Compression paddles for breast biopsies

Described herein are paddles for breast biopsies. A reverse paddle and a compression paddle may be used in a breast biopsy. Both paddles may each have an aperture. When pressed against the breast, the reverse paddle and the compression paddle may allow the breast to bulge out of the aperture of both paddles during the biopsy. As the breast tissue bulges out of both paddles, the breast tissue to be examined via biopsy may be enlarged, thereby lessening the use of excisional biopsies on subjects with thin breasts.

TECHNICAL FIELD

The present application relates generally to equipment for performing breast biopsies, including but not limited to compression paddles for breast biopsies.

BACKGROUND

Various types of biopsies may be performed on a breast to diagnose any potential issues with the breast (e.g., an anterior lesion within). Performing such a biopsy on a thin breast of a patient may be difficult. Moreover, performing a mammography on thin breasts can also be challenging.

SUMMARY

In stereotactic biopsies, a patient may lay horizontally facedown onto an upper horizontal surface of a table. The table may include an opening fully spanning from the upper horizontal surface to a lower horizontal surface. A breast of the patient (or subject) may be positioned through the opening, and may extend beneath the lower horizontal surface. With the breast extending through the opening of the table, a plate may be used to press the breast against another surface to expand a surface area of the breast while reducing the thickness. As the breast is compressed, a scanning device (e.g., X-ray machine) beneath the table may be pointed at the breast to perform a mammogram. If there are any lesions detected within the breast, a biopsy needle may be inserted at the location along the surface of the breast identified using the mammogram.

Under one technique, however, it may be difficult to perform such a biopsy when the breast is thin and thus does not extend sufficiently far through the opening. For example, the biopsy needle may puncture through a thin breast onto the opposite side of the breast and contact an imaging plate, resulting in damage to the imaging plate for the mammogram. In addition, the breast tissue may not envelop the biopsy device bowl, leading to poor suction within the breast. This may ensue with the patient undergoing excisional biopsy (sometimes referred to as a surgical biopsy) to diagnose any issues in the breast.

The technical problems of performing breast biopsies using such techniques may be solved by using two compression paddles with aligned openings pressed against the breast from opposite directions as discussed herein. The two paddles may include a reverse paddle and a compression paddle. The reverse paddle may each an aperture and the compression paddle may have one or more apertures. When pressed against the breast, the reverse paddle and the compression paddle may allow the breast to bulge out of the aperture of both paddles during the biopsy. As the breast tissue bulges out of both paddles, the breast tissue to be examined via biopsy may be enlarged, thereby avoiding or reducing the use of excisional biopsies on patients with thin breasts.

One aspect of the present disclosure is directed to a stereotactic biopsy reverse paddle. The reverse paddle may include a body. The body may be of a polygonal prismatic shape (e.g., a rectangular prism). A longitudinal surface of the body may define an aperture. The aperture may be of a polygonal shape (e.g., a rectangle). The aperture may be generally positioned toward a center of the longitudinal surface. The aperture may have a length and a width each ranging from 0.5″ to 4″ (inches). The aperture may at least partially engage with a portion of a breast. The longitudinal surface of the body may also include an edge portion about the aperture. The edge portion may correspond to a remainder of the longitudinal surface of the body excluding the aperture. The edge portion may at least partially engage with a portion of the breast. When the breast is pressed between the reverse paddle and a compression paddle, at least a portion may expand into the aperture of the reverse paddle and outward from a volume defined between the reverse paddle and the compression paddle.

Another aspect of the present disclosure is directed to a compression tray for stereotactic biopsy compression paddles. The compression tray may be of a polygonal prismatic shape (e.g., a rectangular prism). The compression tray may define a plurality of apertures along a longitudinal surface. Each aperture may have a diameter (or a length or width for non-circular apertures) ranging from ⅛″ to 1½″ (inches). The plurality of apertures may be arranged in a staggered layout along the longitudinal surface. A centroid of each aperture may be at a predefined distance from a centroid of an adjacent aperture. The compression tray may be inserted into a mounting bracket of compression paddle. The compression tray may at least partially engage with a portion of the breast. When the breast is pressed between the compression paddle and a reverse paddle, corresponding portions of a surface of the breast may expand out into the plurality of apertures.

