Systems and methods for lateral treatment of the breast

Abstract

An adapter for securing a biopsy guidance module to a breast imaging system includes an adapter body including a first side and an opposite second side. An armature extends from the first side of the body. A latch mechanism is disposed proximate an end of the armature distal from the first side of the body. The latch mechanism includes an adapter latch and an actuator. The adapter latch is configured to engage with an interface on the breast imaging system. The actuator engages with the adapter latch and moves the adapter latch from an unlocked position to a locked position. In the locked position, the adapter latch is releasably engaged with the interface. A retainer is disposed on the second side of the body. The retainer is configured to receive the module latch from the biopsy guidance module.

Description

[Background technology]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to and benefit of U.S. Provisional Application No. 63 / 401,842, filed August 29, 2022, filed as a PCT International Application on August 29, 2023, the disclosure of which is hereby incorporated by reference in its entirety.

[0002] (background) Mammography is a well-established method of breast imaging that can be used for breast cancer screening and diagnosis. Screening mammograms are preferably obtained annually. If a mass or calcification ("area of ​​interest") is identified during a screening mammogram, the patient may request further diagnosis. Such diagnosis may involve taking a biopsy of the area of ​​interest and analyzing the excised tissue.

[0003] Various imaging modalities have historically been used during breast biopsy. Imaging modalities include ultrasound imaging, X-ray imaging, and magnetic resonance imaging. Performing a breast biopsy typically involves positioning the patient, visualizing the area of ​​interest using imaging equipment, targeting the coordinates of the area, and retrieving cells or tissue from the targeted area. Cells or tissue can be retrieved in various ways, including through open surgery, fine needle aspiration, core needle biopsy, or vacuum-assisted biopsy. Open surgery, the most invasive procedure, is generally performed by a radiologist placing a wire into the breast while visualizing the area of ​​interest, where the wire extends into the area to be excised. The patient is then transferred to surgery, and tissue is retrieved using the wire to locate the area of ​​interest.

[0004] Fine needle aspiration, core needle biopsy, and vacuum-assisted biopsy are less invasive than open surgery, allowing cells and tissue to be obtained without the need for open surgery. All are needle biopsies; the size of the needle, and therefore the corresponding size (and number) of the biopsy samples, is the differentiating factor. In each procedure, the patient is positioned, the area of ​​interest is visualized, the needle of the biopsy device is advanced to the target area of ​​interest, and tissue is retrieved. Fine needle aspiration and core needle biopsy devices typically retrieve one tissue sample, and their advancement toward the target can be monitored using an imaging modality such as ultrasound. Vacuum-assisted biopsy devices generally have a larger needle and can extract multiple cores.

[0005] Following the biopsy procedure, a biopsy site marker can be delivered to the biopsy site under image guidance (e.g., ultrasound, x-ray imaging, etc.). The marker can be used to target the lesion during a follow-up biopsy or surgical procedure. Also, other minimally invasive procedures, such as cryoablation, can be performed under image guidance.

[0006] X-ray imaging in stereotactic mode is generally used for breast biopsy because it is desirable to visualize and target an area in a three-dimensional volume. Stereotactic biopsy uses x-ray images acquired in at least two planes to obtain volume information. The x-ray images are then processed to locate the target area of ​​interest in three-dimensional space using the principle of parallax to determine the depth or Z dimension of the target area. This imaging modality can also be used for subsequent placement of biopsy site markers, as well as for procedures such as cryoablation. Summary of the Invention [Means for solving the problem]

[0007] (summary) In one aspect, the present technology relates to an adapter for securing a biopsy guidance module to a breast imaging system, the adapter including: an adapter body including a first side and an opposite second side; an armature extending from the first side of the body; a latch mechanism disposed proximate an end of the armature distal from the first side of the body, the latch mechanism including an adapter latch and an actuator, the adapter latch configured to engage an interface on the breast imaging system, the actuator engaged with the adapter latch to move the adapter latch from an unlocked position to a locked position, where the adapter latch is releasably engaged with the interface; and a retainer disposed on the second side of the body, the retainer configured to receive a module latch from the biopsy guidance module. In one embodiment, the retainer includes a plurality of openings, one of the plurality of openings configured to receive the module latch. In another embodiment, the adapter further includes a sensor disposed within the opening configured to receive the module latch, the sensor configured to detect a position of the module latch. In yet another embodiment, the adapter further includes a first plurality of electrical contacts positioned to contact a second plurality of electrical contacts positioned on the biopsy guide module. In yet another embodiment, the adapter further includes an umbilical cord extending from the adapter, the umbilical cord communicatively coupled to at least one of the first plurality of electrical contacts.

[0008] In another embodiment of the above aspect, the retainer includes a pair of retainers, each of the pair of retainers disposed proximate opposite ends of the second side of the body. In some embodiments, the adapter further includes a hanger disposed proximate an end of the armature for liftably engaging the adapter body with an interface of the breast imaging system. In another embodiment, the latch mechanism includes an over-center mechanism.

