One known challenge in mammography and breast tomosynthesis is the discomfort the patient may feel when the breast is compressed, which must be done with sufficient force to immobilize the breast and, in some cases, spread out the breast tissues for x-ray imaging. Discomfort may potentially cause the patient to move, which negatively impacts image quality. Discomfort may also potentially dissuade patients from getting screened for breast cancer. Another known challenge is to ensure that the imaged field includes the desired amount of breast tissue. This discomfort has led to the development of compression paddles having flexible features, e.g., plastic sheets, flexible meshes, foam compressive materials, etc. These flexible features present unique challenges to properly image the breast. In existing imaging systems that utilize flat, rigid compression paddles, thickness of the compressed breast may be fairly easily determined by measuring or calculating a height of the compression paddle above a breast support platform. The use of flexible materials to stabilize a breast, however, make such simple calculations impossible.
In one aspect, the technology relates to a method of imaging a breast compressed with a paddle including a foam compressive element, the method including: emitting an x-ray energy from an x-ray source towards the breast and the foam compressive element and a marker disposed adjacent the foam compressive element, wherein the x-ray energy is emitted over a predetermined time period, and wherein the marker includes a physical characteristic; detecting the x-ray energy at a detector disposed opposite the breast from the x-ray source; generating an image of the compressed breast and the marker based on the detected x-ray energy, wherein the marker in the generated image includes an image characteristic associated with the physical characteristic; comparing the image characteristic to the physical characteristic; and sending a signal when the image characteristic deviates from the physical characteristic by a threshold. In an example, the physical characteristic includes a physical dimension, and wherein the image characteristic depicts a movement of the marker during the emission of the x-ray energy. In another example, the physical dimension includes a marker width and wherein 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 compressive element that contacts the breast during the emission of the x-ray energy. In still another example, the marker is adhered to the breast.
In another example of the above aspect, the movement of the marker results from a movement of a portion of the breast during the emission of the x-ray energy. In an example, the portion of the breast is proximate the marker. In another example, the method further includes processing the image 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. In yet another example, the physical characteristic includes a radiopacity, and wherein the image characteristic corresponds to an attenuation of the x-ray energy passing through the marker during the emission of the x-ray energy. In still another example, the marker includes a marker width and wherein the marker width is greater than a width of a pixel on the detector.
In another example of the above aspect, sending the signal includes displaying a notification.
In another aspect, the technology relates to an apparatus including: an x-ray source; an x-ray detector; a breast support platform for supporting a 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 includes: a rigid substrate; a foam compressive element secured to the rigid substrate; and a marker disposed in contact with the foam compressive 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 an x-ray energy from the x-ray source and though the breast and the marker; receiving the emitted x-ray energy; generating an image from the received x-ray energy, wherein the image depicts the breast and the marker; analyzing the image to identify a movement of the marker; and sending a signal when the movement exceeds a threshold. In an example, analyzing the image includes identifying the marker in the image. In another example, the marker includes a physical characteristic and wherein 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 still another example, the physical characteristic includes a radiopacity of the marker.
In another example of the above aspect, the operations further includes: processing the image 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. In an example, sending the signal includes displaying a notification. In another example, the marker is disposed on a surface of the foam compressive element that is configured to contact the breast during the emission of the x-ray energy. In yet another example, the breast compression paddle includes the marker. In still another example, the marker is disposed on a sheet adhered to the breast.
In another example of the above aspect, the marker includes a plurality of markers arranged in at least one row. In an example, the at least one row includes a plurality of rows. In another example, the row is disposed substantially parallel to a chest wall of the patient. In yet another example, the row is disposed substantially orthogonal to a chest wall of the patient. In still another example, a first row of the plurality of rows is disposed substantially orthogonal to a second row of the plurality of rows.
