Systems and methods for measuring the movement of a compressed breast - Patents.com

Abstract

A method for imaging a breast compressed with a paddle including a foam compression element. The method includes emitting x-ray energy from an x-ray source toward the breast, the foam compression element, and a marker disposed adjacent to the foam compression element. The x-ray energy is emitted for a predetermined period of time. The marker includes a physical characteristic. The x-ray energy is detected with a detector disposed on an opposite side of the breast from the x-ray source. An image of the compressed breast and marker is generated based on the detected x-ray energy. The marker in the generated image includes an image characteristic associated with the physical characteristic. The image characteristic is compared to the physical characteristic. A signal is transmitted if the image characteristic deviates from the physical characteristic by a threshold value.

Description

[Background technology]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application was filed as a PCT international patent application on August 24, 2022, and claims benefit of and priority to U.S. Provisional Patent Application No. 63 / 236,762, filed August 25, 2021, which is incorporated herein by reference in its entirety.

[0002] One known challenge in mammography and breast tomosynthesis is the discomfort that a patient may feel when the breast is compressed, which must be done with enough force to immobilize the breast and possibly spread the breast tissue for x-ray imaging. The discomfort may cause the patient to move, which may negatively affect image quality. The discomfort may deter a patient from being screened for breast cancer. Another known challenge is ensuring that the imaged field includes the desired amount of breast tissue. This discomfort has led to the development of compression paddles with flexible features, such as plastic sheets, flexible mesh, and foam compression materials. These flexible features present unique challenges for properly imaging the breast. In existing imaging systems that utilize flat, rigid compression paddles, the thickness of the compressed breast can be fairly easily determined by measuring or calculating the height of the compression paddle above the breast support. However, the use of flexible materials to stabilize the breast makes such simple calculations impossible. Summary of the Invention [Means for solving the problem]

[0003] In one aspect, the technology relates to a method of imaging a breast compressed with a paddle including a foam compression element, the method including emitting x-ray energy from an x-ray source toward the breast, the foam compression element, and a marker disposed adjacent to the foam compression element, the x-ray energy being emitted for a predetermined period of time, the marker having a physical characteristic; detecting the x-ray energy with a detector disposed on an opposite side of the breast from the x-ray source; generating an image of the compressed breast and the marker based on the detected x-ray energy, the marker in the generated image including an image characteristic associated with the physical characteristic; comparing the image characteristic to the physical characteristic; and transmitting a signal if the image characteristic deviates from the physical characteristic by a threshold value. In one example, the physical characteristic includes a physical dimension, and the image characteristic is indicative of a movement of the marker during emission of the x-ray energy. In another example, the physical dimension includes a marker width, and the marker width is greater than a width of a pixel on the detector. In yet another example, the marker is disposed on a surface of the foam compression element that is in contact with the breast during emission of the x-ray energy. In yet another example, the markers are attached to the breasts.

[0004] In another example of the above aspect, the movement of the marker results from movement of a portion of the breast during emission of the x-ray energy. In one example, the portion of the breast is proximate to the marker. In another example, the method further includes processing an image of the breast and the marker to generate an analysis image and displaying the analysis image, where the marker is not visible in the analysis image. In yet another example, the physical characteristic includes radiopacity and the image characteristic corresponds to attenuation of x-ray energy passing through the marker during emission of the x-ray energy. In yet another example, the marker includes a marker width, where the marker width is greater than a width of a pixel in the detector.

[0005] In another example of any of the above aspects, sending the signal includes displaying a notification.

[0006] In another aspect, the technology relates to an apparatus including an x-ray source, an x-ray detector, a breast support for supporting the breast during an imaging procedure, a breast compression paddle movably disposed between the x-ray source and the x-ray detector, the breast compression paddle including a rigid substrate, a foam compression element secured to the rigid substrate, and a marker disposed in contact with the foam compression element, at least one processor, and a memory storing instructions that, when executed by the at least one processor, cause the apparatus to perform operations including emitting x-ray energy from the x-ray source through the breast and the marker, receiving the emitted x-ray energy, generating an image from the received x-ray energy, the image representing the breast and the marker, analyzing the image and identifying movement of the marker, and transmitting a signal if the movement exceeds a threshold. In one example, analyzing the image includes identifying the marker in the image. In another example, the marker includes a physical characteristic, and analyzing the image includes comparing the physical characteristic of the marker to an imaged characteristic of the marker in the image. In yet another example, the physical characteristic includes a dimension of the marker. In yet another example, the physical characteristic includes a radiopacity of the marker.

[0007] In another example of the above aspect, the operations further include processing the image of the breast and marker to generate an analysis image and displaying the analysis image, where the marker is not visible in the analysis image. In one example, sending the signal includes displaying a notification. In another example, the marker is disposed on a surface of a foam compression element configured to contact the breast during emission of x-ray energy. In yet another example, a breast compression paddle includes the marker. In yet another example, the marker is disposed on a sheet attached to the breast.

[0008] In another example of the above aspect, the marker includes a plurality of markers arranged in at least one row. In one example, the at least one row includes a plurality of rows. In another example, the rows are arranged substantially parallel to the patient's chest wall. In yet another example, the rows are arranged substantially orthogonal to the patient's chest wall. In yet another example, a first row of the plurality of rows is arranged substantially orthogonal to a second row of the plurality of rows. [Brief description of the drawings]

[0009] [Figure 1A] FIG. 1A is a schematic diagram of an exemplary imaging system.

[0010] [Figure 1B] FIG. 1B is a perspective view of the imaging system of FIG. 1A.

[0011] [Figure 2A] 2A-2C are various views of a breast compression paddle having a foam compression element. [Figure 2B] 2A-2C are various views of a breast compression paddle having a foam compression element. [Figure 2C] 2A-2C are various views of a breast compression paddle having a foam compression element.

[0012] [Figure 3A] 3A and 3B show partial side views of an imaging system having a paddle utilizing a foam compression element having markers. [Figure 3B] 3A and 3B show partial side views of an imaging system having a paddle utilizing a foam compression element having markers.

