Abstract:
A tissue marking system is configured to mark a tissue sample. The tissue marking system 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 from the actuated position to the non-actuated position. 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.

Description:
RELATED APPLICATION DATA 
     This application claims benefit under 35 U.S.C. Section 119(e) of U.S. Provisional Application No. 60/800,714, filed May 16, 2006, which is fully incorporated herein by reference. 
    
    
     BACKGROUND 
     The present invention relates to a tissue marking system that is visible during radiographic examination. 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. Should a margin be 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 
     In one construction, the invention provides a tissue marking system configured to mark a tissue sample. The tissue marking system 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 from the actuated position to the non-actuated position. 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 construction, the invention provides a tissue marking system configured to mark a tissue sample. The tissue marking system includes a first clip having a first jaw portion movable between a closed position and an open position. The first jaw portion is configured to engage the tissue sample when moved from the open position to the closed position. A first radiographic indicator is coupled to the first clip and includes first indicia that is opaque to radiographic examination. A second clip includes a second jaw portion movable between a closed position and an open position. The second jaw portion is configured to engage the tissue sample when moved from the open position to the closed position. A second radiographic indicator is coupled to the second clip and includes second indicia that is opaque to radiographic examination. The second indicia is different from the first indicia. 
     In yet another construction, the invention provides a method of marking the orientation of a tissue sample. The method includes actuating a first clip to move a first jaw portion from a closed position to an open position and positioning the first clip adjacent a first surface to be marked, the first clip including first indicia. The method also includes releasing the first clip to allow the first jaw to move from the open position to the closed position to engage the tissue sample, actuating a second clip to move a second jaw portion from a closed position to an open position, and positioning the second clip adjacent a second surface to be marked, the second clip including second indicia different from the first indica. The method further includes releasing the second clip to allow the second jaw to move from the open position to the closed position to engage the tissue sample. 
     Thus, the invention provides a system for use in marking the orientation of a tissue sample. The invention includes clips that are attachable to a tissue sample and that are at least partially opaque in the X-ray region of the electromagnetic spectrum. The clips include teeth that engage the tissue sample and remain engaged during the X-ray process. 
     The invention also provides a method of marking the orientation of a tissue sample for radiographic examination. The method includes attaching clips that are at least partially opaque in the X-ray region of the electromagnetic spectrum to the tissue sample at three different points. In some constructions, the surfaces of the tissue sample to which the clips are attached are also marked, such as with ink, for visual examination. 
     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 perspective view of a tissue sample after being removed from a patient; 
         FIG. 2  is a front perspective view of a clip that is attachable to the tissue sample of  FIG. 1 ; 
         FIG. 3  is top perspective view of the clip of  FIG. 2 ; 
         FIG. 4  is a front perspective view of the clip of  FIG. 2  in an actuated position; 
         FIG. 5  is a front perspective view of another clip in a non-actuated position; 
         FIG. 6  is an exploded front view of a portion of the clip of  FIG. 5 ; and 
         FIG. 7  is a section view of a portion of the clip of  FIG. 5  taken along line  7 - 7  of  FIG. 5 . 
     
    
    
     Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement 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. 
     DETAILED DESCRIPTION 
     With reference to  FIG. 1 , an example of a potential tissue sample  10  is illustrated. A substantially cubical sample  10  is illustrated for the sake of discussion. However, one of ordinary skill in the art will realize that the shape of a tissue sample is generally not cubical but rather is irregular and may more typically resemble an irregular sphere. The invention described herein is applicable to many tissue samples  10  in which orientation is important. For example, breast cancer requires that a tissue sample  10  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 requires 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. 
     As discussed, many different systems are available for marking the tissue sample  10  for visual examination (e.g., different color sutures, different length sutures, different quantity of sutures, etc.). In a preferred construction, the tissue sample  10  is marked using an ink system. The ink system has several advantages over the other systems discussed herein. For example, an ink system allows for an entire plane to be identified rather than just a point. In addition, the ink systems are generally much faster than the prior methods discussed. Furthermore, the ink systems do not present the risk of punctures that may be present with the suture systems. One suitable ink system is described in U.S. patent application Ser. No. 10/978,948, filed Nov. 1, 2004, and fully incorporated herein by reference. 
       FIG. 1  illustrates the tissue sample  10  after removal from a patient and after being marked with three different color inks  15 ,  20 ,  25 . Each color ink  15 ,  20 ,  25  is represented by a different cross hatch pattern. While any three planes or surfaces of the tissue sample  10  can be used to identify the orientation of the sample  10 , it is preferred that three substantially orthogonal surfaces, or an area of concern be identified. 
     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. 
     Once the tissue sample  10  is marked as just described, a visual inspection can be made with the orientation being easily identifiable. However, none of the marking systems discussed herein will appear in an X-ray. As such, a different marking system is required to allow for the use of radiological examinations that can identify orientation in the captured images. 
