Patent Publication Number: US-2012033786-A1

Title: Mammography pad

Description:
TECHNICAL FIELD 
     The present invention relates generally to medical devices, and more particularly to an apparatus and method for providing patient comfort during mammography examinations. 
     BACKGROUND 
     During mammography examinations, a patient&#39;s breast is compressed by opposing plates attached to a mammography unit. Once under compression, an x-ray may be taken to determine the presence or absence of suspect lesions in the breast tissue. An important reason for compressing the breast is to provide a thinner cross-section of tissue for the x-rays to pass through. One of the problems with mammography is that patients may experience discomfort during compression of the breast. Although some patients can tolerate lower units of compression, higher compression units are needed to obtain a more enhanced mammogram increasing the probability of detecting cancers or suspect lesions. Unfortunately, this discomfort may lead many women to avoid mammography. While prior art devices have been designed to provide comfort for patients (i.e., gel pads, heating pads etc.), such devices provide little or no added comfort for the patient, or they lead to significant increases in the cost of examinations. Therefore, there remains a need for comfort devices to reduce or eliminate patient discomfort (i.e., discomfort caused by the coldness and pressures associated with mammography examinations), and to provide a more sanitary device thereby preventing the likelihood of an allergic reaction or cold symptoms, without adding significant costs to mammography examinations. 
     BRIEF SUMMARY 
     An embodiment of the present invention comprises a mammography pad for use with a mammography unit for providing comfort to a patient, and aiding in the positioning of the patient&#39;s breast tissue during mammography examinations. The pad includes a substrate adapted to overlie a compression plate. The substrate has a first and second surface, and at least one score line that defines at least first portion and at least second portion of the substrate. The first portion of the second surface of the substrate includes a fastening means thereon for releasably attaching the pad to the mammography unit. The pad further includes a compressible member secured to the first surface of the substrate. 
     In another embodiment of the present invention, the mammography pad comprises a substrate formed from polymers, like a high density polyethylene. Additionally, the compressible member is formed from medical grade hypoallergenic materials. 
     In another embodiment of the present invention, the mammography pad comprise a substrate having a thickness between about 0.015 inches and 0.10 inches, a compressing member having a thickness between about 0.25 inch and 1 inch, and a fastening means having a thickness between about 0.015 inches and 0.10 inches. 
     In another embodiment of the present invention, the mammography pad comprise a substrate having a score line defining a first and second portion, wherein the first portion has an area equal to or less than the second portion. 
     In another embodiment of the present invention, the mammography pad comprise a substrate having a score line defining a first and second portion, wherein the first portion has an area equal to or greater than the second portion. 
     In another embodiment of the present invention, the mammography pad comprises a fastening means that is an adhesive, wherein the adhesive is a radiolucent foam tape, and includes a selectively removable liner. 
     In another embodiment of the present invention, the mammography pad comprises at least one wing or strap for releasably attaching the mammography pad to the compression plate, wherein the at least one strap includes a fastener at a first end of the at least one strap for releasably attaching the first end to an underside surface of the compression plate. 
     In another embodiment of the present invention, the mammography pad comprises radiopaque markings having origin information that may correspond to the mammography pad. 
     In another embodiment of the present invention, the mammography pad comprises at least one selectively removable sheet adapted to lie over the mammography pad, wherein the sheet is made from a hypoallergenic material, and optionally includes at least one tab selectively attached thereon for selectively removing the sheet from the mammography pad. 
     In another embodiment of the present invention, the mammography pad is adapted to be placed in a second folded position from a first planar position, wherein the first and second portions of the substrate are substantially coplanar to each other in the first position, and the first and second portions are approximately perpendicular to each other in the second position. 