Another aspect of the present disclosure is directed to a method of performing a mammographic breast localization through a compression paddle with apertures. The method may include placing a breast between a breast imaging platform and a compression paddle. The compression paddle may be of a polygonal prismatic shape (e.g., a rectangular prism). The compression tray may define a plurality of apertures along a longitudinal surface. Each aperture may have a diameter (or a length or width for non-circular apertures) ranging from ⅛″ to 1½″ (inches). The plurality of apertures may be arranged in a staggered layout on the longitudinal surface. A centroid of each aperture may be at a predefined distance from a centroid of an adjacent aperture. The method may include positioning the breast into a predefined area within the compression paddle. The method may include compressing the breast using the compression paddle and the breast imaging platform. The method may include imaging the breast, while the breast is compressing using the compression paddle and the breast imaging platform.

Another aspect of the present disclosure is directed to a system for performing breast biopsies. The system can include a mounting structure defining an opening. The system can include a first compression device. The first compression device can be received within the opening defined in the mounting structure. The first compression device can define a plurality of first apertures. The system can include a second compression device. The second compression device can define a second aperture. The second aperture can be aligned with the first compression device and be separated from the first compression device by a distance defined a breast of a subject to be biopsied to cause at least a portion of the breast to extend into the plurality of first apertures.

In some embodiments, the second compression device can be attached with a guide to set the distance between the first compression device and the second compression device. In some embodiments, the guide can include a track to align the breast with an imaging device. In some embodiments, a table can define a third aperture to position the breast of the subject over the distance defined between the first compression device and the second compression device.

In some embodiments, the second aperture of the second compression device can pass through a biopsy needle to perform the biopsy of the breast. In some embodiments, the plurality of first apertures can be arranged on the first compression device to provide a distributed compression of the breast of the subject. In some embodiments, the plurality of first apertures each can have a centroid at a predefined distance from a centroid of adjacent aperture.

In some embodiments, the first compression device can define a first central longitudinal axis aligned with a second central longitudinal axis of the second compression device. In some embodiments, the second compression device can have one or more securing elements configured to maintain the distance between the first compression device and the second compression device.

Another aspect of the present disclosure is directed to a system for performing a mammographic breast localization. The system can include a compression device. The compression device can be attached with a mounting structure. The compression device can define a plurality of apertures to provide a distributed compression of a breast of a subject. Each aperture can have a centroid at a predefined distance from a centroid of adjacent aperture. The compression device can be positioned between the imaging device and an imaging plate separated from the compression device by the breast to be imaged by the imaging device.

In some embodiments, a distance between the centroid and an edge of each aperture defined in the compression device can range between 0.125 to 1.5 inches. In some embodiments, the compression device can be received by the mounting structure to secure the compression device to the imaging device. In some embodiments, the compression device can have a polygonal prismatic shape.

Another aspect of the present disclosure is directed to a method of performing a mammographic breast localization. The method can include securing a compression device to an imaging device, the compression device defining a plurality of apertures. Each aperture can have a centroid at a predefined distance from a centroid of adjacent aperture. The method can include positioning a breast between the compression device and an imaging plate. The method can include moving the compression device and the imaging plate toward each other to provide a distributed compression of the breast of the subject along the plurality of apertures by causing least a portion of the breast to extend into the plurality of first apertures. The method can include acquiring, via the imaging device, a biomedical image of the breast positioned between the compression device and the imaging plate.

In some embodiments, the imaging device can be positioned on a first side of the compression device and the imaging plate can be positioned on a second side of the compression device, the second side opposite of the first side. In some embodiments, the imaging plate can be positioned at a posterior side of the subject and the compression device can be positioned at anterior side of the subject. In some embodiments, moving can include moving the compression device towards the imaging plate.

Another aspect of the present disclosure is directed to a method of performing biopsies. The method can include positioning a breast of a subject through a first aperture of a table on which the subject is supported. The method can include attaching a first compression device to a plate. The first compression device can define a plurality of second apertures. The method can include aligning a second compression device with the first compression device. The second compression device can define a third aperture. The method can include moving the second compression device towards the first compression device to provide a distributed compression of the breast of the subject along the plurality of second apertures by causing least a portion of the breast to extend into the plurality of second apertures.

In some embodiments, the method can include inserting a biopsy needle through the third aperture of the second compression device towards the first compression device. In some embodiments, the method can include positioning the second compression device on a track configured to move the second compression device towards the first compression device.

DETAILED DESCRIPTION

Following below are more detailed descriptions of various concepts related to, and embodiments of, inventive systems, devices, apparatuses, products, and methods for breast biopsies. It should be appreciated that various concepts introduced above and discussed in greater detail below may be implemented in any of numerous ways, as the disclosed concepts are not limited to any particular manner of implementation. Examples of specific implementations and applications are provided primarily for illustrative purposes.

