Visual guidance biopsy system and method for mammography

Abstract

The invention is entitled "Visually Guided Biopsy System and Method for Mammography." The invention discloses a mammography system that includes a biopsy guidance system that employs a simplified mechanical arm support to enable previously unavailable locations to be used in conjunction with a visual guidance and control system for mounting a biopsy device directly to the mammography system, such as on a compression paddle. The visual system operates to determine the position of the biopsy device and biopsy needle tip, and control movement / operation of the biopsy guidance system, such as to a final end-of-device pose or pre-firing position of the biopsy device to perform a biopsy procedure. The visual system visually determines the position of the biopsy device relative to the region of interest being biopsied within the required tolerances of the biopsy procedure using one or more cameras without requiring precise position information to be provided by the biopsy guidance system to the mammography system.

Description

TECHNICAL FIELD

[0001] The present disclosure relates generally to mammography systems and devices, and more particularly to a guidance system for use with a mammography device. BACKGROUND

[0002] Embodiments of the present invention relate generally to X-ray medical imaging, and more particularly to systems and methods for performing a biopsy procedure guided by stereotactic mammography or digital breast tomosynthesis (DBT). In 2D (CESM guided biopsy) or 3D (CEDBT guided biopsy), spectral mammography (SM) can also be used to guide the biopsy procedure with or without injection of contrast agent.

[0003] X-ray mammography (MG) is an X-ray imaging modality used to scan a breast for screening, diagnosis, and / or interventional procedures. The effectiveness of X-ray mammography is influenced by a number of factors, one of which is the two-dimensional (2D) rendering of the images obtained.

[0004] Alternative systems of 2D X-ray mammography are also known for breast imaging. For example, digital breast tomosynthesis (DBT) or mammography-tomo systems are specialized mammography systems that acquire several (e.g., tens of) angularly offset projection X-ray images and reconstruct a three-dimensional (3D) image data set using the resulting X-ray image data.

[0005] When a 3D image data set of a breast has been produced, they are used to guide a biopsy device used with the DBT system into the breast to obtain a biopsy of a region of interest (ROI) identified within the 3D image data set. In a DBT system, the biopsy device is directly provided on the DBT system so as to be able to perform a biopsy with the biopsy device guided to the ROI using the 3D image data set. Since the region constituting the ROI in the breast can be quite small, the precise movement and positioning of the biopsy device from an idle or standby position into the breast to reach a biopsy pre-firing position is required. To achieve this level of precision, + / - 1 mm is typically required for the end of the biopsy device relative to the ROI, the accurate initial positioning, i.e., spatial position and angular orientation, of the end pose segment / end effector of the biopsy guidance system holding the interventional device (e.g., the biopsy device and needle itself or any other interventional tool used for mammography) is determined, which presents a challenging issue in a mammography biopsy procedure.

[0006] To address this issue in the prior art biopsy guidance systems, the biopsy guidance system is constructed as a dedicated robotic arm that sits on top of the mammography system, which is formed with a robust mechanical structure that utilizes heavy machined metal components and associated rotary encoders that are interconnected by micro- motors (e.g., micro-servo motors) to move the various components of the biopsy guidance system in a precisely controlled manner. The structure of the biopsy guidance system is mounted to a gantry to support the weight of the biopsy guidance system while allowing the biopsy device to move within the area of the gantry relative to where the biopsy is to be performed.

[0007] With this over-engineered structure, the biopsy guidance system can be accurately controlled to perform the biopsy procedure by using the signals from the mammography system to the rotary encoders to operate the servo motors. The rotary encoders provide signals to the mammography system regarding the initial position of the end effector of the biopsy guidance system to which the biopsy device and its needle are mechanically mounted. Based on the known position of the end effector and the known position of the ROI in the 3D image data set reconstructed from the X-ray image data, the mammography system uses the signals sent to the rotary encoders to control the movement of the robotic arm of the biopsy guidance system to operate the servo motors and accurately position the end effector (biopsy device) and needle at any position needed to perform the biopsy procedure.

[0008] While it is possible to provide precise positions for the components of the biopsy guidance system and to accurately position the end effector / needle to perform the biopsy procedure, these prior art robotic arm biopsy guidance systems have a number of significant drawbacks. In particular, all of the required information regarding the position and movement of the biopsy device / needle during the biopsy procedure is provided directly from the biopsy guidance system itself. Thus, the components of the robotic arm and biopsy device / needle in the prior art must be precisely machined in order to provide the precise position data of the biopsy device to the mammography system with the tolerances required for the biopsy procedure. Since the needle position for the biopsy procedure is + / - 1 mm, all of the components for the biopsy guidance system must be manufactured to enable the system to operate within this tolerance limit.

[0009] Further, to enable the biopsy guidance system components and the biopsy device to remain within this tolerance limit during repeated use of the system, the components need to be formed from suitable materials that do not deform during use to maintain the accuracy of the position information provided to the mammography system. Thus, the materials used are selected from various metals and / or metal alloys that have the required material properties that allow the materials to maintain their shape over multiple procedures. However, these types of materials are difficult to machine directly due to their required material properties. Further, the size of the machined components used to enhance the ability of the selected materials to maintain their shape results in very dense and heavy components that require significant mounting structures to be added to the mammography system to accommodate the weight of the biopsy system.

[0010] Further, due to the selected materials and the size and associated weight of the components of the biopsy guidance system and device, the movement mechanisms (e.g., servo motors and rotary encoders) disposed between the components must be selected to be sufficiently robust and powerful to accommodate these aspects of the biopsy guidance system, which in turn requires a larger power supply and more complex control system connection with the mammography system for proper operation of the biopsy guidance system and device.

[0011] Accordingly, it is desirable to develop a biopsy guidance system and device that can provide the precision required for performing interventional procedures using a mammography system, but without the apparent drawbacks of current prior art biopsy guidance systems and devices used for this purpose. SUMMARY

[0012] According to one aspect of example embodiments of the present disclosure, a biopsy guidance system is provided that employs a simplified mechanical arm support that is manufactured within significantly wider mechanical tolerances than required for prior art biopsy guidance system mechanical arms in conjunction with a vision guidance and control system. The vision system operates to determine the position of the mechanical arm (such as the last segment or end effector of the mechanical arm), or the position of a biopsy tool and / or biopsy needle tip mounted to the end effector, and controls the movement / operation of the biopsy guidance system, such as at the final end pose or pre-firing position of the biopsy device, to perform the biopsy procedure. The vision system utilizes one or more cameras to visually determine the position of the mechanical arm, for example, one of the segments of the mechanical arm (such as the end effector), or the biopsy device or biopsy device needle, within the required tolerances of the biopsy procedure, without the need to provide precise position information to the mammography system through highly precise mechanical systems on the mechanical arm.

