System and method for determining the performance of breast compression paddles

Abstract

A method for determining performance characteristics of breast compression paddles utilized in a breast imaging system includes receiving a force application signal associated with the application of a compression force by the breast imaging system to a patient's breast using breast compression paddles. The method applies the force application signal to an algorithm to obtain a reduction value. The reduction value is subtracted from a known paddle performance value for the breast compression paddle to obtain an updated paddle performance value for the breast compression paddle.

Description

Background Art

[0001] (Cross - reference to Related Applications) This application was filed as a PCT international patent application on August 26, 2021, claiming priority and benefit to U.S. Provisional Patent Application No. 63 / 078,360, filed on September 15, 2020, which is hereby incorporated by reference in its entirety.

[0002] (Background) Compression during mammography and tomosynthesis imaging serves several purposes. For example, it (1) thins the breast in the direction of the X - ray flux, thereby reducing the patient's radiation exposure from the levels required to image the thicker parts of the uncompressed breast, (2) makes the thickness of the breast more uniform in the direction of the X - ray flux, thereby promoting more uniform exposure in the image plane across the entire breast image, (3) immobilizes the breast during X - ray exposure, thereby reducing image blur, and (4) guides breast tissue from the chest wall into the imaging exposure field, thus enabling further tissue imaging. When the breast is compressed, typically, the technician positions it appropriately and manipulates the breast to counteract the tendency of the compression to push breast tissue out of the image field towards the chest wall. Rigid paddles or paddles with thick compression foam elements can be utilized in breast imaging procedures.

Summary of the Invention

Means for Solving the Problems

[0003] (Summary) In one aspect, the technology relates to a method for determining the performance characteristics of a breast compression paddle used in a mammography system, the method comprising: receiving a force application signal, the force application signal being associated with the application of compression force to the patient's breast by a mammography system using a breast compression paddle; applying the force application signal to an algorithm to obtain a reduction value; and subtracting the reduction value from a known paddle performance value for the breast compression paddle to obtain an updated paddle performance value for the breast compression paddle. In one embodiment, the method further includes transmitting a result signal corresponding to the updated paddle performance value. In another embodiment, the result signal is transmitted to a storage device located on the paddle. In yet another embodiment, the result signal is transmitted to a remote storage device from both the mammography system and the breast compression paddle. In yet another embodiment, the algorithm includes a datum performance value corresponding to a known force.

[0004] In another embodiment of the above aspect, the algorithm further includes dividing the datum performance value by the applied performance value associated with the force application signal to obtain a reduction value. In one embodiment, the updated paddle performance value includes the known paddle performance value for a second application of the force application signal to the algorithm, following a first application of the force application signal to the algorithm and a first subtraction of the reduction value from the known paddle performance value.

[0005] In another aspect, the technology relates to a system for determining the performance characteristics of a breast compression paddle used in a breast imaging system, the system comprising: a breast support platform for supporting a breast; a tube head rotatable relative to the breast support platform; an X-ray source disposed within the tube head; an X-ray detector disposed within the breast support platform; a compression paddle disposed between the X-ray source and the X-ray detector and configured to compress the breast relative to the breast support platform; a controller for controlling the X-ray source; at least one processor communicably coupled to the controller; and a memory communicably coupled to the at least one processor, the memory comprising a computer executable instruction, the computer executable instruction, when executed by the processor, receiving a force application signal, the force application signal being associated with the application of a compressive force to the breast between the breast support platform and the compression paddle, and the method comprising calculating a performance effect on the compression paddle, at least partially based on the force application signal. In one embodiment, the compression paddle includes a data storage device. In another embodiment, the data storage device includes an RFID chip. In yet another embodiment, the data storage device is communicably coupled to at least one processor. In yet another embodiment, the system further includes transmitting a performance effect signal to a data storage device for the compression paddle, the performance effect signal including a calculation of the remaining number of paddle compressions for the compression paddle.

[0006] In another embodiment of the above aspect, the system further includes transmitting an inspection recommendation signal. In one embodiment, at least one processor and memory are located remotely from the controller. In another embodiment, at least one processor and memory are integrated with the controller.