       FIGS. 2 and 3  illustrate one construction of a clip  30  that directly engages a tissue sample  10  to identify the orientation of the tissue sample  10  in an X-ray. In preferred constructions, most or all the clip  30  is transparent or translucent in the X-ray region of the electromagnetic spectrum. This allows an X-ray to be taken through the clips  30  such that they do not interfere with the image. The clip  30  includes a jaw portion  35 , an actuator portion  40 , and a tail  45 . The actuator portion  40  is substantially V-shaped and includes an apex  50  and two arms  55  that connect with one another at the apex  50 . In the illustrated construction, the two arms  55  cooperate to define an angle  60  of about 45 degrees with other angles  60  also being possible. 
     In some constructions, the arms  55  include a knob  65  positioned at the end of the arm  55  opposite the apex  50 . The knobs  65  make it easier to grasp and actuate the actuator portion  40  without the clip  30  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  55  to reduce the likelihood of slippage during actuation. 
     The jaw portion  35  includes two teeth  70 ,  75  with each tooth  70 ,  75  extending from one of the arms  55  of the actuator portion  40 . Each tooth  70 ,  75  is substantially curved and terminates at a point  80 . The curve of each of the teeth  70 ,  75  is such that the two points  80  are pointing substantially toward one another when the clip  30  is in the non-actuated position. 
     One of the teeth  70  is slightly longer than the other tooth  75  such that the teeth  70 ,  75  cooperate to produce a slight overbite  82 . The overbite  82  improves the grip of the teeth  70 ,  75  in the tissue sample  10 , thereby making it less likely that the clip  30  would be accidentally removed from the sample  10 . 
     In some constructions, barbs or other tissue-engaging members could be formed as part of the teeth  70 ,  75  to further enhance their grip on the tissue sample  10  to which they are attached. In addition, more than two teeth  70 ,  75  or teeth  70 ,  75  having more than one point  80  could also be employed if desired. 
     Each tooth  70 ,  75  defines a tooth surface area at the tooth tip. The surface area is related to the biasing force produced by the clip  30 . 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  70 ,  75  attaches to one of the arms  55  of the actuator portion  40  approximately one-third of the length back from the apex  50 . The attachment point of the teeth  70 ,  75  to the arms  55  determines how far open, or apart the points  80  will spread when the clip  30  is in the actuated position. Thus, other constructions could position the teeth  70 ,  75  further away from the apex  50  and/or could increase the angle  60  defined by the arms  55  to increase the opening between the points  80 . Likewise, the opposite arrangement could be employed to reduce the opening if desired. 
     The tail  45  extends from one of the arms  55  of the actuator portion  40  and includes an indicator  85  that is opaque in an X-ray region of the electromagnetic spectrum. In the illustrated construction, the indicator  85  includes a number of balls  90  formed as part of the tail  45 . The balls  90  are substantially opaque in the X-ray region of the electromagnetic spectrum. As such, the balls  90  appear white on an X-ray. In this construction, the number of balls  90  on the tail  45  indicates orientation. For example, as illustrated in  FIG. 1 , one surface of the sample  10  may have a clip  30   a  attached with one ball  90  on the tail  45 . The second surface would then include a clip  30   b  with two balls  90 , and the third surface would include a clip  30   c  with three balls  90 . Because the clips  30   a ,  30   b ,  30   c  and the tails  45  travel with the sample  10 , multiple X-rays at multiple angles can be taken without losing the ability to determine the orientation of the tissue sample  10 . 
     While clips  30  with tails  45  having one, two, or three balls  90  can be provided, one construction employs tails  45  with only three balls  90 . The user then breaks off one ball  90  or two balls  90  to define the different indicators  85 . Furthermore, while the tail  45  is shown and described as being attached to one of the arms  55 , it could be attached to nearly any portion of the actuator portion  40  or the jaw portion  35  if desired. 
     In other constructions, other indicators  85  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. 5  illustrates yet another construction of a clip  130  that is suitable for use in identifying the orientation of a tissue sample. The clip  130  is similar to the clips  30   a ,  30   b ,  30   c  of  FIGS. 1-4  with the exception of a tail  135 . The tail  135  includes an extension portion  140  that connects to one of the arms  55  or some other portion of the clip  130 , and an identifier portion  145  that is attached to the extension portion  140 . 
     In the illustrated construction, the extension portion  140  is fixedly attached to the arm  55 . In preferred constructions, the extension portion  140  is integrally-formed as part of the arm  55  or clip  130 . As illustrated in  FIG. 6 , the identifier portion  145  includes a substantially plate-shaped member  150 . The plate-shaped member  150  defines two relatively large planar surfaces  155  that facilitate the placement of indicia  160  that aids in identifying the orientation of the sample  10  to which the clip  130  is attached. For example, an “L” is placed on one of the planar surfaces  155  to indicate a lateral position. The “L” (Lateral) can be placed on the planar surface  155  using a metallic paint or other system that is visible in an X-ray image. 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. 6 and 7 , the identifier portion  145  attaches to the extension portion  140  using a ball-and-socket joint  165 . In the illustrated construction, a socket  170  is formed in the identifier portion  145  and a ball  175  is formed at the end of the extension portion  140 . The ball  175  fits within the socket  170  and allows movement of the identifier portion  145  with respect to the extension portion  140  and the remainder of the clip  130 . 