[0013] A biopsy guidance system according to exemplary embodiments of the present disclosure includes a motor-controlled robotic arm that includes a plurality of independently movable components or segments that terminate in an end effector forming the last segment of the robotic arm, and a vision system for visually determining the position of one or more segments of the robotic arm, such as the end effector, or the position of a biopsy device or needle / needle tip. The vision system includes at least one camera that is capable of determining information about the exact position of one or more of the different segments of the robotic arm, such as the end effector, the biopsy device, and / or the tip of the needle forming part of the biopsy device relative to the mammography system, and providing that information to the mammography system and the ROI determined within the 3D image dataset reconstructed from the X-ray image data obtained by the mammography system. By using the camera at the initial positioning of the end effector to visually ascertain the position of the end effector, and optionally by the end effector moving to a pre-firing position, the biopsy guidance system can use this visual determination from the camera to precisely position and guide the position of the end effector within the required tolerances of the biopsy procedure, e.g., + / - 1 mm.

[0014] The construction of the biopsy guidance system including the vision system is greatly simplified because the precise determination of the positioning of the end effector is not determined by the continuous segments of the robotic arm and end effector itself, but rather by the vision system disposed externally to the end effector. This eliminates the need for the heavy, precisely machined components, high power servo motors, and robust support structures required by prior art biopsy systems. Thus, only the construction of the robotic arm of the biopsy guidance system is required to tightly control the motion of the end effector, which can be performed by a less complex arm structure and power mechanism connected to the end effector, as the monitoring and guidance of the position of one or more segments of the robotic arm, e.g., the end effector, the biopsy device, or the tip of the needle, is provided by the external vision system.

[0015] Further, the position of the vision system components, e.g., the camera, is determined according to the structure of the mammography system with which the vision system is used, and the known motion patterns of the components of the mammography system in performing the biopsy procedure. In doing so, the camera placement provides the best field of view for the vision system of the end effector and optionally the patient breast, such as for collision management, while also accommodating the presence of other components of the mammography system and obstacles, such as the technician and patient, etc. Further, while a single camera can be used as the vision system to determine the precise position of the end effector, the use of two or more cameras mounted to the mammography system externally to the end effector increases the accuracy of the position determination of the end effector by enabling the use of stereoscopic display / computer stereo vision methods.

[0016] According to another aspect of the exemplary embodiments of this disclosure, utilizing the simplified construction of the robotic arm and end effector, there are an increased number of location options for attaching the robotic arm to the mammography system. More specifically, because the lightweight robotic arm / end effector can be mounted to the mammography system without requiring a robust mounting structure, the robotic arm / end effector can be positioned in areas previously unavailable to the mammography system, such as compression plates or movable compression frames for mounting compression plates.

[0017] According to another aspect of an exemplary embodiment of this disclosure, a mammography system operating in imaging and interventional / biopsy modes includes a gantry movably disposed on a support surface and including an X-ray source, an X-ray detector alignable to the X-ray source, and a compression paddle movable relative to the detector to hold a patient's breast therebetween; and a biopsy system mounted to the gantry, including a movable robotic arm fixed to the gantry and having a plurality of independently movable parts or sections terminating at end effectors disposed on the robotic arm opposite to the gantry. The biopsy system further includes a biopsy device mounted to the end effector opposite to a section of the robotic arm, and includes a needle operably engaged with a firing mechanism within the biopsy device to actuate the needle to obtain a biopsy sample. The mammography system also includes a control system operatively connected to the gantry to control the operation of the X-ray source and X-ray detector, thereby generating X-ray image data in the imaging mode of the mammography system and controlling the operation of the biopsy system in the interventional / biopsy mode of the mammography system. The control system includes a central processing unit and an interconnected database for processing X-ray image data from the detector; a display operatively connected to the control system for presenting information to a user; and a user interface operatively connected to the control system to enable the user to input to the control system and a vision guidance system mounted on the gantry and operatively connected to the control system. The vision system includes at least one camera operable to generate images of one or more segments of the robotic arm, an end effector, a biopsy device, and / or a needle, and to guide the movement of the biopsy system.

[0018] According to yet another aspect of the example embodiments of the present disclosure, a method for guiding a biopsy device while performing a biopsy procedure includes the steps of providing a mammography system having a gantry movably disposed on a support surface and including an x-ray source, an x-ray detector alignable with the x-ray source, and a compression paddle movable relative to the detector to secure a patient breast therebetween; a biopsy system mounted to the gantry, the biopsy system including a movable robotic arm secured to the gantry including a plurality of independently movable segments terminating at an end effector disposed on the robotic arm opposite the gantry, and optionally a biopsy device and needle operably connected to the end effector opposite the robotic arm; a control system operably connected to the gantry to control operation of the x-ray source and the x-ray detector to generate x-ray image data in an imaging mode of the mammography system, and to control operation of the biopsy guidance system in an intervention / biopsy mode of the mammography system, the control system including a central processing unit and interconnected database for processing the x-ray image data from the detector, a display operably connected to the control system for presenting information to a user, and a user interface operably connected to the control system to enable the user to input to the control system; and a visual guidance system disposed on the gantry and operably connected to the control system, the visual system including at least one camera operable to generate images of one or more of the segments of the robotic arm, such as the end effector, the biopsy device or needle, and / or the needle tip to guide movement of the biopsy system; positioning the patient breast between the detector and the compression plate; obtaining a plurality of images of the robotic arm, end effector, and biopsy device or needle using the visual guidance system to determine a position of the needle relative to the patient breast; and moving the robotic arm / biopsy system under the direction of the visual guidance system.

[0019] These and other example aspects, features, and advantages of the present application will become apparent from the following description, in connection with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0020] The accompanying drawings illustrate the best mode presently contemplated of carrying out the application.

[0021] In the drawings:

[0022] Figure 1 is a schematic side view of a mammography system including a biopsy system with visual guidance according to an example embodiment of the present application.

[0023] Figure 2A is Figure 1schematic side view of a mammography system showing a monitored volume to be observed by a vision-guided biopsy system.

[0024] Figure 2B is Figure 1 schematic front view of a mammography system showing a monitored volume to be observed by a vision-guided biopsy system.

[0025] Figure 2C is Figure 1 schematic top view of a mammography system showing a monitored volume to be observed by a vision-guided biopsy system.

[0026] Figure 3A is Figure 1 schematic front view of a mammography system showing a placement volume in which a vision system of a vision-guided biopsy system can be positioned.

