Abstract:
A surgical site marking system for marking, correlating, and verifying that the surgical site which is to undergo the surgical procedure has been identified as the correct surgical site. The system utilizes labels and a series of checks to associate the patient with the correct surgery and appropriate surgical site.

Description:
BACKGROUND  
         [0001]    The present invention relates to a surgical site marking system and more particularly to a system for minimizing wrong-site surgical procedures.  
           [0002]    Statistics show that medical errors are the eighth leading cause of death in the United States, accounting for 44,000 to 98,000 deaths each year. The measurable costs associated with medical errors are estimated to cost Americans nearly $37.6 billion per year. Non-measurable costs include loss of trust in the medical profession; diminished patient satisfaction; physical and psychological discomfort to the patient and the patient&#39;s family; and lower morale and increased frustration on the part of medical professionals themselves. Of these costs, nearly $17 billion per year are believed to be preventable. Prevention of these errors would naturally yield a commensurate positive impact on the non-measurable costs as well.  
           [0003]    Some of these errors are attributable to communication breakdown; documentation errors; x-rays that are mislabeled, misread, and/or positioned incorrectly; chart errors; fatigue; impaired memory; pressure; and a lack of surgical site verification. The lack of surgical site verification often results in the occurrence of surgery being performed in incorrect locations. Moreover, it has been found that there is a statistically higher risk of incorrect or wrong-site surgery being performed in bilateral surgeries such as orthopedic surgery and the like.  
           [0004]    To alleviate these problems it is desirable that a variety of approaches be considered. In addition, the goal is to combine these approaches with a coherent strategy and a devotion to error prevention on the part of the surgical team and hospital staff. Any system considered should be simple, easy to follow, capable of being standardized, and applicable to all surgical patient specialties.  
           [0005]    Providing a simple system that helps minimize the occurrence of wrong-site surgical procedures is an approach that would be expected to go a long way toward meeting these goals.  
         SUMMARY OF THE INVENTION  
         [0006]    As such, one aspect of the present invention discloses a surgical site marking system including an incise material having an adhesive layer on one side for adhesion to a surgical site. The incise material is suitable for performing a surgical procedure therethrough by applying the incise material to the surgical site and performing the surgical procedure directly through the incise material itself. The incise material may be formed from a film, a mesh, or a combination of the two. The incise material also has an area adapted to receive data thereon. The data may be in the form of writing, an ink transfer, a decal, and/or a electronically scannable component, for instance, a bar code or computer chip.  
           [0007]    Another aspect of the present invention is a surgical site marking system for use in a surgical procedure which contains an incise material which is adapted to be applied to a surgical site through which a surgical procedure is to be performed. The incise material may contain a film having an adhesive layer on one side and a removable material on the side opposite the adhesive layer. The adhesive layer may be provided with a releasable backing covering the adhesive layer until the incise material is readied for use. An area adapted for the recordal of data pertaining to the surgical procedure is also provided and may be placed on the removable material. The removable material enables the film portion, at the surgical teams discretion, to remain sterile until the surgical procedure is performed.  
           [0008]    In another aspect, the present invention is a surgical site marking system for use in a surgical procedure having a surgical drape with at least one fenestration and an adhesive backed layer of incise material keyed to the fenestration. The surgical procedure is to be performed through the incise material and fenestration.  
           [0009]    Yet another aspect of the present invention provides for a method for identifying and verifying a surgical site on a patient prior to surgical incision. The method provides for labeling the surgical site with data pertaining to the surgical procedure to be performed and obtaining patient and surgical team verification that the correct surgical site through which the surgical procedure is to be performed has been labeled. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0010]    [0010]FIG. 1 illustrates the present invention in use on a patient&#39;s leg;  
         [0011]    [0011]FIG. 2 illustrates an incise material in accordance with the present invention;  
         [0012]    [0012]FIG. 3 illustrates another embodiment of an incise material in accordance with the present invention;  
         [0013]    [0013]FIG. 4 illustrates still another embodiment of an incise material in accordance with the present invention; and  
         [0014]    [0014]FIG. 5 illustrates use of an incise material in combination with a drape. 
     
    
     DESCRIPTION OF THE INVENTION  
       [0015]    The present invention relates to a surgical site marking system for use in a surgical procedure. Proper use of the marking system enables one to accurately identify and verify the proper location of a surgical site prior to any incision. One embodiment of such a surgical site marking system according to the present invention is depicted in FIG. 1. FIG. 1 depicts an incise material  10  for placement on a patient surgical site  12 . The incise material  10  may be formed of a sterilizable mesh, a membrane which may or may not be clear, an anti-microbial membrane, in addition to or in combination with other structures that allow a surgical procedure to be performed therethrough.  