[0007] In another aspect, the technology relates to a method for determining the performance characteristics of a breast compression paddle used in a breast imaging system, the method comprising: reading a known paddle performance value from a data storage unit located on the breast compression paddle; applying force to the breast using the breast compression paddle while it is supported on a breast support platform; recording the force applied to the breast using the breast compression paddle; applying the applied force to an algorithm to obtain a reduction value; calculating an updated paddle performance value for the breast compression paddle, the updated paddle performance value being at least partially based on the known paddle performance value and the reduction value; and writing the updated paddle performance value to a data storage unit located on the breast compression paddle. In one embodiment, the known paddle performance value is at least partially based on the compression paddle material. In another embodiment, applying the applied force to an algorithm includes dividing the datum performance value at the known force by the applied performance value associated with the applied force. In yet another embodiment, calculating the updated paddle performance value includes subtracting a reduction value from the known paddle performance value. In yet another embodiment, writing updated paddle performance values ​​to a data storage unit includes sending a signal to the data storage unit. This specification also provides, for example, the following: (Item 1) A method for determining the performance characteristics of breast compression paddles used in a breast imaging system, wherein the method is: The system receives a force application signal, which is associated with the application of a compressive force to the patient's breast by the breast imaging system using the breast compression paddles. The force application signal is applied to the algorithm to obtain a reduction value, The reduction value is subtracted from the known paddle performance value for the breast compression paddle to obtain an updated paddle performance value for the breast compression paddle. Methods that include... (Item 2) The method according to item 1, further comprising transmitting a result signal corresponding to the updated paddle performance value. (Item 3) The method according to item 2, wherein the result signal is transmitted to a storage device located on the paddle. (Item 4) The method according to item 2, wherein the result signal is transmitted from both the breast imaging system and the breast compression paddles to a remote storage device. (Item 5) The algorithm is the method described in item 1, which includes a datum performance value corresponding to a known force. (Item 6) The method of item 5, further comprising the algorithm dividing the datum performance value by the applied performance value associated with the force application signal to obtain the reduction value. (Item 7) The method of item 6, wherein the updated paddle performance value comprises a known paddle performance value for a second application of the force application signal to the algorithm, following a first application of the force application signal to the algorithm and a first subtraction of the reduction value from the known paddle performance value. (Item 8) A system for determining the performance characteristics of breast compression paddles used in a breast imaging system, wherein the system is A breast support platform for supporting the breasts, A tube head that is rotatable relative to the breast support platform, An X-ray source placed inside the tube head, An X-ray detector is placed within the breast support platform, A compression paddle is positioned between the X-ray source and the X-ray detector and configured to compress the breast against the breast support platform, A controller for controlling the aforementioned X-ray source, At least one processor communicatively coupled to the controller, A memory that is communicably coupled to at least one of the processors and The memory includes computer executable instructions, and when these computer executable instructions are executed by the processor, Receiving a force application signal, wherein the force application signal is associated with the application of a compressive force to the breast between the breast support platform and the compression paddle, To calculate the performance effect on the compression paddle based at least partially on the force application signal. A system that implements methods including those mentioned above. (Item 9) The compression paddle is a system according to item 8, comprising a data storage device. (Item 10) The data storage device is the system described in item 9, comprising an RFID chip. (Item 11) The system according to item 9, wherein the data storage device is communicably coupled to the at least one processor. (Item 12) The method further comprises transmitting a performance effect signal to the data storage device of the compression paddle, wherein the performance effect signal comprises a calculation of the remaining number of paddle compressions with respect to the compression paddle, according to the system in item 9. (Item 13) The method described above further includes transmitting an inspection recommendation signal, as described in item 12. (Item 14) The system according to item 8, wherein the at least one processor and the memory are located remotely from the controller. (Item 15) The system according to item 8, wherein the at least one processor and the memory are integrated with the controller. (Item 16) A method for determining the performance characteristics of breast compression paddles used in a breast imaging system, wherein the method is: Reading known paddle performance values ​​from a data storage unit placed on the breast compression paddle, Applying force to the breast while it is supported on the breast support platform using the breast compression paddle, Record the force applied to the breast using the breast compression paddle, The applied force is then applied to the algorithm to obtain a reduction value, The calculation of updated paddle performance values ​​for the breast compression paddle, wherein the updated paddle performance values ​​are at least partially based on the known paddle performance values ​​and the reduction values. The updated paddle performance values ​​are written to the data storage unit located on the breast compression paddle. Methods that include... (Item 17) The known paddle performance values ​​are based at least in part on the compression paddle material, according to the method described in item 16. (Item 18) The method of item 16, wherein applying the applied force to the algorithm includes dividing the datum performance value at a known force by the applied performance value associated with the applied force. (Item 19) The method of item 16, wherein calculating the updated paddle performance value includes subtracting the reduction value from the known paddle performance value. (Item 20) The method of item 16, wherein writing the updated paddle performance values ​​to the data storage unit includes transmitting a signal to the data storage unit. [Brief explanation of the drawing]

[0008] [Figure 1A] Figure 1A is a schematic diagram of an exemplary imaging system.

[0009] [Figure 1B] Figure 1B is a perspective view of the imaging system shown in Figure 1A.

[0010] [Figure 2A] Figures 2A–2C depict an embodiment with a flat breast compression paddle. [Figure 2B] Figures 2A–2C depict an embodiment with a flat breast compression paddle. [Figure 2C] Figures 2A–2C depict an embodiment with a flat breast compression paddle.

[0011] [Figure 3A] Figures 3A–3C depict an embodiment with contoured breast compression paddles. [Figure 3B] Figures 3A–3C depict an embodiment with contoured breast compression paddles. [Figure 3C] Figures 3A–3C depict an embodiment with contoured breast compression paddles.

[0012] [Figure 4] Figure 4 illustrates an embodiment of a breast stabilizing paddle that includes a foam compression element.

[0013] [Figure 5] Figure 5 illustrates an example of the performance curve of a compression paddle.