[0027] Figure 3B is Figure 1 schematic top view of a mammography system showing a placement volume in which a vision system of a vision-guided biopsy system can be positioned.

[0028] Figure 4A is Figure 1 schematic front view of a mammography system showing an exemplary embodiment of alternative locations of vision system components and vision system reference points of a vision-guided biopsy system.

[0029] Figure 4B is Figure 1 schematic side view of a mammography system showing an exemplary embodiment of alternative locations of vision system components and vision system reference points of a vision-guided biopsy system.

[0030] Figure 5 is an isometric schematic view of a biopsy device of a vision-guided biopsy system mounted to a compression paddle. DETAILED DESCRIPTION

[0031] One or more specific embodiments will be described below. To provide a context for the description, it is noted that a brief summary of one or more embodiments of the disclosure is provided above. Accordingly, the following detailed description does not limit the scope of the disclosure.

[0032] When introducing elements of various embodiments of the present application, the articles "a," "an," "the" and "said" are intended to mean that there are one or more of the elements. The terms "comprising," "including" and "having" are intended to be inclusive and mean that there can be additional elements other than the listed elements. Additionally, any numerical examples in the following discussion are intended to be non-limiting and, therefore, additional numerical values, ranges and percentages are within the scope of the disclosed embodiments.

[0033] Reference is now made to Figure 1 , schematically illustrating a mammography system 1000. The mammography system 1000 represents any system capable of operating to perform mammography (MG), i.e., an X-ray imaging modality for scanning a breast for screening, diagnosis and / or interventional examination, such as 2D stereotactic mammography, i.e., two X-ray projection images of a breast taken at different angles of the X-ray source, or digital breast tomosynthesis (DBT) guided biopsy examination, which acquires several (e.g., tens of) angularly offset projection images and reconstructs a three-dimensional (3D) image dataset from the acquired X-ray image data. Spectral mammography can also be used in 2D or 3D. When the image dataset of the breast has been produced, they are used to guide a biopsy device used with the mammography system into the breast to obtain a biopsy of a region of interest (ROI) identified within the 3D image dataset.

[0034] Furthermore, it is important to note that there are multiple variations of the basic functionality and components of the mammography system 1000 described herein, but the functionality and elements presented below in the manner of the disclosed mammography system 1000 are intended to broadly cover other configurations and types of mammography systems 1000, such as but not limited to those disclosed in the following U.S. patent application publications: U.S. Patent No. US2020 / 0000442 entitled "System and method for selecting patient position and equipment configuration for a medical procedure," U.S. Patent No. 6,592,257 entitled "Removable apparatus for radiological digital imaging," and / or the GE Healthcare Senographe Pristina mammography system, the disclosures, structures and methods of operation of which are each expressly incorporated herein by reference for all purposes.

[0035] As Figure 1As shown, the generally illustrated mammography system 1000 includes a stand 51 disposed on a support surface 1002, such as a floor 1004, for supporting a gantry 10 that includes the imaging components of the mammography system 1000. The mammography system 1000 additionally includes a control system 2000 that can be incorporated as part of the stand 51, or can be spaced apart from the stand 51, or a combination thereof. The control system 2000 is operatively connected to the imaging components of the mammography system 1000 on the stand 51 and the gantry 10, and includes a processing unit 2002 with associated electronic data storage elements / database 2004 to receive and process X-ray image data from the imaging components (X-ray source 22 and detector 40) on the gantry 10 to generate image data sets and identify any ROIs present therein that require a biopsy procedure to be performed to further analyze the ROI. The control system 2000 also includes a user input 2006, such as a keyboard, mouse, touch screen, joystick, or other suitable manual controls or input devices, etc., for enabling a user to control the components of the mammography system 1000, and a display unit 2008 on which information such as operating status and / or 3D image data sets, etc., can be visually presented to the user.

[0036] The stand 51 houses a translation mechanism 60 that is operatively connected to the gantry 10 of the mammography system 1000 via suitable connections 55. The translation mechanism 60 is operable to vertically move the gantry 10 relative to the stand 51 to position the gantry 10 at an appropriate height to accommodate the size of the patient on which the mammography system 1000 is being used. Figure 3B ) relative to the patient 340.

[0037] The gantry 10 includes a generally C-shaped body 12 that includes a housing 20 at one end. Within the housing 20 is disposed an X-ray source 22 that is operable to emit X-rays 15 out of the housing 20. The X-ray source 22 is positioned opposite a sensor table / detector 40 that is disposed on and mounted to the opposite end of the body 12. In this configuration, regardless of the vertical and / or rotational orientation of the gantry 10, such as positioning the X-ray source 22 and detector 40 relative to a patient breast 35 to obtain X-ray images in various orientations, such as for cranio-caudal (CC) or mediolateral oblique (MLO) views, etc., the X-ray source 22 is disposed in alignment with the detector 40. In this position, the detector 40 is able to receive X-rays 15 from the X-ray source 22 that pass through the patient portion, i.e., the patient breast 35, between the X-ray source 22 and the detector 40 in order to generate X-ray image data for transmission to the control system 2000 of the mammography system 1000 to create a 2D mammogram image, or optionally a 3D mammogram image or reconstructed volume if utilizing multiple X-ray views, such as in DBT, for viewing by a physician, among other known methods.

[0038] Additionally, the X-ray source 22 is attachable to the body 12 of the gantry 10 to rotate and / or move independently of the gantry 10 and detector 40 in order to enable the X-ray source 22 to take X-ray images of the patient breast 35 at various angles (e.g., between + / - 60°) relative to the detector 40. The images obtained between these angles of the X-ray source 22 can be used to create stereoscopic images in a biopsy procedure using the mammography system 1000 or for DBT when operating the mammography system 1000 in imaging mode, although the mammography system 1000 can also operate in DBT or similar mode to provide biopsy guidance.

[0039] To maintain the position of the patient breast 35 stationary during imaging and / or biopsy procedures, the gantry 10 further includes a compression paddle 30 that is spaced apart from the detector 40 thereon. The compression paddle 30 is attached to a paddle support mechanism 45 that is located on and / or within the body 12 that positions the compression paddle 30 directly above and in alignment with the detector 40. The paddle support mechanism 45 is operable within the body 12 at any rotational or vertical position of the body 12 to move the compression paddle 30 in a line toward or away from the detector 40. The paddle support mechanism 45 can have any of a number of different configurations, but in the example embodiment has the form of a compression screw mechanism 50. The compression screw mechanism 50 is operable to move the compression paddle 30 into engagement with the patient breast 35 to apply a predetermined pressure / compression to the breast 35 to maintain the breast 35 in a stationary position between the compression paddle 30 and the detector 40 during imaging and biopsy procedures. Figure 1 The compression screw mechanism 50 is operable to move the compression paddle 30 into engagement with the patient breast 35 to apply a predetermined pressure / compression to the breast 35 to maintain the breast 35 in a stationary position between the compression paddle 30 and the detector 40 during imaging and biopsy procedures.