         [0016]    For example, as shown in the FIG. 2. embodiment, the incise material  10  may comprise a low-density polyethylene film  14  with an adhesive layer  16  on one side of the incise material  10  for adhesion to a surgical site. The film  14 , may be clear, anti-microbial, and/or incorporate mesh. The adhesive layer  16  may be covered with a releasable backing  18 . Such an incise material is available from Bertek Inc., St. Albans, Vt. 05478, or from Medical Concepts Development, Inc., St. Paul, N. Mex. 55125.  
         [0017]    The releasable backing  18  may be formed of any of a wide variety of materials which are commonly available. For example, wax- or silicone-coated papers may be placed over the adhesive layer  16  of the incise material  10  which are removed when the incise material  10  is placed onto the patient surgical site  12 .  
         [0018]    One possible alternative may be to provide the releasable backing  18  in the form of segmented and/or separate sections such as sections  20  and  22 , as shown in FIG. 3. This embodiment may serve to facilitate application of the incise material  10  to the patient surgical site  12  or to make the releasable back sections  20 ,  22  easier to remove from the incise material  10 .  
         [0019]    Still looking to FIG. 3, it is shown that the film  14  side of the incise material  10  may contain a region or area  24  adapted to receive data thereon. The area  24  is adapted to receive data pertaining to the surgical procedure to be performed. Such data may include a surgeon&#39;s signature, the signature of the patient undergoing the procedure, and/or signatures of other members of the surgical team.  
         [0020]    The area  24  may be adapted to receive the signatures and/or other data directly. Alternatively, still looking to FIG. 3 as shown, the area  24  may comprise a material or surface treatment disparate from the remainder of the film  14  so as to better adapt the area  24  to receive written data directly.  
         [0021]    Now, looking back to FIG. 2, another possible embodiment envisions placing the signatures and/or other data on a label or decal  26  that in turn is affixed to the incise material  10 , potentially in area  24 . As such, the film layer  14  may comprise the area  24  (as seen on FIG. 3) which in turn may have a material or surface treatment disparate from the remainder of the film  14  so as to better adapt the area to receive the decal  26 .  
         [0022]    Additional data useful to identify the surgical procedure, the patient, and to verify the proper location of the surgery may also be provided on the incise material  10 . This information could be located on the film  14 , on area  24 , on the decal  26 , or on any combination of these. Possible useful data may include reference to the surgical procedure; may provide indicia for locating the incise material on the surgical site and/or provide indicia for locating surgical incisions; may refer to an appropriate surgical drape suitable for the procedure; corresponding custom procedure tray number; and/or drape pack number suitable for use with the procedure. Check boxes may be utilized as appropriate to allow designation of certain alternatives, such as left or right as shown on FIG. 2. In addition, or alternatively a series of check boxes may serve as a check list of tasks to be performed prior to performance of the surgical procedure.  
         [0023]    Another possible embodiment (not shown) may provide for the application of an ink transfer pattern that may be transferred directly to the incise material  10 , to the surgical site  12  itself, or to both. These ink transfer patterns may be utilized to contain some or all of the data discussed above.  
         [0024]    Moreover, the marking system of the present invention may furnish the incise material  10  in sterile packaging. In some embodiments, the surgical site marking system may include a pen or other marking instrument (not shown). The pen may be sterile, but nevertheless would be suitable for marking on the incise material  10  or decal  26 .  
         [0025]    Another embodiment, shown in FIG. 4, depicts an additional layer or layers of material  28  which may be provided on the film  14  side of the incise material  10 . This material  28  may cover all or a portion of the film  14 . The material  28  may serve in its entirety or in part as the area where all data is entered. At some point prior to the actual surgical procedure, material  28  could be removed from the incise material  10 , thereby exposing the film  14 . This embodiment would preserve the sterility of the incise material  10 , especially the surface of the film  14  until the surgical procedure.  
         [0026]    In addition to, or in lieu of, area  24 , decal  26 , or material  28 , other embodiments envision the use of electronically scannable components such as a computer readable code  30 , a computer chip  32 , and/or both as depicted on FIG. 4. In the case of computer readable or scannable components such as the UPC-, or bar-type computer readable code  30 , and/or computer chip  32 , scanning devices (not shown) are well-known that can read data from such components. Such a scanning device may be in the configuration of the pen already referred to above.  
         [0027]    A number of possibilities exist for which this system may be appropriately utilized. In one manner, at least one member of the surgical team, for example the surgeon, consults with the patient being prepared for the surgery. The surgical team member confirms the location, for instance surgical site  12  in FIG. 1, of the surgery with the patient. At this point, the incise material  10  may be placed on the surgical site  12 .  
         [0028]    The patient, surgical team member, or both, would place their signatures or other confirmatory acknowledgement on the area  24  of the incise material  10  or the decal  26  which is subsequently adhered to the incise material  10  prior to or after placement of the incise material  10  on the surgical site  12 . The surgery may take place under its normal course, providing the surgical team with a higher degree of assurance that the actual surgical site  12  has been verified.  
