Systems and methods for breast lateral therapy

By designing an adapter for breast imaging system, the adapter can support lateral biopsy, solving the problem that breast biopsy is difficult to achieve lateral biopsy in the prior art, and achieving simplification of equipment and cost reduction.

CN119836266APending Publication Date: 2025-04-15HOLOGIC INC
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Patent Information

Application Number
CN202380062466.1
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2022-08-29
Filing Date
2023-08-29
Publication Date
2025-04-15

AI Technical Summary

Technical Problem

Existing mammogram technology is difficult to achieve transverse biopsy during breast biopsy, resulting in complexity of equipment and increased costs.

Method used

An adapter is designed that is able to secure the biopsy guide module to the breast imaging system, providing an automatic electrical connection and enabling a selective latch between the adapter and the breast imaging system, supporting lateral biopsy.

Benefits of technology

The lateral biopsy on the breast imaging system is realized, which simplifies the device structure, reduces costs, and improves the flexibility and efficiency of the biopsy.

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Abstract

An adapter for securing a biopsy guide module to a breast imaging system includes an adapter body including a first side and an opposing second side. The armature extends from a 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 an interface on a breast imaging system. An actuator engages the adapter latch to move the adapter latch from the unlocked position to the 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 a module latch from the biopsy guide module.
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Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application was filed on August 29, 2023 as a PCT international application, and claims priority to and the benefit of U.S. Provisional Application Serial No. 63 / 401,842 filed on August 29, 2022, the disclosure of which is hereby incorporated by reference in its entirety. Background Art

[0003] Mammography is an established breast imaging method that can be used for both breast cancer screening and diagnosis. Screening mammograms are best done annually. If a mass or calcification ("area of ​​concern") is found during a screening mammogram, the patient may need further diagnostics. Such diagnostics may involve taking a biopsy of the area of ​​concern and analyzing the removed tissue.

[0004] Historically, various imaging modalities have been used during breast biopsies. 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 removing cells or tissue from the target area. Removal of cells or tissue can be done in a variety of ways, including through open surgery, fine needle aspiration, core needle biopsy, or vacuum-assisted biopsy. Open surgery is the most invasive procedure and is usually performed by a radiologist, where a wire is placed into the breast during visualization of the area of ​​interest, with the wire extending into the area to be removed. The patient is then transferred to the operating room, and tissue is removed using the wire to locate the area of ​​interest.

[0005] 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 of these are needle biopsies, where the size of the needle, and therefore the corresponding size (and number) of the biopsy sample, 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 removed. Fine needle aspiration and core needle biopsy devices typically remove one tissue sample, and an imaging modality such as ultrasound may be used to monitor their advancement toward the target. Vacuum-assisted biopsy devices typically have larger needles and can extract multiple cores.

[0006] After the biopsy procedure, a biopsy site marker can be delivered to the biopsy site under image guidance (e.g., ultrasound, X-ray imaging, etc.). During a subsequent biopsy or surgical procedure, the marker can be used to target the lesion. In addition, other minimally invasive procedures, such as, for example, cryoablation, can be performed under image guidance.

[0007] X-ray imaging in stereotactic mode is often used for breast biopsy because it is desirable to visualize and target the area in a three-dimensional volume. Stereotactic biopsy uses X-ray images taken 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

[0008] In one aspect, the present technology is directed to an adapter for securing a biopsy guide module to a breast imaging system, the adapter comprising: an adapter body including a first side and an opposing second side; an armature extending from the first side of the body; a latch mechanism disposed near an end of the armature away from the first side of the body, wherein the latch mechanism comprises an adapter latch and an actuator, wherein the adapter latch is configured to engage an interface on the breast imaging system, and wherein the actuator engages the adapter latch to move the adapter latch from an unlocked position to a locked position, wherein in the locked position, the adapter latch is releasably engaged with the interface; and a retainer disposed on the second side of the body, wherein the retainer is configured to receive a module latch from the biopsy guide module. In an example, the retainer comprises a plurality of openings, and wherein one of the plurality of openings is configured to receive the module latch. In another example, the adapter further comprises a sensor disposed in the opening configured to receive the module latch, wherein the sensor is configured to detect a position of the module latch. In yet another example, the adapter further comprises a first plurality of electrical contacts disposed to contact a second plurality of electrical contacts disposed on the biopsy guide module. In yet another example, the adapter further comprises an umbilical cord extending from the adapter, wherein the umbilical cord is communicatively coupled to at least one electrical contact in the first plurality of electrical contacts.

[0009] In another example of the above aspect, the retainer includes a pair of retainers, wherein each retainer of the pair of retainers is disposed near an opposite end of the second side of the body. In an example, the adapter also includes a hanger disposed near an end of the armature for liftingly engaging the adapter body with an interface of a breast imaging system. In another example, the latch mechanism includes an over-center mechanism.

