X-ray breast imaging system and compression paddle for an x-ray breast imaging system

Abstract

An x-ray breast imaging system includes a compression paddle including an anterior wall and a bottom wall. The anterior wall is configured to be positioned proximate to and facing a chest wall of a patient during imaging, and the bottom wall is configured to be positioned adjacent to a length of a top of a compressed breast. The bottom wall extends away from the chest wall of the patient, wherein the bottom wall includes a first portion and a second portion such that the second portion is between the anterior wall and the first portion. The first portion and the second portion are generally non-coplanar, wherein the compression paddle is movable only along a cranial-caudal axis. The x-ray breast imaging system further includes a non-rigid cover releasably fastened to the compression paddle, the non-rigid cover positioned between the compression paddle and the patient.

Description

[0001] This application is a divisional application of the invention patent application entitled "Molybdenum Target X-ray Examination and / or Combined Breast Tomography Technique Using a Compression Paddle", with an international application date of April 24, 2014, international application number PCT / US2014 / 035334, and national application number 201480031539.1.

[0002] Cross-references to related applications

[0003] This application was filed as a PCT international patent application on April 24, 2014, and claims priority to U.S. Provisional Patent Application No. 61 / 950,983, filed March 11, 2014, and U.S. Provisional Patent Application No. 61 / 816,202, filed April 26, 2013. Pursuant to Section 120 of Title 35 of the United States Code, this application also claims priority to and is a continuation to U.S. Patent Application Serial No. 13 / 679,446, filed November 16, 2012, which, pursuant to Section 119 of Title 35 of the United States Code, claims priority to U.S. Provisional Patent Application Serial No. 61 / 561,620, filed November 20, 2011. The disclosures of each of the foregoing applications are incorporated herein by reference in their entirety. Technical Field

[0004] This application relates to an X-ray breast imaging system and a pressure paddle for the X-ray breast imaging system. Background Technology

[0005] In mammography and / or combined breast computed tomography, when sufficient force is applied to compress the breast between two rigid plastic surfaces to hold it in place and extend the breast tissue for X-ray imaging, a significant concern for the patient is the potential discomfort. One challenge is ensuring that the imaging area includes the required amount of breast tissue. Reasons for using compression include: (1) to make the breast thinner in the X-ray flux direction, thereby reducing radiation exposure to the patient from the level required to image the thicker portion of the uncompressed breast; (2) to make the breast more uniform in thickness in the X-ray flux direction, thus facilitating more uniform irradiation across the entire breast image; (3) to hold the breast in place during X-ray irradiation, thereby reducing image blurring; and (4) to allow breast tissue to emerge from the chest wall into the imaging area, thus imaging more tissue. When compressing the breast, it is generally the technician who manipulates the breast to properly position it and resists the tendency of the compression to push the breast tissue against the chest wall and out of the imaging area.

[0006] The standard clamping method for mammography and combined computed tomography uses movable, rigid, transparent plastic clamping paddles, the surfaces of which are perpendicular to each other. The breast is placed on a breast platform, which is generally flat, and then the paddles are clamped onto the breast. Typically, a technician or other healthcare professional simultaneously holds the breast in place and may manipulate it to ensure appropriate tissue coverage in the image receiver's field of view and to help stretch the breast.

[0007] One reason patients may feel discomfort is that the pressure is not evenly distributed across the entire breast. The pressure is concentrated on the thickest part of the breast, typically near the chest wall, the lower anterior edge of the paddle, and the upper anterior angle of the breast plateau. The anterior part of the breast, such as near the nipple, may receive less pressure, or no pressure at all. The paddle may not even contact this part of the breast. The terms anterior, inferior, and superior refer to the use of the CC imaging orientation, where the patient faces the front of the imaging system; however, it should be understood that the same equipment can be used in other imaging orientations, including MLO, and these terms need to be adjusted accordingly.

[0008] Some systems improve patient comfort by providing a tilting paddle that tilts as it compresses the breast. Various paddle sizes are available from Lorad of Danbury, CT, its assignee companies, Hologic Inc. of Bedford, and MA under the trademark FAST (FAST). This tilting paddle provides more even pressure on the breast and a more comfortable breast examination.

[0009] Non-limiting examples of various compression paddles and systems therefore include U.S. Patent Nos. 3,971,950; 5,474,072; 5,506,877 and 6,974,255, U.S. Patent Application Publications Nos. 2005 / 0008117, 2006 / 0050844 and 2013 / 0051520, and Japanese Patent Application Publications Nos. 2011-206438 and 2011-206439. Other methods for improving patient comfort have been proposed, and some are already in clinical use to improve patient comfort. One is the use of a relatively thin foam pad placed above and / or below the breast. This pad deforms to some extent during the compression procedure and can provide improved comfort by distributing pressure to a greater extent than when using a hard-surface paddle and / or breast platform alone. Such a pad system is discussed in jointly owned U.S. Patent Nos. 6,968,033, 6,765,984, 6,577,702, and 7,505,555, and published U.S. Patent Application Publication No. 2003 / 0007597. Another pad system is proposed in U.S. Patent Nos. 6,850,590 and 6,975,701, and published U.S. Patent Application Publications Nos. 2006 / 0050844, 2004 / 0156472, and 2003 / 0099325. These pads are not transparent to visible light. As a result, if such a pad is placed between the breast and the compression paddle, the breast will not be visible through the paddle, which impairs the technician's efforts to position and manipulate the breast during compression. The pad needs to be made of a fairly dense, thin foam to provide meaningful deformability when compressed above or below the breast. If the foam pad slips during positioning and does not cover the entire imaging area, the edges of the pad can cause image artifacts.