[0009] In another aspect, the present technology relates to a breast imaging system including: a gantry; an x-ray source rotatably coupled to the gantry; a breast immobilization structure rotatably coupled to the gantry independent of the x-ray source, the breast immobilization structure including a breast support platform; a breast immobilization paddle movably coupled to a front side of the breast immobilization structure, movably engaged with the front side of the breast immobilization structure and moving substantially orthogonally relative to the breast support platform; a pair of interfaces on a rear side and at least one of two lateral sides of the breast immobilization structure for selectively operably connecting an adapter for a biopsy guidance module to the breast immobilization structure; and an x-ray detector disposed below the breast support platform. In certain examples, a first interface of the pair of interfaces is disposed on the rear side of the breast immobilization structure on a first side of a division axis of the breast immobilization structure, and a second interface of the pair of interfaces is disposed on the rear side of the breast immobilization structure on a second side of the division axis of the breast immobilization structure. In another embodiment, the first interface includes a first plate facing toward a first of the two lateral sides of the breast imaging system, and the second interface includes a second plate facing toward a second of the two lateral sides of the breast imaging system. In yet another embodiment, each of the pair of interfaces includes an interface retainer for receiving an adapter latch on the adapter. In yet another embodiment, each of the pair of interfaces includes a hanger structure for selectively engaging the adapter with the interface.

[0010] In another embodiment of the above aspect, the hanger structure includes an opening in each of the pair of interfaces.In one embodiment, the breast imaging system includes two substantially identical umbilical ports.

[0011] In another aspect, the present technology relates to a method of attaching a biopsy guidance module to a breast imaging system having a breast immobilization structure including a breast support platform, the method including positioning the breast immobilization structure in an adapter-loaded position, engaging the adapter with the breast immobilization structure at an interface of the breast imaging system, selectively latching the adapter to the interface, positioning the breast immobilization structure in a procedure-ready position, engaging the biopsy guidance module with the adapter, and selectively latching the biopsy guidance module to the adapter. In one embodiment, positioning the breast immobilization structure in the procedure-ready position includes engaging an umbilical cord from the adapter with a port on the breast imaging system. In another embodiment, in the procedure-ready position, the interface is substantially vertical, and in the adapter-loaded position, the interface is disposed at an angle relative to the procedure-ready position. In yet another embodiment, the angle is approximately 90 degrees. In yet another embodiment, the method further includes disengaging the biopsy guidance module from a front side of the breast immobilization structure prior to engaging the biopsy guidance module with the adapter. In another embodiment, engaging the adapter with the breast immobilization structure includes activating a secondary lock. [Brief explanation of the drawings]

[0012] [Figure 1] FIG. 1 depicts an X-ray imaging system incorporating a treatment guidance module.

[0013] [Figure 2] FIG. 2 depicts an example of a therapy guidance module with an on-board biopsy device.

[0014] [Figure 3A] 3A and 3B are partial perspective views of another X-ray imaging system and treatment guidance module. [Figure 3B] 3A and 3B are partial perspective views of another X-ray imaging system and treatment guidance module.

[0015] [Figure 4] FIG. 4 is a side view of the therapy guidance module.

[0016] [Figure 5] FIG. 5 is a top view of the therapy guidance module.

[0017] [Figure 6] 6A and 6B are partial front perspective and front views, respectively, of an X-ray imaging system with a treatment guidance module in a lateral orientation.

[0018] [Figure 7A] 7A and 7B are top and bottom perspective views, respectively, of an adapter for securing a therapy guidance module to an X-ray imaging system in a lateral orientation. [Figure 7B] 7A and 7B are top and bottom perspective views, respectively, of an adapter for securing a therapy guidance module to an X-ray imaging system in a lateral orientation.

[0019] [Figure 8A] FIG. 8A is a perspective view of an adapter for securing a therapy guidance module to an X-ray imaging system in a lateral orientation.

[0020] [Figure 8B] FIG. 8B is a partially exploded perspective view of the adapter of FIG. 8A including an interface to an X-ray imaging system and a latch mechanism.

[0021] [Figure 8C] FIG. 8C is an upright rear view of the latch mechanism of the adapter of FIG. 8A.

[0022] [Figure 8D] FIG. 8D is a top or bottom view of the adapter of FIG. 8A.

[0023] [Figure 8E] FIG. 8E is a front view of the adapter of FIG. 8A.

[0024] [Figure 8F] 8F is a partially exploded perspective view of the retainer of the adapter and the module latch of the therapy induction module of FIG. 8A.

[0025] [Figure 9] FIG. 9 illustrates a method for attaching a treatment guidance module to an X-ray imaging system.

[0026] [Figure 10] 10A and 10B depict partial rear perspective views of a breast immobilization structure of an X-ray imaging system in an adapter-mounted position and a procedure-ready position, respectively.

[0027] [Figure 11A] FIG. 11A is a perspective view of another embodiment of a biopsy guidance module.

[0028] [Figure 11B] FIG. 11B is a perspective view of a quick connect holster mount for the therapy guidance module. DETAILED DESCRIPTION OF THE INVENTION

[0029] (Detailed explanation) Breast X-ray imaging systems, such as tomosynthesis and mammography systems, generally include an X-ray source mounted on a rotatable arm of a gantry and an X-ray detector positioned approximately normal to the X-ray source when the X-ray source is in the zero position. During tomosynthesis image acquisition, the X-ray source is rotated through a limited angular range. At various points in the X-ray source trajectory, the source is activated and images are captured by the detector. Each image captured at each point is called a projection image. A computer program is used to reconstruct a three-dimensional volume from the projection images, which is used for lesion detection.

