data store may be the data store 112 of FIGS. 1-2. In other embodiments, the coordinates of the non-compression location may be stored in the patient's EMR. The coordinates of the non-compression location are typically stored in a format that is easily used by the navigation system 156 in cooperation with the ultrasound imaging system 106.

[0073] In operation 516, the coordinates of the predicted non-compression location and the structural markers (if available) are communicated to an optical tracking system in communication with the ultrasound imaging system. In some embodiments, the optical tracking system is tracking system 154 of FIG. 2, which communicates with ultrasound imaging system 106 via communications network 152. Additional details regarding the operation of optical tracking system 154 are provided above with reference to FIG. 2.

[0074] In operation 518, the coordinate model and structural markers (if available) are displayed on a display in communication with the ultrasound imaging system 106. The display may be part of an ultrasound computing device 118 in communication with an ultrasound imaging device 120 as shown in FIG. 1. In some embodiments, the coordinate model, structural markers, and x-ray image are displayed on an ultrasound computing device 118 in communication with the ultrasound imaging device 120. This display assists in guiding a healthcare provider to the area of ​​interest.

[0075] Figure 9 illustrates an example of the GUI 130 of Figure 1. In some embodiments, the GUI 130 is displayed on a computing device, such as the ultrasound computing device 118 of Figure 1. In the example of Figure 9, the GUI 130 displays a side-by-side x-ray image 602 and ultrasound image 604 of the breast 202. A target lesion 606 previously identified during x-ray imaging is displayed in the x-ray image 602 along with a visual marker. A corresponding ultrasound image 604 of the breast 202 shows an indication of a potential lesion 608. A confidence level indicator 610 is displayed providing a percentage of the likelihood that the target lesion 606 and the potential lesion 608 match. In this embodiment, there is a 99.9% match.

[0076] The GUI 130 includes a diagram 612 showing the location of the breast 202 where the ultrasound image 604 is being taken. The diagram 612 includes a marker 620 of the ROI location and an indicator 618 of the current position of the ultrasound probe. Additionally, a coordinate 614 is displayed. In this example, the coordinate 614 shows the location of a potential lesion at the 11:00 clock position of the right breast, 2 cm from the nipple.

[0077] 8 is a block diagram illustrating example physical components of a computing device 400. Computing device 400 may be any computing device utilized in connection with system 100 for locating a region of interest in a breast, such as x-ray computing device 116 or ultrasound computing device 118 of FIG.

[0078] In the embodiment shown in FIG. 8, computing device 400 includes at least one central processing unit ("CPU") 402, a system memory 408, and a system bus 422 connecting system memory 408 to CPU 402. System memory 408 includes random access memory ("RAM") 410 and read only memory ("ROM") 412. ROM 412 stores a basic input / output system containing basic routines that help to transfer information between components within computing device 400, such as during start-up. Computing system 400 further includes mass storage device 414. Mass storage device 414 may store software instructions and data.

[0079] The mass storage device 414 is connected to the CPU 402 through a mass storage controller (not shown) that is connected to the system bus 422. The mass storage device 414 and its associated computer-readable storage media provide non-volatile, non-transitory data storage for the computing device 400. Although the description of the computer-readable storage media contained herein refers to mass storage devices such as hard disks or solid-state disks, it should be recognized by those skilled in the art that the computer-readable data storage media may include any available tangible physical device or product from which data and / or instructions can be read by the CPU 402. In certain embodiments, the computer-readable storage media includes entirely non-transitory media.

[0080] Computer-readable storage media include volatile and non-volatile, removable and non-removable media implemented in any method or technology for storage of information, such as computer-readable software instructions, data structures, program modules, or other data. Exemplary types of computer-readable data storage media include, but are not limited to, RAM, ROM, EPROM, EEPROM, flash memory or other solid-state memory technology, CD-ROM, digital versatile disks ("DVDs"), other optical storage media, magnetic cassettes, magnetic tapes, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to store the desired information and that can be accessed by the computing device 400.

[0081] According to some embodiments, the computing device 400 may operate in a networked environment with logical connections to remote network devices via a network 152, such as a wireless network, the Internet, or other type of network. The computing device 400 may be connected to the network 152 via a network interface unit 404 connected to a system bus 422. It should be appreciated that the network interface unit 404 may be utilized to connect to other types of networks and remote computing systems. The computing device 400 includes an input / output controller 406 that receives and processes input from a number of other devices, including a touch-sensitive user interface display screen or other type of input device. Similarly, the input / output controller 406 may provide output to a touch-sensitive user interface display screen or other type of output device.

[0082] As mentioned briefly above, the mass storage device 414 and RAM 410 of computing device 400 may store software instructions and data. The software instructions include an operating system 418 adapted to control the operation of computing device 400. The mass storage device 414 and / or RAM 410 also store software instructions that, when executed by CPU 402, cause computing device 400 to provide the functionality described herein.