[0010] Scientific Biopsy (www.sbiopsy.com) has proposed another system to improve patient comfort for various purposes—specifically, breast fixation during biopsies. It should be understood that this involves using soft, trough-shaped supports to support the breast, and a flexible band enveloping the breast to apply retaining force. This is illustrated in published patent application US2003 / 0007598 (see, for example...). Figure 7Paragraph

[0115] describes a thin plastic plate for compressing the breast for ultrasound examination rather than for X-ray imaging, but no teaching has been found that the material is transparent to visible light or that the device is useful for X-ray imaging or has a flat breast platform. U.S. Patent No. 6,682,484 discusses the use of a polymer membrane that stretches under tension to restrict the breast during ultrasound examination and / or X-ray imaging. U.S. Patent No. 7,822,457 discusses the use of a tension membrane to compress the breast for medical imaging, and that the membrane can be tensioned using mechanical means or by means of an expandable pouch. U.S. Patent No. 6,587,578 discusses a non-rigid object retainer having an elastic membrane attached to a first member to form an expandable element for holding the object to be examined between the expandable element and a bottom support.

[0011] Commonly assigned U.S. Patent Nos. 7,489,761 and 7,792,244 describe (1) placing a fluid-filled pillow or bag between the compression paddle and the breast before compressing the breast, (2) compressing the breast using a sheet such as Mylar that extends or is at least supported between two rods or rollers (instead of using a conventional compression paddle), and (3) using a paddle with a recessed compressible material liner. Summary of the Invention

[0012] It is believed that there remains a need for further improvements in breast imaging and patient comfort. This technique involves novel approaches to addressing the challenges of breast imaging, particularly X-ray breast imaging.

[0013] A non-limiting example of this novel approach in mammography and / or combined breast computed tomography requires the use of specific adapters to control, distribute, and redirect breast compression forces. Preferably, the adapter includes a non-rigid outer sheath for the compression paddle.

[0014] In one aspect, the technology relates to an X-ray breast imaging system comprising: a compression paddle having: an anterior wall configured to be adjacent to and face the patient's thoracic wall during imaging; a bottom wall configured to extend away from the patient's thoracic wall and approach the top of the compressed breast, wherein the bottom wall has a central portion and two outer edges, wherein the central portion is not coplanar with the two outer edges, wherein the compression paddle is movable; and a first axis substantially perpendicular to the anterior wall. In one embodiment, the two outer edges define a reference plane, wherein the central portion is located above the reference plane to define a recessed surface extending from the first outer edge to the central portion and then to the second outer edge. In another embodiment, the compression paddle further has a rear wall arranged opposite the anterior wall, wherein the central portion of the bottom wall has an inclined surface, wherein a first distance between the central portion and the reference plane near the anterior wall is greater than a second distance between the central portion and the reference plane near the rear wall. In another embodiment, the central portion of the bottom wall is inclined along the first axis from a high point near the anterior wall. In another embodiment, the system includes a breast platform, wherein the compression paddle is adapted to be arranged in: a compression position in which the breast being compressed is arranged between the compression paddle and the breast platform; and a non-compression position in which the breast being compressed is not arranged between the compression paddle and the breast platform, wherein the bottom wall has a substantially similar profile in the compression and non-compression positions.

[0015] In another embodiment of the above aspects, the distance between the center portion and the reference plane is substantially the same in the compressed and uncompressed positions. In another embodiment, the movement of the pressure paddle is selected from the group consisting of: movement only along the head-to-tail axis, movement only laterally, and combinations thereof. In another embodiment, the system includes an X-ray source that selectively emits an imaging X-ray beam, wherein the X-ray source is configured to move along an arc. In another embodiment, the X-ray breast imaging system is a breast combined computed tomography X-ray breast imaging system.

[0016] In another aspect, the technology relates to an X-ray breast imaging system comprising: a compression paddle having a front wall, a bottom wall, and an intermediate portion between the front and bottom walls, the front wall being configured to be adjacent to and face the patient's chest wall during imaging, the bottom wall being configured to be adjacent to a length of the top of the compressed breast, the bottom wall extending away from the patient's chest wall, wherein the intermediate portion is generally non-coplanar with respect to the front and bottom walls, wherein the compression paddle is movable along a head-to-tail axis; and a non-rigid outer cover releasably fastened to the compression paddle, the non-rigid outer cover being located between the compression paddle and the patient. In one embodiment, the non-rigid outer cover is a gel pad cover. In another embodiment, the intermediate portion has a substantially smooth radius of curvature. In another embodiment, the height of the intermediate portion is not greater than the height of the bottom wall. In another embodiment, the height of the intermediate portion is greater than the height of the bottom wall, such that the intermediate portion is closer to the compressed breast relative to the bottom wall. In another embodiment, the bottom wall has a recess and a protrusion relative to the compressed breast.

[0017] In another embodiment of the above aspects, the protrusion is the portion where the bottom wall meets the middle portion. In another embodiment, the middle portion has a curved portion with a radius. In another embodiment, the front wall is slightly inclined from the vertical direction. In another embodiment, the movement of the pressure paddle is selected from the group consisting of: movement only along the head-to-tail axis, movement only laterally, and combinations thereof. In another embodiment, the system includes an X-ray source that selectively emits an imaging X-ray beam, wherein the X-ray source is configured to move along an arc. In another embodiment, the X-ray breast imaging system is a breast combined computed tomography X-ray breast imaging system.