[0040] A biopsy system 23 is also provided on the gantry 10. The biopsy system 23 includes Figure 5 A robotic arm 25 is best shown, which is optionally removably movably mounted to the gantry 10. In the example exemplary embodiment, the robotic arm 25 includes a plurality of different and independently articulatable component segments or sections 33 connected to one another and to various motors / power mechanisms 34 that provide a plurality of different degrees of movement to the robotic arm 25 to enable the robotic arm 25 to be positioned at a desired orientation and spacing relative to a patient breast 35 positioned between the compression paddle 30 and the detector 40.

[0041] The robotic arm 25 extends away from the compression paddle 30 and terminates at an end effector 29, which in the example exemplary embodiment is a movable component on the robotic arm 25 positioned opposite the compression paddle 30 or a section 33 of the robotic arm positioned opposite the paddle 30 Figure 5 The end effector 29 supports thereon a biopsy device 28 that includes a biopsy needle 27 secured thereto, with the needle 27 having a needle tip 31 disposed opposite the biopsy device 28. The biopsy device 28 can be operated to move or fire the needle 27 relative to the biopsy device 28 in a manner that enables the needle 27 to obtain a biopsy of the patient breast 35. The range of movement of the robotic arm 25 allows the biopsy device 28 to be rotated at least + / - 90° about an axis that extends through the patient breast 35 and that is parallel to the rotational axis of the sensor table / detector 40.

[0042] Opposite the biopsy device 28, the robotic arm 25 is optionally detachably mounted to the gantry 10 in the example exemplary embodiment to enable the robotic arm 25 to be fully supported by the gantry 10. In addition, the robotic arm 25 includes operative connections between the power mechanisms 34 (e.g., servo motors) and other positioning devices such as potentiometers and brakes (not shown) through the gantry 10 that are provided on the end effector 29 and other components / sections 33 of the robotic arm 25 to enable the control of these power mechanisms 34 via the control system 2000 to position the biopsy device 28 where needed. While the robotic arm 25 can be mounted to the gantry 10 at any suitable location to place the end effector 29, biopsy device 28 and needle 27 in close proximity to the patient breast 35, such as on the detector 40, in the example exemplary embodiment of Figure 1 The robotic arm 25 is fixed to the compression paddle 30 in the example exemplary embodiment. In this position, the robotic arm 25 and biopsy device 28 provided thereon are movable with the compression paddle 30 by the paddle support mechanism 45.

[0043] Reference is now made to Figures 1 to 3BAlso forming part of the biopsy system 23 is a visual motion guidance system 400, which includes one or more light imaging devices, including but not limited to a structured light system, an infrared (IR) depth sensor or camera 402. The visual system 400 is operably controlled by the control system 2000 to obtain images of the biopsy device 28 and its constituent components, including the end effector 29, the needle 27 and the needle tip 31. The control system 2000 uses the images obtained by the camera 402 to determine the exact position of the end effector 29 or any other segment 33 of the robotic arm 25, the biopsy device 28 and / or the needle 27 or needle tip 31 to determine the required movement of the biopsy device 28 towards the patient breast 35 when performing the biopsy procedure. Since the mammography system 1000 has generated a 3D image dataset representing the patient breast 35 from the X-ray image data obtained during the imaging procedure, thereby determining the location of the one or more ROIs within the patient breast 35 to be biopsied, the mammography system 1000 employs the image data (e.g. visual image data) from the camera 402 of the visual system 400 to position the robotic arm 25 or one or more segments 33 thereof, including the end effector 29, and / or the biopsy device 28 / needle 27 / needle tip 31 with high accuracy relative to the exact position of the ROIs 37 Figure 5 ) and subsequently accurately direct the movement of the robotic arm 25 when performing the biopsy procedure. The accuracy of the visual system 400 eliminates the need for precise mechanical control systems or mechanisms in the robotic arm 25. The visual system 400 can accurately position one or more segments 33 of the robotic arm 25, such as the end effector 29, so that only the movement of the specific segment 33 (e.g. the end effector 29) needs to be accurately controlled by the control system 2000 within the tolerances of the biopsy procedure to correctly position the biopsy device 28 / needle 27 / needle tip 31 at the required location.

[0044] In an exemplary embodiment, the camera 402 in the visual system 400 is shaped as a camera pair 410 so that the visual system 400 obtains images, e.g. synchronized RGB camera pair, from the camera pair 410, which can be used by the control system 2000 in a stereoscopic display method or process to generate a 3D image of the position of the robotic arm 25 and / or the biopsy device 28 / needle 27 / needle tip 31 in order to determine the exact position of the robotic arm 25 / biopsy device 28 relative to the patient breast 35 / ROIs 37. With this precise positioning / position knowledge of the robotic arm 25 / end effector 29 and thus the biopsy device 28 / needle 27 / needle tip 31 mounted thereto, the control system 2000 can accurately control the movement / operation of the robotic arm 25 within the required location tolerances to correctly position the biopsy device 28 at the required location during the performance of the biopsy procedure.

[0045] In another exemplary embodiment, at least two camera pairs 410 Figures 4A to 4B) for use in the vision system 400 to provide images from the camera pair 410, which can be used individually and in combination with each other in a stereoscopic imaging process performed by the control system 2000 in a known manner to generate a 3D image of the precise position of the robotic arm 25 and / or end effector 29, including the biopsy device 28, needle 27 mounted to the end effector 29 and / or needle tip 31 and the position of the patient breast 35.

[0046] In all of the foregoing embodiments, the control system 2000 can use image data from the vision system 400 to locate and determine the exact position of the robotic arm 25 and / or segment 33 / end effector 29 relative to the ROI 37, and in particular, the position of the end effector 29, and thus the biopsy device 28 and associated needle 27 (e.g., the needle tip 31 of the needle 27) to guide or direct movement of the robotic arm 25 in a continuous or intermittent manner throughout all or any portion of the biopsy procedure. For example, in a particular exemplary embodiment, after the robotic arm 25 and end effector 29 are roughly and / or manually positioned adjacent to the patient breast 35, such as via user input on the control system 2000, the vision system 400 then determines the position of the end effector 29 and / or needle tip 31 relative to the ROI 37, with or without vision system 400 monitoring, and uses this information to operate the robotic arm 25 and ultimately position the end effector 29 and needle tip 31 in an end pose or pre-firing position to align the needle 27 with the ROI 37.