[0013] [Figure 3C] FIG. 3C shows an adhesive sheet for attaching the marker to the breast.

[0014] [Figure 4A]4A and 4B show an x-ray image and a magnified partial x-ray image of the breast, respectively, showing no detectable movement of the breast during the imaging procedure. [Figure 4B] 4A and 4B show an x-ray image and a magnified partial x-ray image of the breast, respectively, showing no detectable movement of the breast during the imaging procedure.

[0015] [Figure 5A] 5A and 5B show an x-ray image and a magnified partial x-ray image, respectively, of the breast, showing that there is detectable movement of the breast during the imaging procedure. [Figure 5B] 5A and 5B show an x-ray image and a magnified partial x-ray image, respectively, of the breast, showing that there is detectable movement of the breast during the imaging procedure.

[0016] [Figure 6A] 6A and 6B show an x-ray image and a magnified partial x-ray image, respectively, of the breast, showing that there is detectable movement of the breast during the imaging procedure. [Figure 6B] 6A and 6B show an x-ray image and a magnified partial x-ray image, respectively, of the breast, showing that there is detectable movement of the breast during the imaging procedure.

[0017] [Figure 7] 7A-7C show enlarged partial views of a row of imaged markers exhibiting various degrees of movement.

[0018] [Figure 8] FIG. 8 illustrates a method of imaging a breast compressed with a paddle having a foam compression element.

[0019] [Figure 9] FIG. 9 illustrates an example of a suitable operating environment in which one or more of the examples of the present invention may be implemented. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] Breast compression paddles made entirely of rigid materials effectively compress the patient's breasts and keep them still during imaging. While this is advantageous for obtaining high quality images, the discomfort associated with rigid paddles leads many women to avoid routine screening for breast cancer. Paddles utilizing foam compression materials reduce patient discomfort during imaging procedures and encourage more women to undergo regular screening, which may lead to earlier cancer diagnoses. However, while improving comfort, the flexible nature of the thick foam compression element material may allow the breast to move during the imaging procedure (e.g., if the patient inadvertently or intentionally removes herself from the breast imaging system). When this occurs, the resulting images may be less diagnostically relevant than desired. Thus, while paddles utilizing foam compression elements are more comfortable, such paddles pose a myriad of challenges for how a breast imaging system (e.g., mammography, tomosynthesis, or combined mammography / tomosynthesis system) delivers and produces images of adequate diagnostic quality.

[0021] The technology described herein provides devices and methods to accurately detect movement of the breast under the foam compression element of a compression or fixed paddle. The technology contemplates markers on the area of ​​the foam compression element that may move under applied force. For example, when a patient's breast is compressed by a paddle with a foam compression element, the patient's movement (e.g., pulling away from the imaging system) is transmitted to the portion of the foam compression element that is proximate to the breast, but not to the portion of the rigid substrate that is less susceptible to movement and is located farther from the breast. The amount of movement of the marker(s) may be detected in various ways, for example, through analysis of the acquired image (and the imaged markers therein) or through analysis of individual pixels of the x-ray detector. If the detected movement exceeds a threshold (e.g., no longer shows an image suitable for diagnosis), a notification may be triggered. This notification may require that the breast imaging procedure be performed again, which may be done immediately while the patient is still in the clinic (and even while being compressed). This helps to save time by ensuring that the image is indeed of sufficient quality before it becomes time-consuming review and analysis by a radiologist. Therefore, these techniques are important to create a viable paddle utilizing foam compression materials.

[0022] FIG 1A is a schematic diagram of an exemplary imaging system 100. FIG 1B is a perspective view of the imaging system 100. Referring simultaneously to FIGS. 1A and 1B, the imaging system 100 immobilizes a patient's breast 102 for X-ray imaging (either or both mammography and tomosynthesis) via a breast compression immobilizer unit 104 including a stationary breast support table 106 and a movable compression paddle 108. The breast support table 106 and the compression paddle 108 each have compression surfaces 110 and 112, respectively, that move toward each other to compress and immobilize the breast 102. In known systems, the compression surfaces 110, 112 are exposed for direct contact with the breast 102. The table 106 also houses an image receptor 116, an optional tilt mechanism 118, and an optional anti-scatter grid. The fixator unit 104 is in the path of an imaging beam 120 emanating from an x-ray source 122 such that the beam 120 impinges on the image receptor 116 .

[0023] The fixator unit 104 is supported on a first support arm 124 and the x-ray source 122 is supported on a second support arm 126. For mammography, the support arms 124 and 126 can rotate as a unit about an axis 128 between different imaging orientations, such as CC and MLO, so that the system 100 can take mammography projection images in each orientation. In operation, the image receptor 116 remains in a predetermined position relative to the table 106 while an image is taken. The fixator unit 104 releases the breast 102 for movement of the arms 124, 126 to a different imaging orientation. For tomosynthesis, the support arm 124 remains in a predetermined position, immobilizing and holding the breast 102 in place, while at least the second support arm 126 rotates the x-ray source 122 about the axis 128 relative to the fixator unit 104 and compressed breast 102. The system 100 captures multiple tomosynthesis projection images of the breast 102 at each angle of the beam 120 relative to the breast 102 .

[0024] Simultaneously, and if desired, the image receptor 116 may be tilted synchronously with the rotation of the second support arm 126 relative to the breast support 106. The tilt may be at the same angle as the rotation of the x-ray source 122 all the way, but may also be at a different angle selected all the way so that the beam 120 remains at substantially the same position on the image receptor 116 for each of the multiple images. The tilt may be about an axis 130, which may be, but is not necessarily, in the image plane of the image receptor 116. A tilt mechanism 118 coupled to the image receptor 116 may drive the image receptor 116 in a tilting motion. For tomosynthesis and / or CT imaging, the breast support 106 may be horizontal or at an angle to the horizontal, e.g., an orientation similar to conventional MLO imaging in mammography. System 100 can be a mammography system alone, a CT system alone, or a tomosynthesis system alone, or a "combo" system capable of performing multiple forms of imaging. An example of such a combo system is offered by the assignee of the present application under the trade name Selenia Dimensions.