[0014] [Figure 6A] Figure 6A illustrates the method for determining the performance characteristics of the breast compression paddle.

[0015] [Figure 6B] Figure 6B illustrates how the performance characteristics of the breast compression paddles are tracked.

[0016] [Figure 7] Figure 7 illustrates an embodiment in which one or more of these embodiments may be implemented in a preferred operating environment.

[0017] [Figure 8] Figure 8 illustrates an embodiment of a network in which the various systems and methods disclosed herein may operate. [Modes for carrying out the invention]

[0018] (Detailed explanation) As further explained below, different types of paddles are used by mammography systems. Some paddles have different shapes to accommodate different breast sizes, are made from different materials, and / or are used for different types of procedures. In addition, different technicians apply different amounts of pressure based on their skill and experience or the size or density of the patient's breast. Lifecycle testing typically assumes that a particular paddle will be used a certain number of times to determine its potential time to failure. Such a simple approach is not useful with respect to mammography paddles because different compression forces may be applied during different procedures. A more robust approach that incorporates the variable compression forces used in imaging systems is needed.

[0019] Figure 1A is a schematic diagram of an exemplary imaging system 100, and Figure 1B is a perspective view of the imaging system 100, in which compression paddles are used with the imaging system 100. Figures 1A and 1B are referred to in parallel, but not all elements described below are depicted in both figures. The imaging system 100 immobilizes the patient's breast 102 during X-ray imaging (mammography, tomosynthesis, or both, or other imaging modalities) via a breast compression immobilizer unit 104, which includes a stationary breast support platform 106 and a movable paddle 108. Different paddles, each with a different purpose, are known in the art. Some exemplary paddles are also described herein for context. The breast support platform 106 and paddle 108 each have compression surfaces 110 and 112, respectively, which move toward each other during the imaging procedure to compress, immobilize, stabilize, or otherwise hold and fix the breast 102. In known systems, the compression surfaces 110 and 112 are exposed to direct contact with the breast 102. Either or both of these compression surfaces 110 and 112 may be made of rigid plastic, flexible plastic, elastic foam, mesh, or screen, etc. The platform 106 also houses the image receiver 116, and optionally a tilting mechanism 118, and optionally an anti-scatter grid (not depicted, but located above the image receiver 116). The immobilizer unit 104 is in the path of the imaging beam 120 emitted from the X-ray source 122 so that the beam 120 collides with the image receiver 116.

[0020] The immobilizer unit 104 is supported on a first support arm 124 via a compression arm 134, which is configured to be raised or lowered along the support arm 124. The X-ray source 122 is supported on a second support arm, also referred to as a tube head 126. With regard to mammography, the support arms 124 and 126 can rotate together around axis 128 between different imaging orientations such as CC and MLO, so that the system 100 can acquire mammogram projection images in each orientation. During operation, the image receiver 116 remains in a fixed position relative to the platform 106 while an image is being acquired. The immobilizer unit 104 releases the breast 102 to allow the arms 124 and 126 to move to different imaging orientations. With respect to tomosynthesis, the support arm 124 remains in place, and the breast 102 is immobilized and remains in place, while at least the second support arm 126 rotates the X-ray source 122 around axis 128 relative to the immobilizer unit 104 and the compressed breast 102. The system 100 takes multiple tomosynthesis projection images of the breast 102 at each angle of the beam 120 relative to the breast 102.

[0021] In parallel, and optionally, the image receiver 116 may be tilted relative to the breast support platform 106 in synchronization with the rotation of the second support arm 126. The tilting may be performed through the same angle as the rotation of the X-ray source 122, but may be performed through a different angle of selection so that the beam 120 remains substantially in the same position on the image receiver 116 with respect to each of the multiple images. The tilting may be performed around axis 130, which may, but is not required, be performed within the image plane of the image receiver 116. A tilting mechanism 118 coupled to the image receiver 116 can drive the image receiver 116 in the tilting motion. With respect to tomosynthesis imaging and / or CT imaging, the breast support platform 106 may be horizontal, or at an angle to the horizontal, for example, in an orientation similar to that for conventional MLO imaging in mammography. System 100 can be a “combo” system capable of performing mammography alone, a CT system, a tomosynthesis system alone, other modalities such as ultrasound, or multiple forms of imaging. One embodiment of the system is provided by the assignee of this application under the trademark name Selenia Dimensions.

[0022] When the system is activated, the receiver 116 generates imaging information in response to illumination by the imaging beam 120 and supplies it to the image processor 132 for processing and generating mammography images. A system control and workstation unit 138, including software, controls the operation of the system and interacts with the operator, thereby receiving commands and delivering information including processed ray images.

[0023] The imaging system 100 includes a floor mount or base 140 for supporting the imaging system 100 on the floor. A gantry 142 extends upward from the floor mount 140 and rotatably supports both a tube head 208 and a support arm 210. The tube head 126 and support arm 124 are configured to rotate independently of each other and may be raised or lowered along the surface 144 of the gantry 142 to accommodate patients of different heights. The X-ray source 122 is located within the tube head 208. The tube head 126 and support arm 124 together may be referred to as a C-arm 144.