[0010] In another aspect, the technology relates to a breast imaging system, comprising: a gantry; an X-ray source rotatably coupled to the gantry; a breast fixation structure rotatably coupled to the gantry independently of the X-ray source, wherein the breast fixation structure comprises: a breast support platform; a breast fixation paddle movably coupled to the front side of the breast fixation structure and movably engaged with the front side of the breast fixation structure to move substantially orthogonally relative to the breast support platform; and a pair of interfaces located on the rear side and at least one of the two lateral sides of the breast fixation structure for selectively operably connecting an adapter of a biopsy guide module to the breast fixation structure; and an X-ray detector disposed below the breast support platform. In an example, a first interface in the pair of interfaces is disposed on the rear side of the breast fixation structure, located on a first side of a graticule axis of the breast fixation structure; and a second interface in the pair of interfaces is disposed on the rear side of the breast fixation structure, located on a second side of the graticule axis of the breast fixation structure. In another example, the first interface comprises a first plate facing a first lateral side of the two lateral sides of the breast imaging system, and wherein the second interface comprises a second plate facing a second lateral side of the two lateral sides of the breast imaging system. In yet another example, each of the pair of interfaces includes an interface retainer for receiving an adapter latch on the adapter. In yet another example, each of the pair of interfaces includes a hanger structure for selectively engaging the adapter with the interface.

[0011] In another example of the above aspect, the hanger structure includes an opening in each of the pair of ports.In an example, a breast imaging system includes two substantially identical umbilical ports.

[0012] In another aspect, the technology relates to a method of attaching a biopsy guide module to a breast imaging system having a breast fixation structure including a breast support platform, the method comprising: positioning the breast fixation structure in an adapter mounting position; engaging the adapter with the breast fixation structure at an interface of the breast imaging system; selectively latching the adapter to the interface; positioning the breast fixation structure in a surgery-ready position; engaging the biopsy guide module with the adapter; and selectively latching the biopsy guide module to the adapter. In an example, positioning the breast fixation structure in the surgery-ready position comprises engaging an umbilical cord piece from the adapter with a port on the breast imaging system. In another example, in the surgery-ready position, the interface is substantially vertical; and in the adapter mounting position, the interface is deployed at an angle to the surgery-ready position. In yet another example, the angle is approximately 90 degrees. In yet another example, the method further comprises disengaging the biopsy guide module from a front side of the breast fixation structure before engaging the biopsy guide module with the adapter. In another example, engaging the adapter with the breast fixation structure comprises activating a secondary lock. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 An X-ray imaging system incorporating a treatment guidance module is depicted.

[0014] Figure 2 An example of a treatment guide module with a biopsy device installed is depicted.

[0015] Figure 3A and 3B is another perspective view of a portion of an X-ray imaging system and a treatment guidance module.

[0016] Figure 4 is a side view of the treatment guidance module.

[0017] Figure 5 is a top view of the treatment guidance module.

[0018] Fig. 6A and 6B Partial front perspective and front view, respectively, of an X-ray imaging system with a treatment guidance module oriented laterally.

[0019] Fig. 7A and 7B Top and bottom perspective views, respectively, of an adapter for securing a treatment guide module to an X-ray imaging system in a lateral orientation.

[0020] Fig. 8A is a perspective view of an adapter for securing a treatment guide module to an X-ray imaging system in a lateral orientation.

[0021] Figure 8B X-ray imaging system and Fig. 8A A partially exploded perspective view of the interface of the adapter including the latch mechanism.

[0022] Figure 8C yes Fig. 8A An upright rear view of the latch mechanism of the adapter.

[0023] Fig.8D yes Fig. 8A Top or bottom view of the adapter.

[0024] Fig. 8E yes Fig. 8A Front view of the adapter.

[0025] Fig.8F yes Fig. 8A A partially exploded perspective view of the adapter holder and module latch of the treatment guide module.

[0026] Fig. 9 A method of attaching a treatment guidance module to an X-ray imaging system is described.

[0027] Fig. 10A and10B Rear partial perspective views of a breast fixation structure of an X-ray imaging system are depicted in an adapter mounted position and a surgery ready position, respectively.

[0028] Fig.11A is a perspective view of another example of a biopsy guidance module.

[0029] Fig. 11B is a perspective view of a quick connect holster mount for a treatment guidance module. DETAILED DESCRIPTION

[0030] Breast X-ray imaging systems, such as tomosynthesis and mammography systems, typically include an X-ray source mounted on a rotatable arm of a gantry and an X-ray detector positioned generally perpendicular 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 within a limited range of angles. At various points along the X-ray source trajectory, the source is activated and the detector captures an image. 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, and the three-dimensional volume is used for lesion detection.

