Patent Document

This is a continuation of application Ser. No. 09/611,963 filed Jul. 7, 2000, now U.S. Pat. No. 6,317,266. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention concerns a support apparatus and method for performing mammograms and breast biopsies with the patient positioned in the decubitus position. More particularly, it is concerned with a support apparatus which provides excellent patient support and access by both a technician and a mammography machine during the performance of decubitus breast mammography and biopsy procedures. 
     2. Description of the Prior Art 
     The women&#39;s health field has increasingly benefitted from advances in the field of mammography which enables early detection and treatment of cancerous and precancerous tissues. When a mammogram is taken, it is analyzed by a radiologist and if suspicious images are found, a biopsy of the tissue is taken. Mammography has been typically performed with the patient in the standing position, and the breast positioned between two opposed plates which flatten the tissue and hold it in place. Detection of suspicious tissue has then required that the physician mark the precise area to be biopsied and send the patient to the operating room. This procedure necessitated inserting a needle into the breast, and feeding of a wire through the needle which remains in place until the biopsy is performed, typically at a remote location. 
     An improved method for performing breast biopsies is the core biopsy technique. Again, the patient is standing or sitting in an upright position, wherein the biopsy is taken by positioning the patient with her breast between the opposed plates of a mammography device, and then, using a medical instrument (hereinafter referred to as a “breast tissue sampler”), a core of tissue is cut at the position indicated by the mammogram. This procedure represents a significant advance, in that the patient is not required to remain with a wire projecting from her breast or move to a remote location for the surgical biopsy, but rather can have it performed in the same physical area as the initial mammogram. 
     One problem with such procedures is that during the performance of the core biopsy, the patient can move slightly, or worse to faint. Such vasovagal reactions present significant problems both for the patient and the technician or radiologist. 
     One alternative support table for supporting a patient during core breast tissue sampling is a table with a central, surrounded and not laterally accessible opening therein, wherein the patient lies in a prone position with her breasts hanging through the opening. This support table, known as a “prone table” or “Parker table”, is large and not readily repositionable, making access to the breast region difficult, and presents a problem in attempting to locate tumors where the patient is small breasted or the suspected tumor is adjacent the chest wall, i.e., the ribcage area. 
     Thus it would be beneficial if the patient could have mammograms, needle localizations and core biopsies performed when laying on her side. This is known as the decubitus position, wherein the patient&#39;s breast is oriented toward the mammogram—preferably with the upper breast positioned for mammography or biopsy, but sometimes with the lower breast examined. The patient may thus be positioned in a left lateral decubitus (left side of patient down) or right lateral decubitus (right side of patient down) to present her breast to for examination. This may require the patient to position her head at either end of the support, or to rotate longitudinally (with feet and head remaining at the same relative ends of the bed) to present the breast in the proper position. The patient must be adequately supported and this support must be provided without giving the patient a sense of anxiety about falling off the support. Additionally, the support must permit access by the technician and access to the mammography and core biopsy machine to enable performance of the mammogram and/or biopsy procedure. 
     Prior art patient supports are perhaps best shown in U.S. Pat. Nos. 5,184,363 and 5,461,739 to Falbo, Sr., and U.S. Pat. No. 5,950,262 to Smoler et al., the disclosures of which are incorporated herein by reference. Such supports are beneficially configured with drop-out sections to permit access by the technician to the patient. However, these patient supports are not configured to meet the peculiar demands of decubitus breast mammography and biopsy. For example the U.S. Pat No. 5,184,363 discloses a support bed useful for cardiac sonography having two drop-out sections, the first to permit sonographic diagnosis of a patient lying on the bed, the second to accommodate the legs or other aspect of a person performing the diagnosis. However, the openings do not admit access by a mammography and core biopsy device, nor is the table particularly configured to permit alternate positioning of the patient on either the left or right side. Moreover, a mammography device often must be tilted wherein a bulky portion must lie adjacent the patient&#39;s head and below the top surface of the table, which is not possible with the aforementioned support bed. The U.S. Pat. No. 5,461,739 support apparatus is also designed for performing cardiac sonography, but with the patient in a supine position (resting on the back) and accommodating a pedaling device. It also teaches the use of one, or alternatively two, patient drop-out sections, but is not configured to admit into the openings a mammography and core biopsy device, nor to allow the patient to rest in a variety of different positions to present the breast for examination. 
     There has thus developed a need for an improved patient support apparatus which is designed for the performance of mammography, needle localizations and breast biopsies with the patient in a decubitus position. There has also developed a need for an improved method of performing mammography and breast biopsy which allows the patient to have the mammography and/or breast biopsy performed with the patient in a decubitus position. 
     SUMMARY OF THE INVENTION 
     These needs have largely been met by the method and apparatus of the present invention. That is to say, the method and apparatus of the present invention permit the performance of mammography, needle localization and breast biopsy whereby the patient may be positioned for optimum imaging, provide great flexibility in space utilization, give the patient excellent support while in a decubitus position, and provide economies by permitting a single examination room to serve for mammography, needle localization and core biopsy. 