[0024] Several interfaces and display screens are arranged on the imaging system 100. These include a foot display screen 146, a gantry interface 148, a support arm interface 150, and a compression arm interface 152. Generally, the various interfaces 148, 150, and 152 may include one or more tactile buttons, knobs, and switches, and one or more display screens, including capacitive touch screens with a graphical user interface (GUI) to enable user interaction and control with the imaging system 100. Generally, the foot display screen 146 is primarily a display screen, but a capacitive touch screen may be used if required or desired.

[0025] Referring here to Figures 2A-2C, an embodiment of the compression paddle 240 is shown which includes a generally rounded corner with respect to the front wall at the bottom of the compression paddle and a generally rounded corner with respect to the front wall at the side wall. The compression paddle 240 includes features to promote further softness and greater conformity to breast tissue. The side wall 242 has a height lower than the height of the front wall 244 and / or the back wall 246 in the portion between the front wall 244 and the back wall 246, for example, about 20% to about 80%, preferably about 25% to about 50% lower. Having a side wall with a lower portion promotes the connection of the compression paddle 240 at the front wall 244. The compression paddle 240 may optionally include a slot formed near the back corner to promote further curvature of the compression paddle 240 as well as the entire compression paddle 240, not just at the bottom of the compression paddle. Additional optional modifications to increase the flexibility of the compression paddle 240 include varying the thickness of the paddle (for example, having a portion of the bottom of the compression paddle thicker than other portions, such as a middle portion that is thicker than a portion closer to the side wall) and manufacturing the compression paddle 240 from a material that is softer than known compression paddles (for example, preferably made from a material that is about 40% softer). The compression paddle 240 can be used to compress a patient's breast with or without an inflatable jacket and / or gel pad known in the art. The paddle 240 also includes a data storage element 252 such as an RFID chip.

[0026] Figures 3A–3C depict an embodiment of a contoured compression paddle 360. The bottom wall of the compression paddle 360 ​​includes a generally concave surface 362, which can generally correspond in shape to the breast and / or compressed breast. The generally concave surface 362 can generally extend between the side walls 364 of the compression paddle 362. Alternatively, a portion of the bottom surface includes a generally concave surface 362 that helps to conform to the outline of the breast tissue. The generally concave surface 362 helps to distribute the force applied to the breast more evenly and more closely to the shape of the breast. Such a configuration may help to provide the patient with greater comfort when the breast is compressed. The generally concave surface 362 includes a central portion 368 and two outer edge portions 366 that define a reference plane P. The central portion 368 is non-coplanar with the outer edge portions 366 such that the central portion 368 is elevated relative to or positioned above the reference plane P. The central portion 368 may be horizontal (for example, parallel to the reference plane P or axis A of the paddle 360) or it may be pitched downward from the front wall 370 to the back wall 372 of the paddle 360. This may further help to conform the paddle 360 ​​to the shape of the breast. The paddle 360 ​​also includes a data storage element 374, such as an RFID chip.

[0027] Figure 4 illustrates a breast compression paddle 400 having a foam compression element 402 fixed to a rigid substrate 404. Compression paddles utilizing a foam compression element stabilize the breast but do not produce the significant compression effect typical of rigid compression paddles such as those described above. However, some compression does occur. This compression is limited, however, and is typically sufficient to stabilize the breast for imaging procedures, while also reducing patient discomfort (compared to standard rigid breast compression paddles). Thus, breast compression paddles incorporating a foam compression element can be described as performing the function of stabilizing or immobilizing the breast with a minimal amount of compression. In the context of this application, for clarity, the term “compression” is used to describe its function regardless of the structure of the various types of paddles used for mammography. The paddle 400 includes a bracket portion 406, which is generally integrated with the substrate 404, for connecting the paddle to the compression arm of the imaging system. The paddle 400 also includes an anterior edge surface 408 opposite the bracket portion 406, which is positioned near the patient's chest wall during compression and imaging procedures. In embodiments, the substrate may be rigid. As used herein, the term “rigid” does not imply that the substrate 404 does not flex during breast compression, but rather that the substrate 404 exhibits greater resistance to flexing or deformation than the foam compression element 402 fixed to the bottom of the substrate 404. The raised wall 404a provides additional rigidity.

[0028] The foam compression element 402 may be fixed to the bottom surface of the substrate 404 using a chemical adhesive. In other embodiments, the upper surface of the compression element may be rigid plastic or other material to which the foam compression element 402 is fixed. Multiple bolts, hooks, or other mechanical fasteners (not shown) may be used to connect this rigid plastic to the rigid substrate 404 of the paddle 400. The foam compression element 402 includes several edge surfaces, only a portion of which are depicted in Figure 4. The anterior edge surface 410 is positioned near the anterior edge surface 408 of the substrate 404 so as to be positioned near the patient's chest wall during compression and imaging procedures. Lateral edge surfaces 412 are also depicted. The compression surface 414 contacts and stabilizes the breast during imaging procedures. The paddle 400 also includes a data storage element 416, such as an RFID chip.