     Another embodiment of the present invention comprises a method of administering a mammography exam using the mammography pad. The method includes providing a mammography pad adapted to overlie a compression plate of a mammography unit, wherein the mammography pad comprises a substrate having first and second surfaces, and at least one score thereby defining a first and second portion, a compressible member attached to the first surface of the substrate, and a means for fastening the pad to the compression plate. The method further includes positioning the mammography pad from a first position, wherein the first portion and the second portion are substantial coplanar to each other, to a second position wherein the first portion is approximately perpendicular to the second portion. The method further includes fastening the first portion to the compression plate. The method further includes placing a patient&#39;s breast on the mammography pad, and compressing the breast against the mammography pad. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         FIG. 1  illustrates an underside perspective view of a mammography pad according to an embodiment of the subject invention; 
         FIG. 2   a  illustrate an underside view of a substrate according to an embodiment of the subject invention; 
         FIG. 2   b  illustrates a side view of the substrate according to an embodiment of the subject invention; 
         FIG. 3   a  illustrates an underside view of the mammography pad in a first position and a fastening means according to an embodiment of the subject invention; 
         FIG. 3   b  illustrates a side view of the mammography pad in the first position, the first portion being greater than the second portion, and the first portion having the fastening means according to an embodiment of the subject invention; 
         FIG. 4   a  illustrates a perspective view of the mammography pad in a second position, and including a compressible member according to an embodiment of the subject invention; 
         FIG. 4   b  illustrates a side view of the layers of the mammography pad according to an embodiment of the subject invention; 
         FIG. 5   a  illustrates a top view of a mammography pad having a compressible member and a substrate with different surface areas according to another embodiment of the subject invention; 
         FIG. 5   b  illustrates an underside view of yet another embodiment of a mammography pad having a compressible member and a substrate with different surface areas; 
         FIG. 6  illustrates a flow chart of an embodiment of a method of administering a mammography examination with the mammography pad described herein. 
     
    
    
     DETAILED DESCRIPTION 
       FIG. 1  illustrates an underside perspective view of a mammography pad  100  according to one embodiment of the subject invention. The mammography pad  100  may include a substrate  200 , an optional fastening means  300  with a removable liner  310  for removably attaching the mammography pad  100 , and a compressible member  400  for providing patient comfort. Additionally, the mammography pad  100  may further include at least one removable sheet  500  adaptable to overlie the mammography pad  100 . The mammography pad  100  may be used with a mammography unit  10 , as shown in  FIG. 4 , for providing comfort to patients during a mammography examination. In use, a mammography technician may place the mammography pad  100  on a compression plate  20 , also referred to as a bucky plate, of the mammography unit  10 . The technician will typically peel off the removable liner  310  from the fastening means  300  before removably attaching the mammography pad  100  to the front surface  22  of the compression plate  20  thereby preventing the mammography pad  100  from unintentionally moving during the mammography examination. The patient may then place their breast tissue on the compressible member  400 , or sheet  500  of mammography pad  100 , prior to the mammography unit  10  compressing the breast tissue in order to capture an image of the tissue. All the component herein may be made from a radiolucent materials. 
