Abstract:
The first and second portion may comprise a first and second sticker where the first and second sticker includes a dermal adhesive allowing the sticker to be securely fastened to the skin of the patient. Further, the first and second portion may include a symbol identifying the location of the procedure, the type of procedure or a serial number associating the first and second portion.

Description:
BACKGROUND 
   1. Field of the Invention 
   The present invention generally relates to an indicator for identifying the location of a surgical procedure on a patient. 
   2. Description of Related Art 
   Prior to performing a medical surgical procedure on a patient, the patient is prepared for the procedure. Often a nurse will review the medical records of the patient and identify the procedure to be performed. Generally a few hours before the procedure, a nurse will draw an “X” on the patient where the procedure is to be performed. The “X” or mark is drawn on the skin of the patient with an indelible ink. Since it is drawn by hand, the marks are not consistent between patients or procedures due to the changes in hospital staff. The patient is not involved in marking the location and often the surgeon is not present. Further, the location of the mark and any verification signatures are generally not entered into the patient&#39;s records. Lack of structure in this procedure and misinterpretation of the handwritten markings may lead to a misidentification of the procedure location. Further, additional verification would increase the viability and consistency of the identification and reduce the risk of misinterpretation. 
   In view of the above, it is apparent that there exists a need for an improved method and device for identifying a procedure location on a patient. 
   SUMMARY 
   In satisfying the above need, as well as overcoming the enumerated drawbacks and other limitations of the related art, the present invention provides an indicator which is applied to the patient for identifying the location of the procedure on a patient. The indicator includes a first portion being indicative of a first location approval, and a second portion being indicative of a second location approval. The first and second portions are configured to attach to the patient and cooperate to provide a visual confirmation of the first and second location approvals. The visual confirmation may be due to an interacting geometry between the first and second portion, or the visual confirmation may be color coded such that the visual confirmation is cooperatively formed by a first color on the first portion and a second color on the second portion. 
   The first and second portions may comprise a first and a second sticker, where the first and second stickers include a dermal adhesive allowing the sticker to be securely fastened to the skin of the patient. Further, the first and second portions may include a symbol identifying the location of the procedure, the type of procedure or a serial number associating the first and second portions. 
   Further, the indicator may be included on a form, where the form has a verification region corresponding to the first portion of the indicator. The first verification region is provided for a patient&#39;s signature. Similarly, the second portion of the indicator corresponds to a second verification region provided for the signature of hospital staff. In addition, the form may include a procedure block for identification of the procedure and a surgeon block for identification of the surgeon. The form may also include an adhesive allowing the signed form to be mounted directly into the medical records of the patient. Holes may also be provided and appropriately spaced allowing the form to be pinned into the file of the patient. 
   Further objects, features and advantages of this invention will become readily apparent to persons skilled in the art after a review of the following description, with reference to the drawings and claims that are appended to and form a part of this specification. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
       FIG. 1  is a plan view of a form including an indicator in accordance with the present invention; 
       FIG. 2  is a plan view of the first portion of the indicator removed from the form and attached to the patient; 
       FIG. 3  is a plan view of the first and second portion of the indicator forming a visual confirmation in accordance with the present invention; 
       FIG. 4  is a plan view of the first, second and third portion of the indicator cooperatively forming a visual confirmation of the procedure location in accordance with the present invention; 
       FIG. 5  is a flow chart of a method for verifying the location of a procedure on a patient in accordance with the present invention; 
       FIG. 6  is a plan view of an embodiment of a two-part indicator in accordance with the present invention; 
       FIG. 7  is a plan view of the two-part indicator forming a visual confirmation in accordance with the present invention; 
       FIG. 8  is a plan view of another embodiment of a two-part indicator wherein the first and second portion have the same geometric shape in accordance with the present invention; 
       FIG. 9  is a plan view of the indicator of  FIG. 8  cooperatively forming a visual confirmation in accordance with the present invention; 
       FIG. 10  is a plan view of another embodiment of an indicator having a square shape and including a symbol on each portion; and 
       FIG. 11  is a plan view of the indicator of  FIG. 10  where the symbol on the first and second portion cooperate to form a visual confirmation in accordance with the present invention. 
   

   DETAILED DESCRIPTION 
   Referring now to  FIG. 1 , a system embodying the principles of the present invention is illustrated therein and designated at  10 . The system  10  includes an indicator  12  for verifying the location of the procedure on a patient. The indicator  12 , as shown, includes a first portion  14 , a second portion  24 , and a third portion  34 . The first, second and third portions  14 ,  24 ,  34  are included as part of a form  15 . The first portion  14  is shown as a sticker having a generally circular geometry. The first portion  14  has an annular region  16  formed about a circular region  18  and located concentrically therewith. In addition, the first portion  14  has a symbol  20  printed on the circular region  18  and configured to be legible prior to the procedure. The symbol  20  may be indicative of a location of the procedure, a type of procedure, a serial number, or any combination thereof. For example, the symbol  20  may include an “R” indicative of the right side of the patient, thereby verifying the location of the procedure. However, the symbol  20  may include any combination of letters, numbers or graphics for any of the purposes previously described herein. 
