Abstract:
A biopsy processing system designed to prevent lodging and possible loss of the tissue specimen for analysis. The system includes a biopsy container having a longitudinal wall forming an internal compartment, a biopsy bag attached to an inner surface of the container, a cassette for receiving the biopsy bag, and an automated system for removing the biopsy bag from the biopsy container and placing the biopsy bag in the cassette.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation-in-part application of, and claims the benefit of, U.S. patent application Ser. No. 13/035,981, entitled “Apparatus, System, and Method of Processing Biopsy Specimens” and filed on Feb. 27, 2011. The complete disclosure of said application is hereby incorporated by reference. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not applicable 
       BACKGROUND OF THE INVENTION 
       [0003]    1. Field of the Invention 
         [0004]    This invention relates generally to the art of handling of biopsy specimens, and in particular, to an apparatus, system, and method for processing biopsy specimens in preparation for analysis. 
         [0005]    2. Description of the Related Art 
         [0006]    Diagnosing many diseases, including cancer, requires histological analysis. Before such analysis can be performed, a biopsy is required. Biopsies are most commonly taken from the gastrointestinal tract, genitourinary tract, lung, soft tissue, and other organs. Once the tissue sample is taken, the physician places the tissue in a specimen container, typically filled with formalin. The specimen container, along with a request sheet with the patient identification and clinical information, is sent to the pathology laboratory for processing and analysis. After the container is received in the pathology laboratory, the specimen is accessioned in the pathology computer system and submitted for processing or “grossing.” The grossing process begins with matching the patient identifier on the container and the corresponding request sheet. The specimen is then taken out of the container, and is placed in a labeled specimen cassette. Depending on the tissue biopsied and the suspected disease, some biopsy samples comprise multiple fragments of tissue and are very small in size. Instead of being placed in a specimen cassette, these small samples are placed in a biopsy bag. The small tissue samples can become lodged on the surface of the various instruments and containers utilized during the grossing process, including the specimen container, biopsy bag, tissue forceps, cassette, pipette, and/or the surface of a laboratory table. Each step of the grossing process is performed by a pathology assistant or a pathology resident. Based on the necessity of a person for grossing, and further because most labs do not operate  24  hours per day, the turn-around time for histological analysis of biopsy samples can be lengthy. 
         [0007]    The prior art system also presents substantial risks of error. In a typical pathology laboratory, on average, twenty-five biopsy samples are grossed per day. Because multiple samples may be grossed at the same time, there is a risk of mislabeling the biopsy containers, placing the biopsy samples in the wrong container, or mixing and thus contaminating the samples. The applicants have also observed that on-the-job training of pathology laboratory assistants can lead to these errors in grossing. 
         [0008]    It would therefore be desirable to develop a biopsy pipette, biopsy test tube, biopsy bag, and biopsy cassette that are capable of being utilized in a biopsy specimen processing system that will ease the method of handling biopsy samples and reduce the risk of mix-ups in processing. It would also be desirable to develop a biopsy processing system that is automated to assist pathology laboratory personnel in performing the grossing of biopsy samples, which will decrease the turn-around time for analyzing the biopsy samples and thus improve patient care. 
       BRIEF SUMMARY OF THE INVENTION 
       [0009]    The present invention is directed to a biopsy pipette, biopsy test tube, biopsy bag, and biopsy cassette which may be employed in an automated biopsy specimen processing method and system. 
         [0010]    In a first preferred embodiment, the present invention is directed to a biopsy pipette comprising a pipette, wherein said pipette comprises a wall forming an internal compartment, and a filter, wherein said filter is attached to said wall of said pipette. 
         [0011]    In a second preferred embodiment, the present invention is directed to a biopsy test tube comprising a test tube, wherein said test tube comprises a wall forming an internal compartment, and a biopsy bag, wherein said biopsy bag is attached to said wall of said test tube. 
         [0012]    In a third preferred embodiment, the present invention is directed to a biopsy bag comprising an open end and a closed end, wherein said open end is zip lockable. 
         [0013]    In a fourth preferred embodiment, the present invention is directed to a biopsy cassette wherein said cassette has an opening that is configured to receive a pipette. 
         [0014]    In a fifth preferred embodiment, the present invention is directed to a biopsy processing system comprising (a) a biopsy tissue sample, wherein said sample is in a first specimen container; (b) a biopsy pipette; (c) means for suctioning said biopsy tissue sample with said biopsy pipette from said first specimen container and dispensing said biopsy tissue sample in a second specimen container, wherein said second specimen container is porous; (d) means for placing said second specimen container in a vacuum chamber; (e) means for activating said vacuum chamber; and (f) means for removing said second specimen container from said vacuum chamber. 