[0030] A treatment guidance module may be affixed to an x-ray imaging system to enable image-guided treatment of a patient's breast. One such treatment is the performance of a biopsy on breast tissue. Biopsies are often performed with a needle penetrating the upper surface of the breast. For particularly thin breasts, it may be desirable to enter the breast from a lateral position. Such a lateral approach may also be used on larger breasts, as required or desired for a particular application. Lateral breast biopsies typically require additional components to enable loading of the biopsy needle in a lateral position. This can lead to additional expense or confusion if such components are misplaced within the breast imaging suite, as they may be inadvertently damaged. Other treatments may include those requiring specific image-guided targeting of the treatment site. Such treatments include, but are not limited to, placement of a biopsy site marker (usually performed following a biopsy) and cryoablation. For clarity and ease of explanation, biopsy procedures (and thus the "biopsy guidance module") are primarily described herein, but it will be understood by those skilled in the art that other treatments that benefit from targeted image-guided intervention may also be performed using the guidance system described herein.

[0031] The technology described herein incorporates an adapter into the X-ray imaging system so that the biopsy guide module (used for upright breast biopsies) can also be used for lateral breast biopsies. The adapter may be configured to provide automatic electrical connection to the biopsy guide needle and, once mounted, enable rapid communication with the X-ray imaging system. The adapter may be mounted on both sides of the breast immobilization structure so that left or right lateral biopsies can be performed. The adapter may be secured to the X-ray imaging system while the breast immobilization structure is in various positions, although some positions described herein may be particularly advantageous.

[0032] FIG. 1 depicts an X-ray imaging system 100 (which may be a mammography, tomosynthesis, or combination system) incorporating a treatment guidance module. In the depicted configuration, the treatment guidance module incorporates a biopsy device. The X-ray imaging system 100 is shown to include an acquisition workstation (AWS) 104 and a gantry 101 supporting an X-ray imaging assembly 102. Such an X-ray imaging system 100 is currently available from the assignee of the present invention under the trademark Selenia Dimensions and is representative of but one X-ray system on which the biopsy guidance module 110 described herein may be mounted. The gantry 101 supports a C-arm 103, which can move up and down along the gantry 101 to a selected height, driven by a motor controlled by a technician operating the system. The C-arm 103 carries an X-ray tube 102a at its upper end and a breast support platform 102b at its lower end. Support platform 102b covers a flat-panel X-ray image receiver 102c, which is spaced from support platform 102b by a focused anti-scatter grid 102d (which may be retractable so that it can be removed from the space between support platform 102b and receiver 102c). C-arm 103 also carries an immobilization paddle 102e between source 102a and breast support platform 102b, which is motorized to move away from support platform 102b so that the patient's breast can fit more closely between support platform 102b and paddle 102e, thereby compressing and immobilizing the patient's breast. Together, the biopsy guidance module 110 and the portion of C-arm 103 carrying immobilization paddle 102e, along with breast support platform 102b, form a "breast immobilization structure." Movement of paddle 102e is motorized and controlled by a healthcare professional. Paddles 102e of different sizes and configurations can be fitted on the gantry 101 to suit different breast sizes or imaging needs (ie, for screening or diagnostic).Additionally, as in the Selenia system currently offered by the assignee of the present invention, the technician can move the paddle 102e along the width of the support platform 102b to a position where the paddle 102e matches the position of the breast that is misaligned on the support platform 102b. The system 100 further includes other components, such as a control station 104 having interface devices such as a keyboard 104a and trackball 104b, a display screen 104c, and control and image processing equipment. The biopsy guidance module 110 can be easily mounted between the x-ray source and x-ray detector of the imaging system 102 for upright biopsy procedures. Other examples of biopsy guidance modules are described herein, for example, in the context of FIG. 11B.

[0033] 2 depicts an example of a therapy guide module 210 with a mounted biopsy device 215, although, as described above, a therapy instrument such as a cryoablation device may also be utilized. A support bracket 221 extends between handles 223a and 223b, which facilitates transport of the biopsy guide module 210. The biopsy guide module 210 includes components for controlling the movement of the biopsy device 215. The biopsy device may be, for example, an Eviva CT device manufactured and sold by Hologic, Inc. TMThe biopsy device 215 may be a vacuum-assisted biopsy device. A fixed support arm 217 extends from the guidance module to a connector 231. In one embodiment, the connector 231 connects the angular support arm 212 to the fixed support arm 217 at a fixed angle. Alternative embodiments including an adjustment mechanism for varying the angle of displacement between the angular support arm 212 and the fixed support arm 217 may be substituted herein as equivalents. A holster mount 235 is movably coupled to the angular support arm 212. The linear movement may be controlled mechanically (i.e., via an associated motor and controller) and / or manually using one or both of the thumbwheel knobs 233a and 233b. The holster mount 235 includes an attachment mechanism 236 adapted to receive the biopsy holster 213. The biopsy device 215 is located within the biopsy holster 213. A needle support 211 may advantageously be coupled to the holster mount 235 for needle stabilization. Control module 225 may be mounted to one of handles 223a or 223b via clamp 236. In other examples, control module 225a may be mounted (e.g., on support bracket 221) so as to be visible in several different orientations of the biopsy guidance module. In various embodiments, each handle 223a, 223b may include one or more electrical connectors that enable communication between the clamped control module 225 and guidance module 219, and a medical professional may move the control module to either handle 223a, 223b depending on preference. Control module 225 includes a user interface that allows a medical professional to control the biopsy procedure without having to move away from the patient. Control module 225 includes a display 228 for displaying status or other information about the biopsy and one or more buttons 227 for controlling movement of biopsy device 215 during the procedure. It is envisioned that the display may include a touchscreen interface for controlling the display and / or movement of the biopsy device during the procedure.