[0018] In another aspect, the technology relates to a method for imaging a patient's breast using X-rays from an X-ray breast imaging system, comprising: supporting the base of the breast on a breast platform; and compressing the breast by applying a compression paddle system to the top of the breast, the compression paddle system having a paddle and a non-rigid outer cover connected to the paddle, the paddle having a front wall and a bottom wall, the front wall being configured to be adjacent to and facing the patient's chest wall during imaging, the bottom wall being configured to be adjacent to a length of the top of the compressed breast, the bottom wall extending away from the patient's chest wall, wherein the bottom wall has a first portion and a second portion such that the second portion is between the front wall and the first portion, the first portion and the second portion being generally non-coplanar, the compression paddle being movable only along a head-to-tail axis, and the non-rigid outer cover being located between the compression paddle and the breast. In one embodiment, the non-rigid outer cover is an inflatable outer cover. In another embodiment, the method includes positioning a portion of the compressed breast away from the patient's chest wall after the breast is compressed. In another embodiment, the method includes inflating the inflatable outer cover after the breast is compressed. In another embodiment, the expandable outer cover is inflated with fluid. In yet another embodiment, the method includes moving an X-ray source along an arc and exposing the compressed breast to multiple X-ray beams during this arc movement.

[0019] In another embodiment of the above aspects, the height of the second portion is greater than the height of the first portion, such that the second portion is closer to the compressed breast relative to the first portion. In another embodiment, the bottom wall has a recess and a protrusion relative to the compressed breast. In another embodiment, the protrusion is the portion where the first portion and the second portion meet. In another embodiment, the second portion includes a curved portion with a radius. In another embodiment, the front wall is slightly inclined from the vertical direction. In another embodiment, the movement of the pressure paddle used to compress the breast is selected from the group consisting of: movement only along the head-to-tail axis, movement only laterally, and combinations thereof.

[0020] Other aspects, implementation methods, and the features and advantages of these exemplary aspects and implementation methods are discussed in detail below. Any feature, advantage, implementation method, or example may be combined with or form part of any aspect or implementation method in a manner consistent with at least one principle disclosed herein. The terms “implementation method,” “some implementation methods,” “alternative implementation methods,” “various implementation methods,” “one implementation method,” “example,” “feature,” “advantage,” “implementation method,” etc., are not necessarily mutually exclusive but are intended to indicate that a particular feature, implementation method, structure, or characteristic described may be included in at least one aspect. The appearance of these terms herein does not necessarily refer to the same implementation method. Attached Figure Description

[0021] At least one aspect of an embodiment is described below with reference to the accompanying drawings, which are not intended to be drawn to scale. These drawings are included to provide an illustration and further understanding of the aspects and embodiments; they are incorporated in and form part of this specification, but are not intended to be limited to the art. In these drawings, each identical or nearly identical element illustrated in the various figures is represented by similar numbers. For clarity, each element is not labeled in each figure. In these figures:

[0022] Figure 1 This is a partial schematic diagram and block diagram of a mammography and / or combined tomography system that uses an expandable or expandable paddle cover to image a patient's breast using X-rays.

[0023] Figure 2 It is a partial perspective view not drawn to scale, illustrating a compression paddle with an inflatable or expandable outer shell and a breast platform with a compressible pad on top, as part of a mammography X-ray examination and / or combined tomography system.

[0024] Figure 3 A portion of the compressed propeller with a tightly fitted propeller casing is schematically shown.

[0025] Figure 4 Two exemplary methods for releasably securing the propeller cover to the pressure propeller are schematically illustrated.

[0026] Figure 5 The seam in the propeller cover is shown schematically.

[0027] Figure 6 A variation is shown in which the bottom of the outer casing has multiple chambers that can be pressurized to different degrees.

[0028] Figure 7 It is a perspective view of the expandable outer casing fastened to the pressure paddle (inverted).

[0029] Figure 8 The image shows compression paddles with a tightly fitted, expandable outer shell, which are then fastened together to a breast imaging system.

[0030] Figure 9 A breast imaging system using an expandable outer cover on a pressure paddle is shown.

[0031] Figures 10A-10E Schematic perspective view, side view, partial sectional view, top view and bottom view of a pressurizing paddle according to one embodiment of the present technology are shown respectively.

[0032] Figure 11A-11E Schematic perspective view, side view, partial sectional view, top view and bottom view of a pressurizing paddle according to one embodiment of the present technology are shown respectively.

[0033] Figures 12A-12E Schematic perspective view, side view, partial sectional view, top view and bottom view of a pressurizing paddle according to one embodiment of the present technology are shown respectively.

[0034] Figures 13A-13B A schematic side view of a breast compression method according to one embodiment of the present technology is shown.

[0035] Figures 14A-14C A schematic perspective view and a bottom view of a pressure paddle according to one embodiment of the present technology are shown.

[0036] Figures 15A-15C A schematic perspective view, front view, and side view of a pressure paddle according to one embodiment of the present technology are shown. Detailed Implementation

[0037] Unless otherwise indicated, the articles “one” and “the” mean “one or more”.

[0038] See Figure 1 For X-ray imaging, the patient's breast 10 is fixed between a breast platform 12 and a compression paddle 16. The platform 12 may be the upper surface of a housing 14. At least the lower side of the compression paddle 16 is covered with a non-rigid paddle cover, such as preferably an expandable paddle cover 18. The platform 12 and the paddle 16 constitute a breast fixation unit 20 located in the path of an imaging beam 22 emitted from an X-ray source 24. The beam 22 strikes an image receiver 26 within the housing 14.

[0039] The fixture 20 and housing 14 are supported on arm 28. The X-ray source 24 is supported on arm 30. For mammography, the support arms 28 and 30 can rotate as a unit about an axis, such as 30a between different imaging orientations like CC and MLO, so that the system can acquire a projected mammogram Mp at each orientation. While acquiring image Mp, the image receiver 26 remains in place relative to housing 14. To allow arms 28 and 30 to move to different imaging orientations, the fixture 20 releases the breast 10. For combined tomographic imaging, the support arm 28 remains in place, the breast 10 is fixed and held in place, while at least the source support arm 30 allows the source 24 to rotate about an axis such as 30a relative to the fixture 20 and the breast 10.

