System and method for identifying biopsy location coordinates

Abstract

The invention is entitled System and method for identifying biopsy location coordinates. The invention provides a method for determining a location of a lesion along an X-axis, a Y-axis, and a Z-axis in a patient for a biopsy. The method includes positioning the patient in an examination device to collect an examination image showing the lesion. The method includes positioning the patient in a biopsy device configured for holding the patient during the biopsy and collecting a biopsy image of the patient using the biopsy device. The method includes analyzing the biopsy image to determine a measured x-coordinate and a measured y-coordinate of the lesion along the X-axis and the Y-axis, respectively, analyzing the examination image to determine a calculated z-coordinate along the Z-axis of the lesion, and determining the location of the lesion based on the measured x-coordinate and the measured y-coordinate from the biopsy image and the calculated z-coordinate determined from one or more examination images.

Description

TECHNICAL FIELD

[0001] The present disclosure relates generally to systems and methods for identifying location coordinates for performing a biopsy, and more particularly to systems and methods for providing 3D coordinates of a lesion using a non-angio X-ray mammography device. BACKGROUND

[0002] Screening X-ray mammography has become ubiquitous as an initial step in detecting breast cancer. If suspicious tissue is detected in these screening images, a subsequent biopsy is sometimes required to investigate this suspicious tissue. The initial screening images are collected using an examination device such as the GE Healthcare Senographe Crystal or Senographe Pristina. The examination device emits energy or radiation (X-rays) from an X-ray tube toward an anatomical structure passing through a patient, which is then detected by an X-ray detector positioned on the opposite side of the anatomical structure. The examination device then measures the X-ray absorption of the tissue using the X-ray detector and produces an image of the anatomical structure (in this example, a breast) of the patient. The images are typically collected along a number of views according to practices known in the art, such as a craniocaudal view, a mediolateral oblique view, and a mediolateral view. In these procedures, the tube and detector are rotated together and image the breast in various compression configurations. The clinician subsequently analyzes the images produced by the examination device at each view to detect any lesions or regions of tissue that are suspicious for abnormalities.

[0003] If the clinician detects any such potential abnormalities, a biopsy can be ordered to further investigate a sample of the suspicious anatomical structure. The biopsy can be performed with the anatomical structure positioned in a similar manner as when the screening images were collected with the examination device, but now using a biopsy device configured to perform the biopsy on the same or another mammography system (for clarity, now referred to throughout this disclosure as a biopsy system). An exemplary biopsy device is the GE Healthcare Senographe Pristina Serena biopsy system.

[0004] For clarity, the following notations will be used unless otherwise stated or implied:

[0005] • X, Y, Z: axes of the detector

[0006] • x b-3D , y b-3D , z b-3D ​​: 3D location of lesions in biopsy configuration

[0007] ·x b-2D ,y b-2D : 2D pixel position of the lesion in the biopsy configuration

[0008] "b" refers to biopsy

[0009] ·x i-2D ,y i-2D : 2D pixel position of the lesion in view i

[0010] ·x i-3D ,y i-3D z i-3D : 3D voxel location of the lesion in view i

[0011] "i index" = the number of the view: 0-1-2-3

[0012] “Measured” usually means detected in an image or volume, rather than “computed.”

[0013] In order to perform a biopsy, the 3D coordinates (x,y,z) of the lesion (marked with index "b" in the biopsy configuration) defined in a coordinate system (X,Y,Z) attached to the detector plane where the patient is currently positioned (called the detector reference system) must first be determined. b-3D ,y b-3D ,z b-3D ), so that the clinician knows the correct positioning of the biopsy needle. The X-axis and Y-axis are in the plane of the detector, while the Z-axis is orthogonal to this plane. In order to determine these 3D coordinates and target the lesion, additional images are collected by the biopsy device using at least two views of the anatomy at different angles of the X-ray tube relative to the anatomy. In certain devices, known as "angled devices", the X-ray tube is able to rotate relative to the X-ray detector, in other words, has additional degrees of freedom (DOF) relative to the X-ray tube being fixed to the detector. An exemplary angled device is the GE Healthcare Senographe Pristina mammography equipment. This enables the collection of two views of the anatomy by moving only the X-ray tube, without moving the X-ray detector (and therefore without moving the patient) (see Figure 1 For non-angled biopsy devices, two views are collected by rotating both the X-ray tube and the X-ray detector together relative to the anatomy, such as by 90° or another angle on the gantry (see Figures 2A-2B ).

[0014] If the lesion is located using the projected image, the 2D pixel coordinates of the location of the lesion in the ith X-ray image are combined with the knowledge of the biopsy device geometry to derive the 3D coordinates (x b-3D ,y b-3D ,z b-3D ) of the lesion in the detector reference frame (X, Y, Z) in the biopsy compression configuration. If the lesion is located using the reconstructed 3D volume, the slice containing the lesion and the pixel of the slice where the lesion is located are used to derive the 3D coordinates of the lesion in the detector reference frame.

[0015] Once the (x b-3D ,y b-3D ,z b-3D ) coordinates of the lesion in the detector reference frame are obtained, these coordinates can be converted to other reference frames in order to perform the biopsy, for example, these coordinates can be converted to the biopsy robot reference frame or the examination room reference frame. Once the 3D coordinates of the lesion are calculated using techniques currently known in the art, the biopsy can be performed again using methods currently known in the art. SUMMARY

[0016] This Summary is provided to introduce a selection of concepts that are further described below in the of the Invention. This Summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

[0017] The present disclosure generally relates to a method for determining a location of a lesion for biopsy in a patient along an X-axis, a Y-axis, and a Z-axis of a reference frame attached to a detector. The method includes positioning the patient in an examination device and collecting one or more examination images of the patient using the examination device, wherein the one or more examination images show the lesion. The method includes positioning the patient in a biopsy device configured for holding the patient during a biopsy and collecting a biopsy image of the patient using the biopsy device, wherein the biopsy image shows the lesion. The method includes analyzing the biopsy image to determine a measured x-coordinate and a measured y-coordinate of the lesion along the X-axis and the Y-axis, respectively, and analyzing the one or more examination images to determine a calculated z-coordinate of the lesion along the Z-axis. The method includes determining the location of the lesion along the X-axis, the Y-axis, and the Z-axis based on the measured x-coordinate and the measured y-coordinate from the biopsy image and the calculated z-coordinate determined from the one or more examination images.

