System and method for producing tissue imaging biomarkers

Abstract

A system and method for mapping regions of interest in breast tissue utilizes multiple layers of information to generate a unique digital fingerprint of breast tissue. X-ray and ultrasound imaging are combined with elastography and Doppler to create an architectural map of the breast that includes coordinates marking one or more regions of interest. This map can be used to automatically and virtually locate previously biopsied lesions during future imaging or surgery. The architectural map can be displayed on a user interface of a computing device to guide a user to regions of interest during imaging processing.

Description

Technical Field

[0001] This application was filed as a PCT international patent application on March 24, 2021, claiming the benefit of priority to U.S. Provisional Patent Application No. 63 / 000,707, filed on March 27, 2020, the entire disclosure of which is incorporated herein by reference.

Background Art

[0002] Background Medical images provide a non-invasive method for visualizing the internal structures of a patient. The visualization method can be used for screening and diagnosing cancer in patients. For example, early screening can detect lesions inside the breast that may be cancerous, so that treatment can be carried out at an early stage of the disease.

[0003] Mammography and digital breast tomosynthesis (DBT) utilize X-ray radiation to visualize breast tissue. These techniques are often used to screen patients for potentially cancerous lesions. Conventional mammograms involve obtaining two-dimensional images of the breast from various angles. Tomosynthesis creates multiple X-ray images of layers or slices throughout the thickness of the breast. Tomosynthesis stitches together a three-dimensional visualization of the breast from the two-dimensional images.

[0004] When a lesion is discovered, ultrasound diagnosis is often performed as the next step to determine whether there is a tumor. Ultrasound typically uses sound waves generated by a piezoelectric transducer to image a patient's tissue. In ultrasound imaging, the tissue can be viewed from different angles, so solid masses can be easily identified. The ultrasound probe generates arcuate sound waves and converges the sound waves, which travel through the body and are partially reflected from the layers between different tissues of the patient. The reflected sound waves are detected by the transducer and processed by an ultrasound scanner to be converted into electrical signals that can form an ultrasound image of the tissue.

[0005] After a lesion is identified during image processing, it may be decided that a biopsy of the tissue within the lesion is necessary. In the United States and other countries, it is common practice for medical professionals such as radiologists and surgeons to excise a small portion of tissue from the lesion and mark its location for future reference. Markers are embedded in the tissue and are made of various materials such as titanium, ceramic, and nitinol. Markers are useful for identifying previously biopsy sites in future imaging studies. Furthermore, if the biopsy results indicate that surgery is necessary to remove the lesion, the markers allow the surgeon to easily identify the location of the lesion. [Overview of the project] [Problems that the invention aims to solve]

[0006] While markers are made from materials that are not harmful to patients, there are issues associated with leaving foreign objects in the patient's body. Approximately 85% of biopsies are found to be benign lesions. Some markers, especially in superficial lesions, can be felt by the patient. These markers are unpleasant for patients, reminding them of a stressful medical experience, regardless of whether the biopsy results in a cancer diagnosis. Furthermore, approximately 15% of markers cannot be located by the surgeon for follow-up surgery. Therefore, there is a need for more effective methods for marking biopsy sites.

[0007] This disclosure is made against this backdrop. The technology and improvements are provided herein. [Means for solving the problem]

[0008] summary An example of this disclosure is directed towards a method for mapping areas of interest within the breast.

[0009] In one embodiment, a method for mapping a target site within the breast includes taking a diagnostic medical image of breast tissue containing the target site within the breast. The vascularity and stiffness of the breast tissue containing the target site are measured. The image, vascularity, and stiffness are stored in an architecture map in an electronic record. In some examples, spectral parameters of the breast tissue are recorded and stored along with the architecture map. In some examples, the architecture map of the breast tissue includes margins of normal tissue surrounding the target site.

[0010] In another embodiment, a system for mapping a region of interest within the breast includes at least one data store, a processing device, and a memory for storing instructions that, when executed by a processor, facilitate the execution of an operation. The operation includes mapping the region of interest within the breast by recording at least one image of the region of interest using a diagnostic medical image, measuring the vascularity of the region of interest, and measuring the density of the region of interest. The operation further includes storing at least one image, the vascularity, and the density as an architectural map in an electronic record associated with the breast.

[0011] Furthermore, in another embodiment, a non-temporary machine-readable storage medium stores executable instructions that, when executed by a processor, facilitate the execution of an operation. The operation includes taking an ultrasound image of the entire breast, recording the position coordinates of a region of interest within the breast, measuring the vascularity of the breast tissue containing the region of interest using a microflow Doppler, measuring the stiffness of the breast tissue containing the region of interest using shear wave elastography, and storing the image, position coordinates, vascularity, and stiffness as an architecture map in an electronic record associated with the breast. The operation further includes, at a later time, receiving scan information obtained from the imaging of the breast, accessing the architecture map from the electronic record associated with the breast, and analyzing the scan information to identify the region of interest based on the architecture map.

[0012] Details of one or more techniques are described in the attached drawings and the following description. Other features, purposes, and advantages of these techniques will become apparent from the description, drawings, and claims. [Brief explanation of the drawing]

[0013] [Figure 1] Figure 1 shows an exemplary system for mapping regions of interest within the breast. [Figure 2] Figure 2 is a schematic diagram of an exemplary system for managing healthcare data, including imaging data. [Figure 3] Figure 3 is a schematic diagram of an exemplary X-ray imaging system. [Figure 4] Figure 4 is a perspective view of the X-ray imaging system shown in Figure 3. [Figure 5] Figure 5 illustrates the X-ray imaging system with breast positioning relative to the left longitudinal (LMLO) imaging direction. [Figure 6] Figure 6 illustrates an exemplary ultrasound imaging system. [Figure 7] Figure 7 shows an example of the ultrasound imaging system shown in Figure 6, used on a patient's breast. [Figure 8] Figure 8 is a schematic diagram of the different layers of information used to create the architectural map of the breast. [Figure 9] Figure 9 is a flowchart illustrating an exemplary method for mapping a region of interest within the breast. [Figure 10] Figure 10 shows an example of the graphical user interface displayed in Figure 1. [Figure 11] Figure 11 is a schematic diagram of an exemplary computing system that can be used to implement one or more aspects of the present disclosure. [Modes for carrying out the invention]

[0014] Detailed explanation This disclosure relates to a system and method for mapping regions of interest within breast tissue. In particular, a unique digital fingerprint of breast tissue is created by combining various imaging techniques. During an ultrasound examination, a region of interest can be marked by creating an architectural map of that region from two or more of the following: 2D slides, elastography, texture analysis, quantitative ultrasound, and spectral parametric maps. This architectural map can be used to automatically and virtually indicate the location of the region of interest during future imaging and surgery. The architectural map can be displayed on the user interface of a computing device and can guide the user to the region of interest during imaging. In some examples, the region of interest is a biopsy site. The biopsy site may or may not be marked with a physical marker.