     With continued reference to  FIG. 1  and now  FIG. 2 , an underside view of the substrate  200  according to an embodiment of the subject invention is illustrated. The substrate  200  may be made of a radiolucent material. Additionally, the substrate  200  may be made of a polymer, or any suitable material capable of adapting to surfaces of a compression plate  20  of a mammography unit  10  known to a person having ordinary skill in the art. The polymer may be rigid or flexible. In one embodiment, the polymer may be a high density polyethylene (e.g., Hitec®). The substrate  200  has a first surface  202  and a second surface  204 . The surfaces of the substrate  200  may be substantially smooth and capable of allowing for movement of the substrate  200  across the surface of the compression plate  20  for positioning the mammography pad.  100 . The first surface  202  may be scored thereby creating at least one scoreline or score  230  for partitioning the substrate  200  and thereby defining a first portion  210  and a second portion  220  of the substrate  200 . For purposes consistent with the invention disclosed herein, scoring means to facilitate the bending of the substrate  200  thereby creating an angle. The score  230  may facilitate folding the substrate  200  from a first planar position F (as shown in  FIG. 3   a ), wherein the first portion  210  and the second portion  220  may be substantially coplanar, meaning substantially existing on the same plane, to one another, to a second folded position S (as shown if  FIG. 2   b ), wherein the first portion  210  is approximately perpendicular to the second portion  220 , and the first portion  210  and the second portion  220  share a common edge. The score  230  may also extend the full width W of the substrate  200 . In another embodiment, a plurality of scores  230 , or serrations, as shown in  FIG. 5   a , may be used as a means for releasably attaching the substrate  200  to the mammography unit  10  by facilitating the folding of the mammography pad  100 . In this embodiment, the plurality of scores  230  may be a similar size to each other and spaced apart from each other thereby defining separate portions on the substrate  200 . The spacing may be random, or an equidistance apart. Additionally, a technician or user, may fold or crease the substrate  200  without a score line, with or without a tool, or the substrate  200  may be self-scoring in order to divide the substrate  200  into portions. For example, a laser etch may be used to create the score  230 , thereby defining the first  210  and second  220  portions, for configuring the substrate  200  to bend from the first position F, to the second position S. In one embodiment, the first portion  210  may have an area less than or equal to that of the second portion  220 . For example, the first portion  210  may have a height H, as shown in  FIG. 2   b , of about 2.5 inches. In another embodiment, as shown in  FIG. 3   b , the first portion  210  may have an area greater than that of the second portion  220 . As shown in  FIG. 2   b , the substrate  200  is in the second position S, where the area of the first portion  210  is less that the area of the second portion  220 . The first portion  210  may be of a size similar to the front surface  22  of the compression plate  20  of the mammography unit  10 . Additionally, the substrate  200  may have a thickness of any size such that it will not negatively affect the imaging procedure. In one embodiment, the thickness of the substrate  200  may be between about 0.015 inches and 0.50 inches. In certain embodiments it is contemplated as being approximately 0.030 inches. In a further embodiment it is contemplated as being approximately 0.10 inches. 
     In another embodiment, the substrate  200  may be preformed in an substantially folded shape thereby eliminating the need for scoring the substrate  200  for later folding. In this embodiment, the mammography pad  100  may be placed on the compression plate  20  for providing patient comfort as described herein. 
       FIG. 3   a  illustrates an underside view of the mammography pad  100  in the first position F, and having a first portion  210  with an area less that the second portion  220  and a fastening means  300  removably secured to the first portion  210  for removably attaching the substrate  200  to the compression plate  20  ( FIG. 4 ). The fastening means  300  may be an adhesive, a medical grade foam tape, a double-sided foam tape like Remo-one®, hook and loop, or any fastener capable of removably attaching the substrate  200  to a surface of a mammography unit known to a person having ordinary skill in the art. Hook and loop may be desirable when the mammography pad  100  remains in place for multiple uses and the sheet  500  ( FIG. 1 ) is changed with each patient or examination. In this embodiment, the mammography pad  100  and the compression plate may both include corresponding hook and loop fasteners  300  secured thereon, and the mammography pad  100  remains selectively attached to the mammography unit  10  while only the sheet  500  is changed. In addition to hook and loop, screws, bolts, snaps or the like may be used to removably attach the mammography pad  100  to the mammography unit  10 . Again this configuration may be useful when the mammography pad  100  remains in place relative to the compression