[0031] The treatment guidance module can be fixed to the X-ray imaging system to enable image-guided treatment of the patient's breast. One such treatment is to biopsy breast tissue. Biopsy is usually performed in a way that the needle penetrates the upper surface of the breast. For particularly thin breasts, it may be desirable to enter the breast from a lateral position. This lateral approach can also be used for larger breasts, depending on the needs or expectations of a specific application. Transverse breast biopsy usually requires additional components to enable the biopsy needle to be installed in a lateral position. If these parts are not properly placed in the breast imaging suite, then this will lead to greater costs or confusion because these parts may be accidentally damaged. Other treatments may include treatments that require specific image guidance to target the treatment site. Such treatments include, but are not limited to, placing biopsy site markers (usually performed after biopsy) and cryoablation. For clarity and ease of description, this article mainly describes the biopsy procedure (and therefore the "biopsy guidance module"), but those skilled in the art will understand that other treatments that benefit from targeted image-guided interventions can also be performed using the guidance system described herein.

[0032] The technology described herein combines an adapter with an X-ray imaging system so that a biopsy guide module (used for upright breast biopsies) can also be used for lateral breast biopsies. The adapter can be configured to provide an automatic electrical connection to the biopsy guide needle, allowing rapid communication with the X-ray imaging system after installation. The adapter can be installed on either side of a breast fixation structure so that a left or right lateral biopsy can be performed. The adapter can be secured to an X-ray imaging system when the breast fixation structure of the X-ray imaging system is in a variety of positions, but some of the positions described herein may be particularly advantageous.

[0033] Figure 1An X-ray imaging system 100 (which may be a mammography, tomosynthesis, or combination system) incorporating a treatment guidance module is depicted. In the depicted configuration, the treatment guidance module includes a biopsy device. The X-ray imaging system 100 is shown as including 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 common assignee under the trade name Selenia Dimensions and represents only one X-ray system on which the biopsy guide module 110 described herein may be mounted. The gantry 101 supports a C-arm 103 that may be moved up or down the gantry 101 to a selected height by motor(s) controlled by a technician operating the system. The C-arm 103 carries an X-ray tube 102a at an upper end and a breast support platform 102b at a lower end. The support platform 102b covers a flat panel X-ray image receiver 102c, which is separated from the support platform 102b by a focusing anti-scatter grid 102d (the focusing anti-scatter grid 102d may be retractable so that it can be removed from the space between the support platform 102b and the receiver 102c). The C-arm 103 also carries a fixed paddle 102e, which is located between the source 102a and the breast support platform 102b and is maneuvered away from the support platform 102b so that the patient's breast can fit between the support platform 102b and the paddle 102e, and closer to the support platform 102b so that the patient's breast can be compressed and fixed. The portion of the C-arm 103 carrying the biopsy guide module 110 and the fixed paddle 102e together with the breast support platform 102b form a "breast fixation structure". The movement of the paddle 102e is maneuvered and controlled by a medical professional. Paddles 102e of different sizes and different configurations can be mounted on the gantry 101 to accommodate different breast sizes or imaging needs (i.e., for screening or diagnosis). In addition, 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 not centered on the support platform 102b, as in the Selenia system currently provided by the common assignee. The system 100 also includes other components, such as a control station 104 with interface devices (such as a keyboard 104a and a trackball 104b), a display screen 104c, and control and image processing facilities. The biopsy guide module 110 can be easily installed between the X-ray source and the X-ray detector of the imaging system 102 to perform an upright biopsy procedure. For example, in this article Fig. 11B Other examples of biopsy guide modules are described in the context of .

[0034] Figure 2An example of a treatment guide module 210 with a biopsy device 215 mounted thereon is depicted, but as described above, a treatment instrument such as a cryoablation device may be used. 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 manufactured and sold by Hologic. TM Vacuum assisted biopsy device. Fixed support arm 217 extends from guide module to connector 231. In one embodiment, connector 231 connects angle support arm 212 to fixed support arm 217 at a fixed angle. Alternative embodiments including adjustment mechanisms for changing the displacement angle between angle support arm 212 and fixed support arm 217 may be substituted as equivalents herein. Holster mount 235 is movably coupled to angle support arm 212. Linear movement may be mechanically controlled (i.e., via an associated motor and controller) and / or may be manually controlled using either or both of thumb wheel knobs 233a and 233b. Holster mount 235 includes an attachment mechanism 236 adapted to receive biopsy holster 213. Biopsy device 215 is located within biopsy holster 213. Needle support 211 may advantageously be coupled to holster mount 235 for needle stabilization. Control module 225 may be mounted to either of handles 223b or 223a via clamp 236. In other examples, the control module 225a can be mounted (e.g., on the support bracket 221) to be visible in multiple different orientations of the biopsy guide module. In various embodiments, each handle 223a, 223b can include one or more electrical connectors that enable communication between the clamped control module 225 and the guide module 219, and the medical professional can move the control module to either handle 223a, 223b according to preference. The control module 225 includes a user interface that enables the medical professional to control the biopsy procedure without leaving the patient. The control module 225 includes a display 228 for displaying the status or other information about the biopsy, and one or more buttons 227 for controlling the movement of the biopsy device 215 during the procedure. It is envisioned that the display may include a touch screen interface for controlling the display and / or movement of the biopsy device during the procedure.