     The patient support apparatus of the present invention broadly includes a patient support deck including a frame and pad defining a multiplicity of openings. To provide the most flexibility and safety, the openings are preferably occupied by filler sections which are most preferably shiftably mounted to the frame to permit access by examiners and a mammography device into the openings. The filler sections may be shifted by either pivoting or translational movement, or altogether removed from the frame when an opening is desired. The deck is supported by a deck support, and head and foot supports may be mounted at opposed ends of the deck. The head support preferably has a smaller transverse dimension than the width of the bed to provide an open area adjacent the head support, thereby permitting a mammography device to be tilted into and occupy the open area during examination. 
     The frame and openings are arranged to provide opposite openings (and preferably corresponding filler sections) which permit ingress from the sides of the deck by examiners such as technicians, nurses and physicians, and positioning of the mammography device therein. The openings are sized and positioned to receive mammography devices therein, with the openings preferably separated by a frame member of sufficient strength to bear the weight of the patient thereon. The frame preferably includes a laterally centered, longitudinally extending spine with center and end cross-channels extending perpendicular thereto in a common horizontal plane, thereby defining at least two openings. The two openings could be located on the same side of the apparatus and thereby enable positioning of the patient to ensure that the “up” breast may be presented for imaging. The two openings could also be located on opposite sides of the apparatus, again allowing the patient to be positioned so that either breast is presented in the “up” breast position, but also allowing the examiner or other members of the technical staff to be closer to the patient when they are positioned (e.g., standing or sitting) in the opposite opening. In the preferred embodiment, four openings are provided to provide maximum utilization and flexibility, so that in even confined room configurations, the “up” breast may always be imaged and the examiner or other member of the technical staff can position themselves close to the patient through the utilization of additional openings. Filler sections include release mechanisms which permit them to be locked in a closed position to fill the opening or released whereby the opening is accessible from the side of the deck. 
     The method of the present invention includes positioning the patient in a decubitus position on the support apparatus, releasing as necessary one or more of the filler sections to provide access to the patient&#39;s breast by a mammography device or instrument including probes such as needles and wires for performing needle localizations or circular blades for obtaining core biopsies of breast tissue, and supporting the patient on the apparatus while a portion of the mammography device and/or breast tissue sampler is located in the opening. Advantageously, the method also includes the patient mounting the support apparatus with the filler sections within the openings to provide support, and after the patient is properly positioned thereon, clearing the opening by removing or shifting one or more of the filler sections to clear the corresponding openings. The method further includes repositioning the patient, either by rotating the patient about the longitudinal axis so that she switches the side of the apparatus she is facing, or remaining facing the same side while moving her head to the end of the apparatus where her foot was previously located. This permits examination of the other of the patient&#39;s breasts with each breast presented in an up breast position. 
     As a result, the support apparatus and method allow the patient to be positioned in a position most advantageous for examination of any area of either breast and allows usage of relatively small examination rooms for performing mammograms, needle localizations and breast biopsies. The patient is uniquely afforded support in her critical areas while at the same time permitting access by the examiner and mammography device to optimize the imaging and retain the feeling of patient security. These and other objects will be readily appreciated by those skilled in the art with reference to the drawings and description which follow. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a front perspective view of a first embodiment of the patient support apparatus of the present apparatus, showing a patient presenting for mammography in a left lateral decubitus position; 
     FIG. 2 is a fragmentary front perspective view similar to FIG. 1 with the patient removed to show the positioning of the support apparatus and mammography/breast biopsy device for a patient in a right decubitus position; 
     FIG. 3 is a perspective view of the patient support apparatus taken proximate the foot support end and showing the four access openings available for ingress of equipment or personnel; 
     FIG. 4 is an enlarged, fragmentary bottom perspective view showing the head support mount of the apparatus hereof; 
     FIG. 5 is a side elevational view of the patient support apparatus with filler sections oriented in a closed and supporting position; 
     FIG. 6 is an enlarged vertical sectional view taken along line  6 — 6  of FIG. 5 showing the support pillar, spine, and two opposed pivotally mounted filler sections, one in a closed and supporting position and one in an open access position, of the patient apparatus hereof; 
     FIG. 7 is an enlarged fragmentary elevational view in partial section showing the release mechanism for pivotal movement of the filler sections of the patient support apparatus hereof; 
     FIG. 8 is an enlarged, fragmentary bottom side perspective view showing the mechanism for enabling release and pivoting of the filler sections from a substantially horizontal closed position to a substantially vertical open position; 