plate  20  and only the sheets  500  are changed between procedures. The fastening means  300  may be removably secured to the first portion  210  of the substrate  200 . The fastening means  300  may be positioned in the center of the first portion  210  or at any other position on the first portion  210  chosen with sound judgment. The fastening means  300  may be easily removed from the compression plate  20  with minimal effort. Additionally, the fastening means  300  in the form of an adhesive layer may have a thickness of any size such that it will not negatively affect the imaging procedure. In one embodiment, the thickness of the fastening means  300  may be between about 0.015 inches and 0.10 inches, and in another embodiment about 0.031 inches thick. This fastening means  300  may further include a removable liner  310  attached thereon. The removable liner  310  may remain removably attached to the fastening means  300  prior to use of the mammography pad  100  to eliminate the possibility of the fastening means  300  attaching to an unintended surface. Alternatively the removable liner  310  may include at least one tear line  315  as shown in  FIG. 3   a . The tear line  315  allows for individual sections of the removable liner  310  to be removed thereby partially exposing any one portion or specific portions of the fastening means  300 . In operation, a technician or similar person may remove the liner  310  or sections thereof in preparation for removably attaching the mammography pad  100  to the compression plate  20 . Additionally, the removable liner  310  having a plurality of tear lines  315  may allow for single or multiple use of the same mammography pad  100 . If the liner  310  includes a plurality of tear lines  315 , the tear lines  315  may have different sizes or shapes, or may be spaced apart uniformly or in a non-uniform manner. The liner  310  may be removed prior to forming the mammography pad  100  from the first position F to the second position S, or after forming the mammography pad  100  into the second position S. In an embodiment where the mammography pad  100  has a substrate  200  preformed into a substantially folded position, the liner  310  may be removed prior to placing the mammography pad  100  on the compression plate  20  regardless of any positions. Once the liner  310  is removed, the first portion  210  may be removably attached to the mammography unit  10 , more specifically the front surface  22  of the compression plate  20 . The liner  310  and fastening means  300  may radiolucent. Alternatively, a technician may elect to use the mammography pad  100  without removing the liner  310 , or using the mammography pad  100  without the optional fastening means  300 . In this embodiment, the patient&#39;s person may create enough friction or resistance to position the mammography pad  100  on the compression plate  20 . Additionally, in one embodiment, the fastening means  300  is contemplated as being readily releasable such that the mammography pad  100  may be repositioned between imaging of the same patient, or between examinations for the same patient. For example, a patient may begin her first examination using the mammography pad  100  on one day, and later return on a subsequent day for a second examination using the same pad. Therefore, the fastening means  300  may be used for a single or multiple applications for releasably attaching the mammography pad  100  to the mammography unit  10 . 
     With continued reference to  FIG. 3   a , in one embodiment the mammography pad  100  may include a wing or first strap  320  selectively attached to the mammography pad  100  for releasably attaching the mammography pad  100  to the compression plate  20 . The first strap  320  may be attached to any side of the substrate  200  or in the alternative to the compressible member  400 . In one embodiment, the first strap  320  is attached to the second portion  220  of the substrate  200 . In another embodiment, the mammography pad  100  may further include a second strap  330 . The second strap  330  may be attached to the first portion  210  such that the first strap  320 , and the second strap  330  may attach under the compression plate  20 , as shown in  FIG. 4   a . The first strap  320  may be used together with the fastening means  300 . In this embodiment, the first strap  320  provides an addition means for attaching the mammography pad  100  to the compression plate  20 . The straps may be made from any suitable material capable of releasably attaching the mammography pad  100  to the compression plate  20  known to a person having ordinary skill in the art. Additionally, the first strap  320  or second strap  330  may be made from a radiolucent material. In one embodiment, the first strap  320  may includes a fastener (not shown) for attaching the first strap  320  to an underside surface  26  ( FIG. 4   a ) of the compression plate  20 . Where there are two or more straps attached to the mammography pad, the additional straps may also include fasteners for attaching the straps to each other under the compression plate  20 , or for attaching the straps to the underside surface  26 . The fastener may be made from the same materials as the fastening means  300 , or any material capable of attaching the straps to the compression plate  20  known to a person having ordinary skill in the art. 