Section A describes stereotactic biopsy reverse paddles.

Section B describes compression trays for stereotactic biopsy compression paddles.

Section C describes mammography through compression paddles with apertures

It should be appreciated that various concepts introduced above and discussed in greater detail below may be implemented in any of numerous ways, as the disclosed concepts are not limited to any particular manner of implementation. Examples of specific implementations and applications are provided primarily for illustrative purposes.

A stereotactic biopsy reverse paddle may include a body. The body may be of a polygonal prismatic shape (e.g., a rectangular prism as depicted). A longitudinal surface of the body may define an aperture. The aperture may be of a polygonal shape (e.g., a rectangle). The aperture may be generally positioned toward a center of the longitudinal surface. The aperture may have a length and a width (or a diameter for circular apertures) each ranging from 0.5″ to 4″ (inches). The aperture may at least partially engage with a portion of a breast. The longitudinal surface of the body may also include an edge portion about the aperture. The edge portion may correspond to a remainder of the longitudinal surface of the body excluding the aperture. The edge portion may at least partially engage with a portion of the breast. When the breast is pressed between the reverse paddle and a compression paddle, at least a portion may expand into the aperture of the reverse paddle and outward from a volume defined between the reverse paddle and the compression paddle. Referring first toFIG.1, depicted is a reverse paddle100(also referred generally as a compression device). The reverse paddle100may include body. The body may be connected to two securing elements105L and105R. A body of the reverse paddle100may define an aperture110. The aperture110may extend from one longitudinal surface of the body of the reverse paddle100to another longitudinal surface of the body on the opposite side.

Referring now toFIGS.2A-D, depicted is a reverse paddle setup on stereotactic biopsies from various perspective views. First referring to a first view200A ofFIG.2A, the reverse paddle100may be positioned generally below an opening210of a biopsy table205. The reverse paddle100may have an attachment member toward the top allowing the reverse paddle100to hang on a plate. The reverse paddle100may be centered between two head screws to ensure that the aperture110of the reverse paddle100and an aperture of a compression paddle are aligned. Now referring to a second view200B ofFIG.2B, the reverse paddle100may be installed on a guide220in line with an imaging device (e.g., an x-ray tube for mammograms). The guide220may be, for example, a track to direct the reverse paddle100to the imaging device. The imaging device can be arranged adjacent to a side of the reverse paddle100opposite to a side on which the breast is to be positioned.

Now referring to a third view200C ofFIG.2C, the reverse paddle100may be placed or attached to the guide220. Now referring to a fourth view200D ofFIG.2D, the reverse paddle110and a compression paddle230may be positioned generally beneath the opening210of the biopsy table205. The compression paddle230(also referred herein as a compression device) may also define an aperture or an opening. The aperture of the compression paddle230may be at least partially aligned with the aperture110of the reverse paddle100to allow for imaging and biopsies of the breast to be positioned between the reverse paddle100and the compression paddle230. To align, the aperture of the compression paddle230with the aperture110of the reverse paddle100may face each other. The aperture of the compression paddle230may be longitudinally aligned with the aperture110of the reverse paddle100. The compression paddle230can define or have a central longitudinal axis spanning a length of the compression paddle230. The reverse paddle100can also define or have a central longitudinal axis spanning a length of the reverse paddle100. To align the reverse paddle100and the compression paddle230, the central longitudinal axis of the compression paddle230may be substantially parallel (e.g., within 15%) with the central longitudinal axis of the reverse paddle100. With the alignment, the imaging device can be positioned on a side of the reverse paddle100opposite of the breast and the compression paddle230.

Referring now toFIGS.3A-C, depicted is a breast phantom305secured between the reverse paddle110and the compression paddle230. In lieu of the breast phantom305, a breast of a subject (e.g., a human patient) can be placed and secured between the reverse paddle110and the compression paddle230. Referring more specifically toFIG.3A, the reverse paddle110and the compression paddle230may compress against the breast phantom305. Once compressed, the breast phantom305may expand into the aperture110of the reverse paddle100. For example, at least a portion of the breast phantom305on a side in contact with the reverse paddle100can expand into the aperture110of the reverse paddle100. In addition, the breast phantom305when pressed may expand beyond a distance, a space, a volume defined between the compression paddle230and the reverse paddle100. The distance, space, or volume can encompass or hold at least a portion of the breast of the subject. The securing elements105L and105R of the reverse paddle100can be attached or secured to the compression paddle230to maintain the distance, space, or volume between the compression paddle230and the reverse paddle100. Referring toFIGS.3B and3C, the breast phantom305may extend through the opening210of the biopsy table205, and may be compressed by the reverse paddle100and the compression paddle230. As depicted, a portion of the breast phantom305may expand or bulge into the aperture110of the reverse paddle100. In this manner, the breast tissue bulging out of the reverse paddle100may result in increased thickness of the breast, allowing the patient to have a biopsy.