         [0015]    In a sixth preferred embodiment, the present invention is directed to a biopsy processing system comprising (a) a biopsy test tube comprising a test tube, wherein said test tube comprises a wall forming an internal compartment, and a biopsy bag, wherein said biopsy bag is attached to said wall of said test tube; (b) means for placing a biopsy tissue sample in said biopsy bag; (c) means for removing said biopsy bag from said test tube; (d) means for placing said biopsy bag in a vacuum chamber; (e) means for activating said vacuum chamber; (f) means for removing said biopsy bag from said vacuum chamber; and (g) means for placing said biopsy bag in a biopsy cassette. 
         [0016]    In a seventh preferred embodiment, the present invention is directed to a biopsy processing system comprising (a) a biopsy tissue sample, wherein said sample is in a container; (b) a biopsy cassette, wherein said cassette comprises an opening that is configured to receive a pipette; (c) means for suctioning said biopsy tissue sample with a pipette from said container; (d) means for placing said pipette in said opening of said biopsy cassette; (e) means for dispensing said biopsy specimen from said pipette to said biopsy cassette; (f) means for placing said biopsy cassette in a vacuum chamber; (g) means for activating said vacuum chamber; and (h) means for removing said biopsy cassette from said vacuum chamber. 
         [0017]    In an eighth preferred embodiments, the present invention is directed to a biopsy processing system comprising: (a) a biopsy container, wherein said biopsy container comprises a longitudinal wall forming an internal compartment; (b) a biopsy bag comprising an open end and a closed end, wherein said biopsy bag is attached to an inner surface of said longitudinal wall of said container; (c) a cassette operable for receiving said biopsy bag; and (d) automated means for removing said biopsy bag from said biopsy container and placing said biopsy bag in said cassette. 
         [0018]    These and other features, objects and advantages of the present invention will become better understood from a consideration of the following detailed description of the preferred embodiments and appended claims in conjunction with the drawings as described following: 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0019]      FIG. 1  is a perspective view of an embodiment of a biopsy pipette. 
           [0020]      FIG. 2  is a perspective view of the biopsy pipette of  FIG. 1 . 
           [0021]      FIG. 3  is an exploded view of the biopsy pipette of  FIG. 1 . 
           [0022]      FIG. 4  is an exploded view of a first preferred embodiment of a biopsy test tube. 
           [0023]      FIG. 5  is a perspective view of the first preferred embodiment of the biopsy test tube of  FIG. 4 . 
           [0024]      FIG. 6  is a perspective view of a second preferred embodiment of a biopsy test tube. 
           [0025]      FIG. 7  is a perspective view of the second preferred embodiment of the biopsy test tube of  FIG. 6 . 
           [0026]      FIG. 8  is a perspective view of a biopsy bag. 
           [0027]      FIG. 9  is a perspective view of a biopsy cassette. 
           [0028]      FIG. 10  is a perspective view of a biopsy pipette and biopsy container as the biopsy pipette suctions a biopsy specimen and formalin from a biopsy container. 
           [0029]      FIG. 11  is a perspective view of a biopsy pipette, biopsy container, biopsy bag, and biopsy cassette as the biopsy pipette suctions the contents of a biopsy container and then dispenses those contents into a biopsy bag, and then the biopsy bag is placed in a biopsy cassette. 
           [0030]      FIG. 12  is a perspective view of a biopsy pipette and biopsy cassette as the biopsy pipette dispenses its contents into the biopsy cassette. 
           [0031]      FIG. 13  is a perspective view of a biopsy container, biopsy bag, and biopsy cassette as the contents of the biopsy container are poured into the biopsy bag, and then the biopsy bag is placed into the biopsy cassette. 
           [0032]      FIG. 14  is a perspective view of a biopsy container and biopsy cassette as the contents of the biopsy container are poured into the biopsy cassette. 
           [0033]      FIG. 15  is a perspective view of a biopsy pipette, biopsy test tube, and biopsy cassette as the contents of the biopsy pipette are dispensed into the biopsy bag, and then the biopsy bag is removed from the biopsy test tube and is then placed into the biopsy cassette. 