[0047] Referring now to Figures 2A to 2C , the cameras 402 / camera pairs 410 can be fixed to the gantry 10 at various positions, either in a fixed position or a position that is movable relative to the gantry 10, or a combination thereof. With reference to the present disclosure, those cameras 402 / camera pairs 410 designated as fixed are cameras 402 / camera pairs 410 that are fixed to the gantry 10 in a manner that the cameras 402 / camera pairs 410 remain stationary relative to the detector 40, and those designated as movable or active are cameras 402 / camera pairs 410 that are movable relative to the detector 40. For either embodiment, since the position of the cameras 402 / camera pairs 410 relative to the gantry 10 must be known, either the position is determined by the mechanical design, i.e., the mounting position of the cameras 402 / camera pairs 410 and optional rotary encoders, or by registration, where the cameras 402 / camera pairs 410 view a pattern / marking on the gantry 10 and their position can be determined using the view of the pattern / marking relative to the gantry 10, although other markerless methods for position determination can also be employed.

[0048] The position at which the camera 402 / camera pair 410 is to be mounted on the gantry 10 is determined based on the monitored volume 200 required by the camera 402 / camera pair 410 and in which the robotic arm 25, biopsy device 28 and optionally the patient breast 35 are located. This monitored volume 200 accommodates the entire range of motion of the robotic arm 25 and biopsy device 28 relative to the patient breast 35 so that the camera 402 / camera pair 410 can be positioned and determine the exact position of the robotic arm 25 and biopsy device 28 at all locations during the biopsy procedure.

[0049] In Figures 2A to 2C exemplary embodiments, a mammography system 1000 is shown (in which the housing 20 is omitted in Figure 2C ) the monitored volume 200 is defined by: a parallelepiped volume bounded by the front and back sides of the detector 40; twice the lateral extension of the biopsy device 28 supported by the robotic arm 25 fixed on the compression paddle 30 when placed in a horizontal position, and the total height of the biopsy device 28 supported by the holder fixed on the compression paddle placed in a vertical position plus the variable thickness of the patient breast 35.

[0050] Within this defined monitored volume 200, depending on the required position monitoring quality, in one mode the camera 402 / camera pair 410 of the vision system 400 can be operated to monitor the position of the biopsy device 28 and / or the robotic arm 25 / end effector 29, wherein the control system 2000 relies on the power mechanism incorporated on / in the segment 33 of the robotic arm 25 to precisely control the movement and position of the biopsy device 28 / needle 27 / needle tip 31 at the initial point of positioning both before the start of the biopsy procedure and during the biopsy operation. In the case where an improved position monitoring quality is required, in another mode the vision system 400 can be operated to monitor the position of both the end effector 29 and the biopsy device 28 / needle 27 / needle tip 31 without relying on any data from the robotic arm 25 regarding the position of the biopsy device 28 and needle tip 31.

[0051] Reference is now made to the accompanying Figures 3A to 3B With the defined volume 200, the entire robotic arm 25 and biopsy device 28 observed by the vision system 400 are located in this volume, it is subsequently possible to determine in which areas the camera 402 / camera pair 410 can be positioned around the mammography system 1000 and in what manner, e.g. fixed or active / movable, in order to provide the images required to determine the position of the robotic arm 25 / end effector 29 and / or biopsy device 28 / needle tip 31.

[0052] To provide the desired view of the monitored volume 200, the vision system 400 of the present disclosure can be formed with three specific implementation variations with respect to the configuration of the cameras 402 / camera pairs 410: 1) movable cameras 402 / camera pairs 410; 2) fixed cameras 402 / camera pairs 410; or 3) a combination of movable and fixed cameras 402 / camera pairs 410. However, regardless of the specific configuration of the cameras 402 / camera pairs 410 of the vision system 400, a determination needs to be made as to the area around and / or within the volume 200 where the cameras 402 / camera pairs 410 can be positioned to have a clear view of the volume 200 to obtain the desired images. To make this determination, a first determination is made as to the distance a particular camera 402 in the vision system 400 can be positioned from the volume 200 in order to achieve the desired images of the robotic arm 25 and biopsy device 28. To this end, this distance is identified by a monitoring sphere 300 centered in the middle of the monitored volume 200, where the radius of the monitoring sphere 300 is defined by: 1) the magnification range of the camera 402; and 2) the combined optical resolution and sensor resolution of the camera 402, where the target is a resolution of + / - 1 mm of the location of the needle 27 and / or needle tip 31. As Figures 3A to 3BThe camera placement or location volume 310, 320 will be a reduction in volume of the sphere 300 that accommodates location exclusion zones 330 resulting from obstacles at various locations around and / or inside the camera placement or location volume 310, 320 that prevent the camera from being placed at certain locations within the camera placement or location volume 310, 320. These obstacles that form the exclusion zones 330 can include, but are not limited to, shadows of different components / elements of the mammography system 1000 such as one or more of the housing 20, the detector 40, the robotic arm 25, the biopsy device 28, the compression paddle 30 and paddle support mechanism 45 and other components of the mammography system 1000, as well as the trajectory of the X-rays 15 from the X-ray source 22, and / or shadows of the patient 340 and any technician / physician (not shown) that can also be present around the mammography system 1000. Since the various procedures using the mammography system 1000 and biopsy system 23 will have different operating parameters due to differences in the examination or procedure being performed, such as the number of X-ray images required and / or the number of biopsies, and / or the size of the patient, etc., the determination of the exclusion zones 330 that form the reduction of the sphere 300 to define the camera placement or location volume 310, 320 can be defined manually and / or by the control system 2000 on a procedure-by-procedure basis. However, once the exclusion zones 330 and the camera placement or location volume 310, 320 are determined in any required manner, the exact location of the camera 402 / camera pair 410 for a procedure can be made within the camera placement or location volume 310, 320. Furthermore, if the location of the obstacles changes due to the components of the mammography system 1000 moving during different steps of the execution of the procedure phase, the control system 2000 can determine the exclusion zones 330 at each step in order to define the camera placement or location volume 310, 320 associated with each step of the procedure, enabling the accurate determination of the location of the robotic arm 25 / end effector 29 and / or the biopsy device 28 / needle tip 31 by the vision system 400.