[0018] In certain embodiments, the calculated z-coordinate is determined from the analysis of the one or more examination images.

[0019] In certain embodiments, the method further comprises acquiring additional parameters other than from the biopsy image and the one or more scout images, and further comprising including the additional parameters in the analysis of the one or more scout images to determine the computed z-coordinate of the lesion.

[0020] In certain embodiments, the one or more scout images include a first scout image taken in a foot-head view and a second scout image taken in one of a medial-lateral oblique view and a medial-lateral view.

[0021] In certain embodiments, the biopsy of the lesion is performed by inserting a needle into the patient at the determined location non-parallel to the Z-axis.

[0022] In certain embodiments, the analyzed biopsy image is exactly one biopsy image, and the exactly one biopsy image is the only image of the patient analyzed in determining the location of the lesion that was collected while the patient was positioned in the biopsy device.

[0023] In certain embodiments, the biopsy device includes an X-ray tube and an X-ray detector opposite the X-ray tube, wherein the biopsy image is collected only when the X-ray detector is positioned below the lesion.

[0024] In certain embodiments, the X-ray tube of the biopsy device is non-angled.

[0025] In certain embodiments, the method includes analyzing the one or more scout images to determine a computed z-coordinate of the lesion, including identifying one or more markers in the at least one biopsy image and in the one or more scout images.

[0026] In certain embodiments, the computed z-coordinate is determined based on a distance between the marker and the lesion. b-3D

[0027] In certain embodiments, the method includes dividing the one or more scout images into segments, wherein analyzing the one or more scout images to determine a computed z-coordinate of the lesion includes identifying which one of the segments the lesion is located in.

[0028] In certain embodiments, the segments are divided into layers stacked along the z-axis between a top and a bottom of the patient, and the computed z-coordinate of the location of the lesion is determined based on the one of the segments identified as having the lesion in the one or more scout images.

[0029] In certain embodiments, the biopsy is performable using a needle extending between a tip and a handle along a longitudinal axis, wherein the needle defines a notch therein, wherein the notch has a notch height parallel to the longitudinal axis, and the segments have a segment height along the Z-axis, and wherein the notch height is at most equal to the segment height.​

[0030] In certain embodiments, the segments include five segments of equal height along the Z-axis.

[0031] In certain embodiments, the method includes determining a change in morphology of the patient caused by the patient being positioned in the examination device, and determining the computed z-coordinate of the lesion includes analyzing an effect of the change in morphology in the one or more examination images.

[0032] In certain embodiments, the segments have a segment height along the Z-axis, wherein the segment height is determined based at least in part on the change in morphology.

[0033] In certain embodiments, at least one of deep learning and artificial intelligence is used for at least one of analyzing the biopsy image to determine the measured x-coordinate and the measured y-coordinate, analyzing the one or more examination images to determine the computed z-coordinate, and determining the location of the lesion based on the measured x-coordinate, the measured y-coordinate, and the computed z-coordinate.

[0034] In certain embodiments, the method further includes providing training examination images and known z-coordinates of training lesions corresponding thereto to train the at least one of deep learning and artificial intelligence.

[0035] In certain embodiments, the at least one of deep learning and artificial intelligence applies a biomechanical model.

[0036] Another embodiment in accordance with the present disclosure generally relates to a system for collecting a biopsy of a lesion within a patient based on one or more examination images previously collected from an examination device, where the lesion has a location along an X-axis, a Y-axis, and a Z-axis. The system includes an X-ray tube configured to emit energy toward the patient and an X-ray detector opposite the X-ray tube, where the X-ray detector is configured to detect the energy emitted toward the patient after passing through the patient. A compression paddle defines a biopsy window therein and is configured to compress the patient between the compression paddle and the X-ray detector as the energy is emitted from the X-ray tube and detected by the X-ray detector. A processing system is in communication with a memory system and the X-ray detector, where the processing system is configured to: generate a biopsy image of the patient based on the energy detected by the X-ray detector, where the biopsy image includes the lesion; access the one or more examination images of the patient previously collected using the examination device, where the one or more examination images include the lesion; analyze the biopsy image to determine a measured x-coordinate and a measured y-coordinate of the lesion along the X-axis and the Y-axis, respectively, while the patient remains compressed between the compression paddle and the X-ray detector; analyze the one or more examination images to determine a calculated z-coordinate of the lesion along the Z-axis; and determine the location of the lesion based on the measured x-coordinate and the measured y-coordinate from the biopsy image and the calculated z-coordinate from the one or more examination images. The system is configured for a biopsy of the lesion while the patient remains compressed between the compression paddle and the X-ray detector.

[0037] Various other features, objects, and advantages of the present disclosure will be made apparent to those of ordinary skill in the art from the following detailed description of embodiments, when considered in connection with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0038] The present disclosure is described with reference to the following drawings.

[0039] Figure 1 An exemplary isometric view of a biopsy device currently known in the art is depicted;

[0040] Figure 2A and Figure 2B A front view of an alternative biopsy device currently known in the art having an X-ray tube and an X-ray detector is depicted;

[0041] Figure 3 is a front view of a biopsy device in accordance with the present disclosure, depicting a lesion likelihood line detected from one or more images from an X-ray detector;

[0042] Figures 4A-4C depicts an exemplary image identifying a 3D location of a lesion using examination images collected using an examination device and applied in accordance with the present disclosure to along Figure 3 a lesion likelihood line shown;

[0043] Figure 5A and Figure 5B depicts exemplary images collected from an examination device similar to Figure 4B depicted in FIG. 1, which are now segmented according to the present disclosure to identify the 3D location of the lesion;

[0044] Figure 6 depicts a biopsy device of Figure 3 which now incorporates additional information collected from images of Figures 4A-4C and / or Figure 5A and Figure 5B to identify the 3D location of the lesion along a lesion-likely line for biopsy;