[0025] When the system is operated, the image receptor 116 generates imaging information in response to illumination by the imaging beam 120 and provides it to the image processor 132 for processing and generation of a mammogram. A system control and workstation unit 138, including software, interacts with an operator to control operation of the system and receive commands and deliver information, including processed line images.

[0026] One challenge with the imaging system 100 is how to immobilize and compress the breast 102 for the desired or required imaging. A medical professional, typically an x-ray technician, generally adjusts the breast 102 within the immobilizer unit 104 to hold the breast in place with as much breast tissue as possible between the compression surfaces 110, 112 while pulling the tissue toward the imaging area and moving the compression paddle 108 toward the breast support 106 to immobilize the breast 102. This can cause discomfort to the patient.

[0027] To improve patient comfort, compression paddles utilizing foam compression elements have been developed. Compression paddles utilizing foam compression elements are generally described in PCT International Patent Application Nos. PCT / US2019 / 033998, PCT / US2019 / 034001, and PCT / US2019 / 034010, all filed May 24, 2019, the disclosures of which are incorporated herein by reference in their entireties. Such paddles provide slight compression and stabilization of the breast while reducing the discomfort associated with compression paddles having only a rigid compression surface.

[0028] 2A-2C are various views of an example of a breast compression paddle 200 having a foam compression element 202 secured to a rigid substrate 204. FIGS. 2A-2C are described simultaneously. The paddle 200 includes a bracket portion 206 substantially integral with the substrate 204 for connecting the paddle to a compression arm of an imaging system. The paddle 200 also includes a leading end surface 208 opposite the bracket portion 206, which is positioned adjacent to the patient's chest wall during compression and imaging procedures. In an example, the substrate may be rigid. As used herein, the term "rigid" does not mean that the substrate 204 does not bend during compression of the breast, but rather that the substrate 204 resists bending or deformation to a greater extent than the foam compression element 202 secured to the bottom of the substrate 204. The raised wall 204A provides additional rigidity.

[0029] The foam compression element 202 may be secured to the bottom surface of the substrate 204 by a chemical adhesive. In other examples, the top surface of the compression element may be a rigid plastic or other material to which the foam compression element 202 is secured. A number of bolts, hooks, or other mechanical fasteners (not shown) may be used to connect the rigid plastic to the rigid substrate 204 of the paddle 200. If such mechanical fasteners are used, it may be desirable to position the fasteners away from areas of the foam compression element 202 that are expected to compress against the breast to avoid compression points and the resulting discomfort associated therewith, and to prevent artifacts appearing in the resulting x-ray images.

[0030] The foam compression element 202 includes several edge surfaces. A leading edge surface 210 is disposed adjacent to the leading edge surface 208 of the substrate 204 so as to be disposed adjacent to the patient's chest wall during the compression and imaging procedure. A trailing edge surface 212 is disposed opposite the leading edge surface 210, adjacent to the bracket portion 206. Side edge surfaces 214, 216 are also shown. Generally, these side edge surfaces 214, 216 may be referred to as medial or lateral side edge surfaces, consistent with the terms typically used to describe the medial and lateral sides of the breast. Of course, one skilled in the art will recognize that the same compression paddle 200 may be used to compress either breast at a time, which would effectively change the application of the terms "medial" and "lateral" to the side edge surfaces of the foam compression element 202. Additionally, a midplane 220 is disposed between and approximately midway between the side edge surfaces 214, 216. The central plane 220 is disposed substantially perpendicular to the compression surface 218 disposed on the underside of the foam compression element 202. A portion of the compression surface 218 contacts the breast during compression. In another example, the foam compression element 202 may be covered by a biocompatible cover that may prevent the foam compression element 202 from absorbing bodily fluids. In an example, the cover may be disposable or washable. To improve the patient experience, the cover may be manufactured from a soft material where it contacts the patient. An opposing plastic surface may contact the foam compression element 202 to prevent fluid migration into the foam compression element 202. An interface 222 is disposed where the compression surface 218 meets the leading edge surface 210. The shape of the interface 222 during compression helps define the foam compression element 202 and its function.

[0031] 3A and 3B show partial side views of an imaging system 300 having a paddle 302 utilizing a foam compression element 304 having multiple markers thereon. Unless otherwise noted, the suffixes of the reference numbers shown in FIGS. 3A and 3B correspond to the particular features described without the suffix in the description of those figures. A plurality of markers 306, 310, 312, 314, 316, 318 arranged in multiple rows proximate the top and bottom surfaces of the foam compression element 304 (as described in more detail herein) allows for detection of movement of the compressed breast. As discussed above, markers (e.g., markers 314, 316, 318) arranged in or on the foam compression element 304 proximate the breast are more likely to move as a result of breast movement. As such, while markers 314, 316, 318 located on the foam compression element are more relevant to the techniques described herein, markers on the rigid substrate 308 (e.g., markers 306, 310, 312) may also be included for various purposes. For example, detected movement of markers 314, 316, 318 located proximate to the breast (e.g., on or in the foam compression element) may exceed a certain threshold to trigger a notification signal, while detected movement of markers 306, 310, 312 distal to the breast (e.g., on the rigid substrate) may trigger a notification signal if it exceeds a much lower threshold. This is because any movement exerted by the rigid paddles is less likely to indicate any type of problem with the paddles or compression system, significant patient movement, or any other error or problem. However, for clarity, for purposes of this application, the movement detection techniques are described in the context of movement of markers closer to the breast, such as markers 314, 316, 318.