     In one embodiment, the first strap  320  and second strap  330  may be selectively attached the mammography pad  100  such that the first strap  320  and second strap  330  is approximately perpendicular to the fastening means  300 . In another embodiment, the first strap  320  and second strap  330  may extend along different sides of the compression plate  20  such that the first strap  320  and second strap  330  are approximately perpendicular to each other. Additionally, the first strap  320  and second strap  330  may extend along opposed sides of the compression plate  20  such that the first strap  320  and second strap  330  are approximately parallel to one another. 
     In another embodiment, the first strap  320  may be made from an elastic material such that the first strap  320  may be stretched to fit over the compression plate  20  causing elastic forces for releasably attaching the mammography pad  100  to the compression plate  20 . Additionally, the straps may be used with an embodiment of the mammography pad  100  that does not include the fastening means  300 . 
       FIG. 4   a  illustrates a perspective view of the mammography pad  100  in the second position S with the compressible member  400  secured to surface of the substrate  200 . The compressible member  400  may be formed from a foam, a medical grade foam, a hypoallergenic foam, or any material capable of compressing when used with a mammography unit  10  known to a person having ordinary skill in the art. Hypoallergenic materials are materials that have a lesser likelihood, if any, to cause an allergic reaction. The compressible member  400  may have a thickness of any size such that it will not negatively affect the imaging procedure. In one embodiment, the thickness of the compressible member  400  may be between about 0.25 inches and 1 inch. In certain embodiments the compressible member may have thicknesses of about 0.375 inches or about 0.5 inches. The compressible member  400  may be radiolucent, leaving no artifacts on any readable media. However, for example, when using a mammography phantom, the mammography pad  100  may alter grayscale values (on a 256 grayscale) by no more than 10 values. With continued reference to  FIG. 4   a  and now  FIG. 4   b , the compressible member  400  may be permanently secured to the substrate  200  using a securing means  410 . The securing means  410  may be an adhesive, like a foam tape, more particularly a medical grade foam tape. The securing means  410  for attaching the substrate  200  to the compressible member  400  may differ from the fastening means  300 , in that the securing means  410  may permanently secure substrate  200  to the compressible member  400 , whereas the fastening means  300  may be removable. In another embodiment, the compressible member  400  may be secured to the substrate  200  using a liquid adhesive, or any other element capable of securing the compressible member  400  to the substrate  200  known to a person having ordinary skill in the art. The adhesive may be used on the entire area of the compressible member  400 , or near the outer edges ( 402   a - d ) of the compressible member  400 , thereby securing the compressible member  400  to the substrate  200 . Alternatively, the adhesive may be used in a single area, or selective areas on the compressible member  400  or the substrate  200 . The area may be around or about the centermost area of the compressible member  400 , or in selective areas chosen with sound judgment, and capable of securing the compressible member  400  to the substrate  200 . The adhesive may be applied to the compressible member  400 , the substrate  200  or both for securing the components. For example, a double sided foam tape may be used to secure both components together. Here the adhesive surface may be attached to both the substrate  200  and the compressible member  400 . Additionally, the compressible member  400  may be secured to the substrate  200  after the substrate  200  is scored and when the substrate  200  is in the first position F. However, the compressible member  400  may be secured while the substrate  200  is in the second position S, or in a preformed substantially folded position without exceeding the scope of the subject invention. It shall appreciated that the compressible member  400  may be used with any of the embodiments of the substrate  200  disclosed herein. 
     With continued reference to  FIG. 4 , and now  FIG. 5 , in another embodiment, the compressible member  400  may have a thickness equal to or greater than the substrate  200  thereby providing a higher compressibility, however a compressible member  400  having a thickness less than the substrate  200  may suffice for providing comfort to the patient. Additionally, the surface area of the substrate  200  may be different than the surface area of the compressible member  400 . For example, as shown in  FIG. 5   a , the compressible member  400  may have a surface area comparable to the size of a patients breast tissue, while the surface area of the substrate  200  covers the entire surface of the compression plate  20 . In the alternative, the surface area of the compressible member  400  may be larger than the surface area of the substrate  200 . Here, as shown in  FIG. 5   b , the surface area of the compressible member  400  may cover the top surface  24  and the front surface  22  of the compression plate  20 , while the surface area of the substrate  200  covers the front surface  22  and at least a portion of the top surface  24  of the compression plate  20 . Alternatively, the substrate  200  may include at least two first portions  210   a  and  210   b , as shown in  FIG. 5   b , for removably attaching the compressible member  400  to the compression plate  20 . In this embodiment, the fastening means  300  may be included on one of the portions or both. 