[0053] With reference to the embodiment in which the vision system 400 includes only a movable camera 402 / camera pair 410, each camera 402 / camera pair 410 can need to be independently moved or repositioned at each step of the biopsy procedure in order to maintain an unobstructed view of the monitored volume 200 due to movement of the components of the mammography system 1000 to determine the exact position of the mechanical arm 25 / end effector 29 and / or biopsy device 28 / needle tip 31. Whether manually controlled or controlled by the control system 2000, the movement of the camera 402 / camera pair 410 is predetermined based on the camera placement or position volume 310, 320 defined by the presence of the obstruction / exclusion zone 330 during a particular configuration of the mammography system 1000 during a step or phase of the biopsy procedure. In one exemplary embodiment, to limit the number of exclusion zones 330 that need to be accounted for, as the X-ray source 22 is only used during the imaging mode for the biopsy procedure, the housing 20 can serve as a support for the active camera 402 / camera pair 410 of the vision system 400, thereby removing the housing 20 as a potential obstruction. Alternatively, or in combination with the movement of the camera 402, the X-ray source 22 can be moved from the imaging position to a parked position to allow for the removal of the X-ray source 22 as an obstruction within the camera placement or position volume 310, 320.

[0054] Additionally, with respect to the manner in which embodiments of the vision system 400 including one or more movable cameras 402 / camera pairs 410 operate, once the movable cameras 402 / camera pairs 410 are set in place in the camera placement or location volume 310, 320, it is necessary to initially operate the cameras 402 / camera pairs 410 to obtain images, such as to generate a 3D image of the location of the cameras 402 / camera pairs 410 using other cameras 402 of the vision system 400 in a stereoscopic display manner to locate the position of the cameras 402 / camera pairs 410 relative to the fixed portion of the mammography system 1000. By determining the known position of the cameras 402 / camera pairs 410 relative to at least a portion of the mammography system 1000, such as the position of the components of the mammography system 1000 to which the cameras 402 / camera pairs 410 are mounted, the position of the cameras 402, 410 can be used in subsequent stereoscopic display processes to determine the position of the mechanical arm 25 / end effector 29 and / or the biopsy device 28 / needle tip 31, the mechanical arm 25 / end effector 29 and / or the biopsy device 28 / needle tip 31 during a biopsy procedure. Further, while the position of the cameras 402 / camera pairs 410 can also be ascertained by determining the position of the cameras 402 / camera pairs 410 within the camera placement or location volume 310, 320 as previously described, due to the tolerance requirements for the position accuracy of the position of the needle tip 31, any variation in the exact position of the cameras 402 / camera pairs 410 due to variations in the support structure, such as the angle of the cameras 402 / camera pairs 410 by any support structure (not shown) holding the cameras 402 / camera pairs 410, can be compensated for by using the cameras 402 / camera pairs 410 to accurately position the cameras 402 / camera pairs 410 relative to the mammography system 1000. Once the position of the cameras 402 / camera pairs 410 is determined, the cameras 402 / camera pairs 410 can then be operated in subsequent stereoscopic display processes to define the position of the mechanical arm 25 / end effector 29 and / or the biopsy device 28 / needle tip 31 during the performance of a biopsy procedure.

[0055] Alternatively, as Figures 4A to 4BAs shown, instead of taking one or more images of the mammography system 1000 / stand 10 using a stereoscopic display process to determine the exact position of the camera 402 / camera pair 410, the mammography system 1000 can include reference points 420, 430, 440 located on the stand 10. The reference points 420, 430, 440 can be formed as optical targets that are easily located by the camera 402 / camera pair 410 and have positions that are mechanically defined by the construction of the stand 10 / mammography system 1000 or by indexed mechanical motion (e.g., mechanical design and / or encoder values). By taking images of multiple reference points 420, 430, 440, the positions of the camera 402 / camera pair 410 can be determined using the images of the reference points 420, 430, 440 and the known positions of the reference points 420, 430, 440 on the stand 10 / mammography system 1000. As Figure 4A and Figure 4B As shown, the reference points 420, 440 can be provided in multiple locations on the front or sides of certain portions of the stand 10, such as the detector 40 and paddle support mechanism 45. Additionally, the reference point 430 can be provided on the mechanical arm 25 / end effector 29 and / or biopsy device 28, such as on the top of the mechanical arm 25, to allow for easier monitoring of the position of the device 28 based on the known position of the reference point 430 on the arm 25 or other portions of the biopsy device 28.

[0056] In other embodiments of the vision system 400, the camera 402 / camera pair 410 can be provided in a fixed mounting position that does not move relative to the mammography system 1000. One configuration of a fixed camera 402 / camera pair 410 involves placing the camera 402 / camera pair 410 on a ceiling or other mounting surface (not shown) located directly above the mammography system 1000. Provided that the distance between the ceiling and the mechanical arm 25 / end effector 29 and / or biopsy device 28 / needle tip 31 within the volume 200 falls within the camera placement or position volume 310, 320 defined by the camera resolution and the exclusion zone 330 defined by any obstructions, a direct ceiling mounting of the camera 402 / camera pair 410 above the mechanical arm 25 / end effector 29 and / or biopsy device 28 / needle tip 31 can be employed. In alternative exemplary embodiments, the camera 402 / camera pair 410 can be mounted to portions of the stand 10 and / or support 51 in a fixed position as desired.

[0057] In another exemplary embodiment, the fixed mounting of the camera 402 / camera pair 410 can be accomplished directly on the gantry 10. In this configuration, the cameras 402, 410 are fixed to a portion of the gantry 10 having a known position relative to the detector 40 and to the image reference or plane in which the target ROI 37 to be biopsied is located. If there is no camera calibration performed using images from the camera 402 / camera pair 410, the cameras must be fixed relative to the detector 40 and the image plane in which the lesion / ROI 37 coordinates are set in order to provide the necessary position information from the images. With respect to the position of the camera 402 / camera pair 410 on the gantry 10, any suitable position falling within the camera placement or position volume 310, 320 can be utilized, such as on the paddle support mechanism 45.