   A verification block  22  may be located on the form  15  and aligned with the first portion  14 . The verification block  22  may be identified as a patient signature block such that the patient may sign the verification block  22  as he removes the first portion  14  of the indicator  12  from the form  15  and attaches the first portion  14  to the procedure location. The verification block  22  may include other common forms of verification, such as fingerprints or social security numbers. 
   The second portion  24  of the indicator  12  is also shown as a sticker. The second portion  24  includes a semi-annular region  26  corresponding to a portion, such as half, of the annular region  16 . The second portion  24  also includes a symbol  28  that may be indicative of the location of the procedure, the type of procedure, or a serial number relating to the first portion  14 . Preferably, the symbol  28  would be identical to, or cooperate with, the symbol  20  on the first portion  14  of the indicator to create predetermined indicia, also providing a visual confirmation of the procedure location. The second portion  24  is aligned with a verification block  30 . The verification block  30  may be a signature block for the surgeon and may be labeled as such. However, as previously mentioned herein, other common forms of verification may be used. 
   A third portion  34  of the indicator  12  is also attached to the form  15 . The third portion  34  includes a semi-annular region  36  that corresponds to the annular region  16  of the first portion  14 . In addition, the semi-annular region  36  may compliment the semi-annular region  26  of the second portion  24 , such that the semi-annular region  26  and semi-annular region  36  cooperate to form a shape corresponding to the annular region  16  of the first portion  14 . The third portion  34  may also include a symbol  38 . As previously described, the symbol  38  may be indicative of a location, a procedure, a serial number, or any combination thereof. The third portion  34  is aligned with a verification block  32 . The verification block  32  may be a signature block for hospital staff, such as a nurse, and may be identified as such. Although, other commonly used identifiers may be used in verification block  32 , as described previously herein, with relation to verification blocks  22  and  30 . The form  15  may also include a procedure block  40  for indicating the procedure to be performed on the patient. In addition, a surgeon block  42  may also be provided to indicate the surgeon that will perform the procedure identified by the procedure block  40 . 
   As described above, the first, second and third portion  14 ,  24 ,  34  are shown as stickers and therefore may include a dermal adhesive on a backside of the first, second and third portion  14 ,  24 ,  34 . Accordingly, the form  15  may be made of a non-stick paper, such that the indicator  12  may be peeled off of the form  15 . However, the form  15  may also be configured such that the indicator  12  is die cut into the form  15 . As such, the form  15  is attached to a non-stick backing. After the indicator  12  is removed from the form  15 , the rest of the non-stick backing may be removed such that form  15  may be mounted into the medical records of the patient using the adhesive attached to the form  15 . 
   Now referring to  FIG. 2 , the first portion  14  is shown after attachment to the patient. The annular region  16  may include a first color, such as yellow. The circular region  18  may include a second color, such as green. The second portion  24  may be attached to the patient and located within the annular region  16  of the first portion  14 , as shown in  FIG. 3 . Further, the semi-annular region  26  of the second portion  24  may be made of a transparent blue material such that the first color of the annular region  16 , such as yellow, may cooperate with the color of the second portion  24 , such as a transparent blue, to form a green that matches the second color of the circular region  18 . As such, the first and second portions cooperatively form a color coded visual confirmation. Alternatively, the second portion  24  may be made of an opaque material including a color that matches the second color of the circular region  18 . Accordingly, as the second portion  24  is mounted on and covers a portion of the annular region  16 , a continuous colored geometry is cooperatively formed by the second portion  24  and the circular region  18 , thereby providing a visual confirmation of the procedure location. 
   Now referring to  FIG. 4 , a third portion  34  may be mounted on the annular region  16  in a complimentary manner to the semi-annual region  26  of the second portion  24  to fully cover the annular region  16 . Similarly to the second portion  24 , the third portion  34  may also form a color coded or geometric visual confirmation that cooperates with the first and second portion  14 ,  24 . Accordingly, the third portion  34  may be made of a transparent material of a color, such as blue, that when mounted on the annular region  16  of a color, such as yellow, would thereby produce a green color matching the color of the circular region  18  of the first portion  14 . Alternatively, the third portion  34  may be made of an opaque material having a color that matches the second color of the circular region  18 . As such, the first, second and third portions  14 ,  24 ,  34  may all cooperate to form a contiguous region of a common color and may also cooperate to form a common geometry such as a circle thereby providing a three part visual confirmation of the procedure location. Each of the first, second, and third portions  14 ,  24 ,  34  correspond to and are indicative of a location approval. The location approval may include the act of each individual placing the sticker at the procedure site, or more definitively, the location approval may include the location approval of the patient via patient signature in verification block  26 , the location approval of the surgeon via a surgeon signature in verification block  36 , and the location approval of a nurse via a nurse signature in verification block  32 . 
   In addition, it would be readily apparent to one of ordinary skill in the art, that from the embodiment described a two-part verification could be provided such that two stickers or marks could be combined to form a continuous color coded region or to form a common geometric shape thereby providing a visual confirmation in accordance with the present invention. 