[0040] The system acquires multiple combined tomographic projection images of the breast 10 at various angles relative to the breast 10 by the beam 22. Simultaneously, in synchronization with the rotation of the source support arm 30, the image receiver 26 can tilt relative to the breast platform 12. This tilt can occur through the same angle as the source 24 rotates, but preferably through different angles, chosen such that for each of the multiple images Tp, the beam 22 remains substantially in the same position on the image receiver 26. This tilt can be about axis 32a, but this axis 32a need not be on the image plane of the image receiver 26.

[0041] A tilting mechanism 34, also located in housing 14 or otherwise connected to receiver 24, can drive image receiver 24 by tilting motion. As in Figure 1 As can be seen, axes 20a, 24a, and 26a extend to the left and right, but preferably do not coincide. For combined tomographic imaging, the breast platform 12 can be horizontal or at an angle to the horizontal direction, for example, in an orientation similar to conventional MLO imaging in mammography. Figure 1The system can be a mammography system alone, or a combined tomography system alone, or a “combined” system capable of performing both mammography and combined tomography. An example of such a combined system has been provided by the assignee under the trademark name Selenia Dimensions. Non-limiting examples of such combined or combined tomography systems are described in U.S. Patent Nos. 7,869,563; 7,831,296; 7,583,786; 7,430,272; 7,245,694; and 7,123,684. When the system is operated, image receiver 26 generates imaging information in response to illumination from imaging beam 22 and provides it to image processor 34 for processing to produce a mammogram. Fluid control unit 36 ​​is connected to expandable housing 18 via conduit 36a, preferably via quick-release snap connector 48. System control and workstation unit 38 controls the operation of the system and interacts with the user to receive commands and transmit information including the processed X-ray image.

[0042] See Figure 1-6 (These are not drawn to scale), used to illustrate the breast fixation device 20 in more detail. The compression paddle 16 is generally made of transparent plastic and has a front wall 16a, a left side wall 16b, a right side wall 16c, and a bottom wall 16d with a lower side 16e. The side walls 16b and 16c are supported by a bracket 16f, which is supported by a support arm 28 for up-and-down movement along the arm 28. To tilt relative to the breast 10, the paddle 16 utilizes a pin 16g (in... Figure 2 Only the right-hand pin is visible in the image. It is fastened to the support 16 and is elastically biased so that the tip of the paddle 16 rises against the biasing force when it presses against the breast 10. If desired, a compressible pad 40 can be placed on the platform 12 to increase patient comfort, as is known in the system provided by the common assignee. Furthermore, the compression paddle 16 is laterally movable, as in the current system under the trademark Selenia Dimensions provided by this assignee.

[0043] The expandable housing 18 is releasably fastened to the pressure paddle 16 and has a front wall 18a, a left side wall 18b, a right side wall 18c, and a bottom 18d, the bottom 18d having a top wall 18e and a bottom wall 18f, the top wall 18e facing the lower side 16e of the platform 16. The bottom 18d thus includes an expandable chamber formed between the walls 18e and 18f of the housing 18. This chamber 18d is fluidly connected to the fluid control unit 36 ​​via conduit 36a, and thus can be selectively expanded to a desired pressure and selectively deflated to a desired pressure if needed. A quick-connect release snap connector 48 facilitates easy connection and disconnection of the chamber 18d to and from the fluid control unit 36. If needed, the bottom of the housing 18 can be divided into two or more chambers, such as chambers 18h and 18i, by a separator 18g, and each chamber can be provided with separate conduits and connection / disconnection devices (not shown) to allow the two or more chambers to be expanded to desired pressures that can differ from each other.

[0044] The outer cover 18 can be releasably fastened to the paddle 16 in any number of ways so that it can be easily attached to and removed from the paddle 16 so that it will not experience undesirable displacement relative to the paddle 16 or the patient's skin during breast fixation and imaging.

[0045] Figure 3 An example is shown in which at least some surfaces of the outer casing 18 facing the platform 16 are made of or coated with a material bonded to the platform 16, such that the adhesive strength is high enough to substantially prevent undesirable movement between the platform 16 and the outer casing 18, but low enough to allow easy removal of the outer casing 18 from the paddle 16. Preferably, for this purpose at least the upper wall 18e of the outer casing 18 is made of an adhesive material, but not only wall 16e or its alternative, any one or more other walls may also be made of an adhesive material. In this example of using an adhesive to releasably fasten the outer casing 18 to the paddle 16, the front and side walls of the outer casing 18 are preferably shorter than the corresponding walls of the paddle 16, but alternatively they may have the same height or even higher. However, the walls of the outer casing 18 do not need to be of the same height; for example, the front wall 18a may have a lower height than the side walls 18b and 18c.

[0046] Figure 4Other examples of releasably fastening the outer cover 18 to the paddle 16 are shown. In this example, at least one, but preferably two or all three, of the front wall 18a and side walls 18b and 18c are provided with clamping members 42 that clamp onto the top of the respective wall of the platform 16, thereby keeping the outer cover 18 and the platform 16 fastened to each other. The clamping member 42 may be as shown in solid lines, or it may have an extension 42a as shown in dashed lines. The outer cover 18 is generally made of a plastic material such as vinyl, which may be slightly stretched and sized to fit snugly onto the platform 16, such that mechanical friction, along with possibly some electrostatic forces and the adhesiveness of the cover material itself, together hold the cover and the platform in place to prevent undesirable movement relative to each other, but the operator can still easily detach the outer cover 18 from the paddle 16 so that a new cover can be installed for the next patient if needed. Other examples, such as snap-fit ​​connections or other mechanical connections between the cover and the side walls of the compression paddle, are conceivable.