[0058] In yet another exemplary embodiment of the biopsy system 23 including the vision system 400, the cameras 402 / camera pair 410 can be installed in a combination fixed and movable configuration, with one camera 402 / camera pair 410 disposed in a fixed position, such as those previously described, and at least one other camera 402 / camera pair 410 disposed in a movable position. In one example of this configuration, the fixed camera 402 / camera pair 410 is disposed in a position in which the fixed camera 402 / camera pair 410 can monitor the position of the robotic arm 25 / end effector 29 and / or the biopsy device 28 / needle tip 31 (although a separate second fixed camera 402 / camera pair 410 positioned on the mammography system 1000 can be used to monitor the position of the needle tip 31), while the movable or active camera 402 / camera pair 410 is operated to track the position of the needle tip 31 only. In one specific exemplary embodiment, as shown in FIGS. 18A and 18B, which can be used in an exploratory assessment biopsy procedure, the fixed camera 402 / camera pair 410 is positioned on the paddle support mechanism 45 and is combined with the movable camera 402 / camera pair 410 positioned on the front surface of the housing 20. Figure 4A and Figure 4B

[0059] ​In operation of the mammography system 1000 including the biopsy system 23 (including the robotic arm 25 / end effector 29 and biopsy device 28 / needle tip 31 and vision system 400), the vision system 400 is first calibrated for use with the mammography system 1000. To do so, in one exemplary embodiment, a dashed line (not shown) including a ROI at a known location within the dashed line is placed on the detector 40. After operating the mammography system 1000 in imaging mode to detect the ROI within the dashed line, the vision system 400 is operated to detect the same known location in the camera frame, and the camera position with respect to the image frame is then calculated. In an alternative method, after operating the mammography system 1000 in imaging mode to detect the ROI within the dashed line, the vision system 400 is operated to move the robotic arm 25 to position the biopsy device 28 in a pre-firing / end stop position, and the alignment of the needle tip 31 with the selected ROI can be checked. In an alternative method, the vision system 400 can be calibrated by first moving the robotic arm 25 to different positions. At each position, the vision system 400 is operated to locate the end pose of the robotic arm 25 (i.e., the end effector 29 and / or needle tip 31), where the position of the end pose at each position is compared to the position determined for the end pose in an X-ray image taken at the same position of the robotic arm 25.

[0060] After the vision system 400 is calibrated, when a biopsy procedure is performed after an imaging procedure by the mammography system 1000 to identify a ROI 37 within the patient breast 35, the robotic arm 25 is initially operated to roughly, e.g., manually, position the end effector 29 in an initial end pose adjacent the patient breast 35. This movement can optionally be controlled by the control system 2000 under the direction or guidance of the vision system 400, or can be done manually by the user through the user interface. Once disposed adjacent the patient breast 35 in the initial end pose, any passive sections 33 of the robotic arm 25 are locked or disabled for further movement using brakes (not shown) on the arm 25 that can be manually or automatically engaged to eliminate movement of the arm 25 and optionally the end effector 29 other than under the control of the control system 2000 and vision system 400.

[0061] After the robotic arm 25 is prepared, the vision system 400 is operated to take images of the end effector 29 and / or needle tip 31 using the camera 402 / camera pair 410. The images are used in a stereo display / computer stereo vision process to create a 3D image of the end effector 29, biopsy device 28, and / or needle tip 31, defining the position of the end effector 29, biopsy device 28, and / or needle tip 31 relative to the target ROI 37. Since the location of the ROI 37 to be biopsied within the patient breast 35 is known within the 3D image dataset of the patient breast 35 created by the previous x-ray imaging procedure, the position of the end effector 29, biopsy device 28, and / or needle tip 31 from the vision system 400 can be correlated to the ROI location determined by the x-ray imaging system.

[0062] Since the relative positions of the end effector 29, biopsy device 28, and needle tip 31, and the ROI 37 are known, the vision system 400 can operate the power mechanism on the robotic arm 25 to precisely move the end effector 29 from the initial end pose to the desired final end pose / pre-firing position of the biopsy device 28 and needle tip 31. As the robotic arm 25 is moved under the guidance of the vision system 400, the vision system 400 continuously obtains images of the end effector 29, biopsy device 28, and / or needle tip 31 in order to determine the progress of the needle tip 31 to the desired final end pose. The fine motion of the robotic arm 25 under the control of the vision system 400 can be corrected based on the updated images obtained by the camera 402 / camera pair 410 to ensure that the alignment of the needle tip 31 remains within the + / - 1 mm tolerance required for the biopsy procedure.

[0063] Alternatively, the robotic arm 25 can be manually moved to the final end pose / pre-firing position while still under the guidance of the vision system 400. In this embodiment, feedback can be provided from the vision system 400 regarding the operator’s movement of the robotic arm 25 based on the continuous monitoring of the vision system 400 of the position of the end effector 29, biopsy device 28, and / or needle tip 31 relative to the patient breast 35 / ROI 37 to enable the operator to correct the movement of the robotic arm 25 within the required tolerance. The vision system 400 can provide feedback in any suitable manner, such as braking the robotic arm 25 to provide force feedback, haptic feedback through a user input for controlling the robotic arm 25, and / or a notification on a display of the mammography system 1000, etc. After the biopsy device 28 and needle tip 31 are positioned in the desired final end pose position under the guidance of the vision system 400, either automatically or manually, the biopsy device 28 can be operated to perform the biopsy.

[0064] For example, the vision system 400 uses the camera 402 / camera pair 410 with sufficient precision to precisely define the position of the end effector 29, biopsy device 28, and / or needle tip 31 at the initial end pose position to verify that any further motion of the end effector 29 under control of the vision system 400 is also done with sufficient accuracy to place the needle tip 31 against or in the intended position in the patient breast 35 when moving the needle tip 31 from the idle position into the pre-firing position. Moreover, with this level of precision, the position tracking by the camera 402 / camera pair 410 of the vision system 400 can be used to continuously track the position of all parts of the robotic arm 25 and biopsy device 28 (e.g., the position of the mechanical components of the arm 25) individually or collectively so that their positions can be corrected in real-time throughout the biopsy procedure. Moreover, even though the vision system 400 can not be able to monitor the position of the needle tip 31 when disposed within the patient breast 35, the combined knowledge of the length of the needle 27 and the planned motion of the end effector 29, and thus the biopsy device 28 to which the needle 27 is connected, can be used to determine the length of the inserted portion of the needle 27.

[0065] In other alternative embodiments, in addition to the camera 402 / camera pair 410, the vision system 400 can include sensors (not shown) disposed on the robotic arm 25 and / or biopsy device 28. The sensors can include, but are not limited to, various position sensors such as one or more inclinometers disposed on the robotic arm 25 such as on one or more segments 33 and / or the end effector 29.

[0066] This positioning of the biopsy device 28 and robotic arm 25 / end effector 29 in a previously unavailable position on the compression paddle 30 or on the gantry 10 is enabled by the ability to significantly reduce the weight of the components forming the robotic arm 25 due to the relaxed requirements or constraints on the accuracy of movement of the robotic arm 25 due to the adoption of the vision system 400. With a lighter robotic arm 25, the vision system 400 is able to control the movement of the robotic arm 25 during the biopsy procedure with the accuracy needed to achieve the desired results similar to prior art biopsy devices.

