Abstract:
A carrier strip having a plurality of areas for retaining anatomical pathology specimens may have a backing, a cover coupled to the backing along side regions located along opposite longitudinal edges of the carrier strip and along lateral intermediate regions positioned between each of the plurality of areas for retaining anatomical pathology specimens. The carrier strip may be configured to individually retain each of the anatomical pathology specimens in one of the plurality of areas for retaining anatomical pathology specimens between the backing and the cover. Diagnostic studies of anatomical pathology specimens may be facilitated by distributing a digital copy of an image of the specimen may be to a pathologist. A diagnosis may be received from the pathologist based on the digital image of the specimen.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    This application is a continuation of and claims the benefit of and priority to U.S. Provisional Patent Application No. 61/307,876 filed Feb. 25, 2010, entitled SYSTEM AND METHOD FOR ANATOMICAL PATHOLOGY SAMPLE HANDLING, STORAGE, AND ANALYTICAL, which document is hereby incorporated by reference to the extent permitted by law. 
     
    
     BACKGROUND  
       [0002]    The present invention relates to methods of preparing anatomical pathology specimens for study. In particular, the invention relates to methods of preparing histopathology specimens that are conducive to automated processes and more efficient storage. 
         [0003]    The preparation of histological specimens from surgically obtained tissue generally includes fixation, dehydration, clearing, and infiltration of the specimen. Chemical fixation is often applied to prevent degradation of the specimen and allow for later long term storage. An alternative to chemical fixation is frozen section fixation in which a specimen is quickly frozen, sectioned and prepared so that evaluation of the specimen can be done in quickly, at times while the patient is still in surgery. The invention disclosed in the present application is envisioned as being most compatible with chemically fixated specimens, but may be used with frozen section samples as well. 
         [0004]    After fixation of the specimen has been done to preserve the specimen, it may be dehydrated, cleared, and infiltrated. Because specimens will often be prepared in blocks of material and then sliced or sectioned for study, the specimens must be made sufficiently rigid to allow for sectioning. In this process, the specimen is dehydrated with application of a water miscible stripping agent such as ethanol. The ethanol is then cleared from the specimen by application of a hydrophobic clearing agent such as xylene. The specimen may then be infiltrated with a matrix material, such as paraffin wax or epoxy resin, to provide a block in which the specimen is suspended. The block may then be sectioned by a technician and the sections mounted for analysis by a pathologist. 
         [0005]    Traditionally, prepared specimens are mounted to glass or quartz microscope slides for analysis. The slides are fragile and must be transported and stored accordingly. This requires slides to be packaged in cassettes that results in a large amount of wasted space. Accordingly, it is an object of the present invention to provide a system for high density storage of prepared histology specimens. It is a further object of the present invention to provide for an automated system for cataloging stored samples and digital images thereof to facilitate analysis of the specimens by a remotely located pathologist. It is yet another object of the present invention to provide a system of peer review of histological diagnoses provided by one or more pathologists. 
       SUMMARY  
       [0006]    Some aspects of the invention relate to a carrier strip having a plurality of areas for retaining anatomical pathology specimens the carrier strip having a backing, a cover coupled to the backing along side regions located along opposite longitudinal edges of the carrier strip and along lateral intermediate regions positioned between each of the plurality of areas for retaining anatomical pathology specimens. The carrier strip may be configured to individually retain each of the anatomical pathology specimens in one of the plurality of areas for retaining anatomical pathology specimens between the backing and the cover. 
         [0007]    Other aspects of the present invention relate to method of handling anatomical pathology specimens including placing a specimen on a specimen carrier strip backing The specimen may then be stained and covered with a cover material. The cover material may then be coupled to the carrier strip backing to form a carrier strip having a plurality of anatomical pathology specimens disposed. 
         [0008]    Yet other aspects of the invention relate to methods of facilitating diagnostic studies of anatomical pathology specimens. Such methods include imaging an anatomical pathology specimen and storing a digital image of the specimen in a memory. A digital copy of the digital image of the specimen may be distributed to a pathologist. A diagnosis may be received from the pathologist based on the digital image of the specimen. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]      FIG. 1  is an elevation view of a specimen carrier strip. 
           [0010]      FIG. 2  is a partial perspective view of a sample carrier strip. 