[0029] In addition to the compression and stabilizing paddles described above, other types of paddles are also known in the art. Other types of paddles used in mammography systems may include, for example, paddles that include windows or other openings for housing breast biopsy equipment. Further other paddles are hollow, which allows for different compression performance and image visualization. Other paddles include soft components such as plastic coverings that both allow for varying breast compression and allow for disposable coverings to avoid cross-contamination. In other embodiments, the breast compression device may be in the form of a mesh or soft screen straddling multiple rigid components, and embodiments thereof may be used for both X-ray and ultrasound mammography. Regardless of the configuration, the materials used in mammography paddles may degrade over time. This degradation may result from repeated use or application of force, which can lead to bending of rigid materials, permanent compression, stretching, twisting, etc., of foam or other soft materials. Over time, the breast compression paddle or other device may be subjected to stress until it no longer performs as it was originally designed. For example, over time, foam compression elements may not return to their original uncompressed configuration, effectively resulting in a denser foam, which can lead to a different appearance or more uncomfortable compression. Rigid paddles may lose their rigidity, or microcracks may form, which can lead to undesirable performance. Cracks or other stress fractures, which may be visible as artifacts in the image, may appear within the foam or paddle. Other degradations may also occur in different types of paddles or devices. Life cycle testing typically assumes an attempt to determine the potential time to failure by counting the number of uses of a particular component. However, such a simple approach is not useful with respect to breast compression paddles or other devices used to stabilize the breast, as different compression forces may be applied during different procedures.

[0030] Tracking paddle performance is further complicated by the fact that an imaging system may contain multiple different paddles to be used for, for example, large breasts, small breasts, breasts with implants, foam compression paddles, biopsy paddles, etc. A mammography system may have many of one type of breast compression paddle that are used regularly, but may also have a limited number of very specialized paddles that can be shared among multiple imaging systems within the system as needed. Further complexity arises because hundreds or thousands of patients may be imaged using a particular paddle during its lifespan, and the breast tissue density of such patients can vary significantly. In this case, patients with particularly dense breast tissue may require higher compression force for proper imaging compared to patients with less dense breast tissue. Further complexity exists because different technicians may compress to different pressures depending on their experience level, practice requirements, or other factors. Based on the above description, the complexity of tracking breast compression paddle performance becomes clear.

[0031] Thus, the techniques described herein track the usage of paddles as a function of the applied compressive force. Individual types of paddles may be tested, for example, in a performance laboratory, and the lifecycle of each type of paddle may be recorded with respect to the application of known compressive forces. In other applications, performance at a given compressive force may be modeled based on factors such as paddle dimensions (single or multiple), material type, material density or thickness, and the applied pressure or force. As used herein, the term “lifecycle” does not necessarily mean the lifecycle up to the point of physical failure, but rather refers to the period of use after which the paddle will no longer perform as desired. While cracks or other dramatic failures may constitute one measure of the lifecycle, other measures include permanent compression of the compression foam, stretching of elastic elements, bending of the soft mesh, plastic deformation, elastic deformation exceeding an acceptable threshold, etc. Therefore, by conducting a more detailed analysis of paddle usage and predicting unacceptable performance degradation, paddles may be inspected, maintained, or replaced prior to significant performance degradation or at opportunities based on manufacturer or clinic requirements. The techniques described herein may be used to determine the lifecycle of a paddle under such complex usage conditions by calculating the effect on the paddle's performance (lifecycle) after each use. After calculating the performance effect, signals associated with the effect may be stored or transmitted, as described elsewhere in this specification.

[0032] The performance tracking techniques described herein may be implemented in conjunction with advanced artificial intelligence (AI) or machine learning (ML) techniques. For example, performance data for multiple paddles of the same type may be stored in a central repository along with their manufacturing numbers. For example, paddles with related manufacturing numbers indicating they were manufactured from the same material batch may be associated together. Unexpected (e.g., early) performance degradation in multiple paddles that may indicate a inferior material batch may allow the AI ​​or ML technique to update the performance curve for the relevant paddles attributable to the batch material. Thus, the performance curves of the remaining operational paddles may be adjusted to reflect the unexpected performance conditions of a certain type of paddle.

[0033] Figure 5 illustrates an example of a performance curve for a compression paddle. The curve plots the performance of a virtual paddle at three consistently applied compression forces. For example, Figure 5 shows that when the virtual paddle is consistently subjected to a compression force of approximately 25 lb (e.g., in each compression), the paddle exhibits a lifetime performance of approximately 500,000 cycles. For the same type of paddle, applying a compression force of approximately 35 lb results in a lifetime performance of approximately 90,000 cycles. For the same type of paddle, applying a consistent compression force of approximately 50 lb results in a lifetime performance of approximately 8,000 cycles. Thus, the performance curve reveals that increasing compression force applied to the paddle accelerates the decrease in its lifetime performance. Such performance curves can be plotted for any type of paddle based on controlled environment testing, estimations based on material or structural criteria, estimations based on similar known paddles, computer modeling, etc.