[0032] Each paddle 302 includes a rigid substrate 308 and a foam compression element 304 secured to or near its bottom surface. In the figures, the rigid substrate 308 is shown spaced apart from the foam compression element 304, but this is for illustrative purposes only. A plurality of upper markers 306, 310, 312 arranged in a row parallel to the chest wall are secured between the rigid substrate 308 and the foam compression element 304. A first row of upper markers 306 is shown closest to the chest wall, for example, proximate the front of the rigid substrate 308 and the foam compression element 304. A second row of upper markers 310 and a third row of upper markers 312 are positioned a known distance from the first row 306. The upper markers 306, 310, 312 may be secured to the rigid substrate 308 or the foam compression element 304 and may be positioned between these elements. In another example, the top markers 306, 310, 312 may be disposed on the top surface of the rigid substrate 308. Additionally, a greater or lesser number of marker rows may be utilized.

[0033] A plurality of bottom markers 314, 316, 318 arranged in rows parallel to the chest wall are secured to or near the bottom surface of the foam compression element 304. A first row of bottom markers 314 is shown closest to the chest wall. A second row of bottom markers 316 is spaced a distance from the first row 314, and a third row of bottom markers 318 is spaced another distance from the second row 316. Other numbers of rows are contemplated. The bottom markers 314, 316, 318 may be exposed on the bottom surface of the foam compression element 304A, as shown in FIG. 3A, or may be covered by a thin foam cover 320B, as shown in FIG. 3B. The thin foam cover 320B may be formed from the same or a different material as the foam compression element 304 and may be about 5%, about 7%, about 10%, about 12%, about 15%, or about 17% of the thickness of the foam compression element 304. The distance between the various rows of top markers 306, 310, 312 and the rows of bottom markers 314, 316, 318 may be as necessary or desired for a particular application. In general, the separation distance should allow each of the rows of markers 306, 310, 312, 314, 316, 318 to be visible in the resulting image produced by the X-ray radiation from the X-ray tube (its focal point shown at 320). Thus, given the angle of the X-ray energy 322, the distance between the top marker 310 of the second row and the top marker 312 of the third row will allow the bottom marker 316 of the second row to still be visible in the resulting image. The separation distance may be determined based at least in part on the thickness of the foam compression element 304, the length of the individual markers in each row of markers 306, 310, 312, 314, 316, 318, the expected distance between the focal point 322 and the markers 306, 310, 312, 314, 316, 318, and other factors.

[0034] An alternative marker system is shown in FIG. 3C, which shows an adhesive sheet 350 including multiple markers 352, 354. The sheet 350 may include an adhesive on one side that may allow the sheet 350 to temporarily adhere to the breast for imaging. A contact paper (not shown) may cover the adhesive during storage and may be removed prior to adhesion of the sheet 350 to the breast. The sheet 350 may have a defined edge 358 (e.g., marked with a mark 356) that is intended to be positioned adjacent to the patient's chest wall during adhesion. This allows the technician imaging the patient to easily apply the sheet 350 prior to imaging. The multiple markers 352, 254 may be arranged in multiple rows, for example, as shown in FIGS. 3A-3B above and 4A-4B below. In the illustrated example, multiple rows of markers 352 are arranged to be substantially parallel to the edge 358 adjacent the chest wall. A single row of markers 354 is arranged to be approximately perpendicular to the edge 358. Multiple rows of markers 354 may also be utilized. By using one or more rows of markers 354 positioned perpendicular to the chest wall, movement substantially perpendicular to the chest wall (e.g., resulting from the patient withdrawing from compressions) may be more easily detected. These rows of markers 354 positioned perpendicular to the chest wall may also be utilized in the configurations shown in the following figures, but are not shown therein for clarity.

[0035] 4A and 4B show an x-ray image 400 and a magnified partial x-ray image 400 of a breast 402, respectively, showing no detectable movement of the breast 402 during the imaging procedure. The image 400 shows the breast 402, multiple rows of top markers 404, and multiple rows of bottom markers 406. The top row of markers 404 are markers located on a rigid portion of the compression paddle and distal to the breast 402, e.g., between the foam compression element and the rigid substrate of the compression paddle. The bottom markers 406 are located proximate to the breast 402 and on or within the foam compression element. In another example, the bottom row of markers 406 may be located on an adhesive sheet, as shown in FIG. 3C. However, for clarity, the markers 406 in FIGS. 4A and 4B are described in the context of being on or within the foam compression element 402 of the compression paddle. The visibility of such markers may be enhanced or reduced using known image processing techniques. In each row of both the top markers 404 and the bottom markers 406, the individual markers may be the same width and spaced apart at regular separation intervals. For example, both the row of top markers 404 and the row of bottom markers 406 may include individual markers with a width of 250 μm and a separation distance of 250 μm. In other examples, markers with a width of 300 μm and a separation distance of 300 μm are also contemplated. Other examples include markers with a width of 200 μm and a separation distance of 200 μm, markers with a width of 350 μm and a separation distance of 350 μm, and other configurations. The markers may also have a width that is greater or less than the separation distance between adjacent markers. In general, the separation distance provides space around the individual markers to allow detection of movement of the individual markers, as well as movement of the breast itself. In image 400, both the row of top markers 404 and the row of bottom markers 406 exhibit a defined separation between adjacent markers in each row 404, 406. Thus, in Figure 4A, the consistency of the marker widths and separation distances indicates that the markers (and therefore the breast) did not move during the emission of x-ray energy.

[0036] 5A and 5B show an x-ray image 500 and a magnified partial x-ray image 500 of a breast 502, respectively, showing detectable movement of the breast 502 during the imaging procedure. The detectable movement is indicated by a change in the appearance of one or more of the rows of bottom markers 506a, 506b, and 506c. The row of top markers 504 does not typically move given its location close to the rigid substrate. Thus, the individual markers in the row of top markers 504 appear with consistent widths and spacing. However, with respect to the row of bottom markers 506, the movement is indicated by distortion of the individual imaged markers within the row. For example, in the row of bottom markers 506a, which is closest to the chest wall, the individual markers have moved. Over the course of the x-ray exposure, this movement is captured as an apparent increase in the width of each individual marker in the row of bottom markers 506a, and a corresponding decrease in the separation distance between adjacent markers. For purposes of illustration, assuming markers with a physical width and separation distance of 250 μm each, in the image, the imaged width may be about 500 μm, resulting in an imaged separation distance of about 100 μm. This shows the movement of the markers. The movement of the markers corresponds to the movement of the breast because the foam compression element is in contact with the breast proximate the bottom marker 506a of this row. The other rows of bottom markers (e.g., rows 506b, 506c, 506d, etc.) do not reflect their movement.