     FIG. 9 is an enlarged, fragmentary top side perspective view of a second embodiment of the apparatus hereof, wherein one or more of the filler sections are pivotally mounted to swing upwardly to provide a support for a patient positioned in a decubitus position and to permit access by an examiner therein; 
     FIG. 10 is an enlarged, fragmentary bottom side perspective view showing a third embodiment of the apparatus hereof, wherein one or more of the filler sections are pivotally mounted to pivot downwardly about an axis transverse to the longitudinally extending spine and provided with a release mechanism; 
     FIG. 11 is an enlarged, fragmentary bottom side perspective view showing a fourth embodiment of the apparatus hereof, wherein one or more of the filler sections are pivotally mounted to pivot upwardly about an axis transverse to the longitudinally extending spine and provided with a support ledge opposite a hinge; 
     FIG. 12 is an enlarged, fragmentary bottom side perspective view showing a fifth embodiment of the apparatus hereof, wherein the width of the longitudinally extending spine is widened and one or more of the filler sections have a coupler for translating and dropping the filler section from the opening for stowage beneath the spine; 
     FIG. 13 is a fragmentary top side perspective view of the embodiment of FIG. 12, showing the position of the filler section when stowed in solid lines and showing the position of the filler section occupying the opening in phantom lines; 
     FIG. 14 is a fragmentary side elevational view of the embodiment of FIG. 12 similar to that shown in FIG. 6, but showing the coupler permitting the filler section to translate outwardly and rise upwardly to occupy its corresponding opening; 
     FIG. 15 is a fragmentary bottom side perspective view of a sixth embodiment of the apparatus hereof, showing the coupler of FIGS. 12-14 oriented for translation of a filler section in a longitudinal direction; 
     FIG. 16 is a fragmentary upper side perspective view of the embodiment of FIG. 15, showing the filler section in a stowed position in solid lines and in an opening occupying position in phantom lines; 
     FIG. 17 is a fragmentary bottom side perspective view of a seventh embodiment of the apparatus hereof, wherein the filler section is supported by a release mechanism and support ledge to enable removal from the frame when the opening is to be cleared; 
     FIG. 18 is a fragmentary top side perspective view of an eighth embodiment of the apparatus hereof, wherein the apparatus is provided with two opposed filler section halves each pivoting on parallel axes and shown in position to provide access to the opening, and provided with a coupling bar for securing the filler section halves when pivoted upwardly to a horizontal orientation; 
     FIG. 19 is a fragmentary bottom side perspective view of the embodiment of FIG. 18, wherein the filler section halves are pivoted into a closed position and secured by the coupling bar; 
     FIG. 20 is a fragmentary top side perspective view of a ninth embodiment of the apparatus hereof, wherein the apparatus is provided with two filler section halves for pivoting upwardly along opposed parallel axes; 
     FIG. 21 is a fragmentary bottom side perspective view of the embodiment of FIG. 20, showing the filler section halves in a closed position and supported on a ledge coupled to the frame; 
     FIG. 22 is a fragmentary top side perspective view of a tenth embodiment of the apparatus hereof, wherein the apparatus has a filler section which pivots about an outboard axis proximate the ends of the crossbars; 
     FIG. 23 is a fragmentary bottom side perspective view of the embodiment of FIG. 22, showing the pivotal mount and release mechanism for supporting the filler section when in a horizontal orientation; 
     FIG. 24 is a fragmentary top side perspective view of an eleventh embodiment of the apparatus hereof, wherein the apparatus mounts a filler section to pivot and translate toward the central spine to clear the opening; and 
     FIG. 25 is a fragmentary bottom side perspective view of the embodiment of FIG. 24, showing roller mountings for enabling the filler section to slide inwardly after pivoting downwardly to clear its corresponding opening. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
     Referring now to the drawings, a patient support apparatus  10  for use in the performance of mammography and breast biopsy broadly includes a deck  12 , the deck  12  including a frame  14 , a multiplicity of filler sections  16 ,  18 ,  20  and  22 , and a pad  24  overlying the frame  14  for cushioning the patient thereon. The deck  12  is elevated above the floor or other supporting surface by a deck support  26 . Advantageously, a head support  28  and a foot support  30  may be coupled to respective ends of the deck  12 . The patient support apparatus  10  is sized to support an adult human patient  32  thereon, and is especially configured for supporting the patient to permit her to present her breast  34  to a mammography device  36  to which a breast tissue sampler  38  may be attached. The device  36  is positioned in an access site within the deck  12  when one or more of the filler sections is shifted or removed, thereby enabling the patient  32  to be supported by the apparatus  10  with the breast in an optimum position for imaging by the device, as shown in FIG.  1 . 
     While multiple embodiments are shown of the present invention, with like numbers used to refer to the same components, it is to be understood that all are sized and configured to support a human patient thereon, and to accommodate a mammography device and mammotome or an examiner or other member of the technical staff during mammography, needle localization or obtaining a tissue sample. Thus, while the patient  32  is shown only in FIG.  1  and the device  36  shown in FIGS. 1 and 2, each embodiment of the apparatus  10  is adapted for supporting the patient and use with the device. 