[0034] 3A and 3B are partial perspective views of another X-ray imaging system 300 and a treatment guidance module 310. The exemplary X-ray imaging system 300 may include a tube head 332 supporting a cone beam or other X-ray source and a compression platform 330 encasing an X-ray detector. The tube head 332 is rotatably mounted to allow the tube head to rotate generally along an angular trajectory designated by dashed line 341 in FIG. 3B. In one example, the biopsy guidance module 10 includes a clamp, hook, or other attachment element (e.g., as depicted in FIG. 4) for mounting the biopsy guidance module 310 to a C-arm 321 of the X-ray imaging system 300.

[0035] 3A and 3B, holster 313 is coupled to a holster mount (not shown) on fixed-angle arm 312, which is fixedly mounted on support arm 317 at an angle offset from normal by 10 degrees, although it will be readily understood that the offset angle may vary as required or desired for a particular application. Angling arm 312 (and therefore biopsy device 315) allows biopsy device 315 to be advanced to a desired location within a biopsy target area (generally represented by target area 350) without biopsy device 315 and holster 313 introducing artifacts into the x-ray image. As shown in FIG. 3B, cone beam 340 will extend into target area 350, but device 315 does not fall within cone beam 340. While a 10 degree fixed angle is disclosed, it should be noted that the present technology is not limited to any particular fixed angle, and it should be understood that the selected fixed angle may vary depending on the particular geometry of the imaging system and tissue removal tool. The tube head 332 may also rotate along the imaging scan angle 341, for example, during tomosynthesis imaging.

[0036] 4 is a side view of the therapy guidance module 310. In FIG. 4, line A is in a plane that is "normal" to the plane of the X-ray detector 330. Line B illustrates the angular displacement of the biopsy device 315; thus, the device 315 may be offset from the normal in angular measurements of X, depending on the application, although 10 degrees as explained above may be advantageous. As a result, the biopsy device would interfere with the biopsy imaging.

[0037] Also shown in more detail in FIG. 4 are exemplary coupling elements 350a and 350b of biopsy guide module 310. Coupling mechanisms 350a and 350b are adapted to mate with complementary features on the gantry arms. Other types of coupling elements, including latches, hooks, slots, and the like, may be readily substituted herein as equivalents. Further features of coupling elements 350a, 350b are described herein in the context of FIG. 7F.

[0038] 5 is a top view of the treatment guide module 310. Only a subset of the components are labeled for easy reference. When viewing the biopsy guide module 310 from this vantage point, the needle tip displacement or reach N resulting from the angular tilt of the biopsy guide module 310 is readily apparent.

[0039] 6A and 6B are partial front perspective and front views, respectively, of another embodiment of an X-ray imaging system 400 with a treatment guidance module 402 in a lateral orientation. FIGS. 6A and 6B are described in parallel, and not all elements or features are depicted in each figure. The biopsy guidance module 402 is secured to the X-ray imaging system 400 via an adapter 404. The adapter 404 allows the same biopsy guidance module 402 used in the upright biopsy configuration depicted in FIGS. 1-5 to be used in the lateral configuration. This has several advantages in that only a single biopsy guidance module 402 is needed. Previous lateral approaches required additional structure, such as lateral arms secured to a post of the biopsy guidance module 402, to perform a lateral biopsy procedure. These lateral arms can be cumbersome, difficult to secure to a post, and less robust than the biopsy guidance module 402 itself. The biopsy guide module 402 is secured to the adapter 404 by actuation of module latch actuators 406, two of which are depicted in FIG. 6B (only one module latch actuator 406 is visible in FIG. 6A).

[0040] 6A and 6B depict a partial view of an X-ray imaging system, i.e., a breast immobilization structure including a breast support platform 408 and a breast immobilization paddle 410, as well as a tube head. In FIGS. 6A and 6B, the components are described as "procedure-ready," in that all necessary components are connected to enable the performance of a breast treatment (e.g., a biopsy). Typically, a treatment, such as a biopsy, is performed when the imaging system 400 is in the depicted upright position (corresponding to a craniocaudal or CC orientation). In other examples, the treatment may be performed in a mediolateral oblique or MLO orientation. In this procedure-ready position depicted in FIGS. 6A and 6B, the breast immobilization structure is in an upright position (e.g., so that the patient's breast can rest on the breast support platform 408 and be immobilized by the breast immobilization paddle 408). In the procedure-ready position, the biopsy guidance module 402 is connected to an adapter 404, which, in turn, is connected to the X-ray imaging system 400, as described herein. The biopsy needle 412 affixed to the biopsy guide module 402 is generally parallel to the upper surface of the breast support platform 410. In other examples, when the biopsy guide module 402 is in the procedure-ready position of FIGS. 6A and 6B , the biopsy needle 412 may be generally parallel to the front surface of the breast support platform 410, which may abut the patient's chest wall. As used in this context, "procedure-ready" refers to a position in which a biopsy procedure may be performed on a patient's breast, although some additional adjustment of various components of the biopsy guide module 402 and / or the X-ray imaging system 400 itself may be required, desired, or otherwise considered to target an area of ​​interest in the breast. In another example, an umbilical cord 414 (containing power and / or control wiring) extending from the biopsy guide module 402 may be connected to a port 416 on the X-ray imaging system 400 in the procedure-ready position.