[0047] The outer cover 18 can be made of two layers of a material such as vinyl, with a chemical composition and thickness similar to those used for colostomy bags or even kitchen food bags and freezer bags. Preferably, the two layers are fused or bonded together at the front and side walls of the outer cover 18, but not at the bottom 18d of the outer cover 18. Preferably, a seam 44 is formed, for example, using an adhesive material or by melting, which connects the two layers at the junction where the outer cover 18 joins the front and lower sides of the platform 16 when the outer cover 18 is fastened to the platform 16. Figure 5 As shown in the diagram. The joint 42 may extend partially on the front wall 16a and lower side 16e of the platform 16, as... Figure 5 As shown in the diagram (not drawn to scale). Preferably, the seam 42 is positioned such that the expandable volume 18d of the outer cover 18 does not extend forward beyond the front wall 16a of the platform 16, so as not to push patient tissue away from the platform 16.

[0048] See Figure 6 The outer chamber 18d may have two or more sub-chambers, such as those shown as 18h and 18i, each sub-chamber having its own connection to the fluid control unit 36 ​​via snap-fit ​​connectors and tubing, so that each sub-chamber can be expanded to the desired pressure level under operator control or automatic system control.

[0049] The fluid control unit 36 ​​can be powered by an operator using a manual or foot pump and a suitable manual or foot valve. Alternatively, an electric or hydrodynamic pump with suitable valves and an interface such as operator-controlled buttons or switches can be used. Alternatively, the fluid control unit 36 ​​can be fully automatic, such that the expansion / contraction of the cover 18 is under the control of the workstation 38 when operated by an operator and in response to events such as the compression paddle 16 reaching a specific position relative to the patient's breast or platform 12 or applying specific pressure to the patient's breast. The expansion / contraction controller can be part of or at least coupled to the unit 38. In use, the mammography and / or combined computed tomography system operates in a known manner, for example, from systems trademarked as Selenia and Selenia Dimensions provided by the assignee, except for the addition of the expandable paddle cover 18. Thus, prior to patient imaging, the cover 18 is secured to the paddle 16 and connected to the tubing 36 via a snap-fit ​​connector 48. With the patient's breast 10 on platform 12 or pad 40, the technician lowers paddle 16 (to which outer cover 18 is secured) to begin compressing the breast 10 while manually manipulating the breast to stretch and pull the breast tissue away from the patient's chest wall into the X-ray field of view. During this process, before and / or after lowering paddle 16 to its final desired position, the technician can control the degree of expansion of outer cover chamber 18d by adding fluid to and / or releasing fluid from chamber 18d. If chamber 18d has two or more sub-chambers, the technician can control the expansion of each chamber individually in a similar manner. Once the technician or other healthcare professional is satisfied with the position of the breast 10, X-ray imaging can begin in mammography and / or combined tomography modes, as known, for example, from the system provided by the co-assigned.

[0050] Figure 7-9 An example of an inflatable or retractable outer casing 18 fastened to a compression paddle in a breast imaging system is shown. Figure 7 In the middle, the outer cover 18 and the paddle 16 are inverted to better illustrate them, as well as the quick-release connector 48. Figure 8 The propeller 16 and housing 18 are shown in a more typical orientation, and a knob 80 that can be manually rotated to move the propeller 16 and its support from side to side is also shown. Figure 9 A system is shown in perspective, in which the components are made of Figure 1 Identify and combine the reference numerals used in the figures Figure 1 describe.

[0051] While specific examples have been described above, it should be clear that various variations thereof fall within the scope of the technology as defined by the appended claims. As one of many feasible examples, not only on the pressure paddle 16, but also as an alternative to using the outer cover 18, a similar expandable cover can be used on or above the breast platform 12. In this example, such a cover can be similarly fastened to the housing 14, or it can omit the sidewalls so that only a cavity similar to chamber 18d (or multiple sub-chambers) exists on the breast platform 12, which may have a front wall similar to the front wall 18a but extending downward along the front wall of the housing 14.

[0052] See now Figures 10A-10EThe diagram illustrates one embodiment of a compression paddle 100. The compression paddle 100 can be used with any of the features described herein, such as a non-rigid paddle cover (e.g., an expandable paddle cover) used with the aforementioned X-ray imaging system (e.g., a breast combined computed tomography X-ray imaging system). The compression paddle 100 includes at least one protrusion 101 extending from the surface of the compression paddle 100. Although four protrusions 101 are shown, fewer or more protrusions may be used. These protrusions 101 correspond to corresponding structures, such as grooves or holes in a non-rigid cover. In one embodiment, the non-rigid cover may be an expandable cover, thus having a rebound property when expanded, or it may be a gel pad with elastic properties. Furthermore or alternatively, the distal end of the protrusion may be enlarged and have a greater width than the proximal end of the protrusion. The compression paddle 100 also has a front wall 102 and a bottom wall 104. The front wall 102 is configured adjacent to and facing the patient's chest wall. The bottom wall 104 extends away from the patient's chest wall and faces a length of the compressed breast. The bottom wall comprises a first portion 106 and a second portion 108. The first portion 106 and the second portion 108 are generally non-coplanar. In one embodiment, the second portion 108 is rotated from the first portion by approximately 5 degrees to approximately 20 degrees, preferably approximately 10 degrees to approximately 15 degrees, and even more preferably approximately 25 degrees. The generally non-coplanar configuration (e.g., a wedge configuration) between the first portion 106 and the second portion 108 helps to lock breast tissue at the chest wall and / or form a force vector away from the chest wall when the expandable outer cover expands. That is, the pressure paddle of this technology, together with the non-rigid outer cover (to form a pressure paddle assembly), helps to prevent breast tissue at or near the chest wall from being positioned outside the bottom wall or slipping off and / or sliding out of the bottom wall, thereby escaping the field of view during imaging. The second portion helps to push or form a surface having a surface vector away from the chest wall to keep breast tissue within the field of view during imaging. This configuration also helps to ensure that breast tissue is within the field of vision, and helps to maintain more even breast compression on the patient without any pressure points or pinch points that could cause discomfort. In one embodiment, the first portion is substantially straight, and the second portion is substantially straight. Alternatively, the first portion may include a first segment and a second segment, wherein the first segment and the second segment are generally non-coplanar; optionally, the first segment is substantially straight, and the second segment is substantially straight. The anterior wall 102 should be understood as the height of the compression paddle 100. In one embodiment, the first portion 106 and the second portion 108 have different heights relative to the top of the anterior wall. As a non-limiting example, the height (H1) of the first portion 106 is less than the maximum height (H2) of the second portion 108.Alternatively or concurrently, the height (H1) of the first portion 106 can be substantially constant (i.e., horizontal), while the height (H2) of the second portion 108 can vary, for example, linearly or non-linearly. In one embodiment, the anterior wall 102 is vertical. In another embodiment, for example, when a pressure paddle is applied to the breast, the anterior wall 102 is slightly inclined relative to the vertical direction. With the anterior wall of the pressure paddle inclined from the vertical direction, this anterior wall facilitates deeper penetration into the chest wall compared to a known flat pressure paddle.