           [0034]      FIG. 16  is a perspective view of two biopsy test tubes in a test tube rack moving along a conveyor belt. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0035]    With reference to  FIGS. 1-16 , the preferred embodiments of the present invention may be described. As illustrated in  FIG. 1 , the biopsy pipette  10  is comprised of a pipette  12  of a kind known to those of ordinary skill in the art. The pipette  12  is preferably cylindrical in shape and comprises a wall that forms an internal compartment  14 . The pipette  12  has a tip  16  on one end, and a means for suctioning and dispensing materials  18  on the other end, such as a bulb. A filter  20  is attached along its circumference to the interior surface of the wall of the pipette  12 . The filter  20  is attached to the pipette  12  by means well-known to those skilled in the art. The diameter of the filter  20  will depend on the size of the pipette  12 . Because biopsy tissue samples can vary in size from  1 . 0  mm to  1 . 0  cm, the pore size of the filter  20  preferably is less than  1 . 0  mm in size. By manipulating the bulb or other means for suctioning  18 , the biopsy pipette  10  can suction the contents of a specimen container of formalin and the small fragments of tissue sample. The formalin or other liquid can pass through the filter  20 , but the tissue sample cannot. When dispensing, the formalin passes back through the filter towards the tip of the pipette  10 . During this passage, the formalin washes the biopsy tissue sample from its interaction with the filter  20 , thus causing the release of the sample from the biopsy pipette  10 . 
         [0036]    As shown in  FIGS. 4-5 , the biopsy test tube  22  is comprised of a test tube  24 . Test tube  24  is preferably cylindrical in shape and comprises a wall  26  that forms an internal compartment. Two grooves  30  extend longitudinally along the internal surface of the wall  26 . The grooves  30  preferably are located one-half of the diameter of the test tube apart from one another. The grooves  30  are configured to receive the left and right edges of the biopsy bag  32 . While this embodiment is described with reference to a test tube, the scope of the invention is not so limited and the present invention may include any container capable of receiving a biopsy bag. The biopsy bag  32  is preferably made of Tefla, or other like substances, and is preferably 0.5 cm to 2.5 cm in both length and width. The biopsy bag  32  has an open end  34  and a closed end  36 . The biopsy bag  32  is also porous and displays sufficient rigidity to ensure that the bag remains completely engaged by the grooves  30 , thus preventing the bag from collapsing on itself and potential lodging of a biopsy specimen in the bag. In this regard, the biopsy bag  32  may be double-layered around the edges of the biopsy bag  32  for increased support. Alternatively, the edges of the biopsy bag  32  may be made of a more rigid material than the rest of the biopsy bag  32 . The biopsy bag  32  may also be made of a transparent material so that the contents of the biopsy bag  32  are viewable through the biopsy bag  32 . The open end of the test tube  24  is capable of receiving a cap  54 . Cap  54  prevents spillage and other contamination of the biopsy sample after it is placed in the biopsy bag  32 . In an alternative embodiment as shown in  FIGS. 6-7 , to further prevent the collapse of the biopsy bag  32  inside the test tube  24 , the open end  34  of the biopsy bag  32  extends outside the open end of the test tube  24 . Thus, when the cap  54  is attached, the open end  34  of the biopsy bag  32  is secured between the cap  54  and the outside surface of the test tube  24 . 
         [0037]    In an alternative embodiment, the cap  54  has matching internal grooves  30  as those on the internal surface of the test tube wall  26 . The grooves  30 , extending from the cap  54  to the test tube  24 , engage the left and right edges of the biopsy bag  32 . In this embodiment, the cap  54  is also capable of slidably receiving an insert (not shown) in one of its sides. The insert is the same shape as the cap  54 , preferably circular, square, or rectangular. When received by the cap  54 , the insert extends completely through the interior of the cap  54 . It therefore contacts the open end  34  of the biopsy bag  32  and forces the open end  34  to fold over itself. 
         [0038]    The biopsy test tube  22  allows the physician to place the tissue sample directly into the biopsy bag after the biopsy is taken. As shown in  FIG. 8 , at the open end  34  of the bag  32  is means to zip lock  38  the bag  32  to prevent tissue contamination. In an alternative embodiment, instead of a zip lock, the open end  34  of the biopsy bag  32  includes magnetic strips or any other type of fasteners that would be well-known to those skilled in the art, such as VELCRO® fasteners. After the open end  34  of the biopsy bag  32  is closed, the biopsy test tube  22  can be transported to the pathology lab for further processing. Placing the tissue sample directly into the biopsy bag prevents the possible loss or contamination of the sample that exists when the sample is first placed into a cassette or when too many pieces of tissue are placed in a cassette. For example, for proper Fluorescent In Situ Hybridization (FISH), there can be only three breast core biopsies placed in a single cassette because of the risk of overlapping. The burden therefore lies with the pathology assistant to properly identify the biopsy samples as breast biopsies, and ensure that the appropriate number of breast biopsies are removed from the specimen container and placed in each cassette. However, this burden is alleviated by the physician placing the appropriate number of biopsies in the test tube  22  at the time that they are removed. As such, the pathology assistant can simply remove the biopsy bag  32  from the biopsy test tube  22  and place the bag  32  in a cassette. In one embodiment, the biopsy processing system of the present invention includes a camera that takes photographs of the transparent biopsy bag to record the number and size of biopsy samples contained in the biopsy bag. The camera can be operated either manually or as a part of an automated system using a motion sensor to trigger the camera. 