[0015] In some cases, two or more imaging datasets are combined to provide a unique "fingerprint" of the breast tissue containing the region of interest. One set of data is a top-down image of the breast (from the chest wall to the skin). The top-down image can be either an X-ray image or an ultrasound image, or both. The second set of data is navigation coordinates to pinpoint the location of the region of interest. This can indicate the location of a specific lesion or biopsy within the breast tissue. These coordinates may include the "clock position" from the nipple, the depth within the breast, and the distance from the nipple. The third set of data provides a detailed view of the tissue immediately surrounding the region of interest. This is imaged using ultrasound technology, and the vascularity and stiffness of the tissue can be measured. Vascularity can be measured with microflow Doppler, and the blood flow pattern around the lesion can be visualized. Stiffness, or density, can be measured with SHEARWAVE® elastography, and a color map showing the relative stiffness of the entire tissue volume is output. Elastography can also be used to determine whether a patient requires follow-up imaging based on the discovery of microcalcifications within the breast tissue. In some cases, quantitative ultrasound imaging techniques can be used to provide additional information about breast tissue. The resulting “fingerprint” or architectural map can be used to help healthcare professionals navigate to specific areas of interest during breast ultrasound examinations.

[0016] Figure 1 shows an exemplary tissue mapping system 100. In some examples, the tissue mapping system 100 operates to generate virtual biomarkers that can be used to image breast tissue. The system 100 includes a computing system 102, an X-ray imaging system 104, and an ultrasound imaging system 106. In some examples, the tissue mapping system 100 operates to create a digital architecture map of breast tissue using information received from the X-ray imaging system 104 and the ultrasound imaging system 106. The digital architecture map can be used to virtually mark regions of interest within the breast.

[0017] Computing system 102 is operative to process and store information received from X-ray imaging system 104 and ultrasonic imaging system 106. In the example of FIG. 1, computing system 102 includes tissue mapping engine 110 and data store 112. In some examples, tissue mapping engine 110 and data store 112 are housed within the memory of computing system 102. In some examples, computing system 102 accesses tissue mapping engine 110 and data store 112 from a remote server, such as a cloud computing environment. In some examples, computing system 102 also includes tissue deformation model 107 and lesion matching engine 109.

[0018] Tissue mapping engine 110 is operative to combine various types of information to create a digital architectural map of breast tissue and generate imaging biomarkers of regions of interest. In some examples, tissue mapping engine 110 includes architecture map generator 126, trimode scanner 128, and graphical user interface (GUI) 130.

[0019] In some examples, tissue mapping engine 110 receives, analyzes, and synthesizes data from elastography, Doppler, X-ray, and ultrasound to generate a digital architectural map of regions of interest within the breast. Architecture map generator 126 synthesizes three layers of information together to digitally mark the locations of regions of interest within the breast.

[0020] One layer of information is the annotation of the location of the region of interest (ROI). The ROI may be the location where a lesion was identified as potentially cancerous. The lesion may have been biopsied, and healthcare professional H may want to mark its location for future reference. In these examples, the ROI is the point where the needle was inserted into the tissue for the biopsy. In addition to recording the annotation of the ROI location, physical markers may or may not be placed at the biopsy site. In other examples, the ROI is the lesion identified during tomography. In some examples, the annotation is a set of coordinates describing the location of the region of interest within the breast. In some examples, the coordinates include the clock position relative to the nipple, the depth from the breast surface, and the distance from the nipple. In some examples, the coordinates can be determined using a tissue deformation model 107, as described below.

[0021] Another layer of information is a whole-breast image. To image all tissue from the chest wall to the skin surface, one or more X-ray and / or ultrasound images are taken of the breast. This provides a complete, zoomed-out view of the region of interest within the breast. In some cases, images are acquired using B-mode ultrasound. In other cases, images are acquired using tomosynthesis. One or more types of imaging can be used together.

[0022] The third layer of information is the vascular and stiffness patterns of the region of interest and surrounding tissues. Vascular patterns can be measured using ultrasound imaging techniques such as Doppler. Ultrasound imaging can depict blood flow by detecting high-frequency sound waves reflected by red blood cells to create images of blood vessels. In some cases, microflow Doppler imaging is employed to determine the vascular patterns in breast tissue, including and surrounding the region of interest.

[0023] Breast tissue stiffness can be determined by elastography measurements. Typically, ultrasound or magnetic resonance imaging techniques are used to visualize the relative stiffness of the tissue. Quasi-static elastography compares ultrasound images of the tissue before and after applying external pressure. The parts of the tissue that deform less under pressure are the stiffest. Acoustic force impulse imaging (ARFI) and shear wave elastic imaging (SWEI) use acoustic force to push out the tissue. ARFI measures how much the tissue moves when pressed at multiple locations to create a two-dimensional map of qualitative stiffness. SWEI measures the propagation speed of waves in various lateral directions from the point where the tissue is pressed and estimates the stiffness of the tissue between them. ShearWave® PLUS technology, developed by SuperSonic Imagine, is another method for measuring tissue stiffness that provides a quantitative, real-time two-dimensional map. ShearWave® PLUS utilizes the same concept as SWEI, but implements it with supersonic shear waves and uses ultrafast imaging to register wave propagation.

[0024] Magnetic resonance elastography (MRE) uses a mechanical vibrator on the surface of a patient's body to generate shear waves that propagate into deeper tissues. The velocity of these waves is measured using magnetic resonance imaging (MRI) and used to estimate tissue stiffness (shear modulus). MRE creates a quantitative three-dimensional map of tissue stiffness, similar to conventional three-dimensional MRI images. Other methods for determining tissue stiffness are also possible.

[0025] Optional fourth or fifth layers contain additional information about breast tissue. This information can be obtained using quantitative ultrasound techniques to acquire the tissue's spectral parameters.

[0026] The tissue deformation model 107 analyzes information obtained about the region of interest within the breast during X-ray imaging and uses this information to convert it into positional identification information that can be used to navigate to the same region of interest during ultrasound imaging. While the breast tissue is compressed, the coordinates of the region of interest determined during the mammogram are converted into a different set of coordinates used to locate the region of interest during ultrasound imaging of uncompressed breast tissue. The tissue deformation model 107 predicts the ultrasound coordinates based on the density and volume of the breast being imaged.

[0027] In some cases, the tissue deformation model 107 is based on a deformation curve determined based on the amount of breast tissue spread recorded on the mammography paddle. Using the known compressive force of the paddle and the density determined by the X-ray, the tissue deformation model 107 is calculated for each patient.

