Abstract:
According to the present invention, improved methods and apparatus are provided for providing cushioning and other ergonomic surfaces on devices requiring the patient or tissue to be compressed, such as radiography machines, fluoroscopy units, mammography units and the like. In particular a radiolucent pad element is provided for releasable attachment to at least one surface of a compression device to be used under x-ray, for example, during mammography. The pad element of the present invention can be disposable or constructed to be reusable and in some cases may be applied directly to the patient&#39;s breast. Furthermore, a cushioned paddle is provided wherein the compression paddle and the cushion can be separately or integrally formed.

Description:
RELATED APPLICATION DATA 
     This application is a continuation of application Ser. No. 10/946,044, filed Sep. 21, 2004, issuing as U.S. Pat. No. 7,616,732 on Nov. 10, 2009, which is a continuation of application Ser. No. 10/389,392, filed Mar. 14, 2003, now U.S. Pat. No. 6,968,033, which is a continuation of application Ser. No. 09/620,730, filed Jul. 20, 2000, now U.S. Pat. No. 6,577,702, which claims benefit of provisional application Ser. No. 60/187,198, filed Mar. 6, 2000. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates generally to medical apparatus and methods and more particularly to devices and methods for cushioning or padding the surface of compression plates applied to body parts for purposes of obtaining x-ray films for example mammography, or other scans of compressed tissue. 
     Currently, in the case of mammography, a patient&#39;s breast is placed under compression by opposing plates attached to a mammography machine. Once under compression an x-ray is taken to determine the presence or absence of suspect lesions in the breast tissue (e.g. calcifications, tumors). Approximately 25 million screening mammograms are performed yearly, which is estimated to be only a 50% compliance rate among potential patients, meaning that number would double if more patients complied with the recommended screening regime. One of the more common complaints from mammography patients is discomfort during compression of the breast. Most patients can only tolerate up to 10-11 compression units. The current legal limit for clinical mammography is 16-18 units. A device which would reduce discomfort could likely improve compliance for screening. 
     An important reason for compressing the breast during mammography is to provide a thinner cross section of tissue for the x-rays to pass through. When the breast is compressed, it provides optimal imaging of the tissue abnormalities with the lowest possible dose of x-ray radiation to the patient. Furthermore, during a mammogram, it is important for the x-ray plate to be free from radiopaque material, so that the diagnostic film, once processed, can give the physician the best possible picture of the tissue and any abnormalities. 
     Although patients may tolerate the pain during compression, there is a need for improved devices and techniques to provide better screening outcomes by enabling the use of higher compression force, and by providing increased patient comfort during mammograms thereby positively impacting patient compliance with mammographic screening and ultimately impacting early detection of cancer and improving patient survival. 
     Such improved devices must be radiolucent and made of a relatively homogeneous material to avoid striations or other variations on the resulting x-ray image, have a low profile to allow for correct positioning of the breast in the mammography machine, be easily cleaned or disposable for sanitary reasons, and provide structural support and tactile comfort to the patient (both soft to touch and providing a less harsh or “cold” surface). In addition, such improved devices will permit the use of higher compression forces to be applied to the breast during mammograms without the patient reaching her tolerance level for discomfort, resulting in a thinner tissue section, better image quality, and reduced x-ray dose to the patient. 
     It is an objective of the present invention to provide greater patient comfort thereby increasing screening compliance (e.g. patient willingness to have more regular mammograms by reducing discomfort of the procedure). Greater patient comfort also reduces the risk of patient movement (voluntary or involuntary). Motion artifact, caused by patient movement or slippage of the tissue, can result in loss of clarity of the mammographic image. It is a further objective of the present invention to allow for the use of an increased compressive force, for example, up to 16-18 compression units or more thereby providing for a thinner cross-section of breast tissue during the mammogram resulting in an enhanced ability to detect abnormalities in the mammographic image. These objectives are met by the design and use of the present invention. 
     DESCRIPTION OF THE BACKGROUND ART 
     Various patents have issued illustrating inventions in the field of mammography and comfort during x-ray imaging. For example, in the field of mammography, U.S. Pat. Nos. 3,963,933, 4,691,333, 4,943,986, 5,189,686, 5,553,111 and 5,398,272 describe various fixtures useful for breast compression. Further, patents have issued describing devices for increasing comfort during general x-ray procedures, such as U.S. Pat. No. 5,226,070 (radiolucent x-ray mat), U.S. Pat. No. 5,081,657 (bucky warmer for mammography machine), U.S. Pat. No. 5,541,972 (disposable padding device for use during mammography), and U.S. Pat. No. 5,185,776 (padded cover for x-ray cassette). 
     SUMMARY OF THE INVENTION 
     According to the present invention, improved methods and apparatus are provided for cushioning or providing other patient comfort surfaces on devices used for compressing the patient&#39;s tissue, such as radiography machines, fluoroscopy units, mammography units and the like. In particular a pad element is provided for releasable attachment to at least one surface of a compression device to be used under x-ray, or other imaging modality. 