[0041] 7A and 7B are top and bottom perspective views, respectively, of an adapter 450 for securing a therapy guidance module to an x-ray imaging system in a lateral orientation. In this orientation, the adapter 450 may be described as “procedure-ready,” as that term is defined herein. The imaging system may be a breast imaging system 100 as depicted in FIG. 1 and elsewhere herein, while the therapy guidance module may be a biopsy guidance module 110 as depicted in FIG. 1 and elsewhere herein. FIGS. 7A and 7B are illustrated in parallel, and not all features described are depicted in both figures. The adapter 450 includes a body or housing 452 that may be configured as required or desired for a particular application. The body or housing 452 may include one or more structures that act as handles to improve its grip, positioning, and movement. For example, a handle 454 and a tie 456 may be grasped by a technician as desired. The ties 456 may each span a pair of posts 458 configured to receive a retainer 460 that engages with the therapy guidance module. An armature 462 extends from the rear of the body or housing 452. The armature 462 defines an engagement surface 464 from which extend a plurality of locking bolts 466 for locking the adapter 450 to an imaging system, as described elsewhere herein. The locking bolts 466 may be actuated by a lever arm 468, which in this configuration extends from the armature 462. An auxiliary lock 470 may secure the position of the lever 468 when in the locked position to prevent its inadvertent disengagement. The auxiliary lock 470 is depicted here as a button that may activate an electromechanical locking element. In another embodiment, the button may actuate a detent or other mechanical lock that engages (or disengages from, or otherwise prevents movement of) lever 470 or a locking structure to which lever 470 is engaged. Other secondary locking structures will be apparent to those skilled in the art.

[0042] FIG. 8A is a perspective view of an adapter 500 for securing a therapy guidance module to an X-ray imaging system in a lateral orientation. The outer body or housing 504 of the adapter 500 is depicted in dashed lines to more clearly depict the internal structure and components described herein. The housing 500a may have a form factor similar to that of the adapter depicted in FIGS. 7A and 7B or may have a different curvature, surface texture, dimensions, structure, etc. Accordingly, the housing 504 of the lateral adapter 500 is depicted as dashed lines in the following figures, while its internal components are described in more detail. Other views of the adapter 500, or portions thereof, are depicted in FIGS. 8B-8F. Accordingly, FIGS. 8A-8F are generally described in parallel, and not all depicted components are visible or marked in all views. Certain components are described only in the context of certain views. In FIG. 8A, the adapter 500 is positioned in a procedure-ready position, as described in more detail herein. Generally, when the adapter 500 is in the procedure-ready position (further depicted above in the context of FIGS. 6A and 6B ), the retainer 502 is in a generally horizontal configuration. The adapter body 504 may be configured as required or desired for a particular application (e.g., to attach to a particular x-ray imaging system or to have a particular biopsy guidance module attached thereto). The adapter 500 may also include an armature 506 extending from the rear side of the adapter body 504. A handle 508 may also extend from the armature 506 or some other portion of the adapter body 504 to make it easier to lift, move, or connect the adapter 500 to the x-ray imaging system. The retainer 502 is located at the opposite end of the adapter body 504 and generally faces toward its front side, opposite the rear side. A latch mechanism 510 is located proximate the end of the armature 506 and is utilized to selectively connect the adapter 500 to the x-ray imaging system. The adapter 500, holder 502, handle 508, latch mechanism 510, and other components are generally configured such that the adapter 500 is secured onto a first or second side of a breast immobilization structure of an X-ray imaging system.

[0043] FIG. 8B is a partially exploded perspective view of the adapter 500 of FIG. 8A , including an interface 512 of an X-ray system 516 and a latch mechanism 510. The interface 512 may include a rigid plate 514 or other structure that is firmly affixed to a rigid structural element of the X-ray imaging system 516, for example, to a breast immobilization structure 518. The plate 514 defines a plurality of openings 520, each having a receiving portion 520 a and a retaining portion 520 b. The receiving portions 520 a are configured to receive an associated bolt 522, each of which includes an enlarged head 522 a. The enlarged heads 522 a are sized to be received on the receiving portions 520 a of the opening 500. The bolt 522 is then set within the retaining portion 520 b of the opening 520, where the enlarged heads 522 a prevent removal of the bolt 522 along its axis therefrom. A lever or actuator 524, which in some embodiments may include an over-center mechanism, may then be actuated to retract the adapter 500 into intimate contact with the interface 512 of the imaging system 516. Other secure mountings, such as a bayonet mechanism, a robust electromagnet, or other systems, may also be utilized. A secondary lock 530 (here in the form of a button) may be configured to engage with the latch mechanism 510 to prevent its inadvertent disengagement. FIG. 8C is an upright rear view of the latch mechanism 510 of the adapter 500 of FIG. 8A. In this view, the difference in relative diameter or size of the enlarged head 522a compared to the bolt 522 is readily discernible.

[0044] FIG. 8D is a top or bottom view of the adapter 500 of FIG. 8A. The adapter body 504 includes two retainers 502, as described elsewhere herein, although only a single retainer is shown in this view. The retainers 502 are arranged such that a plurality of attachment element hook openings 502a are formed in the front side of the adapter 500, along with at least one latch opening 502b. These openings 502a, 502b are configured to receive a corresponding number of components, such as attachment elements (e.g., hooks) or latches, extending from a biopsy guide module (not shown). FIG. 8E is a front view of the adapter 500 of FIG. 8A, more clearly depicting the electrical contacts 526 on each of the two retainers 502. As described in the context of FIG. 8F, the electrical contacts 526 are configured to communicatively couple to corresponding contacts on a biopsy guide module (not shown) when the biopsy guide module is selectively engaged with the adapter 500. This allows for the transmission of power and control signals between the biopsy guidance module and the imaging system (eg, via the umbilical cord depicted in Figures 6A and 6B).