[0028] The lesion matching engine 109 analyzes X-ray images of the target lesion and ultrasound images of potential lesions to determine whether the potential lesion is the same as the target lesion. An artificial intelligence system is trained on ultrasound-confirmed DBT cases to generate an image classifier. This classifier is used to analyze the images and compare lesions based on features such as shape, color, margins, orientation, texture, pattern, size, and depth within the breast. A confidence score may be generated indicating the likelihood that the ultrasound-identified lesion is the same lesion identified by tomosynthesis.

[0029] The data store 112 operates to store information received from the X-ray imaging system 104, the ultrasound imaging system 106, and the tissue mapping engine 110. In some examples, the data store 112 is actually two or more separate data stores. For example, one data store may be a remote data store that stores images from the X-ray imaging system. Another data store may be housed locally within the computing system 102. In some examples, the data store 112 may be part of an electronic medical record (EMR) system.

[0030] The X-ray imaging system 104 operates to take 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 that communicates with the X-ray imaging device 114. In some examples, the X-ray imaging system 104 performs tomosynthesis. The X-ray imaging device 114 is described in more detail in relation to Figure 3-5. The X-ray computing device 116 operates to receive input from a healthcare professional H to operate the X-ray imaging device 114 and to view the images received from the X-ray imaging device 114.

[0031] The ultrasound imaging system 106 operates to take images of breast tissue using ultrasound. In some examples, the ultrasound imaging system 106 operates to perform one or more of the following: elastography, texture analysis, and Doppler. The ultrasound imaging system 106 is described in more detail with reference to Figure 6-7. The ultrasound imaging system 106 includes an ultrasound computing device 118 and an ultrasound imaging device 120. The ultrasound computing device 118 operates to receive input from a healthcare professional H to operate the ultrasound imaging device 120 and to display the images received from the ultrasound imaging device 120.

[0032] Figure 1 shows how information obtained from the X-ray imaging system 104 and the ultrasound imaging system 106 can be utilized by the tissue mapping engine 110 running on the computing system 102. Healthcare worker H operates the X-ray computing device 116 to acquire an X-ray image of patient P's breast using the X-ray imaging device 114. The X-ray image may be taken as part of a routine health checkup. During the screening, healthcare worker H identifies one or more areas of interest in patient P's breast that require additional analysis to determine whether lesions within those areas of interest are potentially cancerous and require a biopsy. Healthcare worker H may include, for example, a surgeon, a physician, a nurse, a laboratory technician, and an ultrasound technician.

[0033] In some cases, the coordinates of the region of interest may be recorded by an X-ray computing device 116 and communicated to a computing system 102. The coordinates recorded by the X-ray computing device 116 are analyzed using a tissue deformation model 107. In some cases, a first set of coordinates identifies the location of a lesion identified while the breast is compressed. The first set of coordinates is transformed into a second set of coordinates that identifies the predicted location of a lesion identified while the breast is not compressed. The region of interest in the ultrasound image corresponding to the second set of coordinates is identified. This allows the technician to identify potential lesions in the ultrasound image.

[0034] In some examples, X-ray images are displayed on the user interface of the ultrasound computing device 118 along with ultrasound images received from the ultrasound imaging device 120. In some embodiments, visual markers indicating the location of a target lesion are displayed on the image. A healthcare professional H operating the ultrasound computing device 118 identifies the location of a lesion in the ultrasound image that potentially matches a lesion previously identified in an X-ray image of the same patient P, and the display of the ultrasound image and potential lesion is transmitted to the computing system 102 for analysis. In some examples, mammography images, a target region of interest, and B-mode imaging are displayed on the same GUI. The GUI 130 helps to visually guide the ultrasound system operator to the region of interest, while also automating the documentation of ultrasound probe position, orientation, and annotations.

[0035] In some cases, X-ray images containing identified lesions and ultrasound images containing potential lesions are analyzed by the lesion matching engine 109 of the computing system 102. The lesion matching engine 109 outputs an indicator of the confidence level for the potential lesions and transmits this confidence level indicator to the ultrasound computing device 118. The confidence level indicator may be a number, color, or category displayed on the GUI of the ultrasound computing device 118.

[0036] During the image processing procedure, the healthcare professional indicates one or more regions of interest recorded along with the patient's records. These regions of interest may be lesions biopsied during the procedure. In some cases, the regions of interest are lesions identified for further observation. Marked positional coordinates are determined for each region of interest.

[0037] Images and measurements generated by the X-ray imaging system 104 and the ultrasound imaging system 106 are received by the tissue mapping engine 110. The tissue mapping engine 110 generates an architectural map of the patient's breast that includes at least one region of interest and stores the map in the data store 112.

[0038] Later, when the patient returns for another examination or surgery, the healthcare professional may want to look for previously identified lesions or other areas of interest within the patient's breast. Another imaging procedure is performed after minutes, hours, days, or weeks have passed. In some cases, the same patient may be examined with two different imaging procedures during the same visit to the healthcare facility. In some cases, healthcare professional H may be interested in determining whether there has been an overall change in the composition of the breast tissue. For example, the patient may have received chemotherapy and / or radiation since the last time the patient's breast tissue was imaged, and the healthcare professional may want to see how the treatment has affected the health of the breast tissue.

[0039] In one embodiment, a healthcare professional H may operate an ultrasound computing device 118 to image the breast of patient P. The ultrasound computing device 118 accesses an architecture map related to patient P from a data store 112. A tissue mapping engine 110 generates a GUI 130 for display on the ultrasound computing device 118. A trimode scanner 128 presents a trimode view of the breast, including Bmode ultrasound images, blood vessels, and stiffness. The trimode scanner reads the position of the ultrasound probe relative to the patient's breast and assists in navigation to the position coordinates of a previously identified region of interest.

[0040] Figure 2 is a schematic diagram of an exemplary system 150 for managing healthcare data, including image data. System 150 includes multiple computing components communicating with each other via a communication network 152. In addition to the computing system 102, X-ray imaging system 104, ultrasound imaging system 106, and data store 112 described in Figure 1, the computing components may include a tracking system 154, a navigation system 156, an electronic medical record (EMR) system 158, and a display system 160.

[0041] While the “system” is shown in Figure 1 as a functional block, it should be noted that different systems may be integrated into a common device, and communication links may be coupled between fewer than 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 can control image acquisition in the radiology suite. Alternatively, the navigation system 156 and the tracking system 154 may be integrated into the ultrasound imaging system 106, or they may be provided as standalone modules with separate communication links to the display 160, the X-ray imaging system 104, and the ultrasound imaging system 106. Similarly, those skilled in the art will additionally understand 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.

