Abstract:
A container and method of using the container to maintain an excised tissue specimen in a fixed orientation during transport and imaging is described. The container includes a body, a flexible, soft retainer capable of holding various sized specimens, an adjustable soft retainer that interacts with the body to retain the specimen against the soft retainer without significant compression or distortion, and a lid that snaps tightly to the body reducing bodily fluid leakage when the container is placed in a horizontal position, and preventing contamination of the specimen.

Description:
REFERENCE TO RELATED APPLICATION 
       [0001]    The application claims priority to U.S. Provisional Application entitled “Specimen Retention and Indexing Device,” Ser. No. 60/677,935, filed May 6, 2005, and U.S. Provisional Application entitled “Specimen Retention Device,” Ser. No. 60/789,668, filed Apr. 6, 2006, both of which are incorporated herein by reference in their entirety. 
     
     FIELD OF THE INVENTION 
       [0002]    The invention relates to a container to maintain an excised tissue specimen such as an excisional biopsy or partial mastectomy excision in a stable orientation throughout subsequent imaging and transport. 
       DESCRIPTION OF THE PRIOR ART 
       [0003]    When a patient is diagnosed with a tissue abnormality and undergoes a surgical procedure for its removal, there are times when it is advisable to take radiographic views of the resected tissue specimen to assess the adequacy of the resection. As used in the present invention, the term “tissue specimen” may refer to a wide variety of animal tissue specimens. Examples include breast tissue and brain or other organ tissue. The term “tissue specimen” can also refer to vegetable tissues. As the present invention has application in many common pathologic scenarios, for simplicity its application to breast tissue specimen biopsies will be described. 
         [0004]    In evaluating this removed specimen it is useful for the surgeon to see mammographic images of the specimen in an undisturbed condition and in two different planes to ensure that the area of interest is fully contained inside the specimen. If the two images indicate that the specimen fully contains the area of interest, the surgeon can be confident that it has been fully removed and the patient will not have to undergo re-excision. If the two images indicate that the area of interest is too close to the margins of the specimen, the surgeon can remove more material before finalizing the surgery, thereby preventing a return to the operating room for re-excision at a later date. 
         [0005]    A variety of devices are available for securing and transporting such excised tissue for pathologic and/or radiologic evaluation. For example, tissue specimens can be compressed between two plates in a container. However, this type of device creates distortion of the specimen rendering accurate margin analysis nearly impossible. It also does not allow for radiologic evaluation in multiple planes unless the specimen is removed and reoriented, which disturbs the specimen enough to render the images inaccurate. There is also an invention that is rectangular in shape and would allow for multiple plane radiologic analysis (U.S. Pat. No. 6,225,107 to Nagle). However, this device attempts to reshape the specimen into a rectangular space creating some degree of distortion. It also fails to prevent the leakage of body fluids thereby exposing the handlers to potential blood borne pathogens. 
       SUMMARY OF THE INVENTION 
       [0006]    The present invention is directed to a tissue specimen container for analyzing a tissue specimen, comprising a closeable container including a body and a lid, and further comprising an interior chamber between the lid and the body when the container is in a closed position; wherein the lid comprises a top surface and a first edge; wherein the body comprises a top surface having a second edge and a bottom surface, wherein the bottom surface is defined by a specimen-containing depression; and wherein the interior chamber is adapted to contain the specimen between and in contact with the lid and the body in a known, fixed orientation with minimal compression, minimal movement, and minimal fluid leakage. 
         [0007]    The present invention is further directed to a tissue specimen container for analyzing a tissue specimen, comprising a closeable container including a body and a lid, and further comprising an interior chamber between the lid and the body when the container is in a closed position; wherein the lid comprises a top surface and a first edge; wherein the body comprises a top surface having a second edge and a bottom surface, wherein the bottom surface is defined by a specimen-containing concave depression; wherein the interior chamber is adapted to contain the specimen between and in contact with the lid and the body in a known, fixed orientation with minimal compression, minimal movement, and minimal fluid leakage; wherein the container comprises either a transparent or a translucent material for radiographic imaging; and wherein the first edge of the lid is adapted to be sealingly engaged with the second edge of the body to form a leak-proof seal; and at least one retainer formed of a soft flexible radiographically-transparent material to facilitate the retention of the specimen within the container. 
