Abstract:
The present invention comprises a device for anatomically orienting at least one tissue specimen, comprising a dispenser for carrying and selectably dispensing at least one pre-labeled specimen orientation tag. The dispenser comprises a vessel separable along its equator into an inferior base segment and a superior cover segment. The inferior base segment and superior cover segment enclose a dispensing ring that includes at least one set of paired radially projecting retaining prongs, which paired prongs define at least one dispensing bay, in which the specimen orientation tag is disposed for selective dispensation through at least one aperture radially arrayed along the equator of the dispsenser.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     1. Technical Field  
         [0002]     The present invention relates to pathologic evaluation of tissue specimens and in particular to the identification of the anatomic orientation of tissue specimens submitted for pathologic evaluation.  
         [0003]     2. Related Art  
         [0004]     Tissue specimens removed during surgery must be anatomically oriented with respect to structures from which they have been excised and the body of the patient in order for pathologists to make a proper pathological diagnoses.  
         [0005]     By medical consensus and convention, anatomic orientation is made with respect to a standard anatomic position in which a human being stands erect with his or her arms supinated. With respect to the standard anatomic position, the head is superior or cephalad and the feet are inferior or caudad. The chest is anterior or ventral and the back is posterior or dorsal. The arms are lateral and the heart is medial.  
         [0006]     In keeping with this convention, if for example, a tissue specimen is removed from the lobe of a patient&#39;s lung in the approximate form of a cube, the faces of the cube may be identified as: superior or cephalad; inferior or caudad; anterior or ventral; posterior or dorsal; lateral; and, medial.  
         [0007]     Should the exemplary cube of tissue be found by a pathologist to contain a tumor, the orientation of the tumor with respect to the lung from which it has been removed will be critical to the surgical treatment of the patient. Accordingly, surgeons removing tissue specimens for pathological and histopathological diagnoses, and excising tissues until they are assured by a pathologist of tumor-free resection margins, must label the tissue specimens in a manner that unambiguously orients them with respect to the anatomical structure and person from which they are excised.  
         [0008]     Such labeling is typically accomplished by passing a suture through as many faces or aspects of a tissue specimen as are required to orient it unambiguously. For example, a surgeon may place a short black silk suture along a medial aspect of a tissue specimen, and a long black silk suture along an inferior aspect of a tissue specimen. Alternatively, a surgeon may identify a lateral aspect of a tissue specimen by passing a double loop of suture through its lateral margin, and may identify an inferior margin by passing a single loop of suture through its inferior margin. Margins, aspects, or faces of a tissue specimen may also be distinguished and identified with respect to anatomical orientation by passing sutures of different colors.  
         [0009]     In each case, the suture length, suture configuration (i.e., single loop, double loop, etc.) or suture color that establishes an anatomic orientation for a tissue specimen is dictated aloud to another health care provider in the operating room, such as, for example, a circulating nurse. The circulating nurse typically prepares a written legend that correlates each suture with the dictated anatomic orientation. The written legend accompanies tissue specimens to the pathology laboratory, where its anatomic orientating information is used in the pathologic evaluation of the tissue specimens. For example, after checking the orienting sutures against the legend, pathology laboratory personnel will know how each tissue specimen was originally seated prior to its removal. This information is essential to accurate pathologic descriptions of the specimen and its surrounding tissues.  
         [0010]     Establishing the anatomic orientation of a tissue specimen by the use of sutures of different lengths, colors or configuration is confusing and prone to errors. For example, sutures may unravel and the foregoing legend may be transcribed improperly or may be poorly legible.  
         [0011]     Accordingly, there exists a need for the efficient, convenient and unambiguous anatomic orientation of tissue specimens for purposes of pathological diagnoses, and pathologically-guided surgical resections.  
       SUMMARY OF THE INVENTION  
       [0012]     The present invention comprises a device for anatomically orienting at least one tissue specimen, comprising a dispenser for carrying and selectably dispensing at least one pre-labeled specimen orientation tag. The dispenser comprises a vessel separable along its equator into an inferior base segment and a superior cover segment. The inferior base segment and superior cover segment enclose a dispensing ring that includes at least one set of paired radially projecting retaining prongs, each set of which defines at least one dispensing bay, in which the specimen orientation tag is disposed for selective dispensation through at least one aperture radially arrayed along the equator of the dispsenser. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0013]      FIG. 1  is a schematic illustration of the invention held in the left hand of a surgeon as the surgeon uses his right hand to select and dispense a specimen orientation tag with a needle holder bearing a needle attached to a suture ligature.  
         [0014]      FIG. 2  is a perspective view of an exemplary specimen orientation tag bearing the exemplary inscription “INF.” 
         [0015]      FIG. 3  is a front (elevated) view of an exemplary specimen orientation tag, as seen en face.  
         [0016]      FIG. 4  is a top (plan) view of an exemplary specimen orientation tag, as seen on edge and from above.  
         [0017]      FIG. 5  is a lateral (elevated) view of an exemplary specimen orientation tag, as seen on edge and from the side.  
         [0018]      FIG. 6  is an exploded view of the invention, showing a cover segment superiorly and a base segment inferiorly, between which there is disposed a retaining ring with bays for the disposition of specimen orientation tags.  
         [0019]      FIG. 7  is a lateral (elevated) view of the dispenser, as seen on edge and from the side.  
         [0020]      FIG. 8  is a top (plan) view of the dispenser, as seen from above.  
         [0021]      FIG. 9  is a top (plan) view of the dispenser&#39;s retaining ring seated in the base segment of the dispenser, as seen from above. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0022]      FIG. 1  is a schematic illustration of the invention held in the left hand of a surgeon as the surgeon uses his right hand to select and dispense a specimen orientation tag with a needle holder bearing a needle attached to a suture ligature. As shown in  FIG. 1 , the invention comprises a plurality of specimen orientation tags  500  radially disposed within a dispenser  100  adapted to carry and dispense the specimen orientation tags  500 . Each specimen orientation tag  500  has a body  501 , from which a handle  502  extends through a plurality of apertures  103  that are radially arrayed along an equator  101  of dispenser  100 . The body  501  and handle  502  of each specimen orientation tag  500  forms an eyelet  503  through which a suture ligature, surgical staple or other means for the attachment of the specimen orientation tag to a tissue specimen may be passed.  
         [0023]     In an operating room or other surgical facility, the invention, manufactured as dispenser  100  preloaded with specimen orientation tags  500 , is delivered, for example, by a circulating nurse, out of packaging that maintains the invention in a sterile state. Specimen orientation tags  500  and dispenser  100  are for single patient use only. Specimen orientation tags  500  are intended to orient tissue specimens for pathological evaluation and/or to label tissue specimens for anatomic orientation. Although biologically inert, specimen orientation tags  500  are not intended to remain in the patient.  
         [0024]     The invention&#39;s packaging may be removed or peeled away by the circulating nurse and the sterilized invention is passed onto a sterile field by dropping it there or placing it within the reach of a scrub nurse or surgeon. The scrub nurse carefully verifies that the eyelet  503  of each specimen orientation tag  500 , visibly protrudes through each aperture  103  that is radially arrayed along the equator of dispenser  100 . As show in  FIG. 1 , the surgeon may grasp dispenser  100  in one hand and use a needle holder loaded with a suture ligature to grasp a specimen orientation tag  500  for fixation to an excised tissue specimen.  
         [0025]     Specimen orientation tags  500  are dispensed one at a time by passing a suture needle through eyelet  503  of the desired specimen orientation tag  500  and then releasing it from a dispensing bay (not shown in  FIG. 1 ) with a gentle tug. Each specimen orientation tag  500  is then secured to a tissue specimen with a surgical knot. When the tissue specimen is adequately tagged for orientation, it is passed out of the sterile surgical field to the circulating nurse.  
         [0026]     The number of specimen orientation tags  500  remaining in dispenser  100  and the number of specimen orientation tags  500  that were dispensed should be included in the nurse&#39;s count sheet to verify that all specimen orientation tags  500  are accounted for prior to closure of the surgical wound.  
         [0000]     Specimen Orientation Tags  
         [0027]      FIGS. 2 through 5  are a series of illustrative views of an exemplary specimen orientation tag  500 .  FIG. 2  is a perspective view of an exemplary specimen orientation tag bearing the exemplary inscription  506  “INF.”  FIG. 3  is a front view of an exemplary specimen orientation tag, as seen en face.  FIG. 4  is a top view of an exemplary specimen orientation tag, as seen on edge and from above.  FIG. 5  is a lateral view of an exemplary specimen orientation tag, as seen on edge and from the side.  
         [0028]     In  FIGS. 2 through 5 , an exemplary specimen orientation tag  500  is shown as having an exemplary elliptical shape. As shown in  FIGS. 2 through 5 , each specimen orientation tag  500  comprises a biologically inert and sterilizable body  501  and an eyelet  503 , defined by a handle  502 , through which a needle attached to a suture ligature (shown in  FIG. 1 ) or surgical stapling device or other fixation or attachment means is passed to secure specimen orientation tag  500  to a tissue specimen.  
         [0029]     Specimen orientation tag  500  may be made of a material such as, for example, polymethlymethacrylate, silicone, or any other biologically inert and sterilizable material. Specimen orientation tag  500  may have any shape. Specimen orientation tag  500  may additionally be made of a radio-opaque material to permit its identification on radiological images.  
         [0030]     The exemplary elliptically-shaped specimen orientation tag  500  shown in  FIGS. 2 through 5  may have a major diameter of about 1 cm and a minor diameter of about 0.75 cm. Body  501  may contribute about 0.75 cm to the major diameter, and handle  502  may contribute about 0.25 cm to the major diameter. The exemplary elliptically-shaped specimen orientation tag  500  shown in  FIGS. 2 through 5  may have a thickness of about 0.25 cm.  
         [0031]     Handle  502  of specimen orientation tag  500  may be extruded from body  501  or may be appended to body  501  by a suitable nontoxic, biologically inert adhesive, such as, for example, an acrylic-based glue. Eyelet  503  may alternatively be fashioned by drilling a hole into body  501 .  
         [0032]     Each face of body  501  of specimen orientation tag  500  bears an orientation designation, abbreviation, acronym or symbol  506  denoting an anatomical orientation.  FIG. 2  and  FIG. 3  show an exemplary specimen orientation tag  500  bearing the exemplary orientation acronym “INF,” designating the word “inferior.” Orientation designation, abbreviation, acronym or symbol  506  may be imprinted, engraved or otherwise affixed onto each face of body  501  of each specimen orientation tag  500 .  
         [0033]     The exemplary orientation acronyms appearing in Table 1 may be used as identifiers or anatomic orientation.  
                             TABLE 1                           ORIENTATION ACRONYMS                Anatomic Orientation   Abbreviation                       Medial   MED           Lateral   LAT           Anterior   ANT           Ventral   VEN           Posterior   POS           Dorsal   DOR           Superior   SUP           Cephalad   CEP           Inferior   INF           Caudad   CAU           Left   LFT           Right   RGT           Area of Interest   AOI                      
 
         [0034]     Specimen orientation tags  500  may be of like color or may be color-coded using any scheme that uniquely identifies each specimen orientation tag  500  with an anatomic orientation or the orientation acronym or symbol  506  that it bears.  
         [0035]     Other labels may be created in lieu of an orientation designation, abbreviation, acronym or symbol for specific procedures having other labeling requirements. Moreover, such other labels may comprise designations, abbreviations, acronyms or symbols in foreign languages or icons that designate anatomic orientations.  
         [0036]     As more fully described hereinafter, and as shown in  FIG. 1 , when specimen orientation tags  500  are arrayed for dispensation in dispenser  100 , eyelets  503  are visibly accessible to easily enable a surgeon or scrub nurse to select a specimen orientation tag that is appropriate to label an excised tissue specimen. As shown in  FIG. 1 , once a specimen orientation tag  500  is “threaded,” with a suture ligature, it is released from dispenser  100  with a tug on the suture. The suture carrying specimen orientation tag  500  is then secured to the tissue specimen by tying. Alternatively, specimen orientation tag  500  may be secured to a tissue specimen by means of a surgical stapling or other fastening device.  
         [0037]     After placing the desired number of specimen orientation tags  500  to properly identify the anatomic orientation of a tissue specimen, the specimen is passed out of the surgical field to a circulating nurse and eventually delivered to a pathologist or other specialist for examination. Because specimen orientation tags  500  are placed by a surgeon (or scrub nurse) there is no need for a circulating nurse or other operating room assistant to create a separate written legend in order for a pathologist to orient the specimen.  
         [0000]     Dispenser  
         [0038]      FIGS. 6 through 9  are a series of illustrative views of exemplary dispenser  100  ( FIG. 1 ) of specimen orientation tags  500 .  FIG. 6  is an exploded view of the invention, showing a cover segment superiorly and a base segment inferiorly, between which there is disposed a retaining ring with bays for the disposition of specimen orientation tags.  FIG. 7  is a lateral view of the dispenser, as seen on edge and from the side.  FIG. 8  is a top view of the dispenser, as seen from above.  FIG. 9  is a top view of the dispenser&#39;s retaining ring seated in the base segment of the dispenser, as seen from above.  
         [0039]     As shown in  FIGS. 6 and 7 , exemplary dispenser  100  for carrying and exemplary dispensing specimen orientation tags  500  comprises a vessel, in the exemplary form of a shallow oblate spheroid, separable along its equator  101  ( FIG. 7 ) into an inferior base segment  200 , in the form of a shallow inferior spherical cap, and an opposing superior cover segment  300 , in the form of a shallow superior spherical cap. Base segment  200  and cover segment  300  enclose a dispensing ring  400  ( FIG. 6 ).  
         [0040]     Dispenser  100  and dispensing ring  400  may, for example, be made of sterilizable plastic, such as, for example, polymethylmethacrylate or silicone or any other biologically inert and sterilizable material.  
         [0041]     As shown in  FIG. 7 , dispenser  100  may have a diameter  101 D of about 5 cm. Cover segment  300 , having the same diameter, may have a height  300 H of about 0.5 cm. Base segment  200 , having the same diameter, may also have a height  200 H of about 0.5 cm. As shown in  FIG. 6  and in  FIG. 8 , cover segment  300  includes a central concave depression  303  to facilitate grasping of dispenser  100  by the thumb of a user. Central concave depression  303  may have a diameter of about 3 cm and a depth of about 0.3 cm.  
         [0042]     As shown in  FIG. 6 , a plurality of exemplary superior arcs  302  are fashioned into cover segment  300 , so as to array them radially along equatorial perimeter  301  of cover segment  300 . A plurality of exemplary inferior arcs  202  is fashioned into base segment  200 , so as to array them radially along equatorial perimeter  201  of base segment  200 . Exemplary superior arcs  302  and exemplary inferior arcs  202  appose one another when cover segment  300  is closed upon base segment  200 . As shown in  FIG. 7 , the apposition of each superior arc  302  with its corresponding inferior arc  202  forms a plurality of exemplary elliptical apertures  103  along the equator  101  of dispenser  100 . Perimeter  201  of base segment  200  and perimeter  301  of cover segment  300  are coincident with equator  101  of dispenser  100  when base segment  200  and cover segment  300  are apposed to form dispenser  100 .  
         [0043]     Each exemplary inferior arc  202 , and each exemplary superior arc  302  may have equal corresponding chord lengths  202 C,  302 C of, for example, about 1 cm, and may have corresponding heights  202 H,  302 H of, for example, about 0.2 cm, thereby forming a generally elliptical aperture  103  ( FIG. 7 ) with a major axis of about 1 cm and a minor axis of about 0.4 cm. Each exemplary elliptical aperture  103  provides access to a specimen orientation tag  500  disposed within a corresponding dispensing bay  401  of dispensing ring  400 , more fully described hereinbelow in connection with  FIG. 6  and  FIG. 9 .  
         [0044]     As shown in  FIG. 6  and  FIG. 9 , dispensing ring  400  includes a plurality of paired radially projecting retaining prongs  402  that oppose one another to secure specimen orientation tags  500 . Each set of paired retaining prongs  402  defines a dispensing bay  401  ( FIG. 6 ) having a diameter slightly smaller than a diameter of a specimen orientation tag, thereby permitting a user to easily release a specimen orientation tag from its dispensing bay  401 . Each dispensing bay  401  corresponds to and is accessible through an exemplary elliptical aperture  103 . Dispensing bays  401  are accordingly radially arrayed about retaining ring  400  to enable respective tips  402   a  and  402   b  of each pair of retaining prongs  402  protrude slightly from the opposing lateral margins of each exemplary elliptical aperture  103  in such a way as to retain specimen orientation tag  500  in dispensing bay  401  but not impede its removal.  
         [0045]     As shown in  FIG. 6 , spoon-like indentations  102  are fashioned along the equatorial perimeter of base segment  200  to be coincident with dispensing bays  401  and exemplary elliptical apertures  103 . Mirror-image spoon-like indentations (not shown in  FIG. 6 ) are also fashioned along the equatorial perimeter of cover segment  300  to be coincident with dispensing bays  401  and exemplary elliptical apertures  103 . When apposed, each spoon-like indentation  102  of base segment  200  forms a floor beneath its respective dispensing bay  401 ; and, each spoon-like indentation of cover segment  300  forms a roof over its respective dispensing bay.  
         [0046]     When apposed, each spoon-like indentation  102  of base segment  200  and each corresponding spoon-like indentation of cover segment  300  creates a space in the general shape of an ellipsoid about each dispensing bay  401 , that is accessible through its corresponding aperture  103 . The spaces so formed, permit insertion of the tips of a surgical instrument, such as, for example, a needle holder or forceps, with which a specimen orientation tag may be grasped. Each spoon-like indentation may for example have a diameter of about 1 cm and a depth of about 0.2 cm.  
         [0047]     If base segment  200  and cover segment  300  are made of a transparent material, the orientation designation, abbreviation, acronym or symbol  506  appearing on each specimen orientation tag will be visible through dispenser  100 . If base segment  200  and cover segment  300  are made of a nontransparent material, then the inferior surface of base segment  200  and the superior surface of cover segment  300  are embossed or engraved with paired, radially arrayed If base segment  200  and cover segment  300  are made of a transparent material, the orientation designations, abbreviations, acronyms or symbols, each of which corresponds to the orientation If base segment  200  and cover segment  300  are made of a transparent material, the orientation designation, abbreviation, acronym or symbol of a proximal specimen orientation tag it overlies.  
         [0048]     Dispenser  100  and specimen orientation tags  500  may be fabricated in various embodiments, in which the dimensions of dispenser  100  and specimen orientation tags  500  vary, and in which the number of specimen orientation tags  500  and their corresponding apertures  103 , dispensing bays  401  and indentations  102  vary. For example a much smaller dispenser  100  may contain only a single specimen orientation tag, whereas, for example, a larger dispenser  100  may contain as many as twelve or more specimen orientation tags. This flexibility in features of the structure of the invention permits using specimen orientation tags that are appropriate to different specialized surgical procedures, such as, for example, a neurological biopsy or gynecological biopsy.