[0035] Figure 3A and 3B 3 is a partial perspective view 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 surrounding an X-ray detector. The tube head 332 is rotatably mounted so that the tube head can be moved along the Figure 3BThe dotted line 341 generally indicates the rotation angle. In the example, the biopsy guide module 10 includes a clamp, hook or other attachment element (e.g., Figure 4 ), used to mount the biopsy guide module 310 to the C-arm 321 of the X-ray imaging system 300.

[0036] exist Figure 3A and 3B In the example of FIG. 3 , the holster 313 is coupled to a holster mount (not shown) on the fixed angle arm 312, and the fixed angle arm 312 is fixedly mounted on the support arm 317 at an angle of 10 degrees offset from the normal, but it is readily appreciated that the offset angle may be different as needed or desired for a particular application. Angling the arm 312 (and therefore the biopsy device 315) allows the biopsy device 315 to be advanced to a desired position within a biopsy target area (generally indicated by target area 350) without the biopsy device 315 and holster 313 introducing artifacts into the x-ray image. Figure 3B , the cone beam 340 will extend into the target area 350, but the device 315 will not fall within the cone beam 340. It should be noted that although a 10 degree fixed angle is disclosed, the present technology is not limited to any particular fixed angle, and it should be recognized that the selected fixed angle may vary depending on the specific geometry of the imaging system and the tissue removal tool. The tube head 332 can also be rotated along the imaging scan angle 341 during, for example, tomosynthesis imaging.

[0037] Figure 4 is a side view of the treatment guidance module 310. Figure 4 , line A lies in a plane "perpendicular" to the plane of the x-ray detector 330. Line B illustrates the angular displacement of the biopsy device 315, so the device 315 is offset from the normal by an angular measurement of X, depending on the application, but as described above 10 degrees may be advantageous. Thus, the biopsy device will interfere with the biopsy imaging.

[0038] Figure 4 Also shown in more detail are exemplary coupling elements 350a and 350b of biopsy guide module 310. Coupling mechanisms 350a and 350b are adapted to cooperate with complementary features of rack arms. Other types of coupling elements (including latches, hooks, slots, etc.) may be easily substituted for equivalents herein. Further structure of coupling elements 350a, 350b is described herein in the context of FIG. 7F.

[0039] Figure 5 is a top view of treatment guide module 310. Only a subset of components are labeled for ease of reference. When viewing biopsy guide module 310 from this angle, the displacement or reach N of the needle tip caused by the angular tilt of biopsy guide module 310 will be apparent.

[0040] Fig. 6A and 6B A partial front perspective view and a front view, respectively, of another example of an X-ray imaging system 400 having a treatment guide module 402 oriented laterally. Fig. 6A and 6B The biopsy guide module 402 is fixed to the X-ray imaging system 400 via an adapter 404. The adapter 404 allows the biopsy guide module 402 to be used in a horizontal configuration. Figure 1-5 404 is a biopsy guide module 402 that is used in the upright biopsy configuration depicted in FIG. This has a number of advantages in that only a single biopsy guide module 402 is required. Previous lateral approaches required additional structure, such as lateral arms that were secured to the post of the biopsy guide module 402 in order to perform a lateral biopsy procedure. These lateral arms can be bulky, difficult to secure to the post, and not as sturdy as the biopsy guide module 402 itself. The biopsy guide module 402 is secured to the adapter 404 by actuation of the module latch actuator 406, which is then released when the biopsy guide module 402 is released. Figure 6B Two of the module latch actuators 406 are depicted in FIG. Fig. 6A Only one module latch actuator 406 is visible).

[0041] Fig. 6A and 6B A partial view of an X-ray imaging system is depicted, namely a breast fixation structure including a breast support platform 408 and a breast fixation paddle 410, and a tube head. Fig. 6A and 6B , the components are described as "procedure-ready" because all necessary components are connected to enable breast treatment (e.g., biopsy) to be performed. Typically, treatments such as biopsies are performed when the imaging system 400 is in the upright position depicted (corresponding to a craniocaudal or CC orientation). In other examples, treatments may be performed in a mediolateral oblique or MLO orientation. Fig. 6A and 6B , the breast fixation structure is in an upright position (e.g., such that the patient's breast can rest on the breast support platform 408 and be fixed by the breast fixation paddles 408). In the surgical ready position, the biopsy guide module 402 is connected to the adapter 404, which is in turn connected to the X-ray imaging system 400, as described herein. The biopsy needle 412 fixed to the biopsy guide module 402 is substantially parallel to the upper surface of the breast support platform 410. In other examples, when the biopsy guide module 402 is in the surgical ready position, the biopsy needle 412 is substantially parallel to the upper surface of the breast support platform 410. Fig. 6A and 6B410, which may be against the patient's chest wall. As used in this context, "surgical ready" means a position in which a biopsy procedure may be performed on a patient's breast, but some additional adjustments to the various components of the biopsy guide module 402 and / or the X-ray imaging system 400 itself may be required, desired, or otherwise possible to target the area of ​​interest in the breast. In another example, an umbilical cord 414 (containing power and / or control lines) extending from the biopsy guide module 402 may be connected to a port 416 on the X-ray imaging system 400 in the surgical ready position.