         [0008]    The present invention is further directed to a method of handling a tissue specimen comprising the following steps: a) placing the specimen inside a tissue specimen container, comprising a closeable container including a body and a lid, and further comprising an interior chamber between the lid and the body when the container is in a closed position; wherein the lid comprises a top surface and a first edge; wherein the body comprises a first radiographically-viewing surface having a second edge, a second radiographically-viewing surface, and a bottom surface, wherein the bottom surface is defined by a specimen-containing depression; and wherein the interior chamber is adapted to contain the specimen between and in contact with the lid and the body in a known, fixed orientation with minimal compression, minimal movement, and minimal fluid leakage; b) closing the lid onto the body such that the specimen is immobilized in the interior of the container; c) placing the container in a first position to produce an x-ray image of the specimen through the first radiographically-viewing surface; and d) placing the container in a second position to produce an x-ray image of the specimen through the second radiographically-viewing surface. 
         [0009]    The tissue specimen container is especially suited to cradle an excised tissue specimen in a secure position without using deforming pressure. Because the tissue specimen can be gently held in a fixed position in the tissue specimen container, the container can be placed in a number of positions without risk of deforming or shifting the specimen. This feature is especially important when taking x-rays along different axes of the excised specimen. The tissue specimen container allows a physician to accurately maintain the natural shape of the excised specimen, relative to the area of interest, and determine if the excision of the tissue specimen was effective. 
         [0010]    The tissue specimen container may also be used to hold the specimen during transport and radiographic imaging. The tissue specimen container allows for radiographic imaging of the specimen in multiple planes without the need for handling the specimen or opening the container. The tissue specimen container ensures that when the specimen is received for pathological assessment, it has not been handled or exposed to potential contaminants since being placed in the container by the surgical staff. 
         [0011]    The container further reduces the likelihood that medical staff will be exposed to potentially hazardous bodily fluids. The present invention has many advantages over prior specimen retention containers. The present invention is easy to use and reduces distortion of the tissue specimen during handling and imaging. The substantially-concave floor of the tissue specimen container allows a generally amorphous, but often spheroid tissue specimen to rest in the tissue specimen container without encountering any sharp corners or flat surfaces. By gently cradling the tissue specimen, the substantially-concave floor does not distort the lower surface of the specimen. 
         [0012]    The addition of a soft lower retainer placed in the substantially-concave floor adds another level of security to the tissue specimen. The soft lower retainer further softens any pressure to the specimen from the floor of the container. In addition, the lower retainer lifts the specimen above the place where the floor meets the walls, an area that could cause distortion in imaging. The soft upper retainer, which is placed on top of the specimen, gently holds the specimen in place within the tissue specimen container. This is accomplished without exerting any distortional force onto the specimen. Therefore, with the specimen secured within a fixed position, X-rays or other radiographs can be taken while maintaining the specimen&#39;s structural integrity and relative frame of reference. 
         [0013]    Because a tissue specimen&#39;s structural integrity is not deformed during imaging, the physician can accurately gauge the spatial location of any specific or notable locations within the specimen. The unique design of the present invention and the method for its use gives physicians a significant tool in their repertoire for treating patients. 
         [0014]    Furthermore, the locking lid helps reduce the leakage of any body fluids associated with the specimen. 
         [0015]    The objects and advantages of the invention will appear more fully from the following detailed description of the preferred embodiment of the invention made in conjunction with the accompanying drawings. 
     
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]      FIG. 1  is a perspective view of the specimen retention container of the present invention. 
           [0017]      FIG. 2  is a perspective cross-section view of the specimen retention container of  FIG. 1  taken along line  2 - 2  of  FIG. 1 . 
           [0018]      FIG. 3  is an exploded perspective view of the container of  FIG. 1 . 
           [0019]      FIG. 4  is a side plan and exploded view of the container of  FIG. 1 . 
           [0020]      FIG. 5  is a side plan view illustrating the assembled specimen retention container of  FIG. 4  in a first position relative to an X-ray source. 
           [0021]      FIG. 6  is a side plan view illustrating the assembled specimen retention container of  FIG. 4  in a second position relative to an X-ray source. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0022]    Referring now to the drawings,  FIGS. 1-3  illustrate an assembled view of the components of the specimen retention container  2 , which includes a body  4  and a separate lid  8 . 
         [0023]    The body  4  is generally boxed-shaped and includes four substantially parallel walls  18  defining an interior  6  of the body  4 , a lower end  15  and an open upper end  17 . The lower end  15  is defined by a substantially-concave floor  16 , which is positioned opposite of the open end  17  and effectively forms an impermeable closed lower end  15 . The concave floor  16  is joined to the outer walls  18  at junction  20  at variable positions distant from the open end  17 . The upper open end  17  of the container is defined by a lip  2  which extends outwardly from the walls  18  for mating engagement with the lid  8 . 