[0045] Figure 7 depicts an alternative method of identifying the 3D location of a lesion according to the present disclosure using images similar to those depicted in Figure 4C ;

[0046] Figure 8 depicts a biopsy device of Figure 3 which now incorporates additional information collected from images of Figures 4A-4C and / or Figure 7 and / or a biopsy system to identify the 3D location of the lesion along a lesion-likely line for biopsy;

[0047] Figure 9 depicts an exemplary control system for operating a system according to the present disclosure; and

[0048] Figure 10 depicts an exemplary method for determining the location of a lesion for biopsy according to the present disclosure. DETAILED DESCRIPTION

[0049] As described in the above BACKGROUND, the present disclosure provides a method for identifying the 3D location of a lesion for biopsy using images collected from an examination device. The method includes the steps of: Figure 1 depicts an exemplary biopsy device having an angle as currently known in the art. As shown, biopsy device 30 is configured for performing a biopsy on a patient or an anatomical structure 2 of a patient, here shown as a breast. Anatomical structure 2 extends between a top 4 and a bottom 5, a left side 6 and a right side 7, and an anterior 8 and a posterior (not shown). As currently known in the art, anatomical structure 2 is shown as being compressed between a biopsy compression paddle 36 and an x-ray detector 34. A top surface 37 of compression paddle 36 is positioned to face an x-ray tube 32, with a lower surface (not numbered) abutting anatomical structure 2. A lesion 12 is shown within anatomical structure 2, the lesion being aligned for imaging using x-ray tube 32, which projects a cone beam 33 (see Figure 2A ), including various beam lines 35 that pass through anatomical structure 2 to be detected by x-ray detector 34. A biopsy window 38 is defined through compression paddle 36 through which a clinician can perform a biopsy of lesion 12.

[0050] The illustrated biopsy device 30 is configured to provide a rotational degree of freedom (DOF) such that the X-ray tube 32 is angled, meaning that the X-ray tube 32 can be rotated relative to the position of both the anatomical structure 2 and the X-ray detector 34. In this case, the X-ray tube 32 is rotated between an angled angle AA+ and -AA on either side of the vertical axis V.

[0051] By capturing images at the angled angles AA+ 15° and -15°, and in combination with knowledge of the specific geometry of the biopsy device 30, the coordinates of the lesion 12 in all 3 axes (X, Y, Z) can be derived according to methods currently known in the art. The X-axis, Y-axis, Z-axis are defined as the axis of the image plane and the axis orthogonal to that plane, respectively. Based on these 3D coordinates, a biopsy of the lesion 12 can then be performed by conventional methods. It will be appreciated that alternative angled angles AA are also possible and need not be centered over the vertical axis V (here coinciding with the Z-axis).

[0052] However, the inventors have recognized that many biopsy devices 30 do not provide angulation of the X-ray tube 32, whereby angulation adds complexity and expense to these devices such that smaller facilities or lower income regions often cannot afford these devices. In these cases, the clinician uses a simpler non-angled biopsy device 30 such as Figure 2A and Figure 2B illustrated, to somehow identify the 3D position of the lesion by alternative methods.

[0053] As illustrated in Figure 2A , a first image is collected via the non-angled biopsy device 30, with the X-ray tube 32 centered over the anatomical structure 2, again with the anatomical structure compressed between the compression plate 36 and the X-ray detector 34 as would be the case during initial screening using the examination device. For purposes of disclosure, the examination device can be the model provided in the above Background section, and can be considered to be the same device as illustrated in Figure 1 or Figure 2A , but used earlier, e.g., prior to compressing the patient for biopsy. However, in contrast to the angled biopsy device 30 of Figure 1 , the technical requirements of the technique of Figures 2A-2B perform a second imaging with the biopsy needle 40 positioned within the anatomical structure 2 during the imaging process prior to taking the biopsy sample. The presently illustrated needle 40 is of a type known in the art, with the needle extending along a longitudinal axis LA between a handle 42 and a tip 44, defining a notch 46 between the handle and the tip. The notch 46 is configured to extract a biopsy sample from the anatomical structure 2 while the anatomical structure 2 remains compressed between the compression plate 36 and the X-ray detector 34 (presently in compression 1C1).

[0054] Once the use of Figure 2A The biopsy device 30 is positioned as shown to collect images, using the Figure 2B The third image is collected by the biopsy device 30 in the configuration shown, in this example, with the X-ray tube 32 and X-ray detector 34 rotated 90° relative to the anatomical structure 2 (corresponding here to a lateral-medial (ML) view). In this case, the biopsy needle 40 remains positioned within the anatomical structure 2, which is then compressed at compression 2C2 between the compression plate 36 and the X-ray detector 34. As will be appreciated, based on the position detected on the X-ray detector 34, the biopsy needle 40 is rotated 90° relative to the anatomical structure 2 (corresponding here to a lateral-medial (ML) view). Figure 2A The biopsy device 30 configured as shown can obtain information related to the location of the lesion 12 within the anatomical structure 2 along the X-axis and the Y-axis. Figure 3 As illustrated in , no information about the position of the lesion in the Z direction can be obtained from the X-ray detector 34, because an infinite number of z positions within the anatomical structure 2 can produce the same detection position on the X-ray detector 34 in this configuration (i.e., any z position along the line segment 17). For this reason, using Figure 2B The configuration shown collects a second image which then provides depth position information of the lesion, thereby collectively providing information for all three coordinates.

[0055] However, the inventors have recognized that for this method (also referred to as 2D lesion location inspection), decompression and recompression of the anatomical structure 2 as the needle 40 is inserted requires very delicate manipulation, which is time consuming and uncomfortable or even painful for the patient. Through experimentation and development, the inventors have created the presently disclosed system and method for performing 2D lesion location inspection using only a biopsy device 30 (e.g., Figure 2A The invention provides a method for determining the 3D location of a lesion within the patient's anatomy using a single view collected from a biopsy device 30 (shown), but without requiring any imaging to be performed while the biopsy needle 40 is inserted into the anatomy 2. In particular, the inventors have recognized that images collected from a previous examination (i.e., images collected by the examination device during an initial screening) can be analyzed and manipulated to estimate or determine the missing Z-axis location of the lesion on the biopsy device. This allows the inventors to identify the 3D location of the lesion for biopsy while eliminating the need to rotate the X-ray tube 32 while the patient is positioned in the biopsy device 30, eliminating the need to capture another image while the patient is positioned in the biopsy device 30, and eliminating the need to insert the needle 40 except for the actual performance of the biopsy.

[0056] Figure 3 Depicted is a biopsy device 30 similar to that previously discussed that is configured for collecting images of an anatomical structure 2, whereby the biopsy device 30 is non-angled and therefore has a more basic form. Figure 3The image collected with the biopsy device 30 at the shown positioning provides only information of the position of the lesion 12 along the X and Y axes as a function of the z coordinate, which will be displayed in the X-ray detector 34 as a single point or area of the detection area 15. Therefore, since the z b-3D coordinate cannot be derived from this image, the position of the lesion 12 within the anatomical structure 2 can only be narrowed down to the existence along a lesion likelihood line 17, which is aligned with the detection area 15 on the X-ray detector 34 (in other words, a line of all positions corresponding to the same projection coordinates of the lesion on the X-ray detector 34).

[0057] In order to determine the missing z b-3D component of the lesion 12, the inventors have realized that images from previous examinations can be analyzed and reused for a new purpose different from the ones currently known in the art. Figures 4A-4C Images 50 collected at three different views of the anatomical structure 2 are depicted, in this case taken along a cranio-caudal view, a mediolateral oblique view and a mediolateral view, respectively, as typically obtained during a screening procedure. The images 50 can be from a 2D mammography examination, but it should be realized that a 3D reconstructed volume (3D examination) can also or alternatively be used. It will also be realized that other views can also be used, and those described above are merely exemplary. In Figures 4A-4C Each of the three images 50 shown corresponds to an image lesion position 13. As will be realized, the image lesion position 13 can then be determined in the image 50 Figure 4A The cranio-caudal view of the image 50 can be used to determine the X and Y axes of the image and Figure 4C the image lesion position 13 in the mediolateral view of the image 50. Information can also be obtained from the mediolateral oblique view or other views by knowing the angular positioning of the X-ray tube 32 relative to the X-ray detector 34. Figure 4B

[0058] Once the image lesion position 13 is identified in the image 50 (which can be detected manually by a clinician and / or using automatic image analysis techniques known in the art), the (x i-2D , y i-2D ) coordinates of the lesion projection 13 (2D examination) or the (x i-3D , y i-3D , z i-3D ) coordinates of the lesion position (3D examination) can be determined. It should be realized that based on the positioning of the X-ray tube 32 and the X-ray detector 34 and the patient positioning when each image 50 was captured, the x b-3D , y b-3D and z b-3D ​coordinates. In other words, each image is initially measured to have an x coordinate measured on the x-ray detector 34 and a y coordinate measured; however, the x-ray detector 34 itself is not always positioned at the same angle of rotation, and the patient position can vary. Therefore, if it is a 3D examination, the measured x 1-2D coordinates and y 1-2D coordinates or measured (x 1-3D ,y 1-3D ,z 1-3D ) can be acquired in a first image of the images 50 (labeled "1") via the x-ray detector 34; if it is a 3D examination, the measured x 2-2D coordinates and y 2-2D coordinates or measured (x 2-3D ,y 2-3D ,z 2-3D ) can be acquired in a second image of the images 50 (labeled "2") taken with the x-ray tube 32 in another position; and so on, if it is a 3D examination, the measured x i-2D and y i-2D coordinates or measured (x i-3D ,y i-3D ,z i-3D ) can be acquired in the i-th image of the images 50 (labeled "i") taken from another position with the x-ray detector 34.

[0059] Additional parameters (collectively referred to as parameters P) corresponding to the geometry, mechanics and / or physical configuration and / or orientation of the acquisition device and / or biopsy device can also be analyzed. These additional parameters provide information in addition to the information that is measurable in the images. For example, these additional parameters P can include the compression force generated by the compression paddle 36, the type of compression paddle 36 used (e.g., the shape and size of the opening therethrough), and / or the breast height measured (e.g., between the compression paddle 36 and the x-ray detector 34) and / or patient related information (e.g., position: sitting / reclining or view name). In certain examples, some or all of these additional parameters have been provided by acquisition devices known in the art. Therefore, the z i-3D coordinate of the lesion 12 can be solved as a function of F({x i-3D ,y i-3D ,z i-2D},{x i-2D ,y b-3D}, P).

[0060] In certain examples, one or more landmarks can be identified within the images 50 (in Figures 4A-4CIdentifications are illustrated as identifications LI-L12, which can be present in other figures as well. By identifying the identifications that are also present in the image 50 of multiple views, the identifications can be used for comparison with the image lesion location 13 to help locate the lesion 12. These identifications can be external features and / or internal features of the anatomical structure 2, as will become apparent. For example, Figure 4A An identification ILI is shown that is defined as the rightmost point 7 of the anatomical structure 2, an identification 2L2 that is defined as the nipple or a portion thereof, and an identification 3L3 of the anterior portion 8 of the anatomical structure 2 (not including the identification 2L2), which can also be considered a base of the identification 2L2. In this example, a distance between the image lesion location 13 and one or more of the identifications can be measured, for example, as a first X distance DXI between the image lesion location 13 and the identification ILI, a second X distance DX2 between the image lesion location 13 and the second identification 2L2, and / or a third X distance DX3 between the image lesion location 13 and the identification 3L3. Likewise, one or more measurements in the Y direction can be analyzed to determine, for example, a first Y distance DYI between the image lesion location 13 and the identification ILI and / or a second Y distance DY2 between the image lesion location 13 and the identification 2L2. Figure 4A

[0061] It will be recognized that additional identifications L4-L12 having corresponding distances to the image lesion location 13 can also be used for various views, such as those shown in Figure 4B and Figure 4C These include, for example, a topmost portion of the nipple LIO, a center point or edge of a tissue region L6 (e.g., characterized as being fatty tissue and / or glandular tissue), and a point where the anatomical structure 2 contacts the chest wall at the subareolar identification 12L12. For example, a seventh Y distance DY7 and an eighth Y distance DY8 are shown in Figure 4C as distances along the Y axis from the image lesion location 13 to the identification 7L7 (e.g., the top of the breast) and the identification 8L8 (e.g., the vertical midpoint of the breast), respectively. Figure 4C Another example measurement in is a tenth Y distance DYIO between the image lesion location 13 and the identification 10LIO (e.g., the top of the nipple).

[0062] Again, as shown in the inner-oblique view of Figure 4B additional information regarding the positioning of the x-ray tube 32 relative to the x-ray detector 34 and the patient positioning can be used to determine the x b-3D , y b-3D , and / or z b-3D coordinates in the biopsy configuration. For example, Figure 4B is shown as an example of a fifth oblique distance DOB5 between the image lesion location 13 and the identification 5L5, which is defined here as the lowest portion of the anatomical structure 2. ​

[0063] In this way, previous images from the examination apparatus are used to determine measured coordinates of the image lesion location 13. As discussed above, by for example utilizing a known relationship between the position of the X-ray tube 32 and the X-ray detector 34 and the patient positioning information at the time each image 50 is captured, the z coordinate of the lesion 12 can be determined from the combined coordinate information measured from the images 50. As discussed above, the z coordinate is determined based on the known relationship between the position of the X-ray tube 32 and the X-ray detector 34 and the patient positioning information at the time each image 50 is captured. Figure 3 As shown in the configuration of the biopsy apparatus 30, a new actual coordinate in the X and Y axes can be determined for the lesion when the lesion 12 within the anatomical structure 2 is positioned in the biopsy apparatus 30. This information from the previous examination images can then be used to derive the 3D coordinates of the lesion 12 positioned in the biopsy apparatus 30. As discussed above, the z coordinate is determined from the combined coordinate information measured from the images 50 based on the positioning of the X-ray tube 32 and the X-ray detector 34 and the patient positioning information at the time each image 50 is captured. b-3D As shown in the configuration of the biopsy apparatus 30, a new actual coordinate in the X and Y axes can be determined for the lesion when the lesion 12 within the anatomical structure 2 is positioned in the biopsy apparatus 30. This information from the previous examination images can then be used to derive the 3D coordinates of the lesion 12 positioned in the biopsy apparatus 30. As discussed above, the z coordinate is determined from the combined coordinate information measured from the images 50 based on the positioning of the X-ray tube 32 and the X-ray detector 34 and the patient positioning information at the time each image 50 is captured. Figure 6 and Figure 8 As shown, this process thus reduces the length of the line segment 17 from the Figure 3 In certain examples, to a single point. By providing this missing information in the Z direction, a biopsy can then be performed with only a single image collected from the biopsy apparatus 30.

[0064] Figures 5A-6 Two processes are depicted for determining the measured x i-2D and y i-2D coordinates of the image lesion location 13 detected on the X-ray detector 34, and thus converting it to the calculated z b-3D coordinate of the lesion 12 when the lesion is positioned in the biopsy apparatus 30. In this example, the anatomical structure 2 depicted in the images 50 is divided into segments 56, in this example, segments 56A-56E. In the example shown, these segments 56A-56E are five segments equally spaced from a horizontal portion. However, it will be recognized that a different number of segments 56 can be used, and such segments 56 need not be of the same size. For example, segments 56 can be provided in multiple directions, for example with another set of segments extending perpendicular to the segments 56A-56E. Figure 5A Figure 5B By dividing the anatomical structure 2 of the images 50 into segments 56A-56E, a clinician can easily discern in which of these segments a lesion in the image lesion location 13 lies, in the current example, within the first segment 56A. Similar segmentation can be provided in multiple views in order to collectively discern the 3D coordinates of the lesion 12 with high precision. As shown, the previous z coordinate of the lesion 12 is known from only a single biopsy apparatus 30 image. Figure 5A

[0065] By dividing the anatomical structure 2 of the images 50 into segments 56A-56E, a clinician can easily discern in which of these segments a lesion in the image lesion location 13 lies, in the current example, within the first segment 56A. Similar segmentation can be provided in multiple views in order to collectively discern the 3D coordinates of the lesion 12 with high precision. As shown, the previous z coordinate of the lesion 12 is known from only a single biopsy apparatus 30 image. Figure 5A Figure 6 Figure 3 ​​​​The line segment 17 shown in the middle can thus be shortened, now corresponding to the segment height H of each of the five segments 56A-56E (in this case to the first segment 56A). These segments can also be more descriptively labeled to aid the clinician's analysis process, for example as very superior (VS), superior (S), middle (M), inferior (I), and very inferior (VI) locations of the segmented anatomical structure 2.

[0066] It will be appreciated that these segments 56 essentially serve as an identification for comparison, which can be used alone or in combination with the comparison of the identifications L1-L12 discussed above.

[0067] The inventors have recognized that it is particularly advantageous for the segment height H to be less than or equal to the sample size of the anatomical structure 2 collected by the needle 40 during the biopsy, to ensure the entire possibility of collecting the lesion location in the Z-axis for analysis. Figure 6 An exemplary needle 40 is depicted in which a notch 46 is defined for obtaining a sample from the anatomical structure 2. The notch 46 has a height 47 along the longitudinal axis LA of the needle 40 and a depth 49 recessed into the needle 40. In this way, the number of segments 56 into which the anatomical structure 2 in the image 50 is divided can be optimally selected such that its segment height H is less than the height 47 of the notch 46 in the needle 40. This ensures the collection of the entire extent of the anatomical structure 2 identified as corresponding to the lesion 12 during the biopsy, thereby avoiding false negatives and / or repeated biopsy procedures.

[0068] More generally, the inventors have recognized that it is particularly advantageous when performing a biopsy using a needle inserted along a particular direction if the uncertainty of the lesion location along the X-axis, Y-axis, Z-axis is lower than the projection of the needle notch along these X-axis, Y-axis, Z-axis.