[0042] Fig. 7A and 7B 4 are top and bottom perspective views, respectively, of an adapter 450 for securing a treatment guide module to an x-ray imaging system in a landscape orientation. In this orientation, the adapter 450 may be described as "surgical ready," as that term is defined herein. The imaging system may be a breast imaging system 100, such as Figure 1 and as depicted elsewhere herein, the treatment guidance module may be a biopsy guidance module 110, such as Figure 1 and as drawn elsewhere in this article. Fig. 7A and 7B Described simultaneously, and not all described features are depicted in both figures. The adapter 450 includes a body or housing 452, which can be configured as needed or desired for a particular application. The body or housing 452 may include one or more structures that act as a handle to improve its gripping, positioning, and movement. For example, a technician may grasp a handle 454 and a tie rod 456 as needed. The tie rod 456 may span a pair of pillars 458, each of which is configured to receive a retainer 460 that engages with a treatment 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 a plurality of locking bolts 466 extend 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 protrudes from the armature 462 in this configuration. An auxiliary lock 470 may secure the position of the lever 468 when in the locked position to prevent it from accidentally disengaging. The auxiliary lock 470 is depicted here as a button that can actuate an electromechanical locking element. In another example, the button may actuate a pawl or other mechanical lock that engages (or disengages, or otherwise prevents movement of) the lever 470 or a locking structure engaged by the lever 470. Other auxiliary locking structures will be apparent to those skilled in the art.

[0043] Fig. 8A5 is a perspective view of an adapter 500 for securing a treatment guide module to an X-ray imaging system in a lateral orientation. The outer body or housing 504 of the adapter 500 is depicted in phantom to more clearly depict the internal structure and components described herein. The housing 500a may have a Fig. 7A and 7B , or may have different curvatures, surface textures, dimensions, structures, etc. Thus, the housing 504 of the lateral adapter 500 is depicted in phantom in the following figures, while its internal components will be described in more detail. Figures 8B-8F Other views of the adapter 500 or portions thereof are depicted in FIG. Figures 8A-8F Often depicted simultaneously, and not every depicted component may be visible or labeled in every figure. Some components are only described in the context of certain figures. Fig. 8A In the embodiment, the adapter 500 is positioned in the surgery-ready position, as described in more detail herein. Generally speaking, when the adapter 500 is in the surgery-ready position (in Fig. 6A and 6B ), the holder 502 is in a generally horizontal configuration. The adapter body 504 can be configured as needed or desired for a particular application (e.g., to attach to a particular X-ray imaging system or to attach a particular biopsy guide module thereto). The adapter 500 can also include an armature 506 extending from a rear side of the adapter body 504. A handle 508 can also extend from the armature 506 or some other portion of the adapter body 504 to more easily lift, move, or connect the adapter 500 to the X-ray imaging system. The holder 502 is disposed at opposite ends of the adapter body 504 and generally faces a front side thereof, which is opposite to the rear side. The latch mechanism 510 is disposed near the end of the armature 506 and is used to selectively connect the adapter 500 to the X-ray imaging system. The adapter 500, the holder 502, the handle 508, the latch mechanism 510, and other components are generally configured so that the adapter 500 can be secured on a first side or a second side of a breast fixation structure of an X-ray imaging system.

[0044] Figure 8B is an interface 512 to an X-ray system 516 and Fig. 8A510. The interface 512 may include a solid plate 514 or other structure rigidly fixed to the x-ray imaging system 516, for example, to fix to the breast fixation structure 518. The plate 514 defines a plurality of openings 520, each having a receiving portion 520a and a retaining portion 520b. The receiving portion 520a is configured to receive an associated bolt 522, each bolt including an enlarged head 522a. The enlarged head 522a is sized to be received on the receiving portion 520a of the opening 500. Thereafter, the bolt 522 is disposed in the retaining portion 520b of the opening 520, wherein the enlarged head 522a prevents removal therefrom along the axis of the bolt 522. The lever or actuator 524, which in some examples may include an over-center mechanism, may then be actuated to pull the adapter 500 into close contact with the interface 512 of the imaging system 516. Other securing implementations may be utilized, such as a bayonet mechanism, a solid electromagnet, or other system.A secondary lock 530 (here in the form of a button) may be configured to engage with the latch mechanism 510 to prevent accidental disengagement thereof. Figure 8C yes Fig. 8A 500 of the adapter 500. In this figure, the relative diameter or size difference of the enlarged head 522a compared to the bolt 522 is easily discernible.