[0037] 6A and 6B show an x-ray image 600 and a magnified partial x-ray image 600 of a breast 602, respectively, showing detectable movement of the breast 602 during the imaging procedure. The detectable movement is indicated by a change in the appearance of one or more of the rows of bottom markers 606a, 606b, and 606c. The row of top markers 604 does not typically move given its location close to the rigid substrate. Thus, the individual markers in the row of top markers 604 appear with consistent widths and spacing. However, with respect to the row of bottom markers 606, the movement is indicated by distortion of the individual imaged markers within the row. For example, in the row of bottom markers 606a, closest to the chest wall, the individual markers have moved, causing a complete "blurring" or "filling in" of the entire row of bottom markers 606a. Because 250 μm wide markers were used with a separation distance of 250 μm, it is clear that the row of bottom markers 606a has moved a total width of 250 μm, thus eliminating the distinction between individual markers within that row 606a. Because the foam compression element is in contact with the breast proximate the bottom marker 606a of this row, the movement of the marker corresponds to movement of the breast.

[0038] The row of bottom markers 606b also displays some distortion of the individual markers, indicating wider markers and therefore a reduced separation distance between them. This distortion of the markers indicates some movement of the breast, but not as much as the movement of the portion of the breast proximal to the bottom marker 606a in the first row. This is because different portions of the breast may move differently under the foam compression element. The row of bottom markers 606c does not display any obvious distortion of the individual markers, thus indicating no movement of the breast proximate that location. Thus, it is clear that in these rows of bottom markers 606a, 606b, 606c, there is substantial movement of the breast proximate row 606a, some movement proximate row 606b, and no detectable movement proximate row 606c.

[0039] The rows of markers shown in Figures 4A-6B are arranged substantially parallel to the chest wall, with the individual markers extending substantially perpendicular to the chest wall. Such markers are therefore configured to more easily indicate movement parallel to the chest wall. The techniques described herein may also be utilized to detect movement substantially perpendicular to the chest wall (e.g., when a patient withdraws from a compression system). In such a configuration, it may be desirable to arrange the rows of markers extending in a direction substantially perpendicular to the chest wall, with the individual markers arranged substantially parallel to the chest wall.

[0040] As described herein, each marker has "physical" and "imaged" properties. Physical properties are properties of the marker in the physical world, such as length, width, separation distance between adjacent markers, radiopacity, etc. Imaged properties are properties of the marker in the image. For example, the imaged width of the marker is shown in the image. Typically, the imaged width (or other imaged dimensions such as length and separation distance) is related to the associated physical property, but likely differs from it in the image. For example, a marker may appear larger or smaller in the image depending on the distance between the marker and the detector, magnification, or other factors. Similarly, the radiopacity of a physical marker at least partially determines the appearance of the marker's artifacts in the image. With these terms in mind, Figures 7A-7C are now described.

[0041] 7A-7C show enlarged partial views of a row 700 of markers 702 showing various degrees of movement. Unless otherwise noted, the suffixes of the reference numbers shown in FIGS. 7A-7C correspond to the particular features described without the suffix in the description of those figures. The scale of each of FIGS. 7A-7C is exaggerated for illustrative purposes. FIG. 7A shows the absence of movement of the markers 702 in the resulting X-ray image. The row of markers 700a includes a plurality of separate markers 702a having a defined imaged width W and separated in the image by an imaged separation distance d. If the physical width and separation distance of the actual markers on the compression foam element of the compression paddle are known, the imaged width W and the imaged separation distance can be compared. A method for making such a comparison is described below. Because the imaged width W and imaged separation distance d of the markers 702a correspond to their physical width and separation distance (factoring in magnification as known in the art), it can be concluded that no detectable movement of the markers 702a (and thus the adjacent portions of the breast) has occurred.

[0042] FIG. 7B illustrates a marker state where some movement has been detected in the X-ray image. The row of markers 700b includes multiple individual markers 702b that have a larger imaged width W' and are separated by a smaller imaged distance d' in the image, both of which do not correspond to the physical width and physical separation distance of the actual markers on the compression foam element of the compression paddle. Thus, by comparing the imaged width W' and / or the imaged separation distance d' to the known physical width and physical separation distance, the amount of movement can be determined. The method of comparison is described below. The imaged width W' and the imaged separation distance d' result from the change in the position of the marker over the time of emission of the X-ray energy due to the movement of the marker 702b. However, the apparent movement of the marker 702b is captured in the image as a larger imaged width W' and a smaller imaged separation distance d'. The larger imaged width W' and the smaller imaged separation distance d' can be calculated to determine the total amount of movement, again taking into account the magnification and other known factors.

[0043] FIG. 7C shows a marker condition where significant movement has been detected in the X-ray image. The imaged row of markers 700c appears in the image as a single marker 702c. It can therefore be concluded that the imaged physical markers have moved enough to merge into a single large solid artifact in the image. Neither the marker width nor the separation distance can be discerned, indicating that the markers have moved a distance at least equal to the physical separation distance of the markers on the foam compression element. The change in the imaged artifact results from the change in the position of the markers 702c over the time of emission of the X-ray energy. Such significant movement may cause the imaging system to issue a notification that the breast has moved so much during imaging that the resulting image is not considered suitable for diagnosis. Movements of a magnitude smaller than that shown in FIG. 7C may also trigger a notification.

[0044] The imaged marker width and / or imaged separation distance may be determined in several ways. Each marker placed on the compression paddle (either the top or bottom marker, as described above) may be characterized by physical properties as described above. Each marker is defined by dimensional information (e.g., length, width) and radiopacity. Changes in these physical properties are reflected in the image as the marker moves during imaging. In one example, the imaged dimensions of the marker may be analyzed to identify any changes that may have occurred due to movement. These can be most easily considered in the context of Figures 7A-7C above by changes in width and separation distance, which may be measured in the x-ray image obtained by image recognition techniques or measured pixel by pixel at the detector. In the latter example, the pixel width of the marker at a particular distance from the detector and at a particular magnification is known. For purposes of illustration, the width of the marker may be three pixels. However, if the imaged width is five pixels, it can be concluded that the marker moved two pixels along the marker width during x-ray emission. Therefore, in many cases it is desirable for the marker to be wider than the dimensions of a pixel.

[0045] In another example, the x-ray energy received at each pixel of the detector can also be measured to detect x-ray absorption at each pixel. Referring again to FIG. 7A, it shows that there is no movement of the markers and that the amount of x-ray energy detected at each pixel corresponding to the marker's location does not change during the x-ray emission. This allows the imaging system to determine that no movement of the markers has occurred (and therefore no movement of the breast). However, in FIG. 7B, each pixel located at each imaged marker receives a greater amount of x-ray energy over the emission time of the x-ray energy due to the movement of each marker. In other words, for a given pixel located under a marker, the pixel receives an amount of x-ray energy that is reduced by the presence of the marker (due to the radiopacity of the marker). However, when that marker moves, the x-ray energy is not blocked by the same pixel for at least a certain period of time, and therefore the total amount of x-ray energy detected at each pixel is different than if the marker had remained stationary above the pixel for the entire emission period. In FIG. 7C, the physical marker has moved a greater distance during the imaging procedure, so the amount of x-ray energy at a greater number of pixels is altered during the x-ray emission.

[0046] FIG. 8 illustrates a method 800 of imaging a breast compressed with a paddle having a foam compression element. The method 800 begins with operation 802 of emitting x-ray energy from an x-ray source. The x-ray energy is emitted toward a breast immobilized or compressed by the paddle and foam compression element. A plurality of markers are disposed on or in one or both of the rigid substrate and foam compression element of the paddle. In operation 804, the x-ray energy is emitted for a predetermined period of time, e.g., less than about 0.5 seconds, less than about 0.4 seconds, less than about 0.3 seconds, passes through the paddle, markers, breast, etc., and is received by a detector, where the x-ray energy is detected. In operation 806, an x-ray image may be generated from this x-ray energy. The x-ray image includes at least the imaged breast and the marker. In the image, the marker includes the imaged characteristic. The image is analyzed in operation 808 to detect movement of the markers. In an example, the analysis may include comparing the imaged marker characteristics to physical marker characteristics that may be obtained from a database in the imaging system. The database may include information regarding the physical characteristics of the paddle, rigid substrate, and foam compression element being utilized, and the physical characteristics of the marker. After the analysis, a signal may be transmitted in operation 810. The signal may be an audible notification signal emitted to the technician or a visual notification signal displayed, and may indicate whether the deviation between the imaged characteristics and the physical characteristics is above or below a threshold. Such a signal may indicate to the technician whether the image obtained is of suitable quality for diagnosis or not. The method 800 may proceed to operation 812, where the image of the breast and markers is processed to obtain an analysis image. The analysis image is characterized by the absence of markers, which may be removed by known image processing techniques, such that the analysis image is more suitable for review and analysis by a radiologist. In operation 814, the analysis image may be displayed.

[0047] 9 illustrates an example of a suitable operating environment 900 in which one or more of the present examples can be implemented. This operating environment can be directly integrated into the imaging system disclosed herein, or can be integrated into a computer system separate from, but used to control, the imaging and compression systems described herein. This is only one example of a suitable operating environment and is not intended to suggest any limitation as to the scope of use or functionality. Other well-known computing systems, environments, and / or configurations that may be suitable for use include, but are not limited to, imaging systems, personal computers, server computers, handheld or laptop devices, multiprocessor systems, microprocessor-based systems, programmable consumer electronics such as smartphones, network PCs, minicomputers, mainframe computers, tablets, distributed computing environments including any of the above systems or devices, and the like.

[0048] In its most basic configuration, the operating environment 900 typically includes at least one processing unit 902 and memory 904. Depending on the exact configuration and type of computing device, the memory 904 (which stores instructions for, among other things, identifying marker characteristics, determining x-ray dosage, comparing imaged marker characteristics to known physical marker characteristics, or performing other methods disclosed herein) may be volatile (such as RAM), non-volatile (e.g., ROM, flash memory, etc.), or some combination of the two. This most basic configuration is illustrated in FIG. 9 by dashed line 906. Additionally, the environment 900 may also include storage devices (removable 908, and / or non-removable 910), including, but not limited to, magnetic or optical disks or tapes. Similarly, the environment 900 may have input device(s) 914, such as a touch screen, keyboard, mouse, pen, voice input, etc., and / or output device(s) 916, such as a display, speakers, printer, etc. One or more communications connections 912, such as LAN, WAN, point-to-point, Bluetooth, RF, etc., may also be included in the environment.

[0049] The operating environment 900 typically includes at least some form of computer-readable media. Computer-readable media may be any available media that can be accessed by the processing unit 902 or other devices having the operating environment. By way of example, and not limitation, computer-readable media may include computer storage media and communication media. Computer storage media includes volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storage of information such as computer-readable instructions, data structures, program modules, or other data. Computer storage media includes RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, digital versatile disks (DVDs) or other optical storage devices, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, solid-state storage devices, or any other tangible medium that can be used to store the desired information. Communication media embodies computer-readable instructions, data structures, program modules, or other data in a modulated data signal, such as a carrier wave or other transport mechanism, and includes any information delivery media. The term "modulated data signal" means a signal that has one or more of its characteristics set or changed in such a manner as to encode information in the signal. By way of example, and not limitation, communication media includes wired media such as a wired network or direct-wired connection, and wireless media such as acoustic, RF, infrared and other wireless media. Combinations of any of the above should also be included within the scope of computer-readable media. A computer-readable device is a hardware device that incorporates computer storage media.