[0042] In one embodiment, the X-ray imaging system 104 is a tomosynthesis capture system that captures a set of projected images of a patient's breast as the X-ray tube scans a path across the breast. The set of projected images is then reconstructed into a three-dimensional volume that can be viewed as slices along any plane. The three-dimensional volume may be stored locally in the X-ray imaging system 104 (either on the X-ray imaging device 114 or on the X-ray computing device 116) or in a data store such as a data store 112 that communicates with the X-ray imaging system 104 via a communication network 152. In some examples, the three-dimensional volume may be stored in a patient file in an electronic medical record (EMR) system 158. Additional details relating to the exemplary X-ray imaging system are described in reference to Figure 3-5.

[0043] The X-ray imaging system 104 may transmit a three-dimensional X-ray image volume to the navigation system 156 via a communication network 152, where such X-ray images can be stored and viewed. The navigation system 156 displays the X-ray images obtained by the X-ray imaging system. Once reconfigured for display on the navigation system 156, the X-ray images can be reformatted and repositioned to view the images in any plane and any slice position or orientation. In some examples, the navigation system 156 displays multiple frames or windows on the same screen showing alternative positions or orientations of X-ray image slices.

[0044] Experts will understand that the X-ray image volume obtained by the X-ray imaging system 104 can be transmitted to the navigation system 156 at any time and does not necessarily have to be transmitted immediately after obtaining the X-ray image volume, but can instead be transmitted upon request from the navigation system 156. In an alternative example, the X-ray image volume is transmitted to the navigation system 156 by a flash drive, CD-ROM, DVD-ROM, diskette, or other such transportable media device.

[0045] The ultrasound imaging system 106 typically uses an ultrasound probe to obtain ultrasound images of 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. 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 examples, the ultrasound images may further be saved to a storage medium such as a hard drive, DVD-ROM, flash drive, or diskette for reconstruction or playback at a later time. Additional details regarding the ultrasound imaging system are described with reference to Figure 6-7.

[0046] In some embodiments, the navigation system 156 can access ultrasound images, in which case the ultrasound imaging system 106 is further connected to a communication network 152, and copies of the ultrasound images obtained by the ultrasound imaging system 106 can be transmitted to the navigation system 156 via the communication network 152. In other embodiments, the navigation system 156 can remotely access and copy ultrasound images via the communication network 152. In alternative examples, copies of ultrasound images are stored in a data store 112 or EMR system 158 communicating with the navigation system 156 via the communication network 152 and can be remotely accessed by the navigation system 156.

[0047] The tracking system 154 communicates with the navigation system 156 via a communication network 152 and can track the physical location of the ultrasound imaging system 106 as it images the patient's tissue. In some examples, the tracking system 154 may be directly connected to the navigation system 156 via a direct communication link or a wireless communication link. The tracking system 154 tracks the location of transmitters connected to the ultrasound imaging system 106 and provides the navigation system 156 with data representing their coordinates in tracker coordinate space. In some examples, the tracking system 154 may be an optical tracking system consisting of an optical camera and an optical transmitter, but those skilled in the art will understand that any device or system capable of tracking the location of an object in space can be used. For example, those skilled in the art will understand that in some examples, a radio frequency (RF) tracking system consisting of an RF receiver and an RF transmitter can be used.

[0048] The ultrasound imaging system 106 can be configured for use with the navigation system 156 through a calibration process using the tracking system 154. A transmitter connected to the ultrasound probe of the ultrasound imaging system 106 may transmit its position to the tracking system 154 in tracker coordinate space, and the tracking system 154 provides this information to the navigation system 156. For example, the transmitter may be positioned on the probe of the ultrasound imaging system 106 so that the tracking system 154 can monitor the position and orientation of the ultrasound probe and provide this information to the navigation system 156 in tracker coordinate space. The navigation system 156 can use this tracked position to determine the position and orientation of the ultrasound probe relative to the tracked position of the transmitter.

[0049] In some embodiments, configuration is performed using a configuration tool. In such embodiments, the position and orientation of the configuration tool may be additionally tracked by a tracking system 154. During configuration, the configuration tool makes contact with the transducer face of the 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 tracker coordinate space to the navigation system 156. Based on the tracked position of the transmitter connected to the ultrasound probe, 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 tracker coordinate space. In alternative embodiments, a database containing configuration data for multiple brands or models of various ultrasound probes can be used to preload field of view configurations into the navigation system 156 during configuration.

[0050] When the ultrasound imaging system 106 is configured with the navigation system 156, patient tissue can 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 to the navigation system 156 in tracker coordinate space. Since the ultrasound imaging system 106 is configured to be used 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.

[0051] The navigation system 156 can be configured to co-align ultrasound images with X-ray images. In some examples, the navigation system 156 can be configured to convert the position and orientation of the ultrasound probe's field of view from tracker coordinate space to position and orientation in the X-ray image, e.g., X-ray system coordinates. This can be achieved by tracking the position and orientation of the ultrasound probe, transmitting this position information in tracker coordinate space to the navigation system 156, and associating this position information with the X-ray coordinate system. In some embodiments, the co-aligned images are displayed on the GUI 130.

[0052] For example, a user can select an anatomical plane within an X-ray image, and then 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 relevant tracked spatial coordinates of the ultrasound image can be captured. The registration of the anatomical axes (up-down (SI), left-right (LR), and anterior-posterior (AP)) between the X-ray image and the tracker coordinate space can be determined from the relative rotational difference between the tracked ultrasound field of view direction and the selected anatomical plane using techniques well known to those skilled in the art.

[0053] This configuration may further include selecting landmarks in an X-ray image using an interface that allows the user to select an anatomical target. In some examples, the landmarks may be internal tissue landmarks such as veins or arteries, while in other examples, the landmarks may be fiducial skin markers or external landmarks such as nipples. The same landmarks selected in the X-ray image can be positioned with an ultrasound probe, and during positioning, a mechanism may be provided for acquiring the coordinates of the target's representation in the tracker coordinate space. The relative difference between the target's coordinates in the X-ray image and the target's coordinates in the tracker coordinate space is used to determine the translational parameters required for alignment between the two coordinate spaces. Previously acquired planar orientation information can be combined with the translational parameters to provide a complete 4x4 transformation matrix that can co-align the two coordinate spaces.

[0054] Next, the navigation system 156 can use a transformation matrix to reformat the displayed X-ray image so that the displayed tissue slices are 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 in a single image display frame, or directly superimposed. In some examples, the navigation system 156 may display additional X-ray images in separate frames or positions on the display screen. For example, the X-ray image may be displayed together 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 sliced ​​through a 3D representation of the X-ray image. In other embodiments, annotations may be additionally displayed, which indicate the location of instruments imaged by the ultrasound imaging system 106, such as biopsy needles, guide wires, imaging probes, or other similar devices.