[0034] Returning to the hypothetical paddle performance depicted in Figure 5, when subjected to a consistent compressive force of 25 lb, the paddle has a lifespan of approximately 500,000 cycles. Therefore, a single 25 lb compress on a new paddle reduces its lifespan to 499,999 cycles, based on the following equation.

number

[0035] Therefore, for a compression force of 25 lb applied to a new paddle having a performance curve as depicted in Figure 5, Equation 1 becomes as follows:

number

[0036] Compare the above equation (at 25 lb) with the following equation, which represents another new paddle to which a force of 50 lb is applied, and is consistent with the one depicted in Figure 5. In that case, with respect to the applied compressive force of 50 lb, equation 1 becomes:

number

[0037] Figure 6A illustrates a method 600 for determining the performance characteristics of a breast compression paddle, an embodiment thereof described herein. Such a paddle may be used, for example, in a mammography system, also described herein. Method 600 begins with operation 602, i.e., receiving a force application signal. The force application signal is associated with the application of a compression force to the patient's breast by a mammography system using a breast compression paddle. This force may be measured by a suitable sensor on the imaging system, which is known in the art, and may be transmitted to a remote or local processor for the required calculation. In some embodiments, the force application signal may be the applied force. Method 600 continues with operation 604, i.e., applying the force application signal to an algorithm. In embodiments, this algorithm may be equation 1, described above in the context of Figure 5. In response to the application of the force application signal, a reduction value is obtained. In embodiments, the algorithm may include a datum performance value corresponding to the paddle performance at known or datum compression forces. This datum force may be a compressive force consistently applied to a similar type of paddle, which may be performed to test the lifetime of such a paddle. In this regard, the datum performance value may be the lifetime of the paddle when the datum force is consistently applied. In specific embodiments, the datum performance value may be divided by the applied performance value associated with the force application signal, as described in operation 606.

[0038] Once a reduction value is obtained, operation 608 is performed, i.e., subtracting the reduction value from a known paddle performance value for the breast compression paddle. In response to performing this subtraction, an updated paddle performance value for the breast compression paddle in question is obtained. The known paddle performance value may be the known remaining life of the paddle in question being used. The remaining life of the paddle may be constantly updated after each force application. In this case, after the first application of the force application signal to the algorithm (e.g., operations 604 and / or 606), and the first subtraction of the reduction value from the known paddle performance value (e.g., operation 608), the updated paddle performance value is the known paddle performance value for subsequent force applications and the performance of method 600 using the paddle.

[0039] Method 600 may conclude with operation 610, namely, transmitting a result signal corresponding to the updated paddle performance value. In an embodiment, the result signal may be transmitted to a storage device located on the paddle, for example, an RFID chip as depicted in the above figure. In another embodiment, the information may be stored in the mammography system along with identification information from the paddle (e.g., serial number) which can be read from the RFID chip prior to each use. In another embodiment, the result signal may be transmitted from both the mammography system and the breast compression paddle to a remote storage device, for example, a hospital or clinic network. The associated information (e.g., paddle serial number) may also be stored for future access. In another embodiment, the signal may be transmitted to a display on the mammography system indicating, for example, that a particular compression paddle has reached the end of its lifecycle and should be repaired or replaced. This signal may also be transmitted to a central computer system, which may in turn transmit the signal to the paddle manufacturer to initiate ordering for new paddles, inspection of existing paddles, etc. In another embodiment, the signal may be used for predictive maintenance, which may include scheduling inspections before a predetermined date. For example, with regard to the determination of the remaining number of uses a paddle has, that number of uses may correspond to a specific period (e.g., one or two weeks) based on the historical usage data of the imaging system and the expected applied compression force (one or more). This allows scheduling an inspection appointment on a specific date before that period to avoid failure.

[0040] Figure 6B illustrates a method 650 for tracking the performance characteristics of a breast compression paddle. Method 650 begins with operation 652, which involves reading a known paddle performance value from a data storage unit located on the breast compression paddle. In some embodiments, the known paddle performance value may be the remaining lifespan of a particular compression paddle. As described elsewhere in this specification, this known paddle performance value may be based at least in part on the material used to construct the compression paddle (or part thereof), the paddle dimensions, etc. For example, with respect to a paddle such as the one depicted in Figure 2C, which depicts a foam compression element fixed to a rigid substrate, the known paddle performance value may be based on the foam material, which is more likely to degrade over time than the rigid substrate. Similar to known imaging procedures, operation 654 may be performed, i.e., applying a compression force to the breast using the breast compression paddle, while the breast is supported on a breast support platform. This applied compression force is recorded in operation 656. The compression force applied by the compression paddle is then applied to an algorithm to obtain a reduction value. In embodiments, this algorithm may be the equation described above in the context of Figure 5. In embodiments, the algorithm may include a known or datum performance value corresponding to a datum compressive force. This datum compressive force may be a compressive force consistently applied to a paddle, which may be performed to test the lifetime of a similar type of paddle. In this regard, the datum performance value may be the lifetime of the paddle when the datum compressive force is consistently applied. In specific embodiments, the datum performance value may be divided by the applied performance value associated with the force application signal, as described in operation 660.