[0069] As Figure 5B segments 56 need not be equal and need not be linear. For example, the inventors have recognized that the outer surface or shape 10 of the anatomical structure 2 changes based on the compression thereof and the relative positioning of the compression plate with respect to the anatomical structure 2. Moreover, the morphology of the shape 10 of the anatomical structure 2 depends not only on the amount of compression generated by the compression plate 36, but also based on the original shape 10 of the anatomical structure 2 to begin with. The size, profile, density, and distribution of the anatomical structure 2 all play a role in how the anatomical structure 2 will respond under compression, including for example the specific distribution and concentration of fatty and glandular tissue within the anatomical structure 2.

[0070] Figure 7 and Figure 8An alternative process is shown in . In this example, identifier 13L13 is defined as the highest portion of the anatomical structure 2, and identifier 14L14 is defined as the lowest portion of the anatomical structure, each as depicted in image 50 collected in a lateral-lateral (ML) view. A first total measurement TY1 on the Z axis is determined between identifier 13L13 and identifier 14L14 to define 100% of the height of the anatomical structure 2 on the Z axis. A first lesion measurement LY1 on the Z axis is also measured between identifier 14L14 and the image lesion location 13. These values ​​can then be compared (here divided) to determine a percentage of the total height of the image lesion location 13 relative to the anatomical structure 2, in this example approximately 80% to the top (designated as identifier 13L13). This value can then be used, in some examples, based on the distance from the examination device to the image lesion location 13. Figure 8 Any morphological changes in the shape 10 between the images 50 collected by the biopsy device 30 are corrected to again determine the calculated z-axis of the lesion 12. b-3D Coordinates that are more specific than line segment 17 provided by a single image captured by biopsy device 30 alone.

[0071] More specifically, the second total Z measurement TZ2 is measured based on images collected by the biopsy device 30 between the highest and lowest parts of the anatomical structure 2 (using the same markers 13L13 and 14L14 as described above). Figure 7 50 in FIG1 (in other words, without correction for the morphological changes of the shape 10), the position of the lesion 12 will again be 80% of the height of the second total Z height TZ2, here essentially the measurement between the compression plate 36 and the X-ray detector 34. Then, as Figure 8 As shown, the actual or calculated z of the lesion 12 b-3D The coordinate will be 80% times the second total Z height TZ2.

[0072] Therefore, if Figure 5B As shown, segments 56 can be defined by biomechanical modeling to account for morphological influences on the shape 10 of the anatomical structure 2 captured in the image 50, so that when subsequently applied to a single image of the anatomical structure 2 as positioned in the biopsy device 30, correction to the specific shape 10 of the anatomical structure 2 can be achieved, for example. Figure 6 Such modeling may be based, for example, on geometrical properties of the shape 10 of the anatomical structure 2, on biomechanical properties of breast tissue and / or on determinations made from images 50 from an examination device.

[0073] In certain examples, a regression model (e.g., a linear regression model, a neural network, a regression tree, etc.) is used that can learn geometric mapping transformations between views and between different 3D compression geometries. For example, a Multi-layer Perceptron can be used as one type of regression modeling, which is known in the art. This technique allows any measured x i-2D coordinates in the one or more exam images to be associated with measured y i-2D coordinates and z b-3D coordinates of a lesion in a biopsy image. In certain examples, artificial intelligence techniques such as deep learning and / or machine learning techniques (alone or in combination with traditional image analysis techniques and biomechanical modeling) can be employed to determine the x b-3D , y b-3D , and z b-3D coordinates of a lesion 12 from measured coordinates of an image lesion location 13. For example, TensorFlow TM or other commercially available platforms can be used to analyze the data.

[0074] Figure 9 An exemplary overall system 1 for collecting a biopsy of a lesion within a patient or anatomy 2 based on one or more exam images 50 previously collected from an exam device, which can be similar to the biopsy device 30 described above as shown and described above, is depicted as previously described, whereby the lesion 12 has a location along an X-axis, a Y-axis, and a Z-axis.

[0075] The system 1 includes a biopsy device 30 having an X-ray tube 32 configured to emit energy toward the patient or anatomy 2 and an X-ray detector 34 opposite the X-ray tube 32, whereby the X-ray detector 34 is configured to detect energy emitted toward the patient or anatomy 2 after passing through the patient or anatomy 2. A compression paddle 36 defining a biopsy window 38 therein is configured to compress the anatomy 2 between the compression paddle 36 and the X-ray detector 34 when X-rays are emitted from the X-ray tube 32 and detected by the X-ray detector 34.

[0076] The processing system 110, discussed further below, is in communication with the memory system 120 and the X-ray detector 34. The processing system 110 is configured to generate a biopsy image (similar to the image 50 shown previously) of the anatomical structure 2 based on the X-rays detected by the X-ray detector 34, wherein the biopsy image includes a depiction of the lesion in the image lesion location 13. The processing system 110 is further configured to access one or more inspection images 50 of the anatomical structure 2 previously collected using an inspection device, wherein the image 50 also includes the lesion in the image location 13. In other words, the lesion 12 can be seen within the image 50. The processing system 110 is further configured to analyze the biopsy image while the anatomical structure 2 remains compressed between the compression plate 36 and the X-ray detector 34 to determine the measured x and y coordinates of the lesion along the x-axis and y-axis, respectively, when the lesion 12 appears within the biopsy image. b-2D Coordinates and measured y b-2D One or more inspection images 50 are then analyzed to determine the measured z coordinates along the z-axis of the lesion. b-3D coordinates, as shown by the lesion in the image lesion location 13 within the image 50, which, as previously described, may include a single point or a line of possible locations, such as constituting the segment height SH when the anatomical structure 2 is segmented into segments 56 within the image 50. Finally, the x coordinates are then based on the measurements from the biopsy image. b-2D Coordinates and measured y b-2D coordinates and calculated z from one or more inspection images 50 b-3D The coordinates are used to determine the location of the lesion 12. The system 1 is then configured for a biopsy at the location determined for the lesion 12, the biopsy being performed through the biopsy window 38 of the compression plate 36 while the anatomical structure 2 remains compressed between the compression plate 36 and the X-ray detector 34.