Referring now toFIGS.4A and4B, depicted are two views400A and400B of a biopsy of the breast305secured between the reverse paddle100and the compression paddle230. A patient may be recommended to have a stereotactic biopsy when there is a suspicious finding on the mammogram such as calcifications or a mass. After the subject arrives, the radiologist may explain the procedure to the patient to obtain consent. The technician may place the subject prone (e.g., on stomach) on the stereotactic table. The breast305to be biopsied may be placed in the opening210in the table205. The breast305may be positioned with the area of concern visualized in the window of the compression paddle230and compressed between the compression paddle230with the aperture and the reverse paddle100with the aperture110. This may create more surface area to biopsy and to cover the opening of the biopsy device. Once a lesion portion410is identified within the breast305, a biopsy needle405may be inserted through the aperture110of the reverse paddle100into the breast305to intersect the lesion portion410. The biopsy needle405may extend through the other side of the breast305and into the compression paddle230.

B. Compression Trays for Stereotactic Biopsy Compression Paddles

A compression tray for stereotactic biopsy compression paddles. The compression tray may be of a polygonal prismatic shape (e.g., a rectangular prism as depicted). The compression tray may define a plurality of apertures along a longitudinal surface. Each aperture may have a diameter (or a length or width for non-circular apertures) ranging from ⅛″ to 1½″ (inches). The plurality of apertures may be arranged in a random or staggered layout along the longitudinal surface of the compression tray. A centroid of each aperture may be at a predefined distance from a centroid of an adjacent aperture. The compression tray may be inserted into a mounting bracket of a compression paddle. The compression tray may at least partially engage with a portion of the breast. When the breast is pressed between the compression paddle and a reverse paddle, corresponding portions of a surface of the breast may expand out into the plurality of apertures.

Referring now toFIG.5, depicted is a compression paddle230with a compression tray500(sometimes referred herein as a mounting structure). The compression paddle230may be comprised of any material, such as a ceramic, a metallic, or an acrylic material. The compression paddle230may include a set of apertures. The mounting structure500may include a mounting bracket505for holding the compression tray500. Once the compression paddle230is placed and secured into the mounting bracket505, the compression paddle230may be held into the mounting bracket505using bracket mounting securing element510(e.g., a screw).

Referring now toFIGS.6A and6B, depicted are two views600A and600B of a stereotactic breast biopsy of an anterior lesion. A subject (e.g., a patient) may be recommended to have a stereotactic biopsy when there is a suspicious finding on the mammogram such as calcifications or a mass. After the subject arrives, the radiologist may explain the procedure to the subject to obtain consent. The technician may place the subject prone (e.g., on stomach) on the stereotactic table. The breast305to be biopsied may be placed in the opening210in the table205. The breast305may be positioned with the area of concern visualized in the window of the compression paddle230and compressed between the compression paddle230with the aperture and the reverse paddle100with the aperture110. By inserting the compression paddle230into the window of the compression tray500, uniform compression of the breast305may be more achievable. In the two views600A and600B, without the compression paddle230, it may be difficult to perform a stereotactic biopsy, as the breast305may be inadequately compressed. When the breast does not cover the aperture of the compression paddle230, an aluminum foil605folded over the paddle may be used to absorb the scatter.

Referring now toFIG.7A-D, depicted is stereotactic breast biopsy table and subject position in various perspectives. Referring specifically to view700A ofFIG.7A, a subject may be placed on a biopsy table to lay face down. Referring specifically to view700B ofFIG.7B, a breast of the subject may extend through an opening of the biopsy table. Referring specifically to view700C ofFIG.7C, the compression paddle may press against the breast of the subject to commence the stereotactic biopsy. Referring specifically to view700D ofFIG.7D, a tissue of the breast may expand out from the opening of the compression paddle. One point of the tissue may be marked for further inspection and analysis.