[0055] In other embodiments, the ultrasound image displayed by the ultrasound imaging system 106 can be superimposed onto a slice of the X-ray image displayed by the navigation system 156 so that the user can view both the X-ray and ultrasound images simultaneously on the same display. Superimposing ultrasound images onto X-ray images is generally difficult because breast compression and orientation vary depending on the technique used. The computing system 102 can modify the images based on analysis performed on them to generate an artificially synthesized image. In some examples, the navigation system 156 can enhance specific aspects of the superimposed ultrasound or X-ray image to improve the quality of the resulting combined image.

[0056] As shown in Figure 1, the computing system 102 that operates the tissue mapping engine 110 combines information from X-ray images, ultrasound images, position coordinates, spectral parameters, vascular measurements, and stiffness measurements to construct an architectural map of the breast tissue. The map can be viewed using the display of the computing system 102 or a computing device communicating with the ultrasound imaging system 106, and the location of the region of interest can be identified during imaging. In some examples, visualization of tissue vascularity and stiffness overlays a B-mode ultrasound image to generate a combined view to help identify previously marked regions of interest within the breast. In other examples, the combined view simply displays the ultrasound image with the region of interest and the current position of the ultrasound probe, as shown in the example in Figure 10. X-ray images of the ROI can also be displayed alongside the ultrasound image.

[0057] 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 managed by Epic Systems Corporation, Cerner Corporation, Allscripts, and Medical Information Technology, Inc. (Meditech).

[0058] Figure 3 is a schematic diagram of an exemplary X-ray imaging system 104. Figure 4 is a perspective view of the X-ray imaging system 104. Referring to Figures 3 and 4 together, the X-ray imaging system 104 immobilizes the patient's breast 202 for X-ray imaging (either mammography or tomosynthesis) via a breast compression immobilizer unit 204 which includes a static breast support platform 206 and movable compression paddles 208. The breast support platform 206 and compression paddles 208 each have compression surfaces 210 and 212 that move toward each other to compress and immobilize the breast 202. In known systems, the compression surfaces 210, 212 are exposed to be in direct contact with the breast 202. The platform 206 also houses an image receptor 216, an optional tilting mechanism 218, and an optional anti-scatter grid. The immobilizer unit 204 is located in the path of the imaging beam 220 emitted from the X-ray source 222, so that the beam 220 collides with the image receptor 216.

[0059] The immobilizer unit 204 is supported by a first support arm 224, and the X-ray source 222 is supported by a second support arm 226. In the case of mammography, the support arms 224 and 226 can rotate as a unit around axis 228 between different imaging directions such as CC and MLO, so that the system 104 can acquire mammogram projection images in each direction. During operation, the image receptor 216 remains in place relative to the platform 206 while the image is being acquired. The immobilizer unit 204 releases the breast 202 to allow the arms 224 and 226 to move in different imaging directions. In the case of tomosynthesis, the support arm 224 fixes the breast 202 in place, and at least the second support arm 226 rotates the X-ray source 222 relative to the immobilizer unit 204 and the compressed breast 202 around axis 228. System 104 acquires multiple tomosynthesis projection images of the breast 202 at each angle of the beam 220 relative to the breast 202.

[0060] Simultaneously and optionally, the image receptor 216 can be tilted relative to the breast support platform 206 in synchronization with the rotation of the second support arm 226. The tilt can pass through the same angle as the rotation of the X-ray source 222, but can also pass through different angles selected so that the beam 220 remains substantially in the same position on the image receptor 216 for each of the multiple images. The tilt can be centered on an axis 230, which may or may not be in the image plane of the image receptor 216. A tilt mechanism 218 coupled to the image receptor 216 can drive the image receptor 216 in a tilting motion.

[0061] For tomosynthesis imaging and / or CT imaging, the breast support platform 206 can be positioned horizontally or obliquely to the horizontal, and can also be positioned horizontally, for example, in the same orientation as in conventional MLO imaging in mammography. The X-ray imaging system 104 may be a mammography system, a CT system, a tomosynthesis system, or a "combo" system capable of performing multiple forms of imaging. Examples of such combo systems are offered by the assignee of the present invention under the trade name Selenia Dimensions.

[0062] When the system is activated, the image receptor 216 generates image information in response to illumination by the imaging beam 220 and supplies it to the image processor 232 to process and generate a mammogram. The system control and workstation unit 238, including software, controls the operation of the system, interacts with the operator to receive commands, and provides information including the processed X-ray image.

[0063] Figure 5 shows an exemplary X-ray imaging system 104 in a breast positioning configuration for left longitudinal oblique MLO (LMLO) imaging. The tube head 258 of system 104 is oriented so as to be approximately parallel to the gantry 256 of system 104, or otherwise not normal to the flat portion of the support arm 260 on which the breast rests. In this position, the technician can position the breast more easily without having to crawl or squat under the tube head 258.

[0064] The X-ray imaging system 104 includes a floor mount or base 254 for supporting the X-ray imaging system 104 on the floor. The gantry 256 extends upward from the floor mount 252 and rotatably supports both the tube head 258 and the support arm 260. The tube head 258 and the support arm 260 are configured to rotate discretely from each other and can be raised and lowered along the surface 262 of the gantry to accommodate patients at different heights. An X-ray source, described elsewhere in this specification and not shown herein, is located within the tube head 258. The support arm 260 includes a support platform 264, which contains an X-ray receptor and other components (not shown) within it. The 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 for compressing the patient's breast during imaging procedures. The tube head 258 and the support arm 260 together are sometimes referred to as the C-arm.

[0065] The X-ray imaging system 104 is equipped with numerous interfaces and display screens. These include a foot display screen 270, a gantry interface 272, a support arm interface 274, and a compression arm interface 276. Generally, the various interfaces 272, 274, and 276 may include one or more display screens, including capacitive touchscreens having one or more tactile buttons, knobs, switches, and a graphical user interface (GUI), to enable user interaction and control with the X-ray imaging system 104. In the example, interfaces 272, 274, and 276 may also include control functionality available in system controls and workstations, such as the X-ray computing device 116 in Figure 1. Any individual interface 272, 274, and 276 may, at least partially based on a given setting, user preference, or operating requirements, continuously or selectively include functionality available in other interfaces 272, 274, and 276. Generally, and as described below, the foot display screen 270 is primarily a display screen, but a capacitive touchscreen may be used if necessary or desired.