Breast compression paddles made entirely of rigid materials effectively compress a patient breast, as well as hold the breast still during imaging. While this is advantageous to obtain high-quality images, the discomfort associated with rigid paddles lead many women to avoid regular screening exams for breast cancer. Paddles utilizing foam compressive materials reduce patient discomfort during imaging procedures, which may persuade more women to have regular examinations, thus leading to early cancer diagnosis. However, while comfort is improved, the flexible nature of the thick foam compressive material may allow for movement of the breast during imaging procedures (e.g., if the patient pulls away from the breast imaging system, inadvertently or deliberately). If this occurs, the resulting image may be less diagnostically-relevant than desired. Thus, while paddles utilizing foam compressive elements are more comfortable, such paddles introduce myriad challenges to how a breast imaging system (e.g., a mammography, tomosynthesis, or combination mammography/tomosynthesis system) takes exposures and produces images of diagnostically-relevant quality.
The technologies described herein provide devices and methods to accurately detect movement of a breast under a foam compressive element of a compression or immobilization paddle. The technology contemplates markers on areas of the foam compressive element that may move when subject to an applied force. For example, if a patient breast is compressed by a paddle having a foam compressive element, movement of the patient (e.g., pulling away from the imaging system) would be translated to portions of the foam compressive element proximate the breast, but not to portions of the rigid substrate, which are less susceptible to movement and located far from the breast. The amount of movement of the marker(s) may be detected in a variety of ways, for example, via an analysis of the resulting image (and the imaged marker therein) or via an analysis of discrete pixels of an x-ray detector. If the detected movement exceeds a threshold (e.g., so as to no longer be indicative of a diagnostically-relevant image), a notification may be triggered. This notification may require the breast imaging procedure to be performed again, which may take place immediately, while the patient is still at the medical clinic (and even under compression). This helps save time by ensuring the image is actually of sufficient quality, before being the time-consuming review and analysis by a radiologist. Thus, these technologies are critical to make viable paddles utilizing a foam compressive material.
The immobilizer 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, 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 a mammogram projection image at each orientation. In operation, the image receptor 116 remains in place relative to the platform 106 while an image is taken. The immobilizer unit 104 releases the breast 102 for movement of arms 124, 126 to a different imaging orientation. For tomosynthesis, the support arm 124 stays in place, with the breast 102 immobilized and remaining in place, while at least the second support arm 126 rotates the x-ray source 122 relative to the immobilizer unit 104 and the compressed breast 102 about the axis 128. The system 100 takes plural tomosynthesis projection images of the breast 102 at respective angles of the beam 120 relative to the breast 102.
Concurrently and optionally, the image receptor 116 may be tilted relative to the breast support platform 106 and in sync with the rotation of the second support arm 126. The tilting can be through the same angle as the rotation of the x-ray source 122, but may also be through a different angle selected such that the beam 120 remains substantially in the same position on the image receptor 116 for each of the plural images. The tilting can be about an axis 130, which can but need not be in the image plane of the image receptor 116. The tilting mechanism 118 that is coupled to the image receptor 116 can drive the image receptor 116 in a tilting motion. For tomosynthesis imaging and/or CT imaging, the breast support platform 106 can be horizontal or can be at an angle to the horizontal, e.g., at an orientation similar to that for conventional MLO imaging in mammography. The system 100 can be solely a mammography system, a CT system, or solely a tomosynthesis system, or a “combo” system that can perform multiple forms of imaging. An example of such a combo system has been offered by the assignee hereof under the trade name Selenia Dimensions.
When the system is operated, the image receptor 116 produces imaging information in response to illumination by the imaging beam 120, and supplies it to an image processor 132 for processing and generating breast x-ray images. A system control and work station unit 138 including software controls the operation of the system and interacts with the operator to receive commands and deliver information including processed-ray images.
One challenge with the imaging system 100 is how to immobilize and compress the breast 102 for the desired or required imaging. A health professional, typically an x-ray technologist, generally adjusts the breast 102 within the immobilizer unit 104 while pulling tissue towards imaging area and moving the compression paddle 108 toward the breast support platform 106 to immobilize the breast 102 and keep it in place, with as much of the breast tissue as practicable being between the compression surfaces 110, 112. This can cause discomfort to the patient.
To improve comfort for the patient, compression paddles utilizing foam compressive elements have been developed. Compression paddles utilizing foam compressive elements are described generally 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 hereby incorporated by reference herein in their entireties. Such paddles stabilize and compress slightly the breast, while reducing discomfort associated with compression paddles having only rigid compressive surfaces.