     Thus, the clip  130  of  FIGS. 5-7  includes an identifier portion  145  that is articulatable with respect to the remainder of the clip  130  to which it is attached. In one construction, the identifier portion  145  is articulatable with respect to the extension portion  140 . In another construction, the extension portion  140  is articulatable with respect to the remainder of the clip  130  and the identifier portion  145  is fixed with respect to the extension portion  140 . In this construction, the ball-and-socket joint  165 , or other joint is formed between the arm  55  and the extension portion  140  similar to the one illustrated in  FIG. 2 . In still other constructions, both the extension portion  140  and the identifier portion  145  are articulatable with respect to the remainder of the clip  130 . 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  145  is articulatable with respect to the remainder of the clip  130  to allow an X-ray technician to position the identifier portion  145  for optimum viewing in an X-ray image. 
     One of ordinary skill in the art will realize that many different indicators  85  can be employed so long as they are easily identifiable from any angle on an X-ray image. In addition, while only three clips  30 ,  130  are required to define an orientation, any number of clips  30 ,  130  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. 3 , a width  95  of the clip  30  is small enough to allow the tissue sample  10  and the clip  30  to be compressed during the X-ray process without affecting the connection of the clip  30  and without the clips  30  interfering with the process. 
     In preferred constructions, the actuator portion  40  and the jaw portion  35  are integrally-formed as a single component. For example, in one construction, the actuator portion  40  and the jaw portion  35  are injection molded as a single part in one manufacturing step. By integrally-molding the actuator portion  40  and the jaw portion  35 , the overall cost of the clip  30  is reduced. 
     In more preferred constructions, the actuator portion  40 , the jaw portion  35 , and the tail  45  or a portion of the tail  45  are integrally-formed as a single component. In these constructions the actuator portion  40 , the jaw portion  35 , and the tail  45  can be made from one material in a single injection molding step. Alternatively, two different materials could be used with the actuator portion  40  and the jaw portion  35  being made from a material that is translucent in the X-ray region of the electromagnetic spectrum, and the tail  45  being made from a more opaque material. In these constructions, a co-molding or two step injection molding process may be employed. 
     With reference to  FIGS. 1 ,  4 , and  5 , the use of the clip  30  will be described. Once the tissue sample  10  is removed from the patient, the surfaces to be marked are identified. The actuator portion  40  of the first clip  30   a  is grasped and compressed to move the clip  30   a  into the actuated position as shown in  FIG. 4 . It should be noted that  FIG. 4  illustrates an Alice Clamp  100  holding the clip  30   a  in the actuated position. However, the clip  30   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  80  of the teeth  70 ,  75  are positioned adjacent the surface of the tissue sample  10  to be marked and the actuator portion  40  is released. Once released, the teeth  70 ,  75  move to their non-actuated positions and the points  80  engage the tissue sample  10 . These steps are repeated for each additional clip  30   b ,  30   c  that is attached to the tissue sample  10 . Generally, three clips  30   a ,  30   b ,  30   c  are required to identify the orientation of the sample  10 . However more or fewer clips  30  can be employed if desired. 
     When using the clips  130  of  FIGS. 5-7 , once the clips  130  are attached, an X-ray technician or other user is able to articulate the identifier portions  145  of the various clips  130  to provide optimum viewing in any X-ray images. Thus, the X-ray technician is able to reorient the tissue sample  10  as desired without worrying about losing the orientation and with the knowledge that the identifier portions  145  can be reoriented as required to provide the optimum view of the indicia  160  in any X-ray images. 
     While the clips  30  can be used as just described to mark the orientation of the tissue sample  10 , in a more preferred use, the clips  30  are used in conjunction with an ink marking system. In this use, the three surfaces to be marked are first marked with ink  15 ,  20 ,  25 . Clips  30   a ,  30   b ,  30   c  are then placed in the same three surfaces, or different surfaces if desired, to further mark the orientation of the tissue sample  10 . 
     In one construction, the clips  30   a ,  30   b ,  30   c  are provided with the ink system and are color coded to match the ink colors  15 ,  20 ,  25 . Thus, the tissue sample  10  is marked with ink  15 ,  20 ,  25  and the clips  30   a ,  30   b ,  30   c  are then attached to the surface of the tissue sample  10  corresponding to their particular color. 
     Once the tissue sample  10  is marked with both ink and the clips  30 , both X-ray and visual inspection can be performed without confusing the orientation of the tissue sample  10 . 
     Thus, the invention provides, among other things, a new and useful marking system for use in marking the orientation of a tissue sample  10 . The constructions of the clip  30  and the methods of using the clip  30  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.