[0066] In the embodiment, the gantry interface 272 may enable functionality such as selection of imaging direction, display of patient information, adjustment of support arm elevation or support arm angle (tilt or rotation), and safety functions. In the example, the support arm interface 274 may enable functionality such as adjustment of support arm elevation or support arm angle (tilt or rotation), adjustment of compression arm elevation, and safety functions. In the example, the compression arm interface 276 may enable functionality such as adjustment of compression arm elevation and safety functions. Furthermore, one or more displays associated with the compression arm interface 276 may display more detailed information such as applied compression arm force, selected imaging direction, patient information, and support arm elevation or angle setting. The foot display screen 270 may also display information similar to that displayed by the displays of the compression arm interface 276, or additional or different information, as required or desired for a particular application.

[0067] Figure 6 illustrates an example of an ultrasound imaging system 106. The ultrasound imaging system 106 includes an ultrasound probe 302 containing 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 also be configured to detect ultrasound waves, such as ultrasound waves reflected from internal parts of a patient, such as lesions inside the breast. In some examples, the ultrasound transducer 304 may incorporate a capacitive transducer and / or a piezoelectric transducer, as well as other appropriate conversion techniques.

[0068] The ultrasound transducer 304 is also operably connected (e.g., by wire or wirelessly) to the display 310. The display 310 may be part of a computing system such as the ultrasound computing device 118 in Figure 2, which 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.

[0069] The ultrasound imaging performed in the ultrasound imaging system 106 is primarily B-mode imaging, resulting in a two-dimensional ultrasound image of a portion of the patient's internal structure. The brightness of the pixels in the resulting image generally corresponds to the amplitude or intensity of the reflected ultrasound.

[0070] Other ultrasound imaging modes may also be used. For example, the ultrasound probe may operate in 3D ultrasound mode, acquiring ultrasound image data from multiple angles relative to the breast to construct a 3D model of the breast.

[0071] In some cases, ultrasound images may not be displayed during the acquisition process. Rather, ultrasound data is acquired and a 3D model of the breast is generated without B-mode images being displayed.

[0072] The ultrasound probe 302 may also include a probe localization transceiver 308. The probe localization transceiver 308 is a transceiver that emits signals providing localization information for the ultrasound probe 302. The probe localization transceiver 308 may include a radio frequency identification (RFID) chip or device for transmitting and receiving information, as well as an accelerometer, gyroscope device, or other sensors that can provide directional information. For example, the signals emitted by the probe localization transceiver 308 may be processed to determine the orientation or position of the ultrasound probe 302. The orientation and position of the ultrasound probe 302 may be determined or provided in three-dimensional components such as Cartesian coordinates or spherical coordinates. Alternatively, the orientation and position of the ultrasound probe 302 may be determined or provided in relation to other items such as cutting instruments, markers, magnetic direction, and normals to gravity. The orientation and position of the ultrasound probe 302 can generate and provide additional information to the surgeon to help guide the surgeon to a lesion in the patient, as will be further described below. The term "transceiver" is used herein, and this term is intended to cover both transmitters, receivers, and transceivers, along with any combination thereof.

[0073] Figure 7 illustrates an example of an ultrasound imaging system 106 used on a patient's breast 312. The ultrasound probe 302 is in contact with a portion of the breast 312. In the position shown in Figure 7, the ultrasound probe 302 is used to image a lesion 314 in the breast 312. To image the lesion 314, the ultrasound transducer 304 emits an array of ultrasound 306 into the breast 312. Some of the ultrasound 306 is reflected from internal breast components such as the lesion 314, if the lesion is within the field of view, and returns to the ultrasound probe 302 as reflected ultrasound 316. The reflected ultrasound 316 may be detected by the ultrasound transducer 304. For example, the ultrasound transducer 304 can receive the reflected ultrasound 316, convert the reflected ultrasound 316 into an electrical signal, process and analyze it to generate ultrasound image data on the display 310.

[0074] The depth of lesions 314, etc., on the imaging plane can be determined from the time from when the ultrasound probe 302 emits a pulse of ultrasound 306 until the reflected ultrasound 316 is detected by the ultrasound probe 302. For example, the speed of sound is well known, and the effect of the speed of sound based on soft tissue can also be determined. Thus, the depth of an object in the ultrasound image can be determined based on the time of flight of the ultrasound 306 (more specifically, half of the time of flight). Other corrections or methods for determining object depth that compensate for the refraction and velocity variation of waves through tissue may also be implemented. Those skilled in the art will understand further details of depth measurement in medical ultrasound imaging techniques. Such depth measurement and determination may be used to construct a 3D model of the breast 312. This 3D model may be useful for a variety of other applications in which the 3D model correlates with other 3D breast schemes used by other types of techniques.

[0075] Furthermore, multiple frequencies or modes of ultrasound technology may be utilized. For example, real-time and simultaneous transmission and reception multiplexing of localization frequencies may be performed, as well as imaging and capture frequencies. The use of these capabilities provides information for co-aligning or fusing multiple datasets from ultrasound technology to enable visualization of lesions and other medical images on the display 310. The imaging frequencies and capture sequences may include, among other imaging modes and techniques, B-mode imaging (with or without composite), Doppler mode (e.g., color, dual), harmonic modes, shear wave and other elastography modes, and contrast-enhanced ultrasound.

[0076] Figure 8 is a schematic diagram of the various layers of information used to construct an architectural map of the breast. X-ray images 352 and ultrasound images 354 of the entire breast are taken and aligned on top of each other. The tissue deformation model 107 in Figure 1 can be used to determine the location coordinates 356 of the region of interest. If the region of interest is a lesion, a lesion matching engine 109 can be used to confirm that the same lesion found in the ultrasound image was initially identified in the mammogram. Elastography 358 and Doppler 360 are used to determine the stiffness and vascularity of the tissue surrounding the region of interest. Maps showing relative stiffness and vascular patterns are laid over the X-ray and ultrasound images of the breast, providing an overall view of the breast and region of interest in the resulting architectural map 362.

[0077] Referring here to Figure 9, an exemplary method 500 for mapping a region of interest within the breast is illustrated. In some examples, the systems and devices described in Figure 1-7 may be used to carry out method 500. In particular, the computing system 102 in Figure 1-2 operates to generate an architectural map of a region of interest within the breast and to carry out the steps of method 500 to assist healthcare professionals in locating that region of interest later during imaging procedures or surgery.

[0078] In operation 502, an image of the region of interest within the breast is recorded. The region of interest can be a lesion or an area of ​​tissue containing one or more lesions. In some cases, one or more regions of interest are identified within the breast. In some cases, the margins of the tissue surrounding the region of interest are also imaged. The amount of margin tissue varies, but is intended to provide some "normal" tissue for comparison with the region of interest. In some cases, an image of the entire breast from the chest wall to the skin is taken. The images can be recorded using either or both of the following techniques: X-ray and ultrasound imaging.