[0067] It should be understood that the foregoing compositions, devices, and methods of the present disclosure are not limited to the particular embodiments and methods described as these can vary. It should also be understood that the terminology used herein is for the purpose of describing particular example embodiments only and is not intended to limit the scope of the present disclosure which will be limited only by the appended claims.

Claims

1. A method for guiding a biopsy system while performing a biopsy procedure, the method comprising the steps of: providing a mammography system, the mammography system comprising: a gantry disposed on a support surface and including an x-ray source, an x-ray detector alignable with the x-ray source, and compression paddles movable relative to the x-ray detector to secure a patient breast therebetween; a biopsy system mounted to the compression paddles, the biopsy system including a movable robotic arm secured to the gantry, a biopsy device disposed on the robotic arm opposite the gantry, and a biopsy needle operatively connected to the biopsy device opposite the robotic arm; a control system operatively connected to the gantry to control operation of the x-ray source and the x-ray detector to generate x-ray image data in an imaging mode of the mammography system and to control operation of the biopsy system in an intervention / biopsy mode of the mammography system, the control system including a central processing unit and interconnect database for processing the x-ray image data from the x-ray detector, a display operatively connected to the control system for presenting information to a user, and a user interface operatively connected to the control system to enable a user to input to the control system; and a visual guidance system disposed on the gantry and operatively connected to the control system, the visual guidance system including at least one camera operable to generate images of the robotic arm and the biopsy device and the biopsy needle to guide movement of the biopsy system throughout a biopsy procedure; positioning a patient breast between the x-ray detector and the compression paddles; acquiring a plurality of images of the robotic arm and the biopsy device and the biopsy needle using the visual guidance system; determining, by the control system, a position of the biopsy system relative to a region of interest from the plurality of images to determine a required movement of the robotic arm, wherein the region of interest is identified in a data set created from the x-ray image data obtained by the mammography system operating in the imaging mode; and moving, by the control system, the robotic arm to a pre-firing position to align the biopsy needle with the region of interest, the method further comprising the step of determining a placement volume for positioning of the at least one camera prior to positioning the patient breast between the x-ray detector and the compression paddles, wherein the step of determining the placement volume comprises the steps of: determining a monitored volume on the gantry; determining a monitoring sphere about the monitored volume; determining a location of an obstruction within the monitoring sphere that prevents the visual guidance system from imaging the monitored volume; and defining an exclusion zone within the monitoring sphere based on the location of the obstruction, wherein the exclusion zone modifies the monitoring sphere to the placement volume.

2. The method of claim 1, wherein the volume monitored is defined by a volume encompassing the entire range of motion of the biopsy device.

3. The method of claim 2, wherein the monitoring sphere is defined by a magnification range of the at least one camera and a combined optical resolution, sensor resolution, or a combination thereof of the at least one camera required to achieve a desired resolution of the at least one camera.

4. The method of claim 3, wherein the desired resolution of the at least one camera is selected such that positioning of an end effector can be within + / - 1 mm of a positional tolerance.

5. The method of claim 1, wherein the step of determining a location of an obstruction within the monitoring sphere includes determining a first location of an obstruction within the monitoring sphere during a first procedure step, and wherein the method further comprises the steps of: determining a second location of an obstruction within the monitoring sphere during a second procedure step; and defining an exclusion zone within the monitoring sphere for the second procedure step based on the second location of the obstruction, wherein the exclusion zone modifies the monitoring sphere to the placement volume.

6. The method of claim 1, further comprising the step of placing the at least one camera within the placement volume.

7. The method of claim 6, wherein the placement of the at least one camera within the placement volume is a fixed camera placement, a movable camera placement, or a combination thereof.

8. The method of claim 1, wherein the at least one camera comprises at least one pair of cameras, and wherein the step of obtaining the plurality of images comprises the steps of: obtaining a plurality of pairs of images from the at least one pair of cameras; and processing the plurality of pairs of images in a stereoscopic display process to generate a 3D image of the position of the robotic arm.

9. The method of claim 8, further comprising the step of manually moving the robotic arm toward an initial end pose position of the patient breast prior to obtaining the plurality of images.

10. The method of claim 9, wherein the step of moving the robotic arm comprises: comparing a position of the robotic arm at the initial end pose position identified in the x-ray image to the region of interest; and operating the robotic arm to move a tip of the biopsy needle from the initial end pose position to the pre-firing position.

11. The method of claim 10, wherein the step of operating the robotic arm comprises the steps of: continuously obtaining images from the at least one pair of cameras to update the position of the robotic arm relative to the region of interest; and moving the robotic arm within a set tolerance range based on the updated position of the robotic arm relative to the region of interest to align the tip of the biopsy needle with the region of interest.

12. A mammography system operable in an imaging mode and an intervention / biopsy mode, the mammography system comprising: a gantry disposed on a support surface and including an x-ray source, an x-ray detector alignable with the x-ray source, and a compression paddle movable relative to the x-ray detector to secure a patient breast therebetween; a biopsy system mounted to the compression paddle, the biopsy system including a movable robotic arm secured to the gantry, a biopsy device disposed on the robotic arm opposite the gantry, and a biopsy needle operatively connected to the biopsy device opposite the robotic arm; a control system operatively connected to the gantry to control operation of the x-ray source and the x-ray detector to generate x-ray image data in an imaging mode of the mammography system and to control operation of the biopsy device in an intervention / biopsy mode of the mammography system, the control system including a central processing unit and interconnect database for processing the x-ray image data from the x-ray detector to identify a region of interest, a display operatively connected to the control system for presenting information to a user, and a user interface operatively connected to the control system to enable a user to input to the control system; and a visual guidance system disposed on the gantry and operatively connected to the control system, the visual guidance system including at least one camera operable to generate a plurality of images of the robotic arm and the biopsy device and the biopsy needle to guide movement of the biopsy system throughout a biopsy procedure, wherein the control system is configured to determine a position of the biopsy system relative to the region of interest from the plurality of images generated by the visual guidance system to determine a required movement of the robotic arm and to move the robotic arm to a pre-firing position to align the biopsy needle with the region of interest, wherein the control system is further configured to determine a placement volume for positioning of the at least one camera prior to positioning the patient breast between the x-ray detector and the compression paddle, wherein determining the placement volume includes: determining a monitored volume on the gantry; determining a monitoring sphere about the monitored volume; determining a location of an obstruction within the monitoring sphere that prevents the visual guidance system from imaging the monitored volume; and defining an exclusion zone within the monitoring sphere based on the location of the obstruction, wherein the exclusion zone modifies the monitoring sphere to the placement volume.

Images