[0045] Fig.8D yes Fig. 8A 500. The adapter body 504 includes two retainers 502, as described elsewhere herein, but only a single retainer is shown in this view. The retainers 502 are arranged so that a plurality of attachment element hook openings 502a, and at least one latch opening 502b are formed on the front side of the adapter 500. These openings 502a, 502b are configured to receive a corresponding number of components protruding from a biopsy guide module (not shown), such as attachment elements (e.g., hooks) or latches. Fig. 8E yes Fig. 8A 500, and more clearly depicts the electrical contacts 526 at each of the two retainers 502. Fig.8F As described in the context of FIG. 5 , when the biopsy guide module is selectively engaged with the adapter 500, the electrical contacts 526 are configured to communicatively couple to corresponding contacts on the biopsy guide module (not shown). This allows power and control signals to be transmitted between the biopsy guide module and the imaging system (e.g., via Fig. 6A and 6B umbilical cord piece as shown in the figure).

[0046] Fig.8F yes Fig. 8AA partially exploded perspective view of the adapter holder 502 and the latch module 600 of the treatment guide module. Fig.8F , for clarity, only relevant structural components are depicted (e.g., adapters and biopsy guide modules are not shown). As described above, the holder 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 face of the holder 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 a latch module 600 of a biopsy guide module. The latch opening 502b is configured to receive a latch 600b that selectively extends 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) tight to holder (of adapter) 502, thereby ensuring contact between the plurality of electrical contacts 526a and a corresponding number of contacts 604a on latch module 600. Fig.8F The same number of contacts 604a are depicted in FIG, but a different number of contacts may be utilized and included in the exposed area 604 of the latch module 600. Either or both sets of contacts 526a / 604a may be spring biased to ensure adequate contact therebetween.

[0047] Fig. 9 A method 700 of attaching a treatment guidance module to a breast imaging system is depicted. The imaging system may be as described herein and include, for example, a breast fixation structure including a breast support platform. The breast imaging system may be fixed to a central location on the front side of the breast fixation structure, a biopsy guidance module, or other treatment module. This configuration may be used, for example, in Figure 3A Thus, method 700 may begin with optional operation 702, disengaging the biopsy guide module from the front side of the breast fixation structure. In examples where the biopsy guide module is not engaged with the imaging system, method 700 may begin with operation 704, positioning the breast fixation structure in an adapter mounting position. Fig. 10A This position is depicted in FIG, which depicts a partial rear view of the breast fixation structure 750. In the adapter mounted position, the breast fixation structure 750 is rotated so that the breast support platform ( Fig. 10A 75 (not shown) is deployed at an angle to the horizontal plane. The angle can be about 90°, about 85°, about 80°, about 75°, or about 70° to the horizontal plane. In general, positioning the breast support platform at such an angle can make the interface plate 752 more accessible for attaching an adapter and / or a biopsy guide module. Fig. 10AThe position depicted in is particularly advantageous because a (relatively light) adapter can be connected to the interface plate 752, and then the (slightly heavier) biopsy guide module can be held in a vertical orientation with the handle to facilitate attachment to the adapter. The breast fixation structure 750 can be automatically deployed to this position, for example, by a technician pressing a button on the breast imaging system, or the breast fixation structure 750 can be selectively rotated to the desired position.

[0048] Thereafter, operation 706 is performed, which includes engaging the adapter with the breast fixation structure 750 at the interface of the breast imaging system. This can be performed by the technician by lifting the adapter and engaging a latch assembly thereon with the interface plate 752, and can optionally include engaging a secondary lock to further secure the adapter. Once engaged, operation 708 is performed to selectively latch the adapter to the interface plate 752, thereby securely securing the two components. Thereafter, the breast fixation structure 750 is positioned in a surgically ready position, operation 710, which is performed in Fig. 10B As used herein, the term "surgical ready" means a position in which a patient can have her breast secured in breast securement structure 750 and can undergo a procedure such as an imaging procedure or a biopsy or other treatment or surgery. Typically, imaging occurs prior to the biopsy. In another example, positioning breast securement structure 750 in a surgical ready position may include operation 712 of engaging an umbilical cord piece from an adapter with a port on a breast imaging system.

[0049] The precise angular position of the fixation structure 750 in the adapter mounted position and the surgery ready position can be determined according to the needs or expectations of a particular application. In addition, the above description describes these positions in the context of a breast support platform. In another example, the adapter mounted position and the surgery ready position can be described in the context of the position of the interface plate 752. For example, in the surgery ready position, the interface plate 752 is substantially vertical, while in the adapter mounted position, the interface plate 752 is deployed at an angle to the surgery ready position. In an example, the angle can be about 90°, about 85°, about 80°, about 75°, or about 70°. The adapter mounted position can be any position in which the adapter can be more easily mounted to the breast fixation structure. The method 700 continues with operation 714, engaging the biopsy guide module with the adapter. In operation 716, the biopsy guide module can be selectively engaged to the adapter, thereby preparing the system for further surgery on the patient's breast.