[0077] The actual coordinates of the lesion 12 positioned within the biopsy device 30 (measured by x b-2D coordinates and y b-2D Coordinates and calculated z b-3D coordinate determination) can be performed on a display device (e.g., as Figure 9 101 in the output device 102), provided as a printed output, or displayed by other mechanisms currently known in the art, such as by a current stereo system ( Figure 1 ) mechanism provided by .

[0078] Now for Figure 9The control system 100 provides additional information. Certain aspects of the present disclosure are described or depicted as functional and / or logical block components or processing steps, which can be executed by any number of hardware, software, and / or firmware components configured to perform the specified functions. For example, certain embodiments employ integrated circuit components such as memory elements, digital signal processing elements, logic elements, look-up tables, or the like, which are configured to perform various functions. The connections between functional and logical block components and the connections between the functional block components and the other components are exemplary only and can be direct or indirect, and can follow alternative paths.

[0079] In certain examples, the control system 100 communicates with each of the one or more components of the system 1 via a communication link CL, which can be any wired or wireless link. The control system 100 is able to receive information and / or control one or more operational characteristics of the system 1 and its various subsystems by sending and receiving control signals via the communication link CL. In one example, the communication link CL is a controller area network (CAN) bus; however, other types of links can be used. It will be recognized that the degree of connectivity and the communication link CL can in fact be one or more shared connections or links between some or all of the components in the system 1. Further, the communication link CL lines are intended to merely show that the various control elements are able to communicate with each other, and do not represent the actual wiring connections between the various elements, nor do they represent the only communication paths between the elements. Additionally, the system 1 can incorporate various types of communication devices and systems, and thus the communication link CL shown can in fact represent various different types of wireless data communication systems and / or wired data communication systems.

[0080] The control system 100 can be a computing system that includes a processing system 110, a memory system 120, and an input / output (I / O) system 130 for communicating with other devices, such as input devices 99 (e.g., the examination device 20 and biopsy device 30 that perform the initial screening) and output devices 101, any of which can also or alternatively be stored in the cloud 102. The processing system 110 loads and executes executable programs 122 from the memory system 120, accesses data 124 stored within the memory system 120, and directs the operation of the system 1 as described in further detail below. The system 1 need not include the examination device 20 and / or biopsy device 30 as inputs, but can instead simply load images 50 collected from the examination device and / or biopsy device, which can be stored in the memory system 120, for example.

[0081] The processing system 110 can be implemented as a single microprocessor or other circuit, or distributed across multiple processing devices or subsystems that cooperate to execute the executable programs 122 from the memory system 120. Non-limiting examples of processing systems include general-purpose central processing units, special-purpose processors, and logic devices.

[0082] The memory system 120 can include any storage media capable of being read by the processing system 110 and capable of storing the executable programs 122 and / or data 124. The memory system 120 can be implemented as a single storage device, or distributed across multiple storage devices or subsystems that cooperate to store computer-readable instructions, data structures, program modules, or other data. The memory system 120 can include volatile and / or non-volatile systems, and can include removable and / or non-removable media for storing information implemented in any method or technology. For example, the storage media can include non-transitory and / or transitory storage media, including random access memory, read-only memory, magnetic disks, optical disks, flash memory, virtual and non-virtual memory, magnetic storage devices, or any other medium that can be used to store information and that can be accessed by an instruction execution system.

[0083] As described above and as shown in Figure 10 The present disclosure also relates to a method 200 for determining the position of a biopsy lesion in a patient or anatomical structure 2 along the X-axis, Y-axis, and Z-axis of a detector reference frame. The method includes positioning the anatomical structure 2 in an examination device in step 202, which, as described above, can be an examination device currently known in the art and similar to the examination device as shown in biopsy device 30 and as described above. The method includes collecting one or more examination images 50 of the anatomical structure 2 using the examination device (step 204), wherein the one or more examination images 50 show the lesion 12 therein. The method includes positioning the anatomical structure 2 in the biopsy device 30 in step 206, which is configured for holding the anatomical structure 2 during a biopsy, and then collecting a biopsy image of the anatomical structure 2 using the biopsy device 30 in step 208, wherein the biopsy image also shows the lesion 12.

[0084] The biopsy image is then analyzed in step 210 to determine the measured x b-2D coordinate and the measured y b-2D coordinate of the lesion 12 as depicted along the X-axis and Y-axis, respectively, in the biopsy image. Next, step 212 provides for analyzing the one or more examination images 50 previously collected with the examination device to determine the calculated z b-3D coordinate (or z b-3D coordinates, such as segments) along the Z-axis of the lesion 12 as depicted in the images 50 when the anatomical structure 2 was positioned within the examination device. Finally, step 214 provides for determining the position of the biopsy lesion 12 along the X-axis, Y-axis, and Z-axis of the detector reference frame based on the measured x b-2D coordinate and the measured yb-2D coordinates and calculated z from one or more inspection images 50 b-3D coordinates to determine the location of the lesion 12.

[0085] The inventors have recognized that even in the case of an angled biopsy device, such as Figure 1 In the case shown, there is also a further benefit in analyzing pre-existing images from the examination device. With a non-angled biopsy device, the above-described system and method provides for calculating or inferring the z-plane in which the lesion is located, since this information cannot be provided by a single image taken by the biopsy device alone. An angled biopsy device does include information about the z-plane of the anatomy of interest, and in fact includes many "slices" of the image along the z-axis that together form a reconstructed view of the anatomy. However, the inventors have recognized that while the z-plane of the lesion may be b-3D Coordinates can therefore be identified in the reconstructed volume, but it requires the clinician to actually scrutinize many slices to determine which slice includes the lesion.

[0086] Thus, the inventors have recognized that the presently disclosed systems and methods can also be used to provide clinicians with estimates of potentially interesting z-planes, thereby saving valuable time and costs when reading 3D volumes from tomosynthesis. In this way, the presently disclosed systems and methods improve the process of identifying lesions not only for non-angled biopsy devices, but also for devices that provide angled and 3D image acquisition.

[0087] In certain embodiments, the system can indicate to the clinician the estimated z of the lesion. b-3 The D coordinates go a step further, such as highlighting or differentiating only the z coordinates corresponding to potential interest. b-3D For example, the system can automatically display the estimated z coordinates corresponding to the lesion. b-3D z within a certain percentage of the coordinate b-3D A subset of the image coordinates and / or a portion of the reconstructed image.