[0045] FIG. 8F is a partially exploded perspective view of the retainer 502 of the adapter and the module latch 600 of the therapy guidance module of FIG. 8A. In FIG. 8F, only relevant structural components are depicted for clarity (e.g., the adapter and biopsy guidance module are not shown). As described above, the retainer 502 includes at least one hook opening 502a and at least one latch opening 502b. An electrical contact pad 526 including a plurality of electrical contacts 526a is disposed on the front surface of the retainer 502. A physical switch, proximity sensor, or other sensor 528 is disposed at or near the latch opening 502b. The hook opening 502a is configured to receive a hook 600a extending from the latch module 600 of the biopsy guidance module. The latch opening 502b is configured to receive a latch 600b selectively extended from the latch module 600 by actuation of an actuator 602 thereon. Extending latch 600b into latch opening 502b draws latch module 600 (and biopsy guide module) tightly against retainer 502 (of the adapter), thus ensuring contact between the plurality of electrical contacts 526a and a corresponding number of contacts 604a on latch module 600. Although an equal number of contacts 604a are depicted in FIG. 8F, a different number of contacts may be utilized and may be contained within exposed area 604 of latch module 600. One or both sets of contacts 526a / 604a may be spring-loaded to ensure proper contact therebetween.

[0046] FIG. 9 depicts a method 700 of attaching a therapy guidance module to a breast imaging system. The imaging system may include a breast immobilization structure, such as that depicted herein, including, for example, a breast support platform. The breast imaging system may be affixed to a central location on the front side of the breast immobilization structure, a biopsy guidance module, or another therapy module. Such a configuration is depicted, for example, in FIG. 3A . Thus, method 700 may begin with optional operation 702, which disengages the biopsy guidance module from the front side of the breast immobilization structure. In an embodiment, if the biopsy guidance module is not engaged with the imaging system, method 700 may begin with operation 704, which positions the breast immobilization structure in an adapter mounting position. Such a position is depicted in FIG. 10A, which depicts a partial rear view of breast immobilization structure 750. In the adapter mounting position, breast immobilization structure 750 is rotated so that the breast support platform (not shown in FIG. 10A ) is disposed at an angle relative to the horizontal. This angle may be about 90°, about 85°, about 80°, about 75°, or about 70° from horizontal. Generally, positioning the breast support platform at such an angle may make the interface plate 752 more easily accessible for attachment of the adapter and / or biopsy guidance module. The position depicted in FIG. 10A is particularly advantageous because the (relatively lightweight) adapter can be connected to the interface plate 752, and then the (slightly heavier) biopsy guidance module can be held with its handle oriented vertically for easy attachment to the adapter. The breast immobilization structure 750 may be automatically positioned in this position, for example, by a technician pressing a button on the breast imaging system, or the breast immobilization structure 750 may be selectively rotated to the desired position.

[0047] Operation 706 is then performed, which includes engaging the adapter with breast immobilization structure 750 at the interface of the breast imaging system. This may be performed by a technician by lifting the adapter and engaging a latch assembly thereon with interface plate 752, and may optionally include engaging a secondary lock to further secure the adapter. Once engaged, operation 708 is performed, selectively latching the adapter to interface plate 752, which rigidly secures the two components. Breast immobilization structure 750 is then positioned in the procedure-ready position (operation 710), depicted in FIG. 10B. As used herein, the term "procedure-ready" refers to a position in which a patient can have their breast immobilized in breast immobilization structure 750 and a procedure, such as an imaging procedure or a biopsy procedure or other treatment or procedure, can be performed. Typically, imaging occurs prior to biopsy. In another embodiment, positioning the breast immobilization structure 750 in a procedure-ready position may include act 712, engaging an umbilical cord from an adapter with a port on the breast imaging system.

[0048] The precise angular position of the immobilization structure 750 when in the adapter-mounted position and the procedure-ready position may be as required or desired for a particular application. Furthermore, the above description describes the position in the context of a breast support platform. In another embodiment, the adapter-mounted position and the procedure-ready position may be described in the context of the position of the interface plate 752. For example, in the procedure-ready position, the interface plate 752 is generally vertical, while in the adapter-mounted position, the interface plate 752 is disposed at an angle relative to the procedure-ready position. In embodiments, the angle may be approximately 90°, approximately 85°, approximately 80°, approximately 75°, or approximately 70°. The adapter-mounted position may be any position at which the adapter can be easily mounted by the breast immobilization structure. Method 700 proceeds to operation 714, which engages a biopsy guidance module with the adapter. The biopsy guidance module may be selectively engaged to the adapter in operation 716, thereby completing preparation of the system for an additional procedure on the patient's breast.

[0049] FIG. 11A is a perspective view of another embodiment of a biopsy guidance module 900. The biopsy guidance module 900 may be used in conjunction with a biopsy device similar to that depicted in the context of FIGS. 1-5. The biopsy guidance module 900 may include a bracket 902 disposed on one or both sides of the housing 904 of the module 900. In an embodiment, the bracket 902 may be disposed near the handle 906, although other locations are contemplated. By disposing the bracket 902 on both sides of the housing 904, a biopsy controller 908 may be positioned on both sides of the biopsy guidance module 900, depending on the particular procedure and the side of the compression arm on which the biopsy guidance module 900 is mounted. The controller 908 may be affixed to an articulating arm 910 to allow for further positioning by a technician during the biopsy procedure. The distal end of the articulating arm 910 may include a mount 912 that may be removably engaged with either bracket 902. The depicted configuration utilizing brackets 902 may present an advantage to the technician in that the brackets 902 are not disposed on the handles 906, thus leaving them unencumbered for easier grasping. The biopsy guide module 900 also includes a holster mount 920, as illustrated in FIG.