[0053] To compress the breast, a compression paddle assembly of this technology, having compression paddles and a non-rigid outer cover, is applied to the breast for initial compression. The compression paddle assembly is applied to the breast in a craniocaudal direction. Alternatively or additionally, the compression paddle assembly can move only in the craniocaudal direction by tilting it, by moving it laterally, or a combination of both. When the compression paddle assembly can move laterally, it can move under manual control or, in the case of motorized control, optionally under software control. The assembly can move automatically according to the desired view of the breast. When the height of the first portion is less than the height of the second portion, the second portion can contact the breast tissue during the initial compression while a gap exists between the breast tissue and the first portion. During the initial compression, a technician or skilled professional can further position at least a portion of the breast tissue. In one embodiment, the non-rigid outer cover can be elastic, for example, by inflating an expandable cover to place the breast in a compressed state via secondary compression. In another embodiment, the non-rigid outer cover can be a gel pad that becomes elastic when placed to compress the breast tissue.

[0054] See now Figure 11A-11EThis illustration shows another compression paddle 110 of the present technology, wherein the bottom wall 114 has a first portion 116 and a second portion 118. In this configuration, the first portion 116 and the second portion 118 are generally non-coplanar, and the second portion 118 has a generally smooth bend. In one embodiment, the second portion 118 is generally recessed. The first portion 116 has a lower height (H3) relative to the top of the anterior wall than the highest height (H4) of at least a portion of the second portion 118. In this configuration, the radius of the second portion 118 is approximately 1.5 inches to approximately 3.5 inches, preferably approximately 2.5 inches. The enlarged radius of the second portion 118 (e.g., larger than usual) is intended to improve chest wall comfort by, for example, having a generally smooth patient contact profile. According to one embodiment, the height (H3) of the first portion is substantially constant, while the height (H4) of the second portion is variable. Furthermore or alternatively, the shape of the second portion 118 may be a generally smooth bend or other curved shape. When the pressure paddle is applied to the breast, the anterior wall 112 can be vertical or slightly inclined relative to the vertical direction.

[0055] Figures 12A-12E An embodiment of the compression paddle 120 of this technology is shown. The compression paddle 120 has a front wall 122 and a bottom wall 124. When the compression paddle 120 is applied to the breast, the front wall can be substantially vertical or slightly inclined relative to the vertical direction. The bottom wall 124 includes a first portion 124 and a second portion 128, wherein the second portion is an intermediate portion between the front wall and the first portion. The first portion is substantially horizontal and has a substantially constant height (H5) relative to the top of the front wall of the compression paddle 120. The highest height (H6) of the intermediate portion is not greater than the height (H5) of the first portion. In one embodiment, the height (H6) of the intermediate portion varies linearly, for example, having a substantially smooth bend or being substantially curved. In this configuration, the shape of the intermediate portion reduces the pulling on tissues at the patient's chest wall. The compression paddle 120 can be used as part of a compression paddle assembly having a non-rigid paddle cover (preferably a gel pad paddle cover) for breast compression. Therefore, in alternative embodiments, when the gel pad paddle cover is used with the compression paddle 120, there are no two compression steps. The pressure paddle assembly applies pressure to the breast in a downward motion. Alternatively, but preferably by a technician or skilled professional, the breast tissue is not manipulated during compression.

[0056] See now Figures 13A-13B This illustrates a method of compressing the breast using the compression paddle assembly of this technology. For illustrative purposes, it is shown... Figure 11A-11EThe method includes, but is not limited to, a compression paddle 110, though any other compression paddle described herein may be used. The method comprises at least: positioning the breast on a breast platform; positioning the compression paddle assembly relative to the breast; securing the breast by lowering the compression paddle assembly or compressing the breast using the compression paddle assembly; and optionally, in the case of using an inflatable paddle cover 130, inflating the paddle cover. Where applicable, lowering the compression paddle assembly or initially compressing the breast using the compression paddle assembly applies a first-sized force to the breast. Inflating the paddle cover to the first-sized top applies an additional-sized force to assist in uniformly compressing the breast for X-ray imaging, for example, by uniformly distributing the force across the top surface of the breast.

[0057] As in Figures 13A-13B As illustrated by example, while any of the compression paddles described herein can be used, the breast platform extends laterally to the anterior wall of the compression paddle, for example, to the bottom of the anterior wall. In an alternative embodiment, in a configuration where the anterior wall of the compression paddle is tilted or deflected, the breast platform extends laterally to the location where the anterior wall contacts the patient's chest wall. The breast platform does not simply extend to the termination of the first portion or the first portion is not in a substantially horizontal and parallel position to the breast platform. This configuration helps to minimize the amount of breast tissue protruding from the field of view. In cases where portions of breast tissue are not within the field of view and / or are clamped by the anterior wall, the second portion, and / or the portion between the anterior wall and the second portion of the compression paddle (e.g., due to thick and / or dense breast tissue adjacent to the chest wall), image processing techniques can be used to address this potential distortion. Alternatively, image processing techniques can be used in any case where the tissue adjacent to the chest wall is typically dense and / or thick. In the case of using a known flat compression paddle, this compression paddle needs to significantly compress the breast tissue from front to back in an attempt to keep as much breast tissue as possible within the field of view. The compression paddle of this technology is configured to require less clamping force for imaging breast tissue, thus resulting in a more comfortable mammogram. Preferably, the compression paddle of this technology applies approximately 25% to approximately 50% less clamping force than known flat compression paddles, as measured from the output signal of a force sensor located behind the location where the compression paddle is mounted to the imaging system (i.e., the paddle base).