[0079] In operation 504, a set of coordinates indicating the location of the region of interest may optionally be recorded. Input indicating the region of interest can be received from a healthcare professional on a computing device associated with the imaging device. The coordinates are generated relative to the location indicated by the healthcare professional. In some examples, the coordinates include the clock position relative to the nipple, the distance from the nipple, and the depth from the breast skin.

[0080] In operation 506, the blood vessels in the region of interest are measured. In some cases, the blood vessels are measured using ultrasound techniques such as Doppler. In some cases, the margins of the tissue surrounding the region of interest are also measured to establish a baseline of normal tissue.

[0081] In operation 508, the stiffness of the region of interest is measured. In some cases, stiffness is measured using ultrasound techniques such as shear wave elastic imaging. In some cases, the margins of the tissue surrounding the region of interest are also measured to establish a baseline of normal tissue.

[0082] In operation 509, spectral parameters of the region of interest are optionally recorded. Spectral parameters include quantitative ultrasonic techniques such as spectral flow and scattering parameters.

[0083] In operation 510, recorded images, vascular measurements, and stiffness measurements are combined to generate an architecture map. In some examples, both ultrasound and radiographic imaging are used in combination to create the architecture map. In some examples, the architecture map further includes positional coordinates. In some examples, spectral parameters are also included in the architecture map. The more information the architecture map contains, the more accurate and useful it becomes. The architecture map is stored in the electronic record associated with the breast.

[0084] In operation 512, scan information from a subsequent imaging of the breast is received. Generally, this may be an ultrasound image acquired in real time. The breast may be imaged at a later point in time for the purpose of performing surgery to remove a lesion. In some embodiments, the breast may be imaged to determine whether any changes have occurred in the tissue compared to a previous imaging. For example, the breast may be imaged to determine whether any changes have occurred in the tissue surrounding the site where a biopsy was performed or where a lesion was excised, indicating that cancerous tissue has begun to grow in that location. In some examples, the subsequent imaging of the breast is performed at least one hour after the imaging in operation 502. In some examples, the subsequent imaging is performed at least one day later. In some examples, the subsequent imaging occurs at least one month later.

[0085] In operation 514, the mammary architecture map is accessed from electronic records. In some examples, the architecture map is accessed from patient records stored in an electronic medical record (EMR) system.

[0086] In operation 516, scan information is analyzed to identify a region of interest based on an architecture map. In some examples, coordinates are used to guide the ultrasound probe to the region of interest. The coordinates may be used by a navigation system, such as the navigation system 156 in Figure 2, along with information from the tracking system 154, to guide a healthcare professional to the region of interest.

[0087] In operation 518, an image of the breast is displayed on the graphical user interface along with information from the architecture map. In some examples, a combined view of the breast tissue is displayed, including an overlaid X-ray and / or ultrasound image showing the location of the region of interest. This combined view is useful for assisting healthcare professionals in identifying and navigating the region of interest within the breast. Furthermore, the combined view is useful for identifying any changes that have occurred within the breast tissue. Such changes may affect the vascularity or stiffness of the tissue. In addition, changes in tissue density can be identified in the ultrasound or X-ray images included in the combined view. An example of this combined view is shown in Figure 10.

[0088] Figure 10 shows an example of the GUI 130 in Figure 1. In some examples, the GUI 130 is displayed on a computing device such as the ultrasound computing device 118 in Figure 1. In the example in Figure 10, the GUI 130 displays the X-ray image 602 and ultrasound image 604 of the breast 202 side by side. A target lesion 606, pre-identified during X-ray imaging, is indicated by a visual marker in the X-ray image 602. The corresponding ultrasound image 604 of the breast 202 shows the display of a potential lesion 608. An indicator 610 is displayed that provides a percentage of the likelihood that the target lesion 606 and the potential lesion 608 match. In this example, there is a 99.9% match.

[0089] GUI130 also includes Figure 612 showing the location on the breast 202 where the ultrasound image 604 is being taken. This Figure 612 includes a marker 620 for the ROI location and an indicator 618 for the current position of the ultrasound probe. Furthermore, coordinates 614 are displayed. In this example, coordinates 614 indicate the location of a potential lesion in the right breast at the 11 o'clock position, 2 cm from the nipple.

[0090] Figure 11 is a block diagram showing an example of the physical components of the computing device 400. The computing device 400 may be any computing device used in combination with the tissue mapping system 100 or the system 150 for managing image data, such as the computing system 102, the X-ray computing device 116, and the ultrasound computing device 118.

[0091] In the example shown in Figure 11, the computing device 400 includes at least one central processing unit ("CPU") 402, system memory 408, and a system bus 422 connecting the system memory 408 to the CPU 402. The system memory 408 includes random access memory ("RAM") 410 and read-only memory ("ROM") 412. A basic input / output system, including basic routines that help transfer information between elements within the computing device 400, such as during startup, is stored in the ROM 412. The computing system 400 further includes a mass storage device 414. The mass storage device 414 can store software instructions and data.

[0092] The mass storage device 414 is connected to the CPU 402 via a mass storage controller (not shown) connected to the system bus 422. The mass storage device 414 and its associated computer-readable storage medium provide non-volatile, non-temporary data storage for the computing device 400. While the description of computer-readable storage medium included herein refers to mass storage devices such as hard disks or solid-state disks, those skilled in the art will understand that the computer-readable data storage medium may include any available tangible, physical device or manufactured article from which the CPU 402 can read data and / or instructions. In certain examples, the computer-readable storage medium includes a completely non-temporary medium.

[0093] Computer-readable storage media include volatile and non-volatile, removable and non-removable media implemented in any way or technique for storing 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 technologies, CD-ROM, digital versatile disks ("DVD"), other optical storage media, magnetic cassettes, magnetic tapes, magnetic disk storage or other magnetic storage devices, or any other media that can be used to store desired information and can be accessed by a computing device 400.

[0094] As some examples show, the computing device 400 can operate in a networked environment using a logical connection to a remote network device via a network 152, such as a wireless network, the Internet, or another type of network. The computing device 400 can connect to the network 152 via a network interface unit 404 connected to a system bus 422. It should be understood that the network interface unit 404 can also be used to connect to other types of networks and remote computing systems. The computing device 400 also includes an input / output controller 406 for receiving and processing input from a number of other devices, including a touch user interface display screen or another type of input device. Similarly, the input / output controller 406 may provide an output to a touch user interface display screen or another type of output device.

[0095] As briefly mentioned above, the mass storage devices 414 and RAM 410 of the computing device 400 can store software instructions and data. The software instructions include an operating system 418 suitable for controlling the operation of the computing device 400. The mass storage devices 414 and / or RAM 410 also store software instructions that, when executed by the CPU 402, cause the computing device 400 to provide the functions discussed herein.