[0050] 11B is a perspective view of a quick connect holster mount 920 for mounting a treatment device (not shown), such as a biopsy device. The mount 920 includes two alignment pins 922 that can mate with two alignment openings on the biopsy device. Once aligned, a wheel 924 may be manually rotated by a medical professional. Rotation of the wheel 924 rotates a mating screw 926 connected to it. The mating screw 926 engages with a threaded opening on the biopsy device for its quick attachment to the mount 920.

[0051] Illustrative examples of the systems and methods described herein are provided below. Embodiments of the systems or methods described herein may include any one or more of the following notes, and any combination thereof:

[0052] Appendix 1. An adapter for securing a biopsy guidance module to a breast imaging system, the adapter comprising: an adapter body having a first side and an opposite second side; an armature extending from the first side of the body; a latch mechanism disposed proximate to an end of the armature distal from the first side of the body, the latch mechanism comprising an adapter latch and an actuator, the adapter latch configured to engage an interface on the breast imaging system, the actuator engaged with the adapter latch to move the adapter latch from an unlocked position to a locked position, in the locked position the adapter latch is releasably engaged with the interface; and a retainer disposed on the second side of the body, the retainer configured to receive the module latch from the biopsy guidance module.

[0053] Clause 2. The adapter of Clause 1, wherein the retainer includes a plurality of openings, one of the plurality of openings configured to receive the module latch.

[0054] Clause 3. The adapter of Clause 2, further comprising a sensor disposed within the opening configured to receive the module latch, the sensor configured to detect a position of the module latch.

[0055] Appendix 4. An adapter as described in any of Appendixes 1-3, further comprising a first plurality of electrical contacts arranged to contact a second plurality of electrical contacts arranged on the biopsy guide module.

[0056] Appendix 5. An adapter as described in any of Appendixes 1-4, further comprising an umbilical cord extending from the adapter, the umbilical cord communicatively coupled to at least one of the first plurality of electrical contacts.

[0057] Clause 6. The adapter of any of clauses 1-5, wherein the retainer comprises a pair of retainers, each of the pair of retainers being positioned adjacent opposite ends of the second side of the body.

[0058] Appendix 7. An adapter according to any one of Appendixes 1-6, further comprising a hanger positioned adjacent to an end of the armature for liftably engaging the adapter body with an interface of a breast imaging system.

[0059] Appendix 8. The adapter of any one of Appendixes 1-7, wherein the latching mechanism comprises an over-center mechanism.

[0060] Appendix 9. A breast imaging system comprising: a gantry; an X-ray source rotatably coupled to the gantry; a breast immobilization structure rotatably coupled to the gantry independent of the X-ray source, the breast immobilization structure comprising: a breast support platform; a breast immobilization paddle movably coupled to a front side of the breast immobilization structure, movably engaged with the front side of the breast immobilization structure and moving substantially orthogonally relative to the breast support platform; and a pair of interfaces on a rear side and at least one of two lateral sides of the breast immobilization structure for selectively operably connecting an adapter for a biopsy guidance module to the breast immobilization structure; and an X-ray detector positioned below the breast support platform.

[0061] Appendix 10. A breast imaging system as described in Appendix 9, wherein a first interface of the pair of interfaces is positioned on a posterior side of the breast immobilization structure on a first side of the division axis of the breast immobilization structure, and a second interface of the pair of interfaces is positioned on a posterior side of the breast immobilization structure on a second side of the division axis of the breast immobilization structure.

[0062] Appendix 11. The breast imaging system of Appendix 10, wherein the first interface comprises a first plate facing toward a first of the two lateral sides of the breast imaging system, and the second interface comprises a second plate facing toward a second of the two lateral sides of the breast imaging system.

[0063] Appendix 12. A breast imaging system as described in any of Appendixes 9-11, wherein each of the interface pairs includes an interface retainer for receiving an adapter latch on the adapter.

[0064] Addendum 13. A breast imaging system as described in any of Addendums 9-12, wherein each of the pair of interfaces includes a hanger structure for selectively engaging the adapter with the interface.

[0065] Clause 14. The breast imaging system of clause 13, wherein the hanger structure comprises an opening in each of the pair of interfaces.

[0066] Addendum 15. A breast imaging system according to any one of Addendums 9-14, wherein the breast imaging system comprises two substantially identical umbilical ports.

[0067] Appendix 16. A method of attaching a biopsy guidance module to a breast imaging system having a breast immobilization structure with a breast support platform, the method including: positioning the breast immobilization structure in an adapter mounting position; engaging the adapter with the breast immobilization structure at an interface of the breast imaging system; selectively latching the adapter to the interface; positioning the breast immobilization structure in a procedure-ready position; engaging the biopsy guidance module with the adapter; and selectively latching the biopsy guidance module to the adapter.

[0068] Appendix 17. The method of Appendix 16, wherein positioning the breast immobilization structure in a procedure-ready position includes engaging an umbilical cord from the adapter with a port on the breast imaging system.

[0069] Addendum 18. The method of any of Addendums 16-17, wherein in the procedure-ready position, the interface is substantially vertical, and in the adapter-loaded position, the interface is positioned at an angle relative to the procedure-ready position.

[0070] Clause 19. The method of clause 18, wherein the angle is approximately 90 degrees.

[0071] Clause 20. The method of any of clauses 16-19, further comprising disengaging the biopsy guidance module from the front side of the breast immobilization structure prior to engaging the biopsy guidance module with the adapter.