[0041] Subsequently, operation 662 is performed, namely, calculating an updated paddle performance value for the breast compression paddle. The updated paddle performance value may be based, at least in part, on a known paddle performance value and a reduction value. In an optional operation 664, this calculation may include subtracting a reduction value from a known paddle performance value. In operation 666, the updated paddle performance value is written to a data storage unit (e.g., an RFID chip) located on the breast compression paddle. In an optional operation 668, writing the updated paddle performance value to the data storage unit includes transmitting a signal to the data storage unit.

[0042] Figure 7 illustrates one embodiment of a preferred operating environment 700 in which one or more of these embodiments may be implemented. This operating environment may be directly incorporated into the visualization system disclosed herein, or it may be incorporated into a computer system used to control the mammography system described herein, separate from the mammography system described herein. Such a computer system may be, for example, the workstation depicted in Figure 1A. This is merely one embodiment of a preferred operating environment and is not intended to imply any limitations on 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, e.g., smartphones, network PCs, minicomputers, mainframe computers, tablets, distributed computing environments including any of the above systems or devices, and equivalents.

[0043] In its most basic configuration, the operating environment 700 typically includes at least one processing unit 702 and memory 704. Depending on the exact configuration and type of computing device, the memory 704 (which, in particular, stores instructions for reading from or performing other methods disclosed herein from a data storage device or sensor) can be volatile (e.g., RAM), non-volatile (e.g., ROM, flash memory), or a combination of both. This most basic configuration is illustrated in Figure 7 by a dashed line 706. Furthermore, the environment 700 may also include, but is not limited to, storage devices (removable 708 and / or non-removable 710), including magnetic or optical disks or tapes. Similarly, the environment 700 may also have one or more input devices 714, such as a touch screen, keyboard, mouse, pen, or voice input, and / or one or more output devices 716, such as a display, speaker, or printer. One or more communication connections, such as LAN, WAN, point-to-point, Bluetooth®, RF, etc., may also be included in the environment.

[0044] The operating environment 700 typically includes at least some form of computer-readable medium. The computer-readable medium can be any available medium that can be accessed by the processing unit 702 or other devices having the operating environment. In embodiments, but not limited to, the computer-readable medium may include computer storage mediums and communication mediums. Computer storage mediums include volatile and non-volatile removable and non-removable media implemented in any method or technique for storing information such as computer-readable instructions, data structures, program modules, or other data. Computer storage mediums include RAM, ROM, EEPROM, flash memory or other memory technologies, CD-ROMs, digital versatile disks (DVDs) or other optical storage devices, magnetic cassettes, magnetic tapes, magnetic disk storage devices or other magnetic storage devices, solid-state storage devices, or any other tangible media that can be used to store desired information. Communication mediums include any information delivery medium that embodies computer-readable instructions, data structures, program modules, or other data in modulated data signals such as carrier waves or other transport mechanisms. The term “modulated data signal” means a signal having one or more of its properties set or modified in such a manner with respect to encoding information within the signal. Examples, but not limited to, include wired media such as wired networks or direct wired connections, and wireless media such as acoustic, RF, infrared, and other wireless media. Any combination of the above should also be included within the scope of computer-readable media. A computer-readable device is a hardware device incorporating a computer storage medium.

[0045] Operating environment 700 can be a single computer operating within a networked environment using logical connections to one or more remote computers. Remote computers can be personal computers, servers, routers, network PCs, peer devices, or other common network nodes, typically including many or all of the elements described above, and others not mentioned. Logical connections can include any method supported by available communication media. Such networked environments are common in offices, enterprise-wide computer networks, intranets, and the internet.

[0046] In some embodiments, the components described herein include such modules or instructions executable by a computer system 700, which can be stored on computer storage media and other tangible media and transmitted within communication media. Computer storage media include volatile and non-volatile removable and non-removable media implemented in any method or technique for storing information such as computer-readable instructions, data structures, program modules, or other data. Any combination of the above should also be included within the scope of readable media. In some embodiments, the computer system 700 is part of a network that stores data in remote storage media for use by the computer system 700.

[0047] Figure 8 shows one embodiment of network 800 on which various systems and methods disclosed herein can operate. In the embodiment, a client device, such as client device 802, may communicate with one or more servers, such as servers 804 and 806, via network 800. In the embodiment, the client device may be a standalone imaging system (e.g., imaging system 100 depicted in Figure 1A) that includes all the functionality described herein. The client device may include or incorporate a laptop, personal computer, smartphone, PDA, netbook, or any other type of computing device, such as the computing device in Figure 7. In the embodiment, such a client device may be connected to the imaging system. In the embodiment, servers 804 and 806 may be any type of computing device, such as the computing device illustrated in Figure 7. Network 800 may be any type of network capable of facilitating communication between the client device and one or more servers 804 and 806. For example, surface image data and internal image data may be acquired locally via the imaging system and communicated to another computing device(s), such as an image acquisition workstation or a cloud-based service, for further processing. Examples of such networks include, but are not limited to, LANs, WANs, cellular networks, and / or the Internet.