           [0011]      FIG. 3  is a schematic view of a sample evaluation system. 
           [0012]      FIG. 4  is a perspective view of a multi head staining subsystem. 
           [0013]      FIG. 5  is a perspective view of a covering subsystem. 
           [0014]      FIG. 6  is a schematic view of a computerized system for storing, distributing, and analyzing images of anatomical pathology specimens. 
       
    
    
     DETAILED DESCRIPTION 
       [0015]    The following detailed description of the invention references the accompanying drawing figures that illustrate specific embodiments in which the invention can be practiced. The embodiments are intended to describe aspects of the invention in sufficient detail to enable those skilled in the art to practice the invention. Other embodiments can be utilized and changes can be made without departing from the scope of the present invention. The present invention is defined by the appended claims and the description is, therefore, not to be taken in a limiting sense and shall not limit the scope of equivalents to which such claims are entitled. 
         [0016]    Turning now to the drawing figures, and particularly to  FIG. 1 , a specimen carrier strip  10  includes a backing  12  for supporting a biological specimen  14  shown as an infiltrated histology section. In some embodiments, biological specimen  14  may be a surgical pathology specimen disposed within a specimen block portion  16  that may be made of paraffin or other suitable material. A unique machine readable identifier  18  may be provided for each biological specimen  14 . The machine readable identifier may be a one or two dimensional barcode, or any other machine readable identifier. In addition to the machine readable identifier  18 , an alphanumeric identifier  20  may also be provided so a human technician can manually verify the identity of a biological specimen. While shown as a strip running laterally across strip  10 , the identifiers may be placed longitudinally along a side. When more than one identifier is used, they may be positioned next to one another, as shown, or placed in different areas. 
         [0017]    Strip  10  is segregated into multiple specimen regions  24  by intermediate regions  22 . Intermediate regions  22  may comprise a seam or region of thinned carrier material (as shown in  FIG. 2 ) to allow for bending of strip  10  at intermediate regions  22 . Each specimen region  24  provides space for both biological specimen  14  and a specimen identifier (i.e. machine readable identifier  18  or alphanumeric identifier  20 ). Side regions  26  are along either longitudinal edge of strip  10 . One or both of side regions  26  may be provided with apertures, slots, notches, dimples, or other features to facilitate proper indexing of strip  10  in relation to a piece of machinery. In other embodiments, an indexing feature may be positioned in intermediate regions  22 . A cover material may be attached to backing  12 . The cover may be adhered, fused, or otherwise coupled to backing  12  at regions  22  and  26  to enclose and cover biological specimen  14 . 
         [0018]    Referring to  FIG. 2 , a specimen carrier strip  10  includes a backing  12  for supporting biological specimen  14  that is contained in a specimen block portion  16 . Intermediate region  22  is shown as being a thinned region  28  of backing  12 . Backing  12  may have an adhesive or other means for coupling block portion  16  to region  24 . In general, an anatomical pathology technician would prepare the specimen block  16  and place it in region  24  of strip  10 . A machine could then scan the machine readable identifier  18 , or the technician could manually enter an identifier into a computer database. This identifier could be used to identify the specimen and tie it to a specific patient through an electronic health record or laboratory information system. 
         [0019]    Referring to  FIG. 3 , a specimen evaluation system  100  may include a specimen staining subsystem  30 , a covering subsystem  32 , an imaging subsystem  34  and a storage subsystem  36 . Strip  10  is fed to staining subsystem  30  where a staining device  38  is used to apply a stain to individual biological specimens  14 . The system may be configured to allow for different stains to be applied to adjacent biological specimens  14  on strip  10 . Strip  10  may be fed to specimen evaluation system  100  by any of a variety of passive or driven conveyors or combinations of such conveyors. When a biological specimen  14  is positioned under staining device  38 , staining device  38  may be lowered to prevent the migration of stain to other specimens. When staining device is in place, one or more of a variety of staining compounds may be applied, including biological stains such as antibodies or chemical stains including dyes and pigments. After the stain has been applied, staining device  38  may be raised to allow strip  10  to be indexed forward and position a new biological specimen  14  under staining device  38 . In alternative embodiments, a variety of emersion baths containing solvated stains may be provided. The position of the baths relative to strip  10  may be changed such that one area  24  is positioned above a bath and may then be submerged to apply stain to biological specimen  14 . Strip  10  may be passed through a mild heating zone or maintained at room temperature to facilitate drying of any stain solvent that may be present. 