     In yet another embodiment, the substrate  200  may form a frame or place holder (not shown) along the boundary of the compressible member  400 , thereby leaving the center area of the compressible member resting on the top surface  24 . 
     In another embodiment, with continued reference to  FIG. 1 , the removable sheet  500  may be adapted to overlie at least a portion of the mammography pad  100 . For example, the removable sheet  500  may cover only portions of the mammography pad  100  where the patient will come in contact, or the removable sheet  500  may cover the entire mammography pad  100 . The removable sheet  500  may be used in lieu of changing the mammography pad  100  after each use, a technician or patient may elect to have the sheet  500  change. The sheet  500  may include a tab  510  for assisting with removing the sheet  500  from the mammography pad  100 . Additionally, the sheet  500  may be made of the same materials (i.e. hypoallergenic, medical grade) as the compressible member  400 , or any material capable of resisting moisture and being radiolucent. 
     With continued reference to  FIG. 1  and  FIG. 4 , in yet a further embodiment, the substrate  200  may include radiopaque markings  420  having information corresponding to the origin of the mammography pad  100 . For example, the radiopaque markings  420  may include manufacturing or distribution location information. The information may include information about the manufacturer, any covered intellectual property, or information regarding the materials that make up the mammography pad  100 . Alternatively, the substrate  200  or the fastening means  300  may include radiopaque markings  420  for imparting information on any readable media. Additionally, for breast cancer awareness, the compressible member  400  may be a pink color. The compressible member  400  may have additional colors or patterns, or a combination of colors and patterns (i.e., red, white, blue) or transparent, based on a person&#39;s preference. 
     In yet another embodiment, the substrate  200  may include a second score (not shown). In this embodiment, the mammography pad  100  may include three portions for fitting over three surfaces of the compression plate  20 . For example, the substrate  200  may cover the top surface  24 , the front surface  22 , and the underside surface  26  of the compression plate  20 . Here the compressible member  400  may also extend over the substrate  200 , which extends over the three surfaces, or the compressible member  400  may only extend over the surfaces the patient may come in contact with, like the front surface  22 , the top surface  24  or both. 
       FIG. 6  illustrates a flow chart of an embodiment of a method  600  for administering a mammography examination using the mammography pad  100  described herein. In step  610 , providing the mammography pad  100  that may be adapted to overlie a compression plate  20  of a mammography unit  10 . In step  620 , positioning the mammography pad  100  from the first position F to the second position S. In step  630 , removing the selectively removable liner  310  from the fastening means  300 . It is appreciated that step  630  may be performed prior to step  620 . Additionally, if liner  310  is not present on fastening means  300 , the person may directly proceed to step  640  following step  620 . In step  640 , fastening said first portion F to the mammography unit  10  thereby removably attaching the mammography pad  100  to the mammography unit  10 . For example, a technician may simply apply pressure to the portion of the mammography pad  100  where the fastening means  300  is positioned, thereby fastening it to a surface of the mammography unit  10 . In step  650 , placing at least one patient breast tissue on the mammography pad  100 . In step  660 , compressing the at least one breast against the mammography pad  100 , thereby providing comfort to the patient during the examination. In step  670 , capturing and displaying the mammography image, which may include information corresponding to the origin of the mammography pad  100 . 
     While the invention has been described with reference to certain embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from its scope. Therefore, it is intended that the invention not be limited to the particular embodiment disclosed, but that the invention will include all embodiments falling within the scope of the appended claims.