[0058] See now Figures 14A-14C This illustrates another embodiment of the pressure paddle 140 of this technology. Specifically, Figures 14A-14C The diagram illustrates the pair Figures 12A-12E Modifications to the pressure propeller, however, can be made to any pressure propeller described herein. Figures 14A-14CThe compression paddle shown is substantially rounded around its anterior wall to the bottom and also substantially rounded around its anterior wall to the sidewalls. The compression paddle 140 includes modifications to facilitate greater flexibility and consistency of the breast tissue. The sidewall 142 has a lower height around the portion between the anterior wall 144 and the posterior wall 146 than the height of the anterior wall 144 and / or the posterior wall 146, for example, about 20% to about 80%, preferably about 25% to about 50%. The lower portion of the sidewall facilitates articulation of the compression paddle 140 at the anterior wall 144. The compression paddle 140 may also optionally include a slot formed near the posterior corner to facilitate greater flexibility at the bottom of the compression paddle and overall. Further optional modifications to increase the flexibility of the compression paddle 140 include changing the thickness of the paddle (e.g., a portion of the bottom of the compression paddle is thicker than other portions, such as the middle portion being thicker than the portion near the sidewalls) and manufacturing the compression paddle 140 from a material with greater flexibility than known compression paddles (e.g., preferably using a material with about 40% more flexibility). In an example where the middle portion of the bottom surface is thicker than the portion closer to the sidewalls, the thicker middle portion helps prevent the compression paddle 140 from wrapping around the front of the breast (which can cause nipple pain, push the breast against the chest wall, and potentially push the breast away from the detector); making the portion of the bottom surface closer to the sidewalls thinner than the middle portion allows for more support in the MLO position and helps the compression paddle 140 better conform to the shape of the breast. This configuration allows for better compression in the axillary region and folding under the breast. The compression paddle 140 can be used to compress the patient's breast with or without an expandable outer cover and / or gel pad.

[0059] Figures 15A-15C Further features of the compression paddle 160 of this technology are shown. The bottom wall of the compression paddle 160 includes a generally recessed surface 162 whose shape substantially corresponds to the breast and / or the breast being compressed. This generally recessed surface 162 may generally extend between the side walls 164 of the compression paddle 162. Alternatively, a portion of the bottom surface includes the generally recessed surface 162, which helps to match the contour of breast tissue. This generally recessed surface 162 helps to distribute the force applied to the breast more evenly to correspond more closely to the shape of the breast. This configuration helps to provide better patient comfort when compressing the breast. The generally recessed surface 162 includes two outer edges 166 defining a reference plane P and a central portion 168. The central portion 168 is not coplanar with the outer edges 166, such that the central portion 168 protrudes relative to or is positioned above the reference plane P. The central portion 168 can be horizontal (e.g., parallel to the reference plane P or the axis A of the paddle 160) or can slope downwards from the front wall 170 to the rear wall 172 of the paddle 160. This can help to further adapt the paddle 160 to the shape of the breast.

[0060] The generally concave surface 162 can also help prevent breast slippage and movement during image acquisition. As an example, this configuration helps prevent breast slippage in the MLO position by providing more support compared to known flat compression paddles that typically allow breast slippage during image acquisition. The generally concave surface 162 can have smooth bends or any other shape that is generally concave; for example, the surface 162 can include ridges, lines, and / or other elements derived from the injection-molded compression paddle 160, the surface can have a generally trapezoidal shape, and so on. Additionally or alternatively, the compression paddle 160 can be used to compress a patient's breast, with or without an expandable outer sheath and / or gel pad. In another embodiment, the generally concave surface 162 may not be uniformly concave from the anterior wall 170 (i.e., the wall facing the thoracic cavity) to the posterior wall 172. Because the compressed breast tissue does not extend posteriorly to the posterior wall 172, the concavity near the anterior wall 170 is greater than that near the posterior wall 172. As an example, the bottom surface 167 may be generally concave near the anterior wall 170 and flatter near the posterior wall 172. In another or alternative example, the radius of this generally concave surface is larger near the anterior wall than the bottom surface near the posterior wall. This inhomogeneity can help provide a more uniform compression from the nipple of the breast to the chest wall.

[0061] In summary, the compression paddles of this technique described herein make patients with compressed breasts more comfortable during mammograms or X-ray imaging. The compression paddles of this technique generally require less clamping force to achieve the same level of tightness as known flat compression paddles. These paddles can be made of substantially rigid or flexible materials. The use of rigid materials allows the paddles to clamp the breast sufficiently without deformation. For example, in… Figures 15A-15C In the embodiments illustrated herein, the distance between the center portion 168 and the reference plane can be substantially the same whether the paddle 160 is pressing against the breast or not. For example, the concave profile of the bottom wall can be substantially the same. The specific shape and profile disclosed herein can reduce or eliminate discomfort during breast compression.

[0062] In embodiments where an inflatable bag is used to compress the paddle, a pressure sensor can be used to prevent the bag from over-inflating or under-inflating. In alternative embodiments, the volume of the inflatable bag can be calculated using a syringe. Furthermore, or alternatively, motorized equipment can be used to inflate the bag; alternatively, mechanical components such as lead screws can be used to prevent over-inflating.