The foam compressive element 202 may be secured to a bottom surface of the substrate 204 with a chemical adhesive. In other example, an upper surface of the compressive element may be a rigid plastic or other material to which the foam compressive element 202 is secured. A plurality of bolts, hooks, or other mechanical fasteners (not shown) may be used to connect this rigid plastic to the rigid substrate 204 of the paddle 200. If such mechanical fasteners are used, it may be desirable to dispose said fasteners away from areas of the foam compressive element 202 that are expected to compress against a breast, so as to avoid pressure points and resulting discomfort associated therewith, as well as to prevent artifacts from appearing in any resulting x-ray images.
The foam compressive element 202 includes a number of edge surfaces. A leading edge surface 210 is disposed proximate the leading face 208 of the substrate 204 so as to be disposed proximate the chest wall of a patient during compression and imaging procedures. A trailing edge surface 212 is disposed opposite the leading edge surface 210, proximate the bracket portion 206. Lateral edge surfaces 214, 216 are also depicted. In general, these lateral edge surfaces 214, 216 may be depicted as inner or outer lateral edge surfaces, consistent with terminology typically used to describe inner and outer sides of the breast. Of course, a person of skill in the art will recognize that the same compression paddle 200 may be used to compress either breast, one at a time, which would effectively change the application of the terms “inner” and “outer” to the lateral edge surfaces of the foam compressive element 202. Further, a mid-plane 220 is disposed between the lateral edge surfaces 214, 216, at an approximate midpoint thereof. The mid-plane 220 is disposed substantially orthogonal to a compressive surface 218 that is disposed on an underside of the foam compressive element 202. Portions of the compressive surface 218 will contact the breast during compression. In another example, the foam compressive element 202 may be covered with a biocompatible cover, which may protect the foam compressive element 202 from absorbing bodily fluids. In examples, the cover may be disposable or cleanable. To improve the patient experience, the cover may be manufactured of a soft material where it contacts the patient. To prevent fluid transfer into the foam compressive element 202, an opposite plastic side may contact the foam compressive element 202. An interface 222 is located where the compressive surface 218 meets the leading edge surface 210. The shape of the interface 222 during compression aids in defining the foam compressive element 202 and the function thereof.
Each paddle 302 includes a rigid substrate 308 and a foam compressive element 304 secured at or near a bottom surface thereof. In the figures, the rigid substrate 308 is depicted spaced apart from the foam compressive element 304, but this is for illustrative purposes only. Secured between the rigid substrate 308 and the foam compressive element 304 are a plurality of top markers 306, 310, 312 arranged in rows parallel to the chest wall. The first row of top markers 306 is depicted closest to the chest wall, for example, proximate a front surface of the rigid substrate 308 and the foam compressive element 304. A second row of top markers 310 and a third row of top markers 312 are disposed known distances from the first row 306. The top markers 306, 310, 312 may be secured to the rigid substrate 308 or the foam compressive element 304 and may be disposed between those elements. In another example, the top markers 306, 310, 312 may be disposed on an upper surface of the rigid substrate 308. Further, a greater or lesser number of marker rows may be utilized.
Secured to or near a bottom surface of the foam compressive element 304 are a plurality of bottom markers 314, 316, 318 arranged in rows parallel to the chest wall. The first row of bottom markers 314 are depicted closest to the chest wall. A second row of bottom markers 316 is disposed a distance from the first row 314, while a third row of bottom markers 318 are disposed another distance from the second row 316. Other numbers of rows are contemplated. The bottom markers 314, 316, 318 may be exposed at the bottom surface of the foam compressive element 304a, as depicted in
An alternative marker system is depicted in
The row of bottom markers 606b also displays some distortion of individual markers, as indicative of wider markers and, by extension, reduced separation distance therebetween. This distortion of markers is indicative of some movement of the breast, but not as much as that of the portion of the breast proximal the first row of bottom markers 606a. This is because different portions of the breast may move differently under a foam compressive element. The row of bottom markers 606c displays no apparent distortion of individual markers, thus indicating no movement of the breast proximate that location. Thus, with these rows of bottom markers 606a, 606b, 606c, it is clear that significant movement of the breast occurs proximate row 606a, some movement proximate row 606b, and no detectable movement proximate row 606c.