   Now referring to  FIG. 5 , a method to provide a visual confirmation of a procedure location in accordance with the present invention is illustrated. In block  50 , a form  50  is provided with a site location indicator  12  attached thereto. A hospital staff member such as a surgeon or nurse indicate the procedure to be performed in a procedure block  40  and the surgeon to perform the procedure in the surgeon block  42  of the form  15 , as indicated by block  52 . In block  54 , the patient attaches the first portion  14  of the indicator  12  on the procedure site. As previously discussed, this may be by peeling a sticker from the form  15  and placing it on the site, or alternatively by providing a stamp or other marking on or near the procedure site. The patient may then sign in the patient verification block as denoted by block  56 . A surgeon may then locate the second portion  24  of the indicator on the procedure site such that the second portion  24  of the indicator  12  cooperates with the first portion  14  of the indicator  12  to produce a visual confirmation of the procedure location, as denoted by block  58 . In block  60 , the surgeon may sign the surgeon verification block on the form  15 . In block  62 , another hospital staff member, such as an operating room nurse, locates the third portion  34  of the indicator  12  on the procedure site, such that the first, second, and third portion  14 ,  24 ,  34  of the indicator  12  cooperate to provide a visual confirmation that all three verifications are present. As previously described, the visual confirmation may take the form of matching symbols, cooperating geometries, coordinating colors, or any combination thereof. 
   In block  64 , the completed form may be placed in a patient&#39;s record either by using holes located in the form to pin the form in the patient records, or by mounting the form in the patient records using adhesive attached to the form. In block  66 , the indicator  13  is found at the site and the visual confirmation is checked prior to performing the procedure, as denoted in block  66 . 
   Now referring to  FIG. 6 , a two-part indicator  70  is illustrated. The first portion  72  of the two-part indicator  70  is similar to the first portion  14  of the indicator  12  described above. The first portion  72  has an annular region  74  including a first color or pattern and a second circular region  76  including a different color or pattern. The second portion  80  has an annular region  82  corresponding to the annular region  74  of the first portion  72 . In addition, the second portion  80  has a circular hole  84  corresponding to the circular region  76  of the first portion  72 . As such, the first portion  72  may be placed at the procedure location on the patient and the second portion  80  is attached to the annular region  74  of the first portion  72  such that the circular region  76  fills the hole  84  of the second portion  80 , as shown in  FIG. 7 . Accordingly, the first portion  72  and the second portion  80  cooperate to form a contiguous circular region of a matching pattern or color thereby providing a visual confirmation to the hospital staff of the procedure site location. 
   Now referring to  FIG. 8 , another two-part indicator  100  is provided. A first portion  102  of the two-part indicator  100  includes a semi-circular region  106  having a first pattern or color and optionally may include a second semi-circular region  104  including a second color or pattern different from the first semi-circular region  106 . The second portion  108  also includes a semi-circular region  110  that is complimentary to the semi-circular region  106  of the first portion  102 . Accordingly, the first portion  102  may be attached to the patient at the procedure site location and the second portion  108  may be placed adjacent to the first portion  102 , such that the semi-circular region  108  and the semi-circular region  110  cooperate to form a circular geometry having a consistent color or pattern. The second portion  108  may be placed on the semi-circular region  104  or alternatively, the first portion may omit the semi-circular region  104  and the second portion  108  may be directly attached to the patient&#39;s skin adjacent to the first portion  102  also forming a circular geometry to provide a visual confirmation of the procedure location. 
   Now referring to  FIG. 10 , another indicator using a symbol as a visual confirmation is provided. The indicator  120  includes a first portion  122  and a second portion  130 . The first portion  122  includes a rectangular region  126  including a symbol  128  shown as an arrow or a half “X”. In addition, a second region  124  may optionally be provided. The second portion  130  includes a rectangular region  132  including a symbol  134  shown as a backward arrow or a second half of an “X”. The first portion  122  may be attached by the patient at the procedure site location. The rectangular region  132  of the second portion  130  may be located adjacent the rectangular region  126  of the first portion  122  and attached to the patient or optionally the rectangular region  124 . As such, the first symbol  128  may be aligned with the second symbol  134  forming a graphic or symbol, shown as an “X” and denoted as reference numeral  136 . Accordingly, the first symbol  128  and the second symbol  134  cooperate to form a visual confirmation  136  of the procedure site location, as shown in  FIG. 11 . In addition, the rectangular region  124  and the rectangular region  132  cooperate to form a square geometry, thereby providing a geometric visual confirmation as well. 
   Clearly, one of ordinary skill in the art can envision other modifications in the form of visual confirmation including other symbols, geometries, and colors that are contemplated within the significant advancement of the art that falls within the scope of the present invention. 
   Further, as a person skilled in the art will also readily appreciate, the above description is meant as an illustration of the principles this invention. This description is not intended to limit the scope or application of this invention in that the invention is susceptible to modification, variation and change, without departing from the spirit of this invention, as defined in the following claims.