[0063] It should be understood that the implementations of the methods and apparatus discussed herein are not limited in application to the structural details and component configurations described below or illustrated in the accompanying drawings. The methods and apparatus can be implemented and performed in other embodiments and in various ways. Examples of specific embodiments provided herein are for illustrative purposes only and are not intended to be limiting. In particular, the actions, elements, and features discussed in conjunction with any one or more embodiments are not intended to exclude similar functionality in any other embodiment.

[0064] Furthermore, the wording and terminology used herein are for descriptive purposes and should not be considered limiting. Embodiments or elements or actions of systems and methods relating to the singular form herein also include embodiments comprising a plurality of such elements, and any embodiments or elements or actions relating to the plural form herein may also include embodiments comprising only a single element. The terms “comprising,” “including,” “having,” “containing,” “involving,” and variations thereof, as used herein, mean to include the items listed following them and their equivalents as well as additional items. “Or” can be interpreted as including, so that any term used in the description of “or” can indicate single, more than one, or all of the stated terms.

[0065] All parts, proportions, and percentages herein are by weight, and all numerical definitions are used in conjunction with the normal level of precision to be tolerated in the art, unless otherwise stated.

[0066] The dimensions and values ​​disclosed herein are not to be construed as strict limitations on the exact numerical values ​​listed. Rather, unless otherwise stated, each such dimension is intended to mean the listed value and a functionally equivalent range around that value. For example, a dimension disclosed as “40mm” is intended to mean “approximately 40mm”.

[0067] It should be understood that each maximum number limit given throughout the specification includes each lower number limit, as these lower number limits are explicitly stated herein. Each minimum number limit given throughout the specification includes each higher number limit, as these higher number limits are explicitly stated herein. Each number range given throughout the specification includes each narrower number range falling within that wider number range, as these narrower number ranges are explicitly stated herein.

[0068] All references cited in the relevant sections herein are incorporated herein by reference; any reference to any reference shall not be construed as prior art. In the event of any conflict between any meaning or definition of a term in this sense or in any meaning or definition in this written document and in any reference incorporated herein by reference, the meaning or definition given to that term in this written document shall prevail.

[0069] At least one embodiment has been described above in several aspects, and it should be appreciated that various alternatives, modifications, and improvements will be apparent to those skilled in the art. These alternatives, modifications, and improvements are intended to be part of the invention and are intended to be within the scope of this technology. Therefore, the foregoing description and figures are merely examples.

Claims

1. An X-ray breast imaging system, comprising: X-ray source; X-ray detector; A breast support platform is disposed between the X-ray source and the X-ray detector; and A compression paddle, made of a substantially rigid material and disposed between the X-ray source and the breast support platform, the compression paddle comprising: Anterior wall, which is configured to be adjacent to and face the patient's chest wall during imaging; A bottom wall extending from the anterior wall, the bottom wall being configured to extend away from the patient's chest wall and adjacent to and contacting the top of the compressed breast of a certain length, wherein the bottom wall includes a central portion and two outer edge portions, wherein the two outer edge portions define a reference plane, wherein the central portion slopes downward from the anterior to the posterior wall of the compression paddle, wherein the compression paddle is movable; and The first axis is substantially perpendicular to the front wall. The central portion of the bottom wall slopes along the first axis from a high point near the front wall and protrudes relative to the reference plane. The central portion is disposed above the reference plane to define a recessed surface that extends from a first outer edge of the two outer edges to the central portion and then to a second outer edge of the two outer edges, and the radius of the recessed surface is larger near the front wall than the bottom surface near the rear wall.

2. The X-ray breast imaging system of claim 1, wherein the reference plane is substantially parallel to the breast support platform.

3. The X-ray breast imaging system according to claim 1, wherein the compression paddle is adapted to be arranged in a compression position and a non-compression position. In this compressed position, the compressed breast is located between the compression paddle and the breast support platform. In the non-compressed position, the compressed breast is not located between the compression paddle and the breast support platform, and the bottom wall comprises a substantially similar profile in both the compressed and non-compressed positions.

4. The X-ray breast imaging system according to claim 3, wherein the distance between the center portion and the reference plane is substantially the same in the pressed position and the unpressed position.

5. The X-ray breast imaging system of claim 1, wherein the motion of the compression paddle is selected from the group consisting of: movable only along the head-to-tail axis, movable only laterally, and combinations thereof.

6. The X-ray breast imaging system of claim 1, wherein the X-ray source selectively emits an imaging X-ray beam, wherein the X-ray source is configured to move along an arc.

7. The X-ray breast imaging system according to claim 6, wherein the X-ray breast imaging system is a mammography X-ray breast imaging system.

8. A pressure paddle for an X-ray breast imaging system, the pressure paddle being made of a substantially rigid material, the pressure paddle comprising: Anterior wall, which is configured to be adjacent to and face the patient's chest wall during imaging; The rear wall opposite to the front wall; and A base wall, configured to be adjacent to and contact the top of the compressed breast along a length of its length, extends between the anterior and posterior walls and away from the patient's thoracic wall. The base wall includes two outer edges and a central portion that is not coplanar with the two outer edges, both extending between the anterior and posterior walls. The central portion slopes downward from the anterior to the posterior wall of the compression paddle. The central portion is disposed above a reference plane defined by the two outer edge portions to define a recessed surface extending from a first outer edge portion of the two outer edge portions to the central portion and then to a second outer edge portion of the two outer edge portions, and the radius of the recessed surface is larger near the front wall than the bottom surface near the rear wall.

9. The pressure paddle of claim 8 further includes an intermediate portion disposed between the front wall and the center portion, and including a substantially smooth radius of curvature.

10. The compression paddle of claim 9, wherein the bottom wall has a recess and a protrusion relative to the compressed breast.

Images