[0088] The functional block diagrams, operational sequences, and flow charts provided in the accompanying drawings represent exemplary architectures, environments, and methods for performing the novel aspects of the present disclosure. Although, for purposes of simplicity of illustration, the methods included herein may be in the form of functional diagrams, operational sequences, or flow charts, and may be described as a series of actions, it should be understood and appreciated that the methods are not limited by the order of the actions, as some actions may occur in a different order and / or concurrently with other actions shown and described herein. For example, one skilled in the art will understand and appreciate that a method may alternatively be represented as a series of interrelated states or events, such as in a state diagram. Furthermore, not all actions shown in a method may be necessary for a novel implementation.

[0089] This written description uses examples to disclose the application, including the best mode, and also to enable one of ordinary skill in the art to practice and use the application. Certain terms are used throughout the description for simplicity and ease of understanding. No unnecessary limitations are meant by such terms as they are used for descriptive purposes only and are intended to be broadly construed. The patentable scope of the application is defined by the claims and can include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have structural elements in common with the words of the claims or if they do not differ from the words of the claims materially or if they include equivalent features or structural elements.

Claims

1. A method for determining the position of a lesion for biopsy in a patient along the X-axis, the Y-axis, and the Z-axis, the method comprising: positioning the patient in an examination device; collecting one or more examination images of the patient using the examination device, wherein the one or more examination images show the lesion; positioning the patient in a biopsy device configured to hold the patient during the biopsy; collecting a biopsy image of the patient using the biopsy device, wherein the biopsy image shows the lesion; analyzing the biopsy image to determine a measured x-coordinate and a measured y-coordinate of the lesion along the x-axis and the y-axis, respectively; analyzing the one or more examination images to determine a calculated z-coordinate of the lesion along the z-axis; as well as The position of the lesion along the X-axis, the Y-axis, and the Z-axis is determined based on the measured x-coordinate and the measured y-coordinate from the biopsy image and the calculated z-coordinate determined from the one or more inspection images. 2 . The method of claim 1 , wherein the calculated z-coordinate is determined based on an analysis of at least two of the one or more inspection images.

3. The method of claim 1 , further comprising acquiring additional parameters in addition to those from the biopsy image and the one or more inspection images, and further comprising including the additional parameters in the analysis of the one or more inspection images to determine the calculated z-coordinate of the lesion. 4 . The method of claim 1 , wherein the one or more examination images include a first examination image captured in a cranio-caudal view and a second examination image captured in one of a medio-lateral oblique view and a medio-lateral view.

5. The method of claim 1 , wherein the biopsy image analyzed is exactly one biopsy image, and wherein the exactly one biopsy image is the only image of the patient collected while the patient is positioned in the biopsy device that is analyzed in determining the location of the lesion.

6. The method of claim 1, wherein analyzing the one or more inspection images to determine the calculated z-coordinate of the lesion comprises identifying one or more landmarks in at least one of the biopsy images and in the one or more inspection images. 7 . The method of claim 6 , wherein the calculated z-coordinate is determined based on a distance between the landmark and the lesion in a first inspection image of the one or more inspection images.

8. The method of claim 1 , further comprising dividing the one or more inspection images into segments, and wherein analyzing the one or more inspection images to determine the calculated z-coordinate of the lesion comprises identifying in which of the segments the lesion is located.

9. A method according to claim 8, wherein the segments are divided into layers stacked along the Z axis between the top and the bottom of the patient, and wherein the calculated z coordinate of the position of the lesion is determined based on the one of the segments identified as having the lesion in the one or more examination images.

10. The method of claim 9, wherein the biopsy is capable of being performed using a needle extending along a longitudinal axis between a tip and a handle, wherein the needle defines a notch therein, wherein the notch has a notch height parallel to the longitudinal axis, and the segment has a segment height along the Z axis, and wherein the notch height is at most equal to the segment height.

11. The method of claim 8, further comprising determining a morphological change of the patient caused by positioning the patient in the examination device, and wherein determining the calculated z-coordinate of the lesion comprises analyzing an effect of the morphological change in the one or more examination images.

12. The method of claim 11, wherein the segments have a segment height along the Z axis, and wherein the segment height is determined at least in part based on the morphological change.

13. The method of claim 1 , wherein at least one of deep learning and artificial intelligence is used for at least one of: analyzing the biopsy image to determine the measured x-coordinate and the measured y-coordinate, analyzing the one or more inspection images to determine the calculated z-coordinate.

14. The method of claim 1, further comprising providing a training examination image and known z-coordinates of training lesions corresponding to the training examination image to train at least one of deep learning and artificial intelligence.

15. A system for collecting a biopsy of a lesion in a patient based on one or more examination images previously collected from an examination device, the lesion having a position along an X-axis, a Y-axis, and a Z-axis, the system comprising: an X-ray tube configured to emit energy toward the patient; an X-ray detector opposite the X-ray tube, wherein the X-ray detector is configured to detect energy emitted toward the patient after passing through the patient; a compression plate defining a biopsy window therein, wherein the compression plate is configured to compress the patient between the compression plate and the X-ray detector when the energy is emitted from the X-ray tube and detected by the X-ray detector; a processing system in communication with a memory system and the X-ray detector, wherein the processing system is configured to: generating a biopsy image of the patient based on the energy detected by the X-ray detector, wherein the biopsy image includes the lesion; accessing the one or more examination images of the patient previously collected using the examination device, wherein the one or more examination images include the lesion; analyzing the biopsy image to determine a measured x-coordinate and a measured y-coordinate of the lesion along the X-axis and the Y-axis, respectively, while the patient remains compressed between the compression plate and the X-ray detector; analyzing the one or more examination images to determine a calculated z-coordinate of the lesion along the z-axis; as well as determining the position of the lesion along the X-axis, the Y-axis, and the Z-axis based on the measured x-coordinate and the measured y-coordinate from the biopsy image and the calculated z-coordinate determined from the one or more inspection images; Wherein the system is configured to perform the biopsy of the lesion while the patient remains compressed between the compression plate and the X-ray detector.

Images