[0050] The operating environment 900 may be a single computer operating in a networked environment using logical connections to one or more remote computers. The remote computers may be personal computers, servers, routers, network PCs, peer devices, or other common network nodes, and typically include many or all of the above elements, as well as other elements not so mentioned. The logical connections may include any manner supported by the available communications media. Such networking environments are commonplace in offices, enterprise-wide computer networks, intranets, and the Internet.

[0051] In some embodiments, the components described herein include modules or instructions executable by computer system 900 that can be stored on computer storage media and other tangible media and transmitted over communication media. Computer storage media includes volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storage of information such as computer readable instructions, data structures, program modules, or other data. Combinations of any of the above should also be considered to be included within the scope of readable media. In some embodiments, computer system 900 is part of a network that stores data on remote storage media for use by computer system 900.

[0052] In embodiments, the various systems and methods disclosed herein may be performed by one or more server devices. For example, in one embodiment, a single server, such as server 904, may be used to perform the systems and methods disclosed herein, such as the methods for imaging described herein. Client device 902 may interact with server 904 via network 908. In further embodiments, client device 902 may also perform the functionality disclosed herein, such as scanning and image processing, which may then be provided to server 904 and / or 906.

[0053] Illustrative examples of the systems and methods described herein are provided below. An embodiment of the system or method described herein may include any one or more, and any combination, of the provisions described below.

[0054] Clause 1. A method for imaging a breast compressed with a paddle having a foam compression element, the method including: emitting x-ray energy from an x-ray source toward the breast, the foam compression element, and a marker positioned adjacent to the foam compression element, the x-ray energy being emitted for a predetermined period of time, the marker having a physical characteristic; detecting the x-ray energy with a detector positioned on an opposite side of the breast from the x-ray source; generating an image of the compressed breast and marker based on the detected x-ray energy, the marker in the generated image including an image characteristic associated with the physical characteristic; comparing the image characteristic to the physical characteristic; and transmitting a signal if the image characteristic deviates from the physical characteristic by a threshold amount.

[0055] Clause 2. The method of clause 1, wherein the physical characteristics comprise physical dimensions and the image characteristics indicate movement of the marker during emission of X-ray energy.

[0056] Clause 3. The method of clause 2, wherein the physical dimension comprises a marker width, the marker width being greater than a width of a pixel in the detector.

[0057] Clause 4. A method according to any one of clauses 1 to 3, wherein the marker is disposed on a surface of the foam compression element that is in contact with the breast during emission of X-ray energy.

[0058] Clause 5. The method of any one of clauses 1 to 4, wherein the marker is attached to the breast.

[0059] Clause 6. A method according to any one of clauses 2 to 5, wherein movement of the marker results from movement of a portion of the breast during emission of X-ray energy.

[0060] Clause 7. The method of clause 6, wherein the portion of the breast is proximate to the marker.

[0061] Clause 8. The method of any one of clauses 1 to 7, further comprising processing the images of the breast and the marker to generate an analysis image, and displaying the analysis image, wherein the marker is not visible in the analysis image.

[0062] Clause 9. A method according to any one of clauses 1 to 8, wherein the physical characteristic comprises radiopacity and the imaging characteristic corresponds to the attenuation of X-ray energy passing through the marker during emission of the X-ray energy.

[0063] Clause 10. A method according to any one of clauses 2 to 9, wherein the marker has a marker width, the marker width being greater than a width of a pixel in the detector.

[0064] Clause 11. The method of any one of clauses 1 to 10, wherein sending a signal includes displaying a notification.

[0065] Clause 12. An apparatus comprising: an x-ray source; an x-ray detector; a breast support for supporting the breast during an imaging procedure; a breast compression paddle movably disposed between the x-ray source and the x-ray detector, the breast compression paddle comprising a rigid substrate, a foam compression element secured to the rigid substrate, and a marker disposed in contact with the foam compression element; at least one processor; and a memory storing instructions that, when executed by the at least one processor, cause the apparatus to perform operations including emitting x-ray energy from the x-ray source through the breast and the marker; receiving the emitted x-ray energy; generating an image from the received x-ray energy, the image being representative of the breast and the marker; analyzing the image and identifying movement of the marker; and transmitting a signal if the movement exceeds a threshold.

[0066] Clause 13. The apparatus of clause 12, wherein analyzing the image includes identifying markers in the image.

[0067] Clause 14. The apparatus of clause 13, wherein the marker has a physical property, and analyzing the image includes comparing the physical property of the marker with an imaged property of the marker in the image.

[0068] Clause 15. The apparatus of clause 14, wherein the physical characteristics comprise dimensions of the marker.

[0069] Clause 16. A device as described in any one of clauses 14 to 15, wherein the physical property comprises radiopacity of the marker.

[0070] Clause 17. An apparatus as described in any one of clauses 12 to 16, wherein the operations further include processing the images of the breast and the marker to generate an analysis image and displaying the analysis image, wherein the marker is not visible in the analysis image.

[0071] Clause 18. The apparatus of any one of clauses 12 to 17, wherein sending a signal includes displaying a notification.

[0072] Clause 19. An apparatus as described in any one of clauses 12 to 18, wherein the marker is disposed on a surface of a foam compression element configured to contact the breast during emission of X-ray energy.

[0073] Clause 20. An apparatus as described in any one of clauses 12 to 19, wherein the breast compression paddle is provided with a marker.

[0074] Clause 21. A device described in any one of clauses 12 to 20, wherein the markers are disposed on a sheet attached to the breast.

[0075] Clause 22. An apparatus as described in any one of clauses 12 to 21, wherein the marker comprises a plurality of markers arranged in at least one row.