[0048] In embodiments, various systems and methods disclosed herein may be implemented by one or more server devices. For example, in one embodiment, a single server, such as server 804, may be employed to implement the systems and methods disclosed herein, such as the imaging method discussed herein. A client device 802 may interact with server 804 via network 800. In further embodiments, client device 802 may perform functionalities disclosed herein, such as scanning and image processing, which can then be provided to servers 804 and / or 806.

[0049] This disclosure describes several embodiments of the Art with reference to the accompanying drawings, which show only some of the possible embodiments. However, other aspects can also be embodied in many different forms and should not be construed as being limited to the embodiments described herein. Rather, these embodiments are provided so that this disclosure may be thorough and complete, and so as to convey to those skilled in the art the scope of the possible embodiments.

[0050] Although specific examples have been described herein, the scope of the Art is not limited to those specific examples. Those skilled in the art will recognize other examples or improvements that fall within the scope of the Art. Accordingly, specific structures, functions, or media are disclosed merely as illustrative examples. Unless otherwise stated herein, examples of the Art may be combinations of elements or components of those disclosed generally but not expressly illustrated in combination. The scope of the Art is defined by the following claims and any equivalents within that scope.

[0051] The following are the claims.

Claims

1. A method for determining the performance characteristics of breast compression paddles used in a breast imaging system, wherein the method is: The system receives a force application signal, which is associated with the application of a compressive force to the patient's breast by the breast imaging system using the breast compression paddles. The force application signal is applied to the algorithm to obtain a reduction value, The reduction value is subtracted from the known paddle performance value for the breast compression paddle to obtain an updated paddle performance value for the breast compression paddle. Methods that include...

2. The method according to claim 1, further comprising transmitting a result signal corresponding to the updated paddle performance value.

3. The method according to claim 2, wherein the result signal is transmitted to a storage device disposed on the paddle.

4. The method according to claim 2, wherein the result signal is transmitted from both the breast imaging system and the breast compression paddle to a remote storage device.

5. The method according to claim 1, wherein the algorithm includes datum performance values ​​corresponding to known forces.

6. The method according to claim 5, further comprising: the algorithm dividing the datum performance value by an applied performance value associated with the force application signal to obtain the reduction value.

7. The method according to claim 6, wherein the updated paddle performance value comprises a known paddle performance value for a second application of the force application signal to the algorithm, following a first application of the force application signal to the algorithm and a first subtraction of the reduction value from the known paddle performance value.

8. A system for determining the performance characteristics of breast compression paddles used in a breast imaging system, wherein the system is A breast support platform for supporting the breasts, A tube head that is rotatable relative to the breast support platform, An X-ray source placed inside the tube head, An X-ray detector is placed within the breast support platform, A compression paddle is positioned between the X-ray source and the X-ray detector and configured to compress the breast against the breast support platform, A controller for controlling the aforementioned X-ray source, At least one processor communicatively coupled to the controller, A memory that is communicably coupled to at least one of the processors and The memory includes computer executable instructions, and when these computer executable instructions are executed by the processor, Receiving a force application signal, wherein the force application signal is associated with the application of a compressive force to the breast between the breast support platform and the compression paddle, To calculate the performance effect on the compression paddle based at least partially on the force application signal. A system that implements methods including those mentioned above.

9. The system according to claim 8, wherein the compression paddle comprises a data storage device.

10. The system according to claim 9, wherein the data storage device comprises an RFID chip.

11. The system according to claim 9, wherein the data storage device is communicably coupled to the at least one processor.

12. The method further comprises transmitting a performance effect signal to the data storage device of the compression paddle, wherein the performance effect signal comprises calculating the number of remaining paddle compressions with respect to the compression paddle, according to claim 9.

13. The system according to claim 12, further comprising transmitting an inspection recommendation signal.

14. The system according to claim 8, wherein the at least one processor and the memory are located remotely from the controller.

15. The system according to claim 8, wherein the at least one processor and the memory are integrated with the controller.

16. A method for determining the performance characteristics of breast compression paddles used in a breast imaging system, wherein the method is: Reading known paddle performance values ​​from a data storage unit placed on the breast compression paddle, Using the aforementioned breast compression paddles, force is applied to the patient's breast while it is supported on the breast support platform. Record the force applied to the breast using the breast compression paddle, The applied force is then applied to the algorithm to obtain a reduction value, The calculation of updated paddle performance values ​​for the breast compression paddle, wherein the updated paddle performance values ​​are at least partially based on the known paddle performance values ​​and the reduction values. The updated paddle performance values ​​are written to the data storage unit located on the breast compression paddle. Methods that include...

17. The method according to claim 16, wherein the known paddle performance values ​​are at least partially based on a compression paddle material.

18. The method according to claim 16, wherein applying the applied force to the algorithm includes dividing the datum performance value at a known force by the applied performance value associated with the applied force.

19. The method according to claim 16, wherein calculating the updated paddle performance value includes subtracting the reduction value from the known paddle performance value.

20. The method according to claim 16, wherein writing the updated paddle performance values ​​to the data storage unit includes transmitting a signal to the data storage unit.

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