[0050] Fig.11A 900 is a perspective view of another example of a biopsy guide module 900. Figure 1-5900 and can be used in conjunction with a biopsy device. The biopsy guide module 900 can include a bracket 902 that is disposed on one or both sides of a housing 904 of the module 900. In an example, the bracket 902 can be disposed near the handle 906, but other locations are also contemplated. By disposing the bracket 902 on both sides of the housing 904, the biopsy controller 908 can be positioned on either side of the biopsy guide module 900, depending on the needs or desires of a particular procedure, and on which side of the compression arm the biopsy guide module 900 is mounted. The controller 908 can be secured to an articulated arm 910 to enable further positioning by a technician during a biopsy procedure. The end of the articulated arm 910 can include a mount 912 that can be removably engaged with either bracket 902. The depicted configuration utilizing the bracket 902 can provide certain advantages to the technician because the bracket 902 is not disposed on the handle 906 and therefore does not obstruct the handle 906 for easier grasping. The biopsy guide module 900 also includes a holster mounting member 920, such as Fig. 11B As described in.

[0051] Fig. 11B 9 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 registration pins 922 that can mate with two registration openings on the biopsy device. Once registered, the medical professional can manually rotate the wheel 924. The rotation of the wheel 924 rotates the mating screw 926 connected thereto. The mating screw 926 engages with a threaded opening on the biopsy device to quickly attach it to the mount 920.

[0052] 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 items and any combination thereof:

[0053] Item 1. An adapter for securing a biopsy guide module to a breast imaging system, the adapter comprising: an adapter body comprising a first side and an opposing second side; an armature extending from the first side of the body; a latch mechanism disposed near an end of the armature distal from the first side of the body, wherein the latch mechanism comprises an adapter latch and an actuator, wherein the adapter latch is configured to engage an interface on the breast imaging system, and wherein the actuator engages the adapter latch to move the adapter latch from an unlocked position to a locked position, wherein in the locked position the adapter latch is releasably engaged with the interface; and a retainer disposed on the second side of the body, wherein the retainer is configured to receive the module latch from the biopsy guide module.

[0054] Clause 2. The adapter of Clause 1, wherein the retainer comprises a plurality of openings, and wherein one of the plurality of openings is configured to receive the module latch.

[0055] Clause 3. The adapter of Clause 2, further comprising a sensor disposed in the opening configured to receive the module latch, wherein the sensor is configured to detect a position of the module latch.

[0056] Clause 4. The adapter of any of Clauses 1-3, further comprising a first plurality of electrical contacts disposed in contact with a second plurality of electrical contacts disposed on the biopsy guide module.

[0057] Clause 5. The adapter of any of Clauses 1-4, further comprising an umbilical extending from the adapter, wherein the umbilical is communicatively coupled to at least one electrical contact of the first plurality of electrical contacts.

[0058] Clause 6. The adapter of any of Clauses 1-5, wherein the retainer comprises a pair of retainers, wherein each retainer of the pair of retainers is disposed proximate an opposite end of the second side of the body.

[0059] Clause 7. The adapter of any of Clauses 1-6, further comprising a hanger disposed proximate an end of the armature for liftably engaging the adapter body with an interface of a breast imaging system.

[0060] Clause 8. The adapter of any of Clauses 1-7, wherein the latch mechanism comprises an over-center mechanism.

[0061] Clause 9. A breast imaging system comprising: a gantry; an X-ray source rotatably coupled to the gantry; a breast fixation structure rotatably coupled to the gantry independent of the X-ray source, wherein the breast fixation structure comprises: a breast support platform; a breast fixation paddle movably coupled to and movably engaged with the front side of the breast fixation structure to move substantially orthogonally relative to the breast support platform; and a pair of interfaces located on a rear side and at least one of two lateral sides of the breast fixation structure for selectively operably connecting an adapter of a biopsy guide module to the breast fixation structure; and an X-ray detector disposed below the breast support platform.

[0062] Clause 10. A breast imaging system as described in Clause 9, wherein: a first interface of the pair of interfaces is deployed on the rear side of the breast fixation structure, located on a first side of a dividing axis of the breast fixation structure; and a second interface of the pair of interfaces is deployed on the rear side of the breast fixation structure, located on a second side of the dividing axis of the breast fixation structure.

[0063] Clause 11. The breast imaging system of Clause 10, wherein the first interface comprises a first plate facing a first lateral side of two lateral sides of the breast imaging system, and wherein the second interface comprises a second plate facing a second lateral side of the two lateral sides of the breast imaging system.

[0064] Clause 12. The breast imaging system of any of Clauses 9-11, wherein each interface of the pair of interfaces comprises an interface retainer for receiving an adapter latch on the adapter.

[0065] Clause 13. The breast imaging system of any of Clauses 9-12, wherein each interface of the pair of interfaces includes a hanger structure for selectively engaging the adapter with the interface.

[0066] Clause 14. The breast imaging system of Clause 13, wherein the hanger structure comprises an opening in each of the pair of interfaces.

[0067] Clause 15. The breast imaging system of any of Clauses 9-14, wherein the breast imaging system comprises two substantially identical umbilical ports.