The rows of markers depicted in
As described herein, each marker has a “physical” characteristic and an “imaged” characteristic. Physical characteristics are characteristics of the marker in the physical world, e.g., length, width, separation distance between adjacent markers, radiopacity, and so on. Imaged characteristics are characteristics of the markers in an image. For example, in an image, the imaged width of a marker is depicted. Typically, the imaged width (or other imaged dimensions, such as length and separation distance), are related to the associated physical characteristic, but likely differ therefrom in the image. For example, the marker may appear larger or smaller in the image, depending on distance between the marker and detector, magnification, or other factors. Similarly, the radiopacity of a physical marker will dictate, at least in part, the appearance of an artifact of the marker in the image. With these terms in mind,
The imaged marker width and/or imaged separation distance may be determined in several ways. Each marker located on the compression paddle (either the top markers or bottom markers, as described above), may be characterized by a physical characteristic as noted above. Each marker is defined by dimensional information (e.g., length, width) and radiopacity. Changes to these physical characteristics are reflected in the image when the marker moves during imaging. In one example, the imaged dimensions of the markers may be analyzed to identify any changes that may be have occurred due to movement. These are most easily contemplated in the context of
In another example, the x-ray energy received at each pixel of the detector may also be measured to detect x-ray absorption at each pixel. Referring again to
In its most basic configuration, operating environment 900 typically includes at least one processing unit 902 and memory 904. Depending on the exact configuration and type of computing device, memory 904 (storing, among other things, instructions to identify marker characteristics, determine x-ray dosages, compare imaged marker characteristics to known physical marker characteristics, or perform other methods disclosed herein) can be volatile (such as RAM), non-volatile (such as ROM, flash memory, etc.), or some combination of the two. This most basic configuration is illustrated in
Operating environment 900 typically includes at least some form of computer readable media. Computer readable media can be any available media that can be accessed by processing unit 902 or other devices having the operating environment. By way of example, and not limitation, computer readable media can 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 (DVD) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, solid state storage, or any other tangible medium which 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 the any of the above should also be included within the scope of computer readable media. A computer-readable device is a hardware device incorporating computer storage media.
The operating environment 900 can be a single computer operating in a networked environment using logical connections to one or more remote computers. The remote computer can be a personal computer, a server, a router, a network PC, a peer device or other common network node, and typically includes many or all of the elements described above as well as others not so mentioned. The logical connections can include any method supported by available communications media. Such networking environments are commonplace in offices, enterprise-wide computer networks, intranets and the Internet.
In some embodiments, the components described herein include such modules or instructions executable by computer system 900 that can be stored on computer storage medium and other tangible mediums and transmitted in communication media. Computer storage media includes volatile and non-volatile, 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 included within the scope of readable media. In some embodiments, computer system 900 is part of a network that stores data in remote storage media for use by the computer system 900.
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 employed to perform the systems and methods disclosed herein, such as the methods for imaging discussed herein. Client device 902 may interact with server 904 via network 908. In further embodiments, the client device 902 may also perform functionality disclosed herein, such as scanning and image processing, which can then be provided to servers 904 and/or 906.
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 clauses described below:
Clause 1. A method of imaging a breast compressed with a paddle comprising a foam compressive element, the method comprising: emitting an x-ray energy from an x-ray source towards the breast and the foam compressive element and a marker disposed adjacent the foam compressive element, wherein the x-ray energy is emitted over a predetermined time period, and wherein the marker comprises a physical characteristic; detecting the x-ray energy at a detector disposed opposite the breast from the x-ray source; generating an image of the compressed breast and the marker based on the detected x-ray energy, wherein the marker in the generated image comprises an image characteristic associated with the physical characteristic; comparing the image characteristic to the physical characteristic; and sending a signal when the image characteristic deviates from the physical characteristic by a threshold.
Clause 2. The method of clause 1, wherein the physical characteristic comprises a physical dimension, and wherein the image characteristic depicts a movement of the marker during the emission of the x-ray energy.
Clause 3. The method of clause 2, wherein the physical dimension comprises a marker width and wherein the marker width is greater than a width of a pixel on the detector.
Clause 4. The method of any of clauses 1-3, wherein the marker is disposed on a surface of the foam compressive element that contacts the breast during the emission of the x-ray energy.