[0083] Although various embodiments and examples are described herein, those skilled in the art will appreciate that numerous modifications thereto may be made within the scope of the present disclosure, and therefore, it is not intended that the scope of the present disclosure be limited in any way by the examples provided.

Claims

1. 1. A method for identifying a location of a region of interest in a breast, comprising: receiving, at a computing device associated with an x-ray imaging device, information indicative of a region of interest within the breast; obtaining compressed position coordinates of a region of interest within the breast when the breast is under compression; predicting uncompressed location coordinates of a region of interest within the breast when the breast is not under compression by applying a mathematical tissue deformation model to compressed location coordinates of the region of interest; and storing the predicted non-compression location coordinates in a data storage device; the mathematical tissue deformation model calculates the predicted uncompressed position coordinates based on density and volume of the breast; The mathematical tissue deformation model is generated based on determining a magnitude of force applied to the breast and a distance the breast will expand under compression. method.

2. the region of interest is identified during an X-ray imaging procedure of the breast while the breast is under compression; The method of claim 1.

3. the uncompressed position coordinates include at least two of an azimuthal direction relative to a nipple of the breast, a depth from a surface of the breast, and a distance from the nipple; The method of claim 1.

4. the compressed position coordinates include at least one of Cartesian coordinates and polar coordinates; The method of claim 1.

5. and reporting predicted non-compressed position coordinates of the region of interest to an optical tracking system in communication with the ultrasound system. The method of claim 1.

6. the x-ray imaging procedure is digital breast tomosynthesis; The method of claim 2.

7. obtaining the compressed location coordinates includes accessing the compressed location coordinates from a remote data store. The method of claim 1.

8. receiving information indicative of a region of interest within the breast includes receiving input indicative of a lesion identified during the X-ray imaging procedure. The method of claim 2.

9. The mathematical tissue deformation model is generated based on the deformation curve and the X-ray image of the breast. The method of claim 1.

10. The method includes reporting a position of at least one biomarker to the optical tracking system; The biomarkers are obtained during an X-ray imaging procedure of the breast when the breast is under compression. The method of claim 5.

11. at least one data storage device; A processing device; a memory storing instructions which, when executed by said processing device, facilitate the performance of predetermined operations; An ultrasound navigation system comprising: The above operation is accessing from said data storage device compressed location coordinates of a region of interest within the breast under compression; calculating predicted uncompressed position coordinates of a region of interest within the breast using a mathematical tissue deformation model when the breast is uncompressed; storing said predicted non-compression location coordinates in said data storage device; the mathematical tissue deformation model calculates the predicted uncompressed position coordinates based on density and volume of the breast; The mathematical tissue deformation model is generated based on determining a magnitude of force applied to the breast and a distance the breast will expand under compression. Ultrasound navigation system.

12. The operations further include reporting predicted non-compressed position coordinates of the region of interest to an optical tracking system in communication with the ultrasound system. The system of claim 11.

13. The operations further include reporting the location of at least one biomarker from the data storage device to the optical tracking system.

13. The system of claim 12.

14. the region of interest is identified during an X-ray imaging procedure of the breast while the breast is under compression; The system of claim 11.

15. determining a distance the breast spreads over a paddle during the x-ray imaging procedure; determining a deformation curve based on the distance and a known force applied to the breast by the paddle.

15. The system of claim 14.

16. and wherein the at least one biomarker is identified during an X-ray imaging procedure of the breast when the breast is under compression. The system of claim 13.

17. the compressed position coordinates include at least one of Cartesian coordinates and polar coordinates; The system of claim 11.

18. the uncompressed position coordinates include at least two of an azimuthal direction relative to a nipple of the breast, a depth from a surface of the breast, and a distance from the nipple; The system of claim 11.

19. A non-transitory machine-readable storage medium comprising executable instructions that, when executed by a processor, facilitate performance of certain operations, the operations including: Recording an X-ray image of the breast; receiving information indicative of a region of interest in the x-ray image of the breast; recording one or more structural markers in or around said region of interest; determining compressed location coordinates of a region of interest within the breast when the breast is under compression; storing the compressed location coordinates and one or more structural markers in a data storage device; predicting uncompressed location coordinates of a region of interest within the breast when the breast is not under compression by applying a mathematical tissue deformation model to compressed location coordinates of the region of interest; storing said predicted non-compression position coordinates in a data storage device; reporting the predicted non-compressed position coordinates and structural markers to an optical tracking system in communication with the ultrasound system; displaying the coordinate model and the anatomic markers on a display in communication with the ultrasound system; the mathematical tissue deformation model calculates the predicted uncompressed position coordinates based on density and volume of the breast; The mathematical tissue deformation model is generated based on determining a magnitude of force applied to the breast and a distance the breast will expand under compression. A non-transitory machine-readable storage medium.

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