         [0020]    After stain has been applied to the biological specimens, strip  10  may be advanced to a covering subsystem  32 . Cover subsystem  32  may include a roller  40 , cover material spool  42 , and a guide roller  44 . Cover material  46  may be wound on spool  42  and fed over guide roller  44 . Roller  40  may draw cover material  46  and laminate or otherwise couple cover material  46  to base  12  along continuous strip  10 . As strip  10  is drawn past roller  40 , each region  24  includes a biological specimen disposed within a specimen block portion  16  and positioned between backing  12  and cover  48 . 
         [0021]    After covering, strip  10  is advanced to imaging subsystem  34 . In a basic form, imaging subsystem  34  includes a light source  50  and a high resolution imaging device  52 . Light source  50  is shown below backing  12  with imaging device  52  positioned above cover  48 . Alternatively, these positions could be reversed. To allow light transmission through strip  10  and to imaging device  52 , backing material  12  and cover  48  are sufficiently transparent to allow for high resolution imaging of biological specimen  14 . Many conventional materials may be used including polyesters (such as polyethylene terephthalate, i.e. MYLAR), polyacrylates, epoxys, polyolefins, and other polymer materials that are sufficiently transparent while allowing for a construction of backing  12  that can support specimen block portion  16  and flex in region  22 . In other embodiments, backing  12  may comprise more than one material. In such embodiments a transparent, rigid material may be used in region  23 , while a more flexible material may be used in region  22 . Such embodiments may lack thinned region  28 . 
         [0022]    A variety of lighting sources may be used depending on the diagnostic testing being done. For example, if a fluorescent stain is used, the light source may be selected to have a higher emission at or near the excitation frequency for the stain. When an image is captured, it will generally include substantially all of region  24  such that the biological specimen and the identifier (i.e. machine readable identifier  18  and/or alphanumeric identifier  20 ) are captured together. The captured image may be a digital image which may be stored in an image database or other memory. In some embodiments, it may be advantageous to have multiple images taken of the same biological specimen with the same or multiple imaging devices. 
         [0023]    After imaging, strip  20  may be fed to a storage subsystem  36 . Storage system  56  comprises a storage spool  54 . As strip  10  is fed to storage spool  54 , strip  10  flexes in regions  22  to wrap around spool  54 . When spool  54  has reached its capacity it may be placed in a specimen library that would provide for high density storage of the specimens. Each spool may be identified with an identifier  56  which could, in turn, be associated with all the specimens on storage spool  54 . Alternatively, segments of strip  10  may be cut and the strips stacked and boxed for storage. This would provide another option for high density storage of specimens. 
         [0024]    Conventional glass microscope slides are typically used for specimen examination and storage. Such slides are typically three inches long and one inch wide. With the use of strip  10 , each biological specimen would only require an area one inch long by one inch wide because additional area on ether side of biological specimen  14  would not be necessary for handling. Also, conventional slides are made of glass or quartz which can be very brittle and easily broken. With the use of strip  10 , other more resilient materials may be utilized. 
         [0025]    Referring to  FIG. 4 , a multi head staining subsystem is provided. In the embodiment shown, the staining device may include three heads  38   a,    38   b,  and  38   c  extending from a base  58 . Base  58  may be rotated to align one of the three heads  38  over a biological specimen  14  on strip  10 . When the appropriate head  38  is aligned over a biological specimen  14 , base  58  and heads  38  may be lowered so that biological specimen  14  is substantially covered by one of heads  38 . A stain may then be applied to the individual biological specimen. After application of the stain, base  58  and heads  38  may be raised away from strip  10 . In some embodiments, base  58  and heads  38  may be moved laterally away from strip  10  such that rotation of base  58  is done away from strip  10 . In this way, no biological specimen would ever pass under more than one of heads  38  thereby preventing unwanted stain migration. 