[0096] The methods and systems described herein offer numerous efficiencies and advantages compared to existing solutions for imaging breast tissue. The synthesis of multiple imaging modalities with positional coordinates provides greater accuracy in identifying lesions or other areas of interest within the breast, as identified by healthcare professionals during imaging procedures. The system combines ultrasound and / or X-ray images with stiffness and elasticity maps to create an informative view of the breast tissue. Healthcare professionals do not need to access and view multiple different types of images to evaluate the tissue. By automatically combining these sets of information, interaction with the computing system is reduced. In some examples, a trimode view of the breast is generated by automatically accessing a patient architecture map from the patient's EMR. Fewer requests for data are required, and therefore, the computing system's capabilities are improved.

[0097] While various embodiments and examples are described herein, those skilled in the art will understand that many modifications can be made to them within the scope of this disclosure. Therefore, the examples provided are not intended to limit the scope of this disclosure in any way.

Claims

1. A method for mapping regions of interest within the breast, wherein the method is: During the first image processing procedure, there is a step of taking a first diagnostic medical image of the breast tissue, The first diagnostic medical image includes the step of identifying a region of interest within the breast, The step of identifying the region of interest in the first diagnostic medical image is: The lesion matching engine receives a set of pre-captured images including a target lesion corresponding to the region of interest, The lesion matching engine receives the first diagnostic medical image including potential lesions, The process involves analyzing the aforementioned set of images taken in advance and the first diagnostic medical image, This includes determining that the potential lesion is the same as the target lesion, The aforementioned method, The steps include: measuring the location of blood vessels in the breast tissue including the region of interest; A step of measuring the firmness of breast tissue including the region of interest, The procedure includes the steps of storing the first diagnostic medical image, the location of the blood vessel, and the stiffness as an architectural map of the region of interest in an electronic record, The architecture map includes a confidence level indicator that shows the likelihood that the target lesion and the potential lesion are the same lesion. The aforementioned method, During the second image processing procedure, the steps include taking at least one second diagnostic medical image of the breast tissue within the breast, The steps include receiving scan information associated with at least one second diagnostic medical image, The steps include: accessing the architecture map of the region of interest in the electronic record; The steps include analyzing scan information associated with the at least one second diagnostic medical image to identify a region of interest within the at least one second diagnostic medical image based on the architecture map, method.

2. The first and second diagnostic medical images are ultrasound images. The aforementioned method further, The steps include recording the spectral parameters of the first and second diagnostic medical images of the breast tissue, The steps include saving the spectral parameters together with the architecture map. The method according to claim 1, including the method described in claim 1.

3. Furthermore, The step of comparing the scan information with the architecture map in the electronic record to identify any changes in the breast tissue. The method according to claim 1, including the method described in claim 1.

4. During the second image processing procedure, scan information associated with the at least one second diagnostic medical image is received at least one hour after the at least one first diagnostic medical image is captured. The method according to claim 1.

5. Furthermore, The step of presenting visual guidance to the region of interest on a display, based on the current position of the ultrasound probe. The method according to claim 1, including the method described in claim 1.

6. The method according to claim 1, wherein the architectural map of the breast tissue includes margins of normal tissue around the region of interest.

7. The first diagnostic medical image of the breast tissue is taken using ultrasound. The method according to claim 1.

8. The first diagnostic medical image of the breast tissue is acquired using B-mode ultrasound. The method according to claim 7.

9. The first diagnostic medical image of the breast tissue is also acquired using digital breast tomosynthesis. The method according to claim 7.

10. The first diagnostic medical image of the breast tissue is acquired using magnetic resonance imaging (MRI). The method according to claim 1.

11. Furthermore, Steps to record the position coordinates of the region of interest. The method according to claim 1, including the method described in claim 1.

12. The method according to claim 11, wherein the position coordinates of the region of interest are defined by the clockwise position of the breast relative to the nipple, the depth from the surface of the breast, and the distance from the nipple.

13. The location of the blood vessel is measured using Doppler imaging. The method according to claim 12.

14. The hardness is measured using elastography. The method according to claim 1.

15. The elastography is shear wave elastography. The method according to claim 14.

16. A system for mapping regions of interest within the breast, the system is At least one data store and Processor and The processor includes a memory that stores instructions that facilitate the execution of an operation when executed by the processor, The operation includes mapping a region of interest within the breast, Mapping the region of interest within the breast includes recording at least one first image of the region of interest using diagnostic medical imaging, The at least one first image is captured during the first image processing procedure. The region of interest is identified in the at least one first image, Identifying the region of interest in at least one of the first images is: The lesion matching engine receives at least one pre-captured image containing a target lesion corresponding to the region of interest, The lesion matching engine receives at least one first image including a potential lesion, Analyzing the aforementioned at least one previously captured image and the aforementioned at least one first image, This includes determining that the potential lesion is the same as the target lesion, Mapping the region of interest within the breast is To measure the location of blood vessels in the region of interest, To measure the density of the region of interest, This includes storing the at least one first image, the location of the blood vessels, and the density as an architectural map in an electronic record associated with the breast, The architecture map includes a confidence level indicator that shows the likelihood that the target lesion and the potential lesion are the same lesion. The aforementioned operation is, During the second image processing step, capture at least one second image of the region of interest, Receiving scan information associated with at least one second image, Accessing the architecture map in the aforementioned electronic record, This includes analyzing scan information associated with the at least one second image to identify a region of interest within the at least one second image based on the architecture map, system.

17. The ultrasound probe's probe localization transceiver receives the current position and orientation of the ultrasound probe, The current position and orientation of the ultrasound probe relative to the breast are displayed on a graphical user interface that includes an image of the breast obtained during at least one of the first and second image processing steps. The system according to claim 16, further comprising a tracking system configured to perform the following.

18. Based on the images captured by the camera system, the current position and orientation of the ultrasound probe are determined, The current position and orientation of the ultrasound probe relative to the breast are displayed on a graphical user interface that includes an image of the breast obtained during at least one of the first and second image processing steps. The system according to claim 16, further comprising a tracking system configured to perform the following.

19. The aforementioned diagnostic medical imaging includes ultrasound imaging and X-ray imaging. The system according to claim 16.

20. Furthermore, The aforementioned operation is, Record a set of coordinates indicating the location of the aforementioned region of interest, The aforementioned set of coordinates is saved together with the architecture map. The system according to claim 16, including the system described in claim 16.

21. The location and density of the blood vessels are measured using ultrasound. The system according to claim 16.

22. The location and density of the blood vessels are measured using B-mode ultrasound. The system according to claim 21.

23. The aforementioned X-ray imaging is performed using digital breast tomosynthesis. The system according to claim 19.

Images