[0076] Clause 23. The apparatus of clause 22, wherein the at least one row comprises a plurality of rows.

[0077] Clause 24. A device according to any one of clauses 22 to 23, wherein the rows are arranged substantially parallel to the patient's chest wall.

[0078] Clause 25. An apparatus according to any one of clauses 22 to 24, wherein the rows are arranged substantially perpendicular to the patient's chest wall.

[0079] Clause 26. An apparatus according to any one of clauses 23 to 25, wherein a first row of the plurality of rows is arranged substantially orthogonal to a second row of the plurality of rows.

[0080] This disclosure has described several examples of the technology with reference to the accompanying drawings, which illustrate only a few of the possible examples. However, other aspects may be embodied in many different forms and should not be construed as being limited to the examples set forth herein. Rather, these examples are provided so that this disclosure will be thorough and complete, and will fully convey the scope of possible examples to those skilled in the art.

[0081] Although specific examples are described herein, the scope of the technology is not limited to these specific examples. Those skilled in the art will recognize other examples or improvements that are within the scope of the technology. Thus, specific structures, acts, or media are disclosed only as illustrative examples. Examples of the technology may also combine elements or components that are generally disclosed but not explicitly illustrated in combination, unless otherwise stated herein. The scope of the technology is defined by the following claims and their equivalents.

Claims

1. A method for imaging a breast compressed with paddles, the method comprising: emitting x-ray energy from an x-ray source toward the breast, the paddle, and a marker positioned adjacent to the paddle, the x-ray energy being emitted for a predetermined period of time, the marker having a physical characteristic; detecting the x-ray energy at a detector positioned on an opposite side of the breast from the x-ray source; generating an image of the compressed breast and the marker based on the detected x-ray energy, the marker in the generated image including an image characteristic associated with the physical characteristic; comparing the image characteristics to the physical characteristics; transmitting a signal when the image characteristic deviates from the physical characteristic by a threshold value; A method comprising:

2. The method of claim 1 , wherein the physical characteristics include physical dimensions and the image characteristics describe movement of the marker during the emission of the x-ray energy.

3. The method of claim 2 , wherein the physical dimension comprises a marker width, the marker width being greater than a width of a pixel in the detector.

4. The method of claim 1 , wherein the markers are disposed on a surface of a foam compression element that is in contact with the breast during the emission of the x-ray energy.

5. The method of claim 1 , wherein the marker is attached to the breast.

6. The method of claim 2 , wherein the movement of the marker results from movement of a portion of the breast during the emission of the x-ray energy.

7. The method of claim 6 , wherein the portion of the breast is proximate to the marker.

8. processing the images of the breast and the markers to generate analysis images; displaying the analysis image; further comprising The method of claim 1 , wherein the markers are not visible in the analysis image.

9. The method of claim 1 , wherein the physical property comprises radiopacity and the imaging property corresponds to the attenuation of the x-ray energy passing through the marker during the emission of the x-ray energy.

10. The method of claim 2 , wherein the marker comprises a marker width, the marker width being greater than a width of a pixel in the detector.

11. The method of claim 1 , wherein transmitting the signal comprises displaying a notification.

12. 1. An apparatus, comprising: an X-ray source; an X-ray detector; a breast support for supporting the breast during the imaging procedure; a breast compression paddle movably disposed between the X-ray source and the X-ray detector, the breast compression paddle including a marker disposed in contact with the paddle, the marker including a plurality of markers arranged in at least one row; at least one processor; Memory that stores instructions Equipped with The instructions, when executed by the at least one processor, emitting x-ray energy from the x-ray source through the breast and the marker; receiving the emitted x-ray energy; generating an image from the received x-ray energy, the image depicting the breast and the marker; analyzing the image to identify movement of the marker; transmitting a signal when said movement exceeds a threshold; An apparatus for causing the apparatus to perform operations including:

13. The apparatus of claim 12 , wherein analyzing the image includes identifying the marker in the image.

14. The apparatus of claim 13 , wherein the marker comprises a physical characteristic, and analyzing the image comprises comparing the physical characteristic of the marker to an imaged characteristic of the marker in the image.

15. The apparatus of claim 14 , wherein the physical characteristics include dimensions of the marker.

16. The device of claim 14 , wherein the physical property comprises radiopacity of the marker.

17. The operation is processing the images of the breast and the markers to generate analysis images; displaying the analysis image; further comprising The apparatus of claim 12 , wherein the markers are not visible in the analysis image.

18. The device of claim 12 , wherein transmitting the signal comprises displaying a notification.

19. The device of claim 12 , wherein the markers are disposed on a surface of a foam compression element configured to contact the breast during the emission of the x-ray energy.

20. The device described in claim 12, wherein the marker is integral with the paddle.

21. The device of claim 12 , wherein the markers are disposed on a sheet attached to the breast.

22. The apparatus of claim 12 , wherein the at least one row comprises a plurality of rows.

23. 13. The device of claim 12, wherein the rows are arranged substantially parallel to the patient's chest wall.

24. 13. The device of claim 12, wherein the rows are arranged substantially perpendicular to the patient's chest wall.

25. 23. The apparatus of claim 22, wherein a first column of the plurality of columns is disposed substantially orthogonal to a second column of the plurality of columns.

26. An apparatus, comprising: an X-ray source; an X-ray detector; a breast support for supporting the breast during the imaging procedure; a breast compression paddle movably disposed between the X-ray source and the X-ray detector, the breast compression paddle comprising: A rigid substrate; a foam compression element secured to the rigid substrate; a marker disposed in contact with the foam compression element; a breast compression paddle comprising: at least one processor; Memory that stores instructions Equipped with The instructions, when executed by the at least one processor, emitting x-ray energy from the x-ray source through the breast and the marker; receiving the emitted x-ray energy; generating an image from the received x-ray energy, the image depicting the breast and the marker; analyzing the image to identify movement of the marker; transmitting a signal when said movement exceeds a threshold; An apparatus for causing the apparatus to perform operations including:

Images