Clause 5. The method of any of clauses 1-4, wherein the marker is adhered to the breast.
Clause 6. The method of any of clauses 2-5, wherein the movement of the marker results from a movement of a portion of the breast during the emission of the x-ray energy.
Clause 7. The method of clause 6, wherein the portion of the breast is proximate the marker.
Clause 8. The method of any of clauses 1-7, further comprising: processing the image 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.
Clause 9. The method of any of clauses 1-8, wherein the physical characteristic comprises a radiopacity, and wherein the image characteristic corresponds to an attenuation of the x-ray energy passing through the marker during the emission of the x-ray energy.
Clause 10. The method of any of clauses 2-9, wherein the marker comprises a marker width and wherein the marker width is greater than a width of a pixel on the detector.
Clause 11. The method of any of clauses 1-10, wherein sending the signal comprises displaying a notification.
Clause 12. An apparatus comprising: an x-ray source; an x-ray detector; a breast support platform for supporting a 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 compressive element secured to the rigid substrate; and a marker disposed in contact with the foam compressive 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 comprising: emitting an x-ray energy from the x-ray source and though the breast and the marker; receiving the emitted x-ray energy; generating an image from the received x-ray energy, wherein the image depicts the breast and the marker; analyzing the image to identify a movement of the marker; and sending a signal when the movement exceeds a threshold.
Clause 13. The apparatus of clause 12, wherein analyzing the image comprises identifying the marker in the image.
Clause 14. The apparatus of clause 13, wherein the marker comprises a physical characteristic and wherein analyzing the image comprises comparing the physical characteristic of the marker to an imaged characteristic of the marker in the image.
Clause 15. The apparatus of clause 14, wherein the physical characteristic comprises a dimension of the marker.
Clause 16. The apparatus of any of clauses 14-15, wherein the physical characteristic comprises a radiopacity of the marker.
Clause 17. The apparatus of any of clauses 12-16, wherein the operations further comprise: processing the image 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.
Clause 18. The apparatus of any of clauses 12-17, wherein sending the signal comprises displaying a notification.
Clause 19. The apparatus of any of clauses 12-18, wherein the marker is disposed on a surface of the foam compressive element that is configured to contact the breast during the emission of the x-ray energy.
Clause 20. The apparatus of any of clauses 12-19, wherein the breast compression paddle comprises the marker.
Clause 21. The apparatus of any of clauses 12-20, wherein the marker is disposed on a sheet adhered to the breast.
Clause 22. The apparatus of any of clauses 12-21, wherein the marker comprises a plurality of markers arranged in at least one row.
Clause 23. The apparatus of clause 22, wherein the at least one row comprises a plurality of rows.
Clause 24. The apparatus of any of clauses 22-23, wherein the row is disposed substantially parallel to a chest wall of the patient.
Clause 25. The apparatus of any of clauses 22-24, wherein the row is disposed substantially orthogonal to a chest wall of the patient.
Clause 26. The apparatus of any of clauses 23-25, wherein a first row of the plurality of rows is disposed substantially orthogonal to a second row of the plurality of rows.
This disclosure described some examples of the present technology with reference to the accompanying drawings, in which only some of the possible examples were shown. Other aspects can, however, be embodied in many different forms and should not be construed as limited to the examples set forth herein. Rather, these examples were provided so that this disclosure was thorough and complete and fully conveyed the scope of the possible examples to those skilled in the art.
Although specific examples were described herein, the scope of the technology is not limited to those specific examples. One skilled in the art will recognize other examples or improvements that are within the scope of the present technology. Therefore, the specific structure, acts, or media are disclosed only as illustrative examples. Examples according to the technology may also combine elements or components of those that are disclosed in general but not expressly exemplified in combination, unless otherwise stated herein. The scope of the technology is defined by the following claims and any equivalents therein.
This application is being filed on Aug. 24, 2022, as a PCT International Patent Application that claims priority to and the benefit of U.S. Provisional Application No. 63/236,762, filed on Aug. 25, 2021, which application is hereby incorporated herein by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2022/075419 | 8/24/2022 | WO |
Number | Date | Country | |
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63236762 | Aug 2021 | US |