     In greater detail, the deck  12  is configured with a first end  40  and an opposite second end  42 , a first preferably linear side  44 , an opposing second preferably linear side  46 , a top surface  48  and a bottom surface  50 . A longitudinal spine  52  extends between the first and second ends and is preferably centered between the first and second sides. The deck  12  further includes a first outer support arm  54  adjacent the first end  40 , a second outer support arm  56  adjacent the second end  42 , and a central support arm  58  positioned intermediate the arms  54  and  56 . The support arms  54 ,  56  and  58  are preferably oriented perpendicular to the spine  52 , and together define four recesses extending inwardly from the sides  44  and  46  to provide openings  60 ,  62 ,  64  and  66  which may receive therein respective filler sections  16 ,  18 ,  20  and  22 . 
     The frame  14  includes a framework of preferably metal, tubular channels including longitudinally extending substantially parallel rails  68  and  70  interconnected by plate  72 , first and second end cross-channels  74  and  76 , and center cross-channel  78 . The rails and cross-channels thus provide stiffness and support for the spine and arms as a part of the deck  12 . The tubular channels are interconnected by welding or mechanical fasteners whereby the channels  74 ,  76  and  78  are oriented perpendicular to the rails  68  and  70  as shown in FIG.  6 . In addition, FIG. 6 shows a rigid panel  80  of wood, plastic, metal or other substantially rigid material is attached to and overlies the rails  68  and  70  and cross-channels  74 ,  76  and  78 . As shown in FIG. 6, the panel  80  serves both to support the pad  24  and rigidify the deck  12 . The panel  80  is shaped and sized to provide the four openings  60 ,  62 ,  64  and  66  and to receive the filler sections  16 ,  18 ,  20  and  22  therein, each opening most preferably being at least about 18 inches and more preferably about 22 inches or greater longitudinally and preferably about 10 inches across in order to accommodate a currently available mammography device or an examiner therein. Each opening  60 ,  62 ,  64  and  66  thus defines an access site for the mammography device  36 , examiner or patient. Although only one, two or three openings may be provided in the apparatus  10 , the openings  60 ,  62 ,  64  and  66  are preferably located so that two openings are located along each side to permit access, and in substantially opposed pairs so that opening  60  is opposite opening  64  and opening  62  is across from opening  66 . Each pair of openings is thus preferably separated by spine  52  and the openings along each side are preferably separated by central support arm  58 . 
     The filler sections  16 ,  18 ,  20  and  22  are sized to be complementarily received in the respective openings  60 ,  62 ,  64  and  66 . While the filler sections may be configured to be removably coupled to the frame  14 , in the embodiment of FIGS. 1-8 and as shown in FIGS. 2,  6  and  8 , the filler sections are pivotally mounted to the frame and provide access from the sides  44  and  46 . To that end, each filler section  16 ,  18 ,  20  and  22  includes a sheet  82  of the rigid material such as described for panel  80 , and an overlying cushion  84  of foam cushioning or the like, covered with fabric, leather, or vinyl cloth  86 . The cloth  86  is slightly overlapped by a panel or web  88  of similar material, as shown in FIG.  6 . Such a panel or web is shown as reference character  82   a  in U.S. Pat. No. 5,184,363, the disclosure of which is incorporated herein by reference. Each filler section  16 ,  18 ,  20  and  22  is pivotally connected to the frame  14  by a hinge  90 , preferably but not necessarily oriented for pivoting on a longitudinally extending axis. Each filler  16 ,  18 ,  20  and  22  section further includes a release mechanism  92 . 
     A typical, and in this case preferred, release mechanism  92  both holds the corresponding filler section in position when engaged with the frame  14  and enables the filler sections to drop and clear the respective openings from obstruction. As shown in FIGS. 5,  6 ,  7  and  8 , the release mechanism  92  includes a release lever  94  and a pair of latches  96  and  98  connected to the release lever  94  by a connector  100  such as cables, mechanical linkages or bead chains. Upon shifting of the handle  102  of release lever  94  to the left as shown in FIG. 8, the connectors  100  actuate the latches  96  and  98  to shift their dogs  104  extending through slots  106  of the cross-channels  74 ,  76  and  78  as shown by FIG.  7 . When the latches  96  and  98  are released and their dogs  104  are out of engagement with the channels, the filler sections may be pivoted and lowered until stopped by gravity as shown by FIG.  6 . 
     The deck  12  includes pad  24  is shaped and configured to overlie the frame  14  for supporting the patient  32  on the spine  52  and supporting arms  54 ,  56  and  58  of the deck  12 . The pad includes a foam cushion  108  and a cover  110  of the same material as cloth  86 . By being superposed relative to the frame  14 , the pad  24  provides both cushioning and support for the human patient  32  resting thereon, and positions the patient  32  on a relatively flat, cushioned, horizontal surface across the deck  12  including those areas over the filler sections as wells as the areas above the frame  14 . 
     The deck support  26  elevates the deck  12  above a floor or other supporting surface and preferably includes a base  112  provided with lockable wheels  114  for permitting the entire patient support apparatus  10  to be easily moved or maintained in place as shown and described in U.S. Pat. No. 5,950,262, the disclosure of which is incorporated herein by reference. Thus, the apparatus may rotate about a central, upright axis, translate to carry the patient therewith, and be locked in position against movement by engaging the locking arms of the wheels  114 . The base  112  carries a motor drive control  116  and a pedestal  118  connected to the frame  14  at plate  72  as shown in FIG.  6 . In the preferred configuration as illustrated herein, the pedestal  118  includes telescoping sections  120  and  122  and a motorized extensible drive (not shown) which permits the deck  12  to be raised and lowered relative to the supporting surface. 
     Advantageously, the cross-channels  74  and  76  each include a laterally centered bracket  124  of stainless steel or the like which removably mounts either the head support  28  or the foot support  30  as shown in FIG.  4 . That is, because both the head support  28  and foot support  30  include a commonly configured mounting bar  126 , the head support  28  may be exchanged in position with the foot support  30 , and coupled to either bracket  124 . In addition, the elevation of the head support may be varied by the insertion of a locking screw  130  through one of the apertures in its mounting bar  126 . It is desirable that the head support  28 , shown trapezoidally shaped, be considerably narrower in width than the width of the deck  12  or pad  24  so that the mammography device  36  shown in FIGS. 1 and 2 may be tilted and the upper camera part  132  thereof may be positioned in clearings  136  or  138  proximate the head support  28  and the respective end cross-channel  74  or  76  to which the head support  28  is mounted. On the other hand, the foot support  30  may be relatively narrow and have only the width of the head support, or extend the width of the apparatus  10 , as shown, as the mammography device  36  is positioned more proximate the patient&#39;s head. By providing a plurality of apertures, the head support  28  may be vertically adjusted to provide comfortable support corresponding to the patient&#39;s physique. 
     The apparatus  10  is configured to accommodate use with a wide variety of mammography devices which comprise one preferred environment of use. The mammography device  36  as illustrated in FIGS. 1 and 2 is a Model Senovision by General Electric Medical Division of Milwaukee, Wis. It is one example of a device  36  useful herewith and may include an integrated breast tissue sampler  38  positioned adjacent the breast compressing plates of the mammography device  36  for performing core biopsies or needle localizations while the breast  34  of the patient  32  is imaged. One breast tissue sampler  38  which may be mounted on a mammography device  36  for performing core biopsies in accordance with the present invention is a Biopsys device manufactured by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio and sold under the trademark Mammotome. 
     In the method of the present invention, the patient  32  is positioned on the patient support apparatus  10  so that her torso and legs are supported on the portion of the spine  52  with her head resting on the head support  28  and her feet supported either by the foot support  30  or, in shorter patients, by the spine  52  or the filler sections  18  and  20  as the apparatus is arranged in FIG.  2 . Any of the filler sections  16 ,  18 ,  20  and  22  may be initially raised and locked in position to fill the corresponding openings  60 ,  62 ,  64  and  66  as illustrated in FIG. 2, so that when the patient moves onto the support apparatus  10  she has good support and a feeling of security during positioning thereon. The apparatus  10  also permits the patient to be supported by the cross-channels and one or more of the filler sections  16 ,  18 ,  20  and  22  when that filler section is in a closed position. FIG. 1 illustrates the apparatus  10  and device  36  arranged to receive a patient  32  in a left lateral decubitus position, whereby the image of the patient&#39;s upper (right) breast  34  would be achieved from the camera  132  above the right shoulder to the film cassette  134  at the patient&#39;s midline, a lateral-medial view. Once the patient  32  is in the decubitus position, as shown in FIG.  1  and preferably over the center or spine  52  of the support apparatus  10 , one or more of the filler sections  16 ,  18 ,  20  or  22  may be dropped to the position shown on the right of FIG. 6 to provide access into that opening by the mammography device  36 . For example, as shown in FIG. 1, the filler section  18  would be dropped to clear opening  62  to receive the device  36 . 
     However, the support apparatus  10  hereof also permits the patient  32  to be positioned to the side of the spine  52 , whereby her torso spans an opening in order to place her breast  34  in position for mammography, needle localization or breast biopsy. For example, in order to place the patient in sufficient proximity to the mammography device  36 , it may be necessary for the patient to move laterally on the support apparatus so that her hips are over the central support arm  58  and her shoulders supported by one of the outer support arms  54  or  56  depending or her positioning on the apparatus  10 , with a filler section dropped to clear the corresponding opening so that some or all of the patient&#39;s torso spans that opening. While the apparatus  10  may be used with the patient  32  in a sitting position, more preferably the patient is positioned in either a left decubitus or right decubitus position. 
     The patient&#39;s breast  34  is then placed between the clamping plates adjacent the film cassette  134  of the mammography device  36 . A better image may often be obtained by imaging the upper breast, and so in the left decubitus position shown in FIG. 1, the head support  28  is positioned at first end  40  and foot support  30  at second end  42 , with the head support  28  vertically adjusted to be slightly above the upper level of the pad  24  for comfort. Filler section  18  is pivoted downwardly to receive the mammography device  36  in the cleared opening  62 . The right breast  34  of the patient  32  is then positioned between the clamping plates of the mammography device  36  for imaging with the breast compressed side to side and the image obtained lateral to medial. In the described position, following the imaging of the breast  34 , it is also possible to perform a needle localization or core biopsy. As described above, obtaining the sample for the biopsy would be performed with the breast tissue sampler  38  sampling in the cranial caudal plane perpendicular to the plane of compression. The apparatus  10  hereof also receives a portion of the mammography equipment of other manufacturers than that illustrated, wherein it is also possible to perform core breast tissue sampling for a biopsy in the same direction as the direction of the movement of the plates during compression. The direction of the movement of the plates shown in FIG. 1 is lateral medial, whereas the direction of movement of the plates shown in FIG. 2 is cranial caudal. 
     Alternatively, the mammography device  36  can be tilted as shown in FIG. 2 if the radiologist desires to obtain a cranial-caudal compression image of the breast, whereby the breast is compressed from top to bottom, advantageously with the patient  32  remaining on the apparatus  10 . FIG. 2 shows the apparatus  10  and mammography device  36  arranged for the patient  32  to assume a right lateral decubitus position, and the image would be obtained from the camera portion  132  adjacent the patient&#39;s head toward the film cassette  134  near the patient&#39;s waist, a cranial-caudal view. In this configuration, filler section  16  would be opened to allow receipt of a portion of the mammography device  36  in opening  60 , and thus film cassette  134  and the clamping plates adjacent thereto are permitted to reach patient  32 . Either filler section  18  or  20  may be opened to permit easy access by the examiner, such as a nurse, technician, physician or other qualified person to position the patient and the mammography device  36 . 
     To obtain the mammogram of each breast  34  in a superior or upper position, the patient may be repositioned in one of two ways by using the apparatus  10  hereof, whichever is more comfortable for the patient and depending on the layout and configuration of the examination room. Starting from FIG. 1 showing the patient presenting her right breast in a superior position for imaging, one alternative available with the present apparatus  10  is that the patient  32  may turn over, rotating longitudinally, so that she faces generally toward opening  66 , and the mammography device  36  is moved from opening  62  accessible from side  46  into the opening  66  accessible from side  44 . The filler section  18  may thus be pivoted upwardly to a horizontal position to provide stability and support while the patient turns, and the head support  28  may remain in position. Alternatively, the patient  32  may turn so that her head moves from first end  40  to second end  42 , and thus the positions of the head support  28  and the foot support  30  are exchanged as shown by the arrangement in FIG.  2 . In this option, the mammography device  36  is merely shifted from its initial location in opening  62  into opening  60  as shown in FIG.  2 . The patient is thus in a right decubitus position with her left breast uppermost, and again her breast is placed between the clamping plates of the mammography device  36  (with either lateral-medial or cranial-caudal compression as described above) so that an image is obtained. A comparison of FIG. 1 with FIG. 3 illustrates a third option, whereby the entire apparatus  10  may be moved on its wheels about a generally upright axis so that the relative positions of the first end  40  and second end  42  are exchanged without the need for repositioning the head support  28  and the foot support  30 , and the patient  32  then turns about her longitudinal axis and either the device  36  or the entire apparatus  10  is shifted laterally so that a portion of the mammography device  36  is received into opening  66  illustrated in FIG.  3 . 
     During any part of the mammography procedure, not only can the patient and mammography device be repositioned, but also the filler sections occupying openings and below the patient may be dropped to permit the examiner to work without undue bending or stretching in order to prepare the mammography device and position the patient&#39;s breast therein for mammography, needle localization or biopsy. In this regard, the legs or torso of an examiner may occupy any one of the openings not occupied by the mammography device  36  in the same manner as illustrated with regard to the examiner  96  shown in FIG. 5 of U.S. Pat. No. 5,950,262. 
     Further, because the deck support  26  elevates the deck  12  above the floor or other supporting surface and the openings are configured to receive the cassette portion  134  of the mammography device  36  medial to the sides  44  and  46  depending on which opening is utilized, the apparatus  10  facilitates use of the mammography device  36  for stereo imaging of the breast when the patient is in a decubitus position. Stereo imaging of the breast typically involves taking two images of the breast to obtain a three dimensional representation of the location of any questionable tissue within the breast. When the patient is in the decubitus position and stereo images in a cranial caudal direction are desired, the mammography device  36  may be oriented to take images with the camera portion  132  positioned below the deck  12  and angled upwardly toward the film cassette portion  134  at an angle of about 15° from that shown in FIG.  2 . Then, to obtain the second, stereo image, the mammography device  36  may then swing so that the camera portion  132  is above the deck  12  and angled downwardly toward the film cassette portion  134  at an angle of about 15° from that shown in FIG. 2, so that about a 30° angle between the first and second images is obtained. 
     If the results of the mammogram reveal suspicious tissue to the radiologist and a biopsy is required, the core biopsy may be obtained with the patient  32  positioned as described above. Typically, during core biopsy, stereotactic images are obtained to provide a three-dimensional image of the tissue and localization of the lesion. Because the breast tissue sampler  38  may be mounted on the mammography device  36  and its position precisely controlled, the insertion of the probe to obtain the core biopsy may be performed with the patient positioned most favorably to obtain access to all breast tissue and conducted in the same room where the initial mammogram is performed. Depending upon the particular mammography device  36  used, the biopsy needle may be introduced in the plane parallel to the axis of compression as shown in FIG. 2, or perpendicular to the axis of compression. After obtaining the core tissue sample, a tissue analysis is performed as is known to those skilled in the art. 
     A number of different options are available for shifting a filler section to clear an opening, as illustrated by the alternative embodiments shown in FIGS. 9 through 25. In the embodiment of the apparatus  10 A shown in FIG. 9, one or more of the filler sections  16 A,  18 A,  20 A and  22 A may be pivotally mounted to swing upwardly rather than downwardly to clear its corresponding opening. Thus, apparatus  10 A shown in FIG. 9 includes a filler section  20 A having pivot pins  140  and  142  adjacent the inboard side  144  and coupled to cross channels  76  and  78 , respectively. Ledges  146  and  148  are welded, screwed, or otherwise fastened to the cross channels  76  and  78  to provide support when the filler section  20 A is horizontal, as shown in FIG.  10 . When the filler section  20 A is pivoted upwardly as shown in FIG. 9, it may provide support against which the patient may lean when in a lateral decubitus position. 
     FIG. 10 illustrates a third embodiment of the apparatus  10 B, which is similar to apparatus  10 , but wherein the filler section  20 B is coupled by a hinge  150  to center cross channel  78  to pivot downwardly about an axis transverse to the longitudinal axis of the spine  52 . When in the up, horizontal position occupying opening  64 , the filler section  20 B is supported opposite hinge  150  by the dog  104  of the latch  96  extending into a slot in one of the end cross channels, e.g. cross channel  76 .. As shown in FIG. 10, any of the filler sections may be provided with a release mechanism  92 . To clear the opening  64 , the handle  102  is shifted to the right as seen in FIG. 10, thereby releasing the dog  104  of latch mechanism  96  to permit the filler section  20 B to swing downwardly. 
     FIG. 11 illustrates a fourth embodiment of the apparatus  10 C similar to apparatus  10 B, but wherein one or more of the filler sections, for example filler section  20 C, may be pivotally coupled to the center cross channel  78  to swing upwardly out of its opening  64 . A hinge  150  is attached by welding, screws or other attachments to the center cross channel  78  and a ledge  152  is welded or fastened to the opposite end cross channel  76 . 
     FIGS. 12,  13  and  14  show a fifth embodiment of the apparatus  10 D wherein one or more of the filler sections, shown as filler section  20 D, is configured to drop and slide laterally toward and beneath the spine  52  to clear the corresponding opening  60 . In this embodiment, the spine  52  would be of sufficient width to permit the filler section  20 D to be received therebeneath. Mount  154  includes arms  156  and  158  on each side thereof which are pivotally coupled to a bracket  160  and to bed  161  attached to a pair of supports  162  attached to the underside of filler section  20 D, whereby the filler section  20 D is maintained in a generally horizontal orientation if desired, or because of the arcuate slots provided in the arm  158 , may be angled if desired. The brackets  160  each slide along a respective track  164  mounted to the panel  80 , whereby the filler section  20 D slides along the tracks  164  from the position shown in solid lines in FIG. 14 until it reaches the outboard end of the tracks, then swings on arms  156  and  158  to fit into the opening  60  as shown in the dotted lines in FIG. 14, whereupon the dogs  104  of the release mechanism  92  shift into the slots  106  to hold the filler section  20 D in place. When the handle  102  of the release mechanism is actuated, the dogs release and the filler section  20 D may drop and slide back beneath the spine  52 . 
     FIGS. 15 and 16 show a sixth embodiment of the apparatus  10 E which includes mount  154  and is similar to the apparatus  10 D shown in FIGS. 12,  13  and  14 , except that one or more of the filler sections, e.g. filler section  20 E, has mount  154  coupled to a widened center cross channel  166 , and the filler section  20 E drops and translates in a longitudinal direction for stowage beneath the central support arm  168  as shown in FIG.  16 . The release mechanism  170  thus includes only a single latch  172  whose dogs enter into the opposite end cross channel  76 . 