         [0024]    As illustrated in  FIG. 1 , the junction  20  forms the upper edge of the substantially-concave floor  16 . In this configuration, the lower end  15  of the container  2  can sit on a flat surface or plane, parallel and opposite the lid  8 . While the outer walls  18  are preferably dimensioned as a square creating a container  2  with a cube-shape, it is within the scope of the present invention to shape the outer walls into a round cylinder, a triangle or other polygon shape (not shown). As illustrated, the junction  20  of the substantially-concave floor  16  and the outer walls  18  is located nearer the lower end  15  of the body  4 . However, it is within the scope of the present invention to place the junction  20  at other locations along the walls  20  closer to the open end  17  if desired. The arc of the substantially-concave floor  16  is variable as long as it still creates a resting place for the tissue specimen. 
         [0025]    The lid  8  can be of any reasonable shape as long is it is adapted to securely fit on the open end  17  of the container  2 . As illustrated in  FIG. 2 , the lid  8  is defined by an upper surface  10 , and walls  11 . The walls  11  are designed to fit in mating engagement over the walls  18  of the body  4  at upper end  17 . The walls  11  include an inner surface  12  which are defined by an indent  13 . The purpose of the indent  13  is to releasibly secure the lip  22  of the body in order to snap fit the lid  8  onto the body preferably in a seal tight fashion to prevent any liquid flowing in or out of the container when the lid  8  is engaged with the body  4 . Although a snap or lock mechanism is illustrated, it is within the scope of the present invention to secure the lid  8  using a screw or twist mechanism or other variations of an interactive fit. 
         [0026]    The entire container  2  is made of a transparent or a translucent material for radiographic imaging. The container  2  is preferably constructed of a radiographically-transparent material, which has the characteristics of an optically-clear radiographically-transparent material so that the physician can visualize the placement of the specimen. Materials suitable for fabrication of the container  2  include glass, and synthetic polymers such as acrylics, polycarbonates, polyolefins, polyurethanes, polystyrenes and the like. A suitable polystyrene is commercially available from Dow Plastics (Midland, Mich.) under the trademark “Styron 666”. 
         [0027]    Referring now to  FIG. 3 , there is illustrated an exploded view of a fully assembled specimen retention container  2 . The order of assembly of the completed specimen retention container  2  is implicitly shown with the optional addition of an upper soft retainer  24  and a lower soft retainer  26 . The retainers  24  and  26  are preferably made of any soft and flexible material that is radiographically-transparent including soft rubber or foam polymers. The retainers  24  and  26  are generally shaped into the same configuration as the interior  6  of the body  4  and designed to fit within the interior  6  of the body  4  in a snug fit manner such that the walls  25  and  27  of each retainer  24 ,  26  are press fit against the interior of the walls  18  of the body  4 . While the retainers  24  and  26  are illustrated in a rhomboid shape having four generally identical side walls  25  and  27 , an upper surface  29  and  31 , and a lower surface  33  and  35 , respectively, it is within the scope of the present invention to provide retainers in any shape or form as long as the retainers  24  and  26  serve the primary purpose of engaging the tissue specimen within the container  2  in such manner to prevent movement of the specimen during analysis while also maintaining the proper shape of the tissue specimen. The surface of the retainers may be smooth, as illustrated in the figures, or convoluted, such as an egg-shell foam shape. Non-limiting examples of materials suitable for use include low-density blown polymers and open-cell polymer foams made from acrylics, polycarbonates, polyolefins, polyurethanes, polystyrenes and the like. A suitable polystyrene is commercially available from Dow Plastics (Midland, Mich.) under the trademark “Voralux HL 430”. 
         [0028]    In operation, the lower soft retainer  26  is placed into the body  4  of the container  2 . The lower soft retainer is gently seated into the concave floor  16  as illustrated in  FIG. 4 , such that the lower surface  35  is adjacent the concave floor  16  and remains fixed in place due to the snug fit meeting of the wall  27  with the interior surface of the continuous outer wall  18 . The interference fit results from the lower soft retainer being slightly wider than the inside of the body  4  of the container  2 . As illustrated in  FIG. 4 , the upper surface  31  of the retainer  26  forms a concave bowl-like shape due to the press fit relationship of the retainer  26  on the concave floor  16 . The retainer  26  also serves the function of placing the specimen  32  above junction  20  in the walls  18  such that no part image of the specimen  32  will be distorted by the line in the wall  18  caused by the junction  20 . 