         [0026]    Referring to  FIG. 5 , a covering subsystem may include a roller  40  and a guide roller  44 . Guide roller  44  maintains the angel at which cover material  46  is supplied to roller  40  while the diameter of spool  42  (shown in  FIG. 3 ) reduces. Roller  40  is driven at the same rate at which strip  10  is advanced. Roller  40  includes edges  60  and  62  that contact regions  24  of strip  10  and cross portions  64  that contact each region  22  as strip  10  advances. Edges  60  and  62 , and cross portions  64  may be provided to couple cover material  45  to strip  10  in one or more of a variety of ways including pressure fusing, partial melting, ultrasonic welding, adhesive lamination, or any other suitable method. 
         [0027]    Referring to  FIG. 6 , a computerized system for storing, distributing, and analyzing images of anatomical pathology specimens  200  is provided. The system includes a subsystem  210  which is utilized to route images and electronic health record information through system  200 . Subsystem  210  could be a subsystem operated by a healthcare provider with an anatomical pathology lab, or it could be operated by a third party. Subsystem  220  is utilized to link image data from image database  222  to an electronic health record database  224 . Subsystem  220  may be a laboratory information system, and electronic health record system or a combination of both. Subsystem  210  may be used to route images to remote locations  226 ,  228 , and  230  where the images may be examined by a pathologist without the need to evaluate the actual anatomical specimens. A report form may be provided with the images to the pathologist. Alternatively, the pathologist may be able to view images and fill in reports using a web based application. When the pathologist has completed a pathology report, subsystem  210  can provide that information to an electronic health record system for inclusion in the patient&#39;s electronic health record. 
         [0028]    In some embodiments, subsystem  210  may include additional functionality to permit the evaluation of the various pathologists who may perform diagnostic studies based on images provided through a credibility test. In such embodiments, a credibility score may be assigned to one or more of the various pathologists according to one of a variety of known credibility testing techniques. One such embodiment includes the distribution of the same images to several pathologists and determining a consensus diagnosis. Variations from the consensus would be tracked and pathologists who most frequently vary from consensus diagnoses could be de-selected for referral of future pathology studies. Additionally, subsystem  210  could be used to determine if a pathological diagnosis provided varies from a subsequent diagnosis provided in the patient&#39;s electronic health record. In some embodiments the credibility score could be calculated as the percentage of diagnostic studies performed by a particular pathologist in which that pathologist&#39;s diagnosis agreed with the consensus diagnosis. 
         [0029]    Although a few exemplary embodiments of the present invention have been shown and described, the present invention is not limited to the described exemplary embodiments. Instead, it would be appreciated by those skilled in the art that changes may be made to these exemplary embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and their equivalents. 
         [0030]    The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used in the description of the embodiments of the invention and the appended claims, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. 
         [0031]    Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. 
         [0032]    It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. It will be understood that relative terms are intended to encompass different orientations of the device in addition to the orientation depicted in the Figures. 
         [0033]    Moreover, it will be understood that although the terms first and second are used herein to describe various features, elements, regions, layers and/or sections, these features, elements, regions, layers and/or sections should not be limited by these terms. These terms are only used to distinguish one feature, element, region, layer or section from another feature, element, region, layer or section. Thus, a first feature, element, region, layer or section discussed below could be termed a second feature, element, region, layer or section, and similarly, a second without departing from the teachings of the present invention. 
         [0034]    It will also be understood that when an element is referred to as being “connected” or “coupled” to another element, it can be directly connected or coupled to the other element or intervening elements may be present. In contrast, when an element is referred to as being “directly connected” or “directly coupled” to another element, there are no intervening elements present. Further, as used herein the term “plurality” refers to at least two elements. Additionally, like numbers refer to like elements throughout. 
         [0035]    Thus, there has been shown and described several embodiments of a novel invention. As is evident from the foregoing description, certain aspects of the present invention are not limited by the particular details of the examples illustrated herein, and it is therefore contemplated that other modifications and applications, or equivalents thereof, will occur to those skilled in the art. The terms “having” and “including” and similar terms as used in the foregoing specification are used in the sense of “optional” or “may include” and not as “required”. Many changes, modifications, variations and other uses and applications of the present construction will, however, become apparent to those skilled in the art after considering the specification and the accompanying drawings. All such changes, modifications, variations and other uses and applications which do not depart from the spirit and scope of the invention are deemed to be covered by the invention which is limited only by the claims which follow. The scope of the disclosure is not intended to be limited to the embodiments shown herein, but is to be accorded the full scope consistent with the claims, wherein reference to an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” All structural and functional equivalents to the elements of the various embodiments described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims.