Abstract:
A tissue marking system for use in marking a tissue sample comprises an ink-based applicator device and at least one tissue marking clip. The ink-based applicator device includes a container, a first number of ink reservoirs at least partially defined by the container, wherein each reservoir contains ink of a different color, a second number of applicators, wherein each applicator is configured to absorb a quantity of ink for application to the tissue sample, and a cover coupled to and cooperating with the container to fully enclose each of the first number of ink reservoirs. The at least one tissue marking clip includes an actuator portion movable between an actuated position and a non-actuated position, and a jaw portion coupled to the actuator portion and movable between an open position and a closed position in response to movement of the actuator portion between the actuated and non-actuated positions.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. application Ser. No. 13/205,195, filed on Aug. 8, 2011, now U.S. Pat. No. 8,594,768 B2, issued on Nov. 26, 2013, which is a continuation-in-part of U.S. application Ser. No. 11/749,552, filed May 16, 2007, now U.S. Pat. No. 8,301,227, issued on Oct. 30, 2012, which claims the benefit of U.S. Provisional Ser. No. 60/800,714, filed May 16, 2006, the entireties of which are hereby incorporated by reference. This application is also a continuation-in-part of U.S. application Ser. No. 11/873,249 (abandoned), filed Oct. 16, 2007, which is a continuation-in-part and claims the benefit of U.S. application Ser. No. 10/978,948 (abandoned), filed Nov. 1, 2004, the entireties of which are hereby incorporated by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates to a tissue marking system. More particularly, the present invention relates to a tissue marking system that identifies tissue orientation during both radiographic and visual examination. 
     During surgery, it is often necessary to remove a sample of tissue and closely examine that tissue sample (e.g., radiographic examination) while knowing its original orientation within the patient. For example, cancerous tumors are often removed from the patient and then examined to verify that a sufficient margin of tissue surrounding the tumor has been removed. To determine this, the tissue sample is examined and the margins on each surface are identified. If a margin is insufficient, it is important for the surgeon to know the orientation of the sample to allow for the removal of additional tissue in the proper area. 
     Presently, different color sutures, different length sutures, or different quantities of sutures are inserted into the tissue sample to identify the orientation of the tissue. However, this is time consuming and the sutures can be accidentally removed making identification of the tissue orientation difficult. Furthermore, sutures are not visible in radiographic (X-ray) images. As such, the tissue sample must be marked in a second way to provide for orientation in any X-ray images that may be taken. 
     SUMMARY OF THE INVENTION 
     The present invention solves the foregoing problems by providing a tissue marking system for use in marking a tissue sample that comprises an ink-based applicator device and at least one tissue marking clip. The ink-based applicator device includes a container, a first number of ink reservoirs at least partially defined by the container, wherein each reservoir contains ink of a different color, a second number of applicators, wherein each applicator is configured to absorb a quantity of ink for application to the tissue sample, and a cover coupled to and cooperating with the container to fully enclose each of the first number of ink reservoirs. The at least one tissue marking clip includes an actuator portion movable between an actuated position and a non-actuated position, and a jaw portion coupled to the actuator portion and movable between an open position and a closed position in response to movement of the actuator portion between the actuated and non-actuated positions. The jaw portion includes a first tooth and a second tooth configured to engage the tissue sample when the jaw portion moves from the open position to the closed position. 
     In another aspect of the invention, a tissue marking method for marking a tissue sample is provided that comprises the steps of providing a container including a first ink reservoir containing a first color ink, a second ink reservoir containing a second color ink, and a third ink reservoir containing a third color ink, applying the first color ink to a first surface of the tissue sample, applying the second color ink to a second surface of the tissue sample, applying the third color ink to a third surface of the tissue sample, providing first, second, and third tissue marking clips, wherein each of the tissue marking clips includes an actuator portion movable between a non-actuated position and an actuated position and a jaw portion coupled to the actuator portion and movable between an open position and a closed position in response to movement of the actuator portion, clipping the first tissue marking clip on the first surface of the tissue sample, clipping the second tissue marking clip on the second surface of the tissue sample, and clipping the third tissue marking clip on the third surface of the tissue sample. 
     Other aspects of the invention will become apparent by consideration of the detailed description and accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a top view of a patient including a tissue sample to be removed from the patient; 
         FIG. 2  is an enlarged top view of a portion of the patient and tissue sample of  FIG. 1 ; 
         FIG. 3  is a side view of the portion of the patient and tissue sample of  FIG. 1 ; 
         FIG. 4  is a perspective view of the tissue sample of  FIG. 1  after being removed from the patient of  FIG. 1 ; 
         FIG. 5  is a perspective view of a tissue marking system; 
         FIG. 6  is a top view of another tissue marking system; 
         FIG. 6   a  is a sectional view of the tissue marking system of  FIG. 6  taken along line A-A of  FIG. 6 ; 
         FIG. 7  is a sectional view of the tissue marking system of  FIG. 6  taken along line  7 - 7  of  FIG. 6 ; 
         FIG. 8  is a perspective view of another construction of the tissue marking system; 
         FIG. 9  is a perspective view of an applicator; 
         FIG. 10  is a perspective view of another construction of the tissue marking system; 
         FIG. 11  is an enlarged perspective view of the tissue sample of  FIG. 4 ; 
         FIG. 12  is a front perspective view of a clip that is attachable to the tissue sample of  FIG. 11 ; 
         FIG. 13  is top perspective view of the clip of  FIG. 12 ; 
         FIG. 14  is a front perspective view of the clip of  FIG. 12  in an actuated position; 
         FIG. 15  is a front perspective view of another clip in a non-actuated position; 
         FIG. 16  is an exploded front view of a portion of the clip of  FIG. 15 ; 
         FIG. 17  is a section view of a portion of the clip of  FIG. 15  taken along line  17 - 17  of  FIG. 15 ; and 
     
    
    
     Before any embodiments of the invention are explained, it is to be understood that the invention is not limited in its application to the details of construction and the arrangements of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof is meant to encompass the items listed thereafter and equivalence thereof as well as additional items. The terms “connected,” “coupled,” and “mounted” and variations thereof are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms “connected” and “coupled” and variations thereof are not restricted to physical or mechanical connections or couplings. 
     DETAILED DESCRIPTION OF THE INVENTION 
     With reference to  FIGS. 1-3 , a patient  10  and a tissue sample  15  are illustrated to show the tissue sample&#39;s orientation in the patient  10 . Before proceeding, it should be noted that the present invention will be described as it relates to a tissue sample  15  removed from a breast. However, one of ordinary skill in the art will realize that the invention is applicable to many other tissue samples in which orientation is important. For example, basal cell carcinoma also requires that a tissue sample be removed, and that its orientation be identified to verify that sufficient margin has been removed. As such, the invention should not be limited only to the uses described herein as it is well suited for use with any tissue that required orientation for pathology and/or radiology. These tissues include but are not limited to samples of breast, bone, thyroid, lymph nodes, brain, sarcomas, kidney, bowel, spleen, soft tissue masses, melanoma, squamous cell skin cancer, basal cell cancer, liver tumors, and the like. 
       FIG. 1  shows a view looking down on the patient  10 . For purposes of description, the direction  20  toward the patient&#39;s head will be identified as superior, while the opposite direction  25  is inferior. The direction  30  toward the patient&#39;s midline is defined as medial, while the opposite direction  35  is defined as lateral. With reference to  FIG. 3 , a side view of a portion of the patient is illustrated to further illustrate orientation. The direction  40  toward the patient&#39;s exterior is defined as superficial, while the opposite direction  45  is defined as deep. 
       FIGS. 2 and 3  illustrate the tissue sample  15  within the patient  10  prior to its removal, while  FIG. 4  shows that same tissue sample  15  after removal. With the sample  15  still in the patient  10 , the three surfaces  50 ,  55 ,  60  that will be marked can be seen. While any three planes or surfaces of the tissue sample  15  can be used to identify the orientation of the sample  15 , it is preferred that at least three substantially orthogonal surfaces be identified, with some applications marking six surfaces. In  FIGS. 2 and 3 , the lateral surface  50 , inferior surface  55 , and superficial surface  60  of the tissue sample  15  are shaded differently for illustrative purposes. In  FIG. 4 , the same three surfaces  50 ,  55 ,  60  are shaded to indicate that they have been marked with a different color. 
     Before proceeding, it should be noted that the term “ink” as used herein is meant to encompass any coloring element that can be applied to a tissue sample  15 , with dye, paint, and stains being a few examples. As such, the invention should not be limited to ink alone. 
     To mark the surfaces  50 ,  55 ,  60 , three different color inks are employed.  FIG. 5  illustrates a container  80  suited for use in marking the tissue sample  15 . The container  80  includes a housing  85  that defines three substantially separated compartments  90 ,  95 ,  100  and a cover  105  pivotally attached to the housing  85 . A perimeter  86  extends around the container  80  and encircles the three compartments  90 ,  95 ,  100 . Each of the three different color inks is disposed within one of the three compartments  90 ,  95 ,  100 . The cover  105  is movable between a covering position where it covers the three compartments  90 ,  95 ,  100  and cooperates with the housing  85  to completely separate the compartments  90 ,  95 ,  100 , and an open position where the ink is accessible. 
     Each compartment  90 ,  95 ,  100  includes a bottom surface and a wall that surrounds the bottom surface. Opposite the bottom surface is an opening that allows for access to the ink during use. 
     In some constructions, each of the inks is simply disposed within one of the compartments  90 ,  95 ,  100 . Generally, the ink in the compartments is in liquid form. In other constructions, an ink absorbent material  110 , such as foam or felt, is disposed within each compartment  90 ,  95 ,  100  and is operable to absorb and hold the ink to inhibit spillage and mixing between the ink compartments  90 ,  95 ,  100 . 
     Each quantity of ink is a different color than the remaining two quantities of ink. Thus, the first quantity of ink may be yellow, the second quantity of ink may be red, and the third quantity of ink may be black. Of course different colors (e.g., black, blue, green, red, yellow, orange, violet, and the like) could also be employed if desired. In addition, different colors may be employed depending on the particular tissue sample  15  to be removed. For example, breast tissue may be better examined if yellow, red, and blue inks are used, while basal cell samples may be better examined using red, blue, and black ink. Thus, the actual colors employed may be varied greatly. 
     Generally, the container  80  is a single use tool that is used during a single surgical procedure or a series of surgical procedures performed during the course of a single day. Thus, the container  80  and its contents are sterilized. While many different sterilization procedures are possible, it is believed that gamma ray sterilization is best suited to the task of sterilizing the container  80  and its contents with other sterilization processes also being possible. The container is subjected to a sufficient time and duration of gamma irradiation to render said container sufficiently sterile for introduction into a surgical operating room. In some constructions, a forceps  115  or tweezers is attached to the cover  105  and can be removed for use in grasping and marking the tissue sample  15 . Thus, the tissue sample  15  can be marked using the enclosed forceps  115  and the forceps  115  and the container  80  can be discarded after use. 
     While many different manufacturing processes are possible it is preferred that the container  80 , including the cover  105 , be injection molded as a single component. In constructions that are molded as a single component, a living hinge  118  would generally be employed between the cover  105  and the housing  85 . Of course, other manufacturing methods and other connections between the cover  105  and housing  85  could be employed if desired. 
       FIG. 6  illustrates another container  120  that supports three ink reservoirs  125 ,  126 ,  127  and is suited for use in marking the tissue sample  15 . Like the container  80 , the container  120  is a single use tool that is used during a surgical procedure or a series of surgical procedures throughout a day. For example, one container could be opened during a first surgical procedure and could be used throughout the day for a series of procedures before being discarded. In preferred constructions, the container  120  and its contents are sterilized before they are opened. The container  120  includes a formed portion  130  that defines the three ink reservoirs  125 ,  126 ,  127 . The reservoirs  125 ,  126 ,  127  are slight depressions in the formed portion  130  that are sized to contain a quantity of ink. A first isolation space  140  is formed between the first reservoir  125  and the second reservoir  126  and a second isolation space  145  is formed between the second reservoir  126  and the third reservoir  127 . The formed portion  130  also defines a perimeter  150  that surrounds the three reservoirs  125 ,  126 ,  127 . In most constructions, the perimeter  150 , the first isolation space  140 , and the second isolation space  145  are all substantially disposed within a single plane and the reservoirs  125 ,  126 ,  127  extend below that plane. 
     In some constructions, a ridge  155  (shown in  FIG. 6   a ) is formed around the perimeter  150  to increase the stiffness of the formed portion  130 . The ridge  155  may have a semi-circular, square, triangular, polygonal, or any other suitable cross-section. Generally, the ridge  155  extends downward below the perimeter to provide the additional stiffness. The ridge  155  also reduces the likelihood of tearing a surgical glove by reducing the number of sharp edges. The increased stiffness that results from the ridge  155  allows the container  120  to be used without being completely supported from beneath the reservoirs  125 ,  126 ,  127 . 
     The ink, dye, or other marking substance is disposed within each of the reservoirs  125 ,  126 ,  127 . As discussed with regard to  FIG. 5 , an ink absorbing material  160  such as felt or foam, can be placed within each of the reservoirs  125 ,  126 ,  127  to hold the ink and reduce the likelihood of spillage and mixing. 
     A cover  165  extends over the top of the open reservoirs  125 ,  126 ,  127  and sealably engages the perimeter  150 , the first isolation space  140 , and the second isolation space  145 . The cover  165  inhibits spillage, mixing, drying, and contamination of the ink before and after sterilization. In most constructions, the cover  165  is a thin plastic film or a thin foil that is adhesively bonded, heat sealed, or otherwise attached to the formed portion  130 . In adhesively bonded constructions, an adhesive is applied to the one or both of the cover  165  and the formed portion  130  in, or adjacent to, the perimeter  150 , the first isolation space  140 , and the second isolation space  145  such that when the cover  165  is positioned as desired, the cover  165  adhesively bonds to the formed portion  130 . Once sealed by the cover  165 , the container  120  and the ink can be sterilized, transported, and stored for future use. 
     It should be noted that the thin plastic cover  165  could be used with the construction of  FIG. 5  in place of, or in conjunction with, the cover  105 . 
     To manufacture the container  120 , the formed portion  130  is first stamped or injection molded from a thermoplastic material. Of course other materials (e.g., metals, composites, and the like) and other manufacturing processes could be used if desired. The ink holding component  160  (e.g., felt, foam, etc.) is positioned within each of the reservoirs  125 ,  126 ,  127  if employed. The different color inks are then placed in the individual reservoirs  125 ,  126 ,  127 . Adhesive is applied to one, or both, of the cover  165  and the formed portion  130  and the cover  165  is positioned on the formed portion  130  to complete the assembly of the container  120 . The container  120  is then sterilized and packaged for use at a future date. 
       FIG. 7  is a sectional view taken along the longitudinal axis of the container  120  of  FIG. 6 . As can be seen, the perimeter  150 , the first isolation space  140  and the second isolation space  145  reside in a single plane that allows the cover to sealably engage the container and seal each reservoir from the other reservoirs. The ridge  155  extends downward to increase the stiffness of the container  120  and to eliminate a thin edge that would otherwise exist and would provide a sharp surface that could tear a surgical glove. 
     In use, the constructions of  FIG. 5  and  FIGS. 6 ,  6   a , and  7  function similarly. The cover  105 ,  165  is first opened or removed to expose the ink. A first surface  50  of the tissue sample  15  is dipped into the first reservoir  90 ,  125 , a second surface  55  of the tissue sample  15  is dipped into the second reservoir  95 ,  126 , and a third surface  60  of the tissue sample  15  is dipped into the third reservoir  100 ,  127 . In most constructions, quick-drying ink is used to further speed the process. Generally, quick-drying ink is ink that dries in less than about 15 minutes with inks that dry in less than 5 minutes being preferred. The ink has a degree of viscosity such that it does not run or drip on the wet tissue after it is applied. Once the three surfaces  50 ,  55 ,  60  are marked, the orientation of the tissue sample  15  is easily identified and someone other than the surgeon can examine the sample while accurately understanding the original orientation of the tissue within the patient&#39;s body. 
     In some constructions, a label  175  is provided with the container  120  as shown in  FIGS. 5 and 6 . The label  175  is pre-marked with the ink colors and a space. The nurse or surgeon can identify the surface marked with each color ink by identifying that surface in the space adjacent the correct color on the preprinted label. The label  175  is then pealed off and affixed to the tissue sample  15  or the container that contains the tissue sample  15 . In still other constructions, preprinted labels include the colors and a preprinted surface identification, thereby eliminating the need to write the orientation on the label. In addition, some constructions include duplicate labels to allow for easy identification on a patients chart. 
     It should be noted that all of the constructions illustrated and discussed herein could also include a stick surface  180  (shown in  FIGS. 6   a  and  7 ). The stick surface reduces the likelihood of the container slipping off of a surface when the container  80 ,  120  is positioned for use. As such, the stick surface  180  is generally positioned opposite a reservoir opening, as illustrated in  FIGS. 6   a  and  7 . Many substances (e.g., rubber, VELCRO, adhesives, and the like) can be used as a stick surface  180 . 
       FIG. 8  illustrates another construction of a single-use tissue marking system  500  that includes a container  505  preferably formed as a single unitary piece using a thermoplastic material. The container  505  defines three reservoirs  510  sized to contain a quantity of ink or die. The container  505  includes another compartment or space  515  sized to receive a container of fixative  520 . The fixative  520  can be applied to the tissue sample before or after the ink or die is applied to improve the adhesion of the ink or die and inhibit running and drops. One fixative  520  suitable for use includes vinegar or a vinegar solution, with other fixatives  520  also being possible depending on the type of ink or die employed. In preferred constructions the fixative  520  is contained in a bottle with a spray nozzle  525 . The spray nozzle  525  assures that a fine mist of fixative is sprayed onto the tissue rather than large droplets. 
     The container  505  defines an elongated space  530  that is sized to receive a plurality of applicators  535 . In preferred constructions, the quantity of applicators  535  equals the quantity of ink reservoirs  505 . As such, the illustrated construction includes three ink reservoirs  505  and three applicators  535 . However, other constructions may include a different number of applicators  535  than reservoirs  505 . For example, one construction could include six ink reservoirs  505  and three applicators  535 . As one of ordinary skill will realize, many different quantities of applicators  535  and reservoirs  505  can be employed. For example, some constructions may include six ink reservoirs  505  and six applicators  535 . 
     In the illustrated construction, the elongated space  530  includes a plurality of separator elements  540  that support and separate the applicators  535  within the space  530 . The positioning within the space  530  allows a surgeon or other user to easily remove the applicators  535  with a gloved hand and with little risk of tearing or puncturing the glove. 
     Each applicator  535  includes a handle portion  545  and a sponge portion  550 . In preferred constructions, the handle portion  545  is formed from a plastic material. The sponge portion  550  is sized to absorb and hold a desired quantity of ink, while facilitating the accurate placement of the ink on the tissue sample. By depressing the sponge  550  onto the tissue sample, the surgeon is able to release a desired quantity of ink without causing drips or runs that can blur or confuse the marking. 
     A removable cover member (not shown) similar to that illustrated in  FIGS. 6 ,  6   a , and  7  is employed to cover the container  505 . The cover adhesively bonds to the container  505  and seals each ink reservoir  510  from the other ink reservoirs, the fixative space  515 , and the elongated space  530  to inhibit leakage of the inks. In preferred constructions, a single one-piece cover is employed to expedite the opening of the ink reservoirs  510  and other spaces  515 ,  530 . 
     As with the prior embodiments, the container  505  is a single-use device that is preferably sterilized prior to use. The user or surgeon grasps a handle  555  and removes the cover from the container  505  to completely expose each of the inks for use. Each applicator  535  is used with one of the inks to apply the ink to the tissue sample. The fixative  520  is applied before or after the ink is applied to assure that the ink remains fixed to the tissue sample. Once the tissue sample is properly marked, the container  505 , cover, and applicators  535  can be discarded. 
     As noted, other constructions of the applicator are also possible. As illustrated in  FIG. 9 , one construction of an applicator  600  includes a handle portion  605 , a first sponge portion  610 , and a second sponge portion  615 . The first sponge portion  610  is similar to the sponge portion  550 . The second sponge portion  615  includes a sponge or other material that will hold a quantity of ink. However, the second sponge portion  615  includes a small edge that allows for the finer more accurate placement of ink should it be necessary. 
     As was also noted, other constructions may employ more reservoirs to hold more colors of ink and may include more applicators. For example,  FIG. 10  illustrates a construction that includes a housing  900  that defines six reservoirs  905  that can be filled with six different colors of ink or dye as desired. In some cases, six different color inks are preferred to allow the surgeon to identify all six sides of the tissue sample. Alternatively, preferred colors can be used depending on the type of tissue or tumor. 
     Each reservoir  905  is surrounded by a ridge  906  that engages a cover (not shown) to assure that when the cover is in place, each reservoir  905  is sealed to inhibit leakage of ink from the reservoir  905 . 
     In some constructions, each of the reservoirs  905  is labeled to aid the surgeon in properly marking the tissue sample. For example, one construction includes one of anterior, posterior, superior, inferior, medial, or lateral adjacent each of the reservoirs  905 . Of course other labels could be employed if desired. 
     The construction of  FIG. 10  also includes a bottle of fixative  910  and six applicators  915  rather than the three illustrated in  FIG. 8 . Each applicator  915  would typically be used with only one color ink to inhibit mixing of colors. While the illustrated applicators  915  include a single sponge end  920 , other constructions could employ the applicator  600  illustrated in  FIG. 9  if desired. 
     As with prior constructions, the housing  900  is covered with a single cover (not shown) that seals each of the reservoirs  905  and is removable to expose each of the six reservoirs  905 , applicators  915 , and fixative  910  for use. Once the cover is removed, the product is used for one or more surgical procedures and then is discarded. Thus, the construction of  FIG. 10  is a single-use device. 
     Now that various ink marking systems in accordance with the invention have been described with reference to  FIGS. 1-10 , several exemplary embodiments of a tissue marking clip that may be used alone or in combination with an ink-based tissue marking system will now be set forth in detail. As will be appreciated by one of ordinary skill in the art, it is not possible to identify orientation of a tissue sample in a radiographic image using different color inks. Therefore, the use of a second marking means such as the marking clips is necessary when both radiographic and visual examination of a tissue sample is required. 
       FIG. 11  illustrates an enlarged perspective view of the tissue sample  15  of  FIG. 4 , which once again has been marked with three different color inks  50 ,  55 ,  60  each represented by a different cross hatch pattern. As those of ordinary skill in the art will appreciate, any suitable ink-based system may be utilized including but not limited to those previously described. 
       FIGS. 12 and 13  illustrate one construction of a clip  230  that may directly engage a tissue sample  15  to identify the orientation of the tissue sample  15  in an X-ray. In preferred constructions, most or all the clip  230  is transparent or translucent in the X-ray region of the electromagnetic spectrum. This allows an X-ray to be taken through the clips  230  such that they do not interfere with the image. The clip  230  includes a jaw portion  235 , an actuator portion  240 , and a tail  245 . The actuator portion  240  is substantially V-shaped and includes an apex  250  and two arms  255  that connect with one another at the apex  250 . In the illustrated construction, the two arms  255  cooperate to define an angle  260  of about 45 degrees with other angles  260  also being possible. 
     In some constructions, the arms  255  include a knob  265  positioned at the end of the arm  255  opposite the apex  250 . The knobs  265  make it easier to grasp and actuate the actuator portion  240  without the clip  230  slipping from the user&#39;s hand or an instrument. In still other constructions, a texture such as ridges or other grip-enhancing surfaces may be formed on the arms  255  to reduce the likelihood of slippage during actuation. 
     The jaw portion  235  includes two teeth  270 ,  275  with each tooth  270 ,  275  extending from one of the arms  255  of the actuator portion  240 . Each tooth  270 ,  275  is substantially curved and terminates at a point  280 . The curve of each of the teeth  270 ,  275  is such that the two points  280  are pointing substantially toward one another when the clip  230  is in the non-actuated position. 
     One of the teeth  270  is slightly longer than the other tooth  275  such that the teeth  270 ,  275  cooperate to produce a slight overbite  282 . The overbite  282  improves the grip of the teeth  270 ,  275  in the tissue sample  15 , thereby making it less likely that the clip  230  would be accidentally removed from the sample  15 . 
     In some constructions, barbs or other tissue-engaging members could be formed as part of the teeth  270 ,  275  to further enhance their grip on the tissue sample  15  to which they are attached. In addition, more than two teeth  270 ,  275  or teeth  270 ,  275  having more than one point  280  could also be employed if desired. 
     Each tooth  270 ,  275  defines a tooth surface area at the tooth tip. The surface area is related to the biasing force produced by the clip  230 . Specifically, the tooth tip surface area is sized to not puncture a glove when only the biasing force of the clip is applied. Thus, when clips with larger biasing forces are employed, larger tooth tip surface areas are employed. 
     Each tooth  270 ,  275  attaches to one of the arms  255  of the actuator portion  240  approximately one-third of the length back from the apex  250 . The attachment point of the teeth  270 ,  275  to the arms  255  determines how far open, or apart the points  280  will spread when the clip  230  is in the actuated position. Thus, other constructions could position the teeth  270 ,  275  further away from the apex  250  and/or could increase the angle  260  defined by the arms  255  to increase the opening between the points  280 . Likewise, the opposite arrangement could be employed to reduce the opening if desired. 
     The tail  245  extends from one of the arms  255  of the actuator portion  240  and includes an indicator  285  that is opaque in an X-ray region of the electromagnetic spectrum. In the illustrated construction, the indicator  285  includes a number of balls  290  formed as part of the tail  245 . The balls  290  are substantially opaque in the X-ray region of the electromagnetic spectrum. As such, the balls  290  appear white on an X-ray. In this construction, the number of balls  290  on the tail  245  indicates orientation. For example, as illustrated in  FIG. 11 , one surface of the sample  15  may have a clip  230   a  attached with one ball  290  on the tail  245 . The second surface would then include a clip  230   b  with two balls  290 , and the third surface would include a clip  230   c  with three balls  290 . Because the clips  230   a ,  230   b ,  230   c  and the tails  245  travel with the sample  15 , multiple X-rays at multiple angles can be taken without losing the ability to determine the orientation of the tissue sample  15 . 
     While clips  230  with tails  245  having one, two, or three balls  290  can be provided, one construction employs tails  245  with only three balls  290 . The user then breaks off one ball  290  or two balls  290  to define the different indicators  285 . Furthermore, while the tail  245  is shown and described as being attached to one of the arms  255 , it could be attached to nearly any portion of the actuator portion  240  or the jaw portion  235  if desired. 
     In other constructions, other indicators  285  may be employed. For example, one construction uses different shaped indicators (e.g., square, rectangular, triangular, etc.) for each clip used to identify orientation (i.e., three clips). Still other constructions may employ indicators that vary by size. For example, one construction could employ a single large ball, a single medium size ball, and a single small ball (or no ball) to indicate orientation. 
       FIG. 15  illustrates yet another construction of a clip  330  that is suitable for use in identifying the orientation of a tissue sample. The clip  330  is similar to the clips  230   a ,  230   b ,  230   c  of  FIGS. 11-14  with the exception of a tail  335 . The tail  335  includes an extension portion  340  that connects to one of the arms  255  or some other portion of the clip  330 , and an identifier portion  345  that is attached to the extension portion  340 . 
     In the illustrated construction, the extension portion  340  is fixedly attached to the arm  255 . In preferred constructions, the extension portion  340  is integrally-formed as part of the arm  255  or clip  330 . As illustrated in  FIG. 16 , the identifier portion  345  includes a substantially plate-shaped member  350 . The plate-shaped member  350  defines two relatively large planar surfaces  355  that facilitate the placement of indicia  360  that aids in identifying the orientation of the sample  15  to which the clip  330  is attached. For example, an “L” is placed on one of the planar surfaces  355  to indicate a lateral position. The “L” (Lateral) can be placed on the planar surface  355  using a metallic paint or other system that is visible in an X-ray image. In one exemplary embodiment, the indicia on the planar surface  355  may be applied with a radiographic label. As appreciated by one of ordinary skill in the art, radiographic labels may provide a brightness that is consistent on the X-ray image with edges that are crisp and highly legible. Some other indicia that may be employed includes A for Anterior/Superficial, P for Posterior/Deep, S for Superior/Cephalad, I for Inferior/Caudal, and/or M for Medial. Of course other indicia could be employed so long as the surgeon and the radiologist or pathologist understand their meaning. 
     As illustrated in  FIGS. 16 and 17 , the identifier portion  345  attaches to the extension portion  340  using a ball-and-socket joint  365 . In the illustrated construction, a socket  370  is formed in the identifier portion  345  and a ball  375  is formed at the end of the extension portion  340 . The ball  375  fits within the socket  370  and allows movement of the identifier portion  345  with respect to the extension portion  340  and the remainder of the clip  330 . 
     Thus, the clip  330  of  FIGS. 15-17  includes an identifier portion  345  that is articulatable with respect to the remainder of the clip  330  to which it is attached. In one construction, the identifier portion  345  is articulatable with respect to the extension portion  340 . In another construction, the extension portion  340  is articulatable with respect to the remainder of the clip  330  and the identifier portion  345  is fixed with respect to the extension portion  340 . In this construction, the ball-and-socket joint  365 , or other joint is formed between the arm  255  and the extension portion  340  similar to the one illustrated in  FIG. 12 . In still other constructions, both the extension portion  340  and the identifier portion  345  are articulatable with respect to the remainder of the clip  330 . These constructions would employ two joints. As one of ordinary skill in the art will recognize, each of these examples describe an arrangement in which the identifier portion  345  is articulatable with respect to the remainder of the clip  330  to allow an X-ray technician to position the identifier portion  345  for optimum viewing in an X-ray image. 
     One of ordinary skill in the art will realize that many different indicators  285  can be employed so long as they are easily identifiable from any angle on an X-ray image. In addition, while only three clips  230 ,  330  are required to define an orientation, any number of clips  230 ,  330  can be employed (e.g., six clips). In addition, a single clip can be employed if desired to identify an area of interest rather than a tissue orientation. 
     As illustrated in  FIG. 13 , a width  295  of the clip  230  is small enough to allow the tissue sample  15  and the clip  230  to be compressed during the X-ray process without affecting the connection of the clip  230  and without the clips  230  interfering with the process. 
     In preferred constructions, the actuator portion  240  and the jaw portion  235  are integrally-formed as a single component. For example, in one construction, the actuator portion  240  and the jaw portion  235  are injection molded as a single part in one manufacturing step. By integrally-molding the actuator portion  240  and the jaw portion  235 , the overall cost of the clip  230  is reduced. 
     In more preferred constructions, the actuator portion  240 , the jaw portion  235 , and the tail  245  or a portion of the tail  245  are integrally-formed as a single component. In these constructions the actuator portion  240 , the jaw portion  235 , and the tail  245  can be made from one material in a single injection molding step. Alternatively, two different materials could be used with the actuator portion  240  and the jaw portion  235  being made from a material that is translucent in the X-ray region of the electromagnetic spectrum, and the tail  245  being made from a more opaque material. In these constructions, a co-molding or two step injection molding process may be employed. 
     With reference again to  FIGS. 11 ,  14 , and  15 , the use of the clip  230  will be described. Once the tissue sample  15  is removed from the patient, one or more of the surfaces is marked using an ink-based marker as previously described. The actuator portion  240  of the first clip  230   a  is grasped and compressed to move the clip  230   a  into the actuated position as shown in  FIG. 14 . It should be noted that  FIG. 14  illustrates an Alice Clamp  300  holding the clip  230   a  in the actuated position. However, the clip  230   a  can also be actuated using other surgical instruments (e.g., clamps, forceps, etc.) or a user&#39;s fingers. Once in the actuated position, the points  280  of the teeth  270 ,  275  are positioned adjacent the surface of the tissue sample  15  to be marked and the actuator portion  240  is released. Once released, the teeth  270 ,  275  move to their non-actuated positions and the points  280  engage the tissue sample  15 . These steps are repeated for each additional clip  230   b ,  230   c  that is attached to the tissue sample  15 . Generally, three clips  230   a ,  230   b ,  230   c  are required to identify the orientation of the sample  15 . However more or fewer clips  230  can be employed if desired. Furthermore, the three clips  230   a ,  230   b ,  230   c  may be attached to the same surfaces that were marked with ink, or different surfaces if desired. 
     When using the clips  330  of  FIGS. 15-17 , once the clips  330  are attached, an X-ray technician or other user is able to articulate the identifier portions  345  of the various clips  330  to provide optimum viewing in any X-ray images. Thus, the X-ray technician is able to reorient the tissue sample  15  as desired without worrying about losing the orientation and with the knowledge that the identifier portions  345  can be reoriented as required to provide the optimum view of the indicia  360  in any X-ray images. 
     In one construction, the clips  230   a ,  230   b ,  230   c  are provided with the ink system and are color coded to match the ink colors  50 ,  55 ,  60 . Thus, the tissue sample  15  is marked with ink  50 ,  55 ,  60  and the clips  230   a ,  230   b ,  230   c  are then attached to the surface of the tissue sample  15  corresponding to their particular color. 
     Once the tissue sample  15  is marked with both ink and the clips  230 , both X-ray and visual inspection can be performed without confusing the orientation of the tissue sample  15 . 
     Thus, the invention provides, among other things, a new and useful marking system for use in marking the orientation of a tissue sample  15 . The constructions of the clip  230  and the methods of using the clip  230  described above and illustrated in the figures are presented by way of example only and are not intended as a limitation upon the concepts and principles of the invention. 
     Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.