     In a preferred embodiment of the present invention a pad assembly is provided consisting of a pad element, an adhesive layer and a release paper layer allowing for temporary attachment to the applied surface (either the mammography paddle, x-ray plate or directly to the patient&#39;s skin). 
     An alternative embodiment of the present invention includes a reusable cushioned paddle configured of a self-skinned foam to allow for easy cleaning between patients. This embodiment may be replaceable after many uses or formed integrally wherein the padded surface and the compression paddle are assembled as one unit. 
     The present invention may also incorporate a dispensing unit for access to single pads for single use. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  illustrates a typical mammography unit having a base and a pivoting x-ray unit attached thereto, the x-ray unit including a compression paddle and an x-ray plate. 
         FIGS. 2A-2B  illustrate detailed construction of the x-ray plate and the compression paddle respectively. 
         FIGS. 3A-3C  illustrate various configurations of compression paddles utilized during mammography in a standard mammography machine; the shape and size depending both on the patient&#39;s anatomy and the type of x-ray view desired by the physician. 
         FIGS. 4A-4B  illustrate various attachments that can be placed on the x-ray plate to enhance the image, including devices for spot compression and magnification. 
         FIG. 5  illustrates a compression paddle and x-ray plate configured for use in a stereotactic biopsy procedure. 
         FIG. 6A  illustrates the pad of the present invention having a padding layer, an adhesive layer and a release paper layer. 
         FIG. 6B  illustrates another pad of the present invention within a “peel away” packet. 
         FIG. 6C  illustrates still another pad of the present invention with an adhesive layer and release paper layer just along the border. 
         FIG. 7  illustrates the installation of the pad of the present invention on an x-ray plate. 
         FIG. 8  illustrates the installation of the pad of the present invention on a compression paddle. 
         FIG. 9  illustrates various pad configurations and geometries according to the present invention depending on the type of compression paddle or x-ray unit used in a given procedure. 
         FIG. 10A  illustrates an alternative embodiment of the present invention, showing the use of a self-skinned foam fastened to a compression paddle intended for use on multiple patients. 
         FIGS. 10B-10C  further illustrate an alternative embodiment of the present invention wherein the pad of and compression paddle are integral as one unit. 
         FIG. 11  illustrates a further feature of the present invention, namely a dispensing unit for storing and dispensing the disposable pads of the present invention to promote ease of use and efficiency. 
         FIG. 12  shows a pad assembly on a film holder and compression plate, and a breast being compressed therebetween. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     A typical or standard mammography unit used to image the breast while under compression is shown in  FIG. 1 . This unit  10  includes a base  12  and a rotating x-ray source  11 , comprising an x-ray source  13 , a movable compression paddle  14  and an x-ray plate  15  that holds the film cassette (not shown) as well as serving as a compression surface against which the compression paddle  14  can compress tissue, e.g., a breast to be imaged. As depicted in  FIG. 2A , typically the x-ray plate  15 , in certain configurations known as a “bucky,” is stationary and includes an opening  16  into which an x-ray cassette  17  is placed prior to imaging. The x-ray plate has two patient contact surfaces, a front face  18 , and a functional surface  19 . The x-ray plate  15 , may optionally include radiopaque markers  19 A at the perimeter of the functional surface  19  to allow various marking schemes to be utilized during a procedure. 
       FIG. 2B  illustrates a more detailed configuration of compression paddle  14 , including a front patient contact surface  20  and a functional patient contact surface  21 . Paddle  14  is typically constructed of a clear radiolucent plastic material and is designed to be removably attached by an interchange assembly  22 , to the movable working arm of the mammography machine (not shown). These paddles are configured in various geometries as depicted in  FIGS. 3A-3C  to accommodate various patient anatomies and specific needs of mammographers, such as coned compression paddles ( 3 A), spot compression paddles ( 3 B) and the axillary paddle shown as  FIG. 3C , all configured to attach to the mammography unit through standard interchange assembly  22 , as shown earlier. 
     Similarly, the x-ray cassette holder may be adapted by various ancillary modules such as the spot compression fitting  41  shown in  FIG. 4A , and a magnification fitting  42  shown in FIG.  4 B. The entire compression system (compression paddle and x-ray plate) can further be modified to accommodate a stereotactic biopsy procedure as illustrated in  FIG. 5 . In this configuration, compression paddle  14 , is modified to include a window  51 , allowing the clinician access to the breast, while still under compression, for purposes of placing a device to identify a specific location in the breast, or to perform an biopsy of tissue. 
     A preferred embodiment of a pad assembly constructed in accordance with the present invention is illustrated in  FIG. 6A . The pad assembly  60  comprises a padding element  61 , an adhesive layer  62 , and a release paper  63  to be removed from contact with the adhesive layer just prior to installation on the surface to be padded. Pad element  61  may be constructed of various materials having the following characteristics: produce no significant visual artifact on the mammogram (i.e. is radiolucent), be deformable under the forces applied during compression to provide comfort. Furthermore, the material should provide conformance to the tissue and the compression surface so as to reduce the propensity for the material to create air pockets or folds that may be of sufficient size to be visible on the x-ray image. Additionally, it may be desirable for the material to be absorptive to external fluids such as sweat. 
     Such materials may be an elastomer or gel, open or closed cell foam consisting of polyolefin, or, preferably a hydrophilic polyurethane open cell foam because of its radiolucent characteristics and soft tactile feel. The padding material  61  may be a thickness of 0.050 inch to 0.500 inch, preferably in the range of 0.200 inch and 0.250 inch. If an adhesive layer is used, adhesive layer  62  may be one of a variety of currently available pressure sensitive adhesives such as acrylic or synthetic rubber based adhesives, to allow sufficient tackiness for secure attachment to the compression surface, while also allowing for easy removal (e.g., leaving no detectable residue of adhesive on the applied surface) and disposal. Alternatively, a non-adhesive gel may be used to secure the pad or another layer of material having a greater coefficient of friction against the applied surface. It is also anticipated by the scope of the present invention, that the pad element may itself be textured such that it is sufficiently “tacky” to enable its use without an adhesive layer, i.e., by means of friction between the element and the tissue and the unit compression surface. 
     The pad element of  FIG. 6A  can be configured with adhesive on the entire surface of the pad, or at certain regions such as just along the border (see  FIG. 6C ).  FIG. 6B  depicts a “peel away” packet configuration to house the pad assembly. Optionally, the peel away packet can serve as a stiffening element to aid installation of the pad by keeping it in a planar configuration to minimize the possibility of misapplying the pad (leading to inadvertent air pockets or folds in the material, etc.) and to aid in positioning the pad prior to adhering it to the applied surface. 
       FIG. 7  illustrates, in stepwise fashion, the installation of the pad assembly  60  of the present invention onto the film holder  15 . The first step comprises opening the packing material housing the pad assembly  60  (S 1 ), and thereafter removing any release paper  63  therefrom (S 2 ). Installation on the patient contact surfaces of the x-ray plate  15  are shown in steps S 3  and S 4 , S 3  showing the placement of the pad element  61  on functional surface  19 , and optionally extending to front face surface  18 . Finally, the pad element may be removed and disposed of and the sequence repeated for the next patient. It may be desirable to score or otherwise provide a fold in the pad element at a fixed point from the edge of the pad to accommodate folding the pad onto the front face of the applied surface. 
     A similar sequence of steps (S 1  to S 4 ) is illustrated in  FIG. 8  showing the installation of pad assembly  60  of the present invention onto compression paddle  14 . It should be noted that the pad of the present invention may be installed on the x-ray plate  15  and the compression paddle  14 , as shown in  FIG. 12 , or one and not the other, and further optionally on the front face of either surface depending on the amount of additional cushioning desired. In experimentation with the present invention, increased comfort was noted in all of the various configurations as compared to unpadded compression surfaces. 
     An alternative technique for use of the pad is to attach it to the breast of the patient instead of on the mammography machine itself. In this technique (not shown) the release paper is removed and the adhesive side of the pad is placed directly on the breast in an area of tissue to be compressed prior to placing the breast into the mammography machine. 
     Typical geometries of the present invention are illustrated in  FIG. 9 , including pad elements for x-ray plate  15  (G 1 ), pad elements with windows for stereotactic use (G 2 ), spot compression paddles (G 3 ), coned compression paddles (G 4 ), and axillary paddles (G 5 ). 
     It is noted that while these configurations reflect the geometries of various commercially available compression paddles and x-ray cassette holders, the present invention may be manufactured in a wide array of sizes and shapes. The present invention includes pad assemblies, where the pad elements are modular (e.g., using more than one pad to cover a desired surface), or cut to fit the desired surface (oversized with an overlay pattern to guide the operator in cutting the pad to fit). 
     An alternative embodiment of the present invention is illustrated in  FIGS. 10A-10C .  FIG. 10A  shows a modular configuration of the present invention wherein the pad assembly is constructed from a self skinned foam (PA), i.e., foam having an impermeable membrane covering, such as a vinyl, deployed over a frame (not shown) and fastened to a compression paddle by suction cups, magnets rivets or adhesive (AD) on the non-functional surface of the compression paddle or x-ray plate. The self-skinned configuration of the pad assembly allows for washing or disinfecting and can therefore be applied for multiple patients.  FIG. 10B  illustrates a pad assembly (PA) attached to the paddle on the non-functional surface by snaps or rivets  110 . 
       FIG. 10C  further illustrates an alternative embodiment of the present invention wherein the pad  120  of and compression paddle  121  are a single integral unit. 
       FIG. 11  illustrates a dispensing unit according to the present invention for housing and dispensing the inventive pad assemblies. Dispensing unit  100  includes a housing  101  allowing multiple pad assemblies  103  to be stacked for compact storage, and an access slot  102  for allowing the user to access one pad assembly at a time. 
     While the above is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used. Therefore, the above description should not be taken as limiting the scope of the present invention.