         [0039]    As shown in  FIG. 9 , the biopsy cassette  40  comprises a base  42 , preferably square or rectangular, with four attached vertical walls  44 . A top  46  connects to the vertical walls  44  along all four sides and is permanently hinged at one end of the cassette  46 . The base  42  and the top  46  of the biopsy cassette  40  are porous. There is an opening  48  in the side of one of the vertical walls  44  that is configured to receive a pipette. The tip of the pipette may be inserted into the opening  48  of the cassette  40 , and thus the suctioned materials in the pipette may be dispensed directly into the cassette  40 . This feature prevents spillage or other contamination of the tissue sample that exists when the prior art cassettes are utilized. Since the diameter of the tip of the pipette ranges from 1 mm to 5 mm, the diameter of the opening  48  will likewise vary. 
         [0040]    As shown in  FIGS. 10-16 , the biopsy pipette  10 , the biopsy test tube  22 , and the biopsy cassette  40  can be used in various combinations in the processing or grossing of biopsy specimen. In most pathology labs, biopsy tissue samples are received in a specimen container filled with formalin, and accompanied by a record identifying the patient and the sample taken. In the present invention, biopsy pipette  10  is used to aspirate or suction the small tissue samples and formalin from the specimen container  50 . The filter  20  of the pipette  10  prevents the suctioned sample from passing through, however, the formalin suctioned is able to pass. When dispensing, the formalin passes back through the filter towards the tip  16  of the pipette  10 . During this passage, the formalin washes the biopsy tissue sample from its interaction with the filter  20 , thus causing the release of the sample from the biopsy pipette  10 . As an alternative, instead of using biopsy pipette  10 , any pipette  52  which would be well-known to those skilled in the art may be used. 
         [0041]    In one preferred embodiment, the tissue sample and formalin suctioned by the pipette ( 10  or  52 ) are dispensed into a biopsy bag  32 . In another preferred embodiment, the tip of the pipette ( 10  or  52 ) is inserted into the opening  48  of the biopsy cassette  40 , and the tissue sample and formalin are dispensed. In yet another preferred embodiment, instead of transferring the tissue sample and formalin to the biopsy bag  32  or specimen cassette  40  by a pipette ( 10  or  52 ), the tissue sample and formalin are poured directly into the biopsy bag  32  or cassette  40 . 
         [0042]    After receiving the tissue sample and formalin, the biopsy bag  32  or cassette  40  is subjected to light negative pressure in a vacuum chamber, which causes the release of the formalin from the porous biopsy bag  32  or porous cassette  40 . Alternatively, light pressure may be applied between two glass or metallic panes to cause removal of the formalin. In the method in which a biopsy bag  32  is utilized, the biopsy bag is then placed in a cassette, or alternatively, the tissue specimen is removed from the biopsy bag  32  and placed in a cassette. Once in a cassette  40 , the biopsy tissue specimen is ready for further processing. 
         [0043]    In an alternative embodiment, the physician places the tissue sample that is biopsied directly into biopsy test tube  22 , which is then transported to the pathology lab. Once at the lab, the technician can remove the biopsy bag  32  from the grooves  30  of test tube  22  and place it in a specimen cassette for further processing. In this method, the step requiring the physician to first place the biopsy sample in a specimen container  50  is eliminated, thus saving time and decreasing risk for loss or contamination of the tissue sample. 
         [0044]    In the preferred embodiments, the method and system of the present invention is completely automated using a series of robotic arms and conveyor belts, which are known to those skilled in the art. Once the specimen container  50  or the biopsy test tube  22  is received in the pathology laboratory, it is accessioned, bar coded, and placed on a conveyor belt. In an alternative embodiment, instead of utilizing bar code, the biopsy test tube  22  is labeled and tracked using radiofrequency identification (RFID) well-known to those skilled in the art. As the specimen container  50  or biopsy test tube  22  moves down the conveyor belt, its bar code or other label is read by a sensor (not shown). The sensor triggers the labeling of a biopsy cassette  40  with a unique pathology identifier number. A series of robotic arms then perform the processing steps described above. 
         [0045]    The automation of the biopsy sample processing system decreases the turn-over time for the processing and analysis of the tissue samples. The automated method and system can operate 24 hours per day without human assistance, thus allowing pathology lab personnel to devote their limited workday to analyzing the samples.