[0068] Clause 16. A method of attaching a biopsy guide module to a breast imaging system having a breast fixation structure including a breast support platform, the method comprising: positioning the breast fixation structure in an adapter mounting position; engaging the adapter with the breast fixation structure at an interface of the breast imaging system; selectively latching the adapter to the interface; positioning the breast fixation structure in a surgically ready position; engaging the biopsy guide module with the adapter; and selectively latching the biopsy guide module to the adapter.

[0069] Clause 17. The method of Clause 16, wherein positioning the breast fixation structure in a surgically ready position comprises engaging an umbilical piece from the adapter with a port on the breast imaging system.

[0070] Clause 18. The method of any of Clauses 16-17, wherein: in the surgery-ready position, the interface is substantially vertical; and in the adapter-mounted position, the interface is deployed at an angle to the surgery-ready position.

[0071] Clause 19. The method of Clause 18, wherein the angle is approximately 90 degrees.

[0072] Clause 20. The method of any of Clauses 16-19, further comprising disengaging the biopsy guide module from the front side of the breast fixation structure before engaging the biopsy guide module with the adapter.

[0073] Clause 21. The method of any of Clauses 16-20, wherein engaging the adapter with the breast fixation structure comprises activating a secondary lock.

[0074] The present disclosure describes some examples of the present technology with reference to the accompanying drawings, of which only some possible examples are shown. However, other aspects may be implemented in many different forms and should not be construed as limited to the examples set forth herein. Instead, these examples are provided to make the present disclosure comprehensive and complete and to fully convey the scope of possible examples to those skilled in the art.

[0075] Although specific examples are described herein, the scope of the present technology is not limited to these specific examples. Those skilled in the art will recognize other examples or improvements within the scope of the present technology. Therefore, specific structures, actions, or media are disclosed only as illustrative examples. Elements or components that are generally disclosed but not explicitly combined for example may also be combined according to examples of the present technology, unless otherwise stated herein. The scope of the present technology is defined by the following claims and any equivalent forms thereof.

Claims

1. An adapter for securing a biopsy guide module to a breast imaging system, the adapter comprising: an adapter body including 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, wherein the latch mechanism includes an adapter latch and an actuator, wherein the adapter latch is configured to engage an interface on the breast imaging system, and wherein the actuator engages the adapter latch to move the adapter latch from an unlocked position to a locked position, wherein in the locked position the adapter latch releasably engages the interface; as well as A retainer is disposed on the second side of the body, wherein the retainer is configured to receive a module latch from the biopsy guide module.

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

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

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

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

6. The adapter of any one of claims 1-5, wherein the retainer comprises a pair of retainers, wherein each retainer of the pair of retainers is disposed near an opposite end of the second side of the body.

7. The adapter of any one of claims 1-6, further comprising a hanger disposed proximate an end of the armature for liftably engaging the adapter body with an interface of a breast imaging system.

8. The adapter of any one of claims 1-7, wherein the latch mechanism comprises an over-center mechanism.

9. A breast imaging system comprising: frame; an X-ray source rotatably coupled to the gantry; A breast fixation structure rotatably coupled to the gantry independently of the x-ray source, wherein the breast fixation structure comprises: Breast support platform; a breast fixation paddle movably coupled to and movably engaged with the front side of the breast fixation structure for movement substantially orthogonally relative to the breast support platform; and a pair of interfaces located on the rear side and at least one of the two lateral sides of the breast fixation structure for selectively operably connecting the adapter of the biopsy guide module to the breast fixation structure; and An X-ray detector deployed beneath the breast support platform.

10. The breast imaging system of claim 9, wherein: A first interface of the pair of interfaces is disposed on a rear side of the breast fixation structure, on a first side of a dividing axis of the breast fixation structure; and The second interface of the pair of interfaces is disposed on the rear side of the breast fixation structure, on a second side of the dividing axis of the breast fixation structure.

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

12. The breast imaging system of any of claims 9-11, wherein each interface of the pair of interfaces comprises an interface retainer for receiving an adapter latch on an adapter.

13. The breast imaging system of any one of claims 9-12, wherein each interface of the pair of interfaces includes a hanger structure for selectively engaging an adapter with the interface.

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

15. The breast imaging system of any of claims 9-14, wherein the breast imaging system comprises two substantially identical umbilical ports.

16. A method of attaching a biopsy guide module to a breast imaging system having a breast fixation structure including a breast support platform, the method comprising: Positioning the breast fixation structure at the adapter mounting location; engaging the adapter with the breast fixation structure at an interface of the breast imaging system; selectively latching the adapter to the interface; Positioning of breast fixation structures in surgically ready position; engaging the biopsy guide module with the adapter; as well as Selectively latch the biopsy guide module to the adapter.

17. The method of claim 16, wherein positioning the breast fixation structure in a surgically ready position comprises engaging an umbilical piece from the adapter with a port on the breast imaging system.

18. The method of any one of claims 16-17, wherein: In the surgical-ready position, the interface is substantially vertical; and In the adapter mounted position, the interface is deployed at an angle to the surgical ready position.

19. 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 fixation structure before engaging the biopsy guide module with the adapter.

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