Referring now toFIG.8A-C, depicted is a setup for a stereotactic breast biopsy with the compression paddle installed with the tray with apertures in various perspectives. Referring specifically to view800A ofFIG.8A, the compression tray500may be installed with a compression paddle230with apertures. The compression tray500may be installed on a guide (e.g., the guide220) for the stereotactic biopsy. Referring specifically to view800B ofFIG.8B, when the compression tray500without the compression paddle230is pressed against the breast305, adequate compression of the breast305may be difficult to achieve, especially in an area of the breast about the nipple. Referring specifically to view800C ofFIG.8C, when the compression tray500is installed with the compression paddle230and is pressed against the breast305, the breast305may be more compressed and the surface area of the breast305available for biopsy may increase.

C. Breast Localization Through Compression Paddles with Apertures

A method of performing a mammographic breast localization through a compression paddle with apertures. The method may include placing a breast between a breast imaging platform a compression paddle. The compression paddle may be of a polygonal prismatic shape (e.g., a rectangular prism). The compression tray may define a plurality of apertures along a longitudinal surface. Each aperture may have a diameter (or a length or width for non-circular apertures) ranging from ⅛″ to 1½″ (inches). The plurality of apertures may be arranged in a staggered layout on the longitudinal surface. A centroid of each aperture may be at a predefined distance from a centroid of an adjacent aperture. The method may include positioning the breast into a predefined area or volume within the compression paddle. The method may include compressing the breast using the compression paddle and the breast imaging platform. The method may include performing a mammographic breast localization, while the breast is compressed using the compression paddle and the breast imaging platform.

Referring now toFIGS.9A-C, depicted is a compression paddle905with apertures for performing a mammographic breast localization from various perspectives shown with the dimensions of components and portions of the compression paddle905. Referring specifically to view900A, shown is a frontal view of the compression paddle905. The compression paddle905may define a set of apertures of a predefined size. The compression paddle905may be of a rectangular prismatic shape. Referring specifically to view900B, shown is a side view of the compression paddle905. The compression paddle905may be of a predefined thickness. Referring specifically to view900C, shown is an isometric view of the compression paddle905. The compression paddle905may define an aperture along one longitudinal plane. The compression paddle may have a wall along the other longitudinal plane. The wall may define the set of apertures.

Referring now toFIGS.10A-C, depicted is a setup with the compression paddle905with apertures for a breast mammography from various perspectives. A subject may be recommended to have a breast localization prior to surgery. The breast305may be positioned with the area of concern visualized in the window of the apertures of the compression paddle905and compressed by the compression paddle905. Using the compression paddle905with apertures, uniform compression of the breast305may be more achievable. Referring specifically to view1000A ofFIG.10A, an imaging device1005may include a joint or element for holding the compression paddle905over a plate as seen from an isometric perspective. Referring specifically to view1000B ofFIG.10B, the compression paddle905may be positioned over the plate of the imaging device1005as seen from the frontal perspective. The imagining device1005can acquire a biomedical image (e.g., an X-ray) of at least a portion of the breast of the subject on the plate. Referring now to view1000C ofFIG.10C, the compression paddle905may be positioned on an anterior side of a subject1010to against a breast of the subject1010. The imaging plate of the imaging device1005can be positioned on a posterior side of the subject1010. After securing the breast between the imaging plate and the compression paddle905, the biomedical image of the breast can be acquired using the imaging device1005.

Referring now toFIGS.11A and11B, depicted is the breast phantom305in the context of a mammography. Referring toFIG.11A, depicted is a plate1110with an aperture1115for performing breast localization of the breast phantom305. As the aperture1115is sized greater than an anterior portion of the breast phantom305, the plate1110may not provide adequate compression, thereby resulting in poor quality mammograms. Referring now toFIG.11B, depicted is the compression paddle905with apertures pressed against the breast phantom305. Juxtaposed with the plate1110, the compression paddle905may provide a more distributed compression of the breast phantom305, thereby yielding a greater surface area for a higher quality mammogram.

Non-limiting examples of various embodiments are disclosed herein. Features from one embodiments disclosed herein may be combined with features of another embodiment disclosed herein as someone of ordinary skill in the art would understand.

It should be noted that the orientation of various elements may differ according to other exemplary embodiments, and that such variations are intended to be encompassed by the present disclosure. It is recognized that features of the disclosed embodiments can be incorporated into other disclosed embodiments.