[0072] Addendum 21. The method of any of Addendums 16-20, wherein engaging the adapter with the breast immobilization structure includes activating an auxiliary lock.

[0073] This disclosure has described several embodiments of the present technology with reference to the accompanying drawings, in which only some of the possible embodiments are shown. However, other aspects may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of possible embodiments to those skilled in the art.

[0074] Although specific embodiments have been described herein, the scope of the present technology is not limited to those specific embodiments. Those skilled in the art will recognize other embodiments or modifications that are within the scope of the present technology. Accordingly, specific structures, acts, or mediums are disclosed only as illustrative examples. Embodiments of the present technology may also combine elements or components that are generally disclosed but not explicitly illustrated in combination, unless otherwise stated herein. The scope of the present technology is defined by the following claims and any equivalents therein.

[0075] The following are the claims:

Claims

1. 1. An adapter for securing a biopsy guidance module to a breast imaging system, said adapter comprising: an adapter body having a first side and an opposing second side; an armature extending from the first side of the body; a latch mechanism disposed proximate an end of the armature distal from the first side of the body, the latch mechanism comprising an adapter latch and an actuator, the adapter latch configured to engage an interface on the breast imaging system, the actuator engaged with the adapter latch to move the adapter latch from an unlocked position to a locked position, wherein the adapter latch is releasably engaged with the interface; a retainer disposed on the second side of the body, the retainer configured to receive a module latch from the biopsy guide module; and An adapter comprising:

2. The adapter of claim 1 , wherein the retainer comprises a plurality of openings, one of the plurality of openings configured to receive the module latch.

3. The adapter of claim 2 , further comprising a sensor disposed within the opening configured to receive the module latch, the sensor configured to detect a position of the module latch.

4. The adapter of any of claims 1-3, further comprising a first plurality of electrical contacts positioned to contact a second plurality of electrical contacts positioned on the biopsy guide module.

5. The adapter of any one of claims 1-4, further comprising an umbilical cord extending from the adapter, the umbilical cord communicatively coupled to at least one of the first plurality of electrical contacts.

6. The adapter of any preceding claim, wherein the retainer comprises a pair of retainers, each of the pair of retainers being positioned adjacent opposite ends of the second side of the body.

7. The adapter of any preceding claim, further comprising a hanger positioned adjacent the end of the armature for liftably engaging the adapter body with the interface of the breast imaging system.

8. The adapter of any preceding claim, wherein the latching mechanism comprises an over-center mechanism.

9. 1. A breast imaging system comprising: The gantry and an x-ray source rotatably coupled to the gantry; a breast immobilization structure rotatably coupled to the gantry independent of the x-ray source, the breast immobilization structure comprising: a breast support platform; a breast immobilization paddle movably coupled to a front side of the breast immobilization structure, movably engaged with the front side of the breast immobilization structure, and adapted to move substantially perpendicular to the breast support platform; a pair of interfaces on a posterior side and at least one of two lateral sides of the breast immobilization structure for selectively operatively connecting an adapter for a biopsy guidance module to the breast immobilization structure; a breast immobilization structure comprising: an x-ray detector positioned below the breast support platform; A breast imaging system comprising:

10. a first interface of the pair of interfaces is disposed on a posterior side of the breast immobilization structure, on a first side of the division axis of the breast immobilization structure; 10. The breast imaging system of claim 9, wherein a second interface of the pair of interfaces is positioned on a posterior side of the breast immobilization structure, on a second side of the dividing axis of the breast immobilization structure.

11. 11. The breast imaging system of claim 10, wherein the first interface comprises a first plate facing toward a first of the two lateral sides of the breast imaging system, and the second interface comprises a second plate facing toward a second of the two lateral sides of the breast imaging system.

12. 12. A breast imaging system according to any one of claims 9 to 11, wherein each of the interface pairs comprises an interface retainer for receiving an adapter latch on the adapter.

13. 13. A breast imaging system according to any one of claims 9 to 12, wherein each of the pair of interfaces comprises a hanger structure for selectively engaging the adapter with the interface.

14. The breast imaging system of claim 13 , wherein the hanger structure comprises an opening in each of the pair of interfaces.

15. A breast imaging system according to any one of claims 9 to 14, wherein the breast imaging system comprises two substantially identical umbilical ports.

16. 1. A method of attaching a biopsy guidance module to a breast imaging system having a breast immobilization structure with a breast support platform, the method comprising: positioning a breast immobilization structure in an adapter mounting position; engaging an adapter with the breast immobilization structure at an interface of the breast imaging system; selectively latching the adapter to the interface; positioning the breast immobilization structure in a procedure-ready position; engaging the biopsy guide module with the adapter; selectively latching the biopsy guidance module to the adapter; A method comprising:

17. 17. The method of claim 16, wherein positioning the breast immobilization structure in the procedure-ready position includes engaging an umbilical cord from the adapter with a port on the breast imaging system.

18. In the procedure-ready position, the interface is generally vertical; The method of any of claims 16-17, wherein in the adapter-loaded position, the interface is positioned at an angle relative to the procedure-ready position.

19. 20. The method of claim 18, wherein the angle is approximately 90 degrees.

20. The method of any of claims 16-19, further comprising disengaging the biopsy guide module from the front side of the breast immobilization structure prior to engaging the biopsy guide module with the adapter.

21. The method of any of claims 16-20, wherein engaging the adapter with the breast immobilization structure comprises activating a secondary lock.

Images