     FIG. 17 illustrates a seventh embodiment of the apparatus  10 F, with one or more of the filler sections, e.g. filler section  20 F, being removably mounted to the frame  14 . A U-shaped ledge  174  is welded or fastened to the rail  68 , center cross channel  78  and end cross channel  76 , whereby actuating the release mechanism  92  enables the filler section  20 F to be lifted or slide outwardly and removed from the apparatus  10 F to clear the opening  60 . In additional embodiments, the apparatus  10 F might have no locking release mechanism and be held in place simply by resting on a U-shaped ledge  174 . Further, the sides of the filler section might be provided with a normally medial to lateral extending slot to allow the filler section to slide into and out of sliding engagement with the deck on U-shaped ledge  174 . Finally, in the simplest variation on this embodiment, the deck  12  might have no filler sections and merely utilize unfilled openings to accommodate and receive therein the patient, portions of the mammography device  36 , or medical personnel such as a technician. 
     FIGS. 18 and 19 illustrate an eighth embodiment of the apparatus  10 G, with one or more of the filler sections bifurcated and separately hinged. Filler section  20 G has filler section halves  178  and  180  each have a respective hinge  182  and  184  secured by welding or fasteners to the center cross channel  78  and end cross channel  76  respectively. The filler section halves  178  and  180  together occupy opening  60  when raised into a horizontal orientation as shown in FIG. 19, and may be held in place by latching bar  182  shiftably received in brackets  184  and  186  and upon which a part of the load applied to the filler section halves is borne. 
     FIGS. 20 and 21 illustrate an ninth embodiment of the apparatus  10 H, wherein one or more of filler sections, e.g. the filler section  20 H, again has filler section halves  188  and  190  which are similar to filler section halves  178  and  180  but have a tapered upper surface  192  adjacent the central support arm  58  and first outer support arm  54 , respectively. The hinges  182  and  184  thus permit the filler section halves  188  and  190  to swing upwardly to clear the opening  60  as shown in FIG. 20, and a ledge  191  is secured by welding or fasteners to rail  68  to support the filler section halves  188  and  190  when in a horizontal position as shown in FIG.  21 . 
     FIGS. 22 and 23 illustrate a tenth embodiment of the apparatus  10 I, wherein pivot mounts  194  and  196  pivotally connect the filler section  20 I adjacent the first side  44  of each the end cross channel  76  and the center cross channel  78 . The release mechanism  92  is thus modified with a longer handle  102 , with the latches  96  and  98  located inboard of the pivot mounts  194  and  196  to permit the filler section  201  to pivot and drop at its inboard edge  198 . 
     FIGS. 24 and 25 illustrate an eleventh embodiment of the apparatus  10 J, similar to apparatus  10 I, but wherein one or more of the filler sections, e.g. filler section  20 J, has pivot mounts  200  and  202  each provided with rollers  204 . The rollers  204  are received within the tubular end cross channel  76  and center cross channel  78  and free to roll in a lateral direction transverse to the longitudinal axis of the apparatus  20 J therewithin. The end cross channel  76  and center cross channel  78  are provided with laterally extending slots  206  whereby the pivot pins  208  of the pivot mounts  200  and  202  may traverse along the slots. Upon actuation of the release mechanism  92 , the filler section  20 J is free to pivot and drop along its inboard edge  198 , and then translate along the slots  206  to clear the opening  60 . 
     As a result of the configuration and operation of the apparatus  10  hereof, mammography and breast biopsy may be performed with patients in the decubitus position even in relatively small rooms. By permitting ingress of the mammography device into one of the openings of the apparatus  10 , and by providing multiple openings, the apparatus facilitates its positioning in a variety of orientations according to the size of the equipment and comfort to the patient. Because the head and foot supports are interchangeable, the patient may remain comfortable in either the left decubitus or right decubitus position when the apparatus  10  and the mammography device  36  are restricted in their ability to be repositioned because of the tight space. The spine and cross-members of the frame still provide firm and stable support so that the patient does not become anxious when a filler section is dropped to clear an opening. The openings and the ability of the pedestal  118  to move the frame and the filler sections up and down enables the technician to have the most favorable access and positioning relative to the patient. Moreover, by providing openings complementally sized to receive either the camera portion or film cassette portion of the mammography device  36 , the mammography device  36  may be tilted in a direction 180° from that shown in FIG. 2 with the camera portion  132  located in opening  62  and the cassette portion  134  located in opening  60  whereby caudal-cranial imaging of a patient in a right lateral decubitus position may be performed. 
     Although preferred forms of the invention have been described above, it is to be recognized that such disclosure is by way of illustration only, and should not be utilized in a limiting sense in interpreting the scope of the present invention. Obvious modifications to the exemplary embodiments, as hereinabove set forth, could be readily made by those skilled in the art without departing from the spirit of the present invention. 
     The inventors hereby state their intent to rely on the Doctrine of Equivalents to determine and assess the reasonably fair scope of their invention as pertains to any apparatus not materially departing from but outside the literal scope of the invention as set out in the following claims.

Technology Category: 1