         [0029]    The tissue specimen  32 , typically an amorphous tissue mass, is then placed on the upper surface  31  of the retainer  26  and is seated in the concave depression on the retainer  26 . The upper soft retainer  24  is gently placed into the body  4  of the container  2  and lowered into contact with the specimen  32  as illustrated in  FIG. 5 . Because the upper soft retainer  24  stays in place due to interference fit, only light pressure is required to keep the specimen  32  in place. Therefore, the specimen  32  is now seated in the container  2  without significant structural deformation. The lid  8  is then secured to the body  4  in a snap fit manner as discussed above. 
         [0030]    When the lower soft retainer  26  and the upper soft retainer  24  are placed around the specimen  32  within the body  4 , a specimen space  28  is created within the container  2 . Because the lower soft retainer  26  and the upper soft retainer  24  are easily adjustable, yet remain in place, the specimen space  28  can be adjusted for different types and sizes of tissue specimens. 
         [0031]    Although  FIGS. 3-6  illustrate both a lower soft retainer  26  and an upper soft retainer  24 , it is within the scope of the present invention to eliminate the use of either retainer  24  and  26  or to use only one retainer  24  or  26 , depending on the size of the tissue specimen  32  or the purpose of the analysis. For example, a sufficiently large specimen may be placed directly onto the concave floor  16  and only require an upper soft retainer  24  to hold the specimen in place (not shown.) 
         [0032]      FIG. 5  illustrates an assembled first view orientation  100  of the fully assembled specimen retention container  2  including a tissue specimen  32 . When fully assembled, the container  2  is oriented in a first view  100  relative to an X-ray source  34 . The x-ray image may be taken at this first orientation  100 . 
         [0033]    After the first orientation  100  is completed, the container  2  is turned onto its side, such that any of the walls  18  face the X-ray source  34 , into a second view orientation  200  as illustrated in  FIG. 6 . As shown in  FIG. 6 , the assembled container  2 , including the specimen  32 , is gently placed on its side relative to the X-ray source  34 . Because the lower soft retainer  26  and the upper soft retainer  24  securely fix the position of the specimen  32 , the specimen  32  does not shift when placed into the second orientation  200 . Furthermore, because the container  2  does not deform the specimen  32 , the resultant X-ray images provide the physician with non-distorted views of the specimen. While  FIG. 5  and  FIG. 6  illustrate two views  100  and  200  of a specimen, more views may be taken. Furthermore, the container  2  can be constructed in different shapes, which may provide different axial views of the specimen  32 . 
       Method of Use: 
       [0034]    The excised specimen  32  is placed on the lower soft retainer  26  or directly onto the substantially-concave floor  16  of the body  4 . The specimen  32  can be oriented in any position a physician desires. The specimen  32  may also be marked with margin orientation markers or ink. The upper soft retainer  24  is inserted into the body  4  by gently pushing it into the body  4  to overcome the interference fit. The upper soft retainer  24  is lowered against the specimen  32  to prevent movement without undue distortion. The upper soft retainer  24  is locked into position by inference fit with the body  4 . The lid  8  is snapped into place over the lip  22  on the outer wall  18  adjacent to the open end  17  of the body  4 . The locking lid  8  prevents specimen  32  contamination and exposure to bodily fluids. 
         [0035]    The container  2  is used by first removing the container  2  from any packaging (not shown.) The container  2  is opened by removing the snap fit lid  8 . Next, the upper soft retainer  24  is removed from the body  4 . The specimen  32  is inserted into the substantially-concave floor  16  either directly or on top of the lower soft retainer  26 . This should be done under the direction of the surgeon to ensure proper orientation and handling. The container  2  is placed on a flat surface, so that it is resting on the extensions  19 . The upper soft retainer  24  is pressed gently into the body  4  in order to overcome the interference fit. The upper soft retainer  24  is gently lowered to the point that it gently but securely contacts the specimen  32 . The upper soft retainer  24  is released to check the strength of the interference fit to ensure the retainer  24  will not move. The lid  8  is placed on the container  2  and the assembled container is placed into an imaging device  34 . A first view  100  is taken of the specimen  32 . The container is placed in a second orientation  200  and a second view is taken. The container is returned to the first orientation  100  and transported to pathology, where the lid  8  and the upper soft retainer  24  are removed. The specimen  32  is removed and pathology is performed as normal. The container can then be discarded in an appropriate biohazard disposal container. 
         [0036]    It is understood that the invention is not confined to the particular construction and arrangement of parts herein illustrated and described, but embraces such modified forms thereof as come within the scope of the following claims.