         [0029]    In the event the incise material  10  includes material  28 , similar acknowledgement and/or signature may be made in the appropriate locations. At some point just prior to the surgical procedure, the material  28  may be removed thus exposing the film  16  which would to that point remain in a sterile condition.  
         [0030]    In the event that the patient is a minor or is otherwise incapacitated, verification and confirmation may be had with the patient&#39;s guardian or appointed representative. Alternatively, the system may be utilized unbeknownst to the patient. That is, verification and confirmation may be performed by and between the surgical team and hospital staff in the manner similar to that described above.  
         [0031]    Of course, the system described is easily adaptable for use with electronic scanning technology. In addition to, or in lieu of handwritten confirmation, the use of bar code scanners and/or computer chip readers may serve to even more accurately correlate the patient&#39;s data to the surgical procedure to be performed.  
         [0032]    In another embodiment, as depicted in FIG. 5, the incise material may be packaged or otherwise designated to be used in conjunction with a specific surgical drape or drapes. In FIG. 5, the incise material  10  is shown in use with a surgical drape  34 . The surgical drape  34  may contain at least one fenestration  36  associated with the incise material  10 , however, additional fenestrations  36  may be provided in the drape  34  for possible use with additional incise materials  10 . The incise material  10  may be manufactured and sold as a separate unit for use with a specific drape or drapes, or it may be sold as a part of a surgical pack including the drape  34 .  
         [0033]    By way of example, a surgical procedure may require more than one incision, such as in a heart bypass operation in which a patient&#39;s leg and chest are operated on. As stated above, specific incise materials  10  may be provided for use with each fenestration  36  in the drape  34 . Alternatively, for bilateral-type surgeries such as arthroscopic knee surgery, a single drape  34  may be provided for simultaneously covering both knees. On these drapes, fenestrations  36  may be provided at each knee. Locating the incise material  10  at the correct surgical site  12  as described above will align the incise material  10  with the correct fenestration  36  through which the surgical procedure is to be performed.  
         [0034]    In either case, as seen in FIG. 5, the incise material  10  may be keyed to the appropriate fenestration  36  in the drape  34 . Keying the incise material  10  to the fenestration  36  may be accomplished in a variety of ways. Some examples include: the use of arrows or other registration indicia  38  to align the incise material  10  with the fenestration  36 ; matching the shape of the fenestration  36  with the shape of the incise material  10 , aligning a border  40  on the incise material  10  with the fenestration  36 ; coding the incise material  10  to a particular fenestration  36  or drape  34 ; etc. Combining different aspects of these examples is also contemplated.  
         [0035]    For example, FIG. 5 depicts both the use of registration indicia  38  markings placed upon the drape  34  at the fenestration  36  as well as the use of the border  40  on the incise material  10  aligning with the fenestration  36 . It should be apparent that registration indicia  38  may also be placed on the incise material  10  to align with registration indicia  38  on the drape  34 . In some embodiments, a perimeter  42 , shown in phantom in FIG. 5, such as the outside perimeter of the incise material  10  may be matched to an appropriately sized fenestration  36 .  
         [0036]    Of course other means and manners of associating an incise material  10  with a fenestration  36  are envisioned and would be apparent to one skilled in the art. Coding of the incise material  10  to the fenestration  36  may also be readily adapted and accomplished through the use of data, either preprinted or electronically scannable such as through the use of the computer readable code  30  and/or computer chip  32 . As such, the above enumerated list serves as an example of only a few such possibilities.  
         [0037]    Use of the incise material  10  with a drape  34  initially is similar to use of the incise material  10  alone as described above. That is, data is associated between the patient, the surgical site and/or procedure, and surgical team and reflected via the data placed upon the incise material  10 . The incise material  10  is applied to the surgical site  12  and verified by the patient, representative of the patient, and/or surgical team member per the above description.  
         [0038]    In some embodiments, at this point, the drape  34  is placed in position over the patient. The fenestration  36  in the drape  34  is properly aligned with the incise material  10  as shown in FIG. 5. The result should be that the drape  34  is appropriately draped over the surgical site  12  with the incise material  10  located at the correct surgical site  12 . In the event that the incise material  10  and the fenestration  36  do not align appropriately, this should signal to the surgical team prior to the procedure to once again verify that the correct surgical site  12  was labeled and that the correct drape  36  was being utilized for the procedure. Of course the patient may be draped with the drape  34  and the incise material  10  may subsequently be placed upon the patient.  
         [0039]    In the event, that a bilateral surgery is to be performed, as depicted in FIG. 5, the drape  34  may be provided with a mirrored fenestration  36  at each surgical site, for instance, a matching fenestration  36  for each knee in a arthroscopic knee surgery drape. In this case, proper surgical site labeling and verification by use of the incise material  10  would result in one of the two fenestrations  36  aligning with the incise material  10  placed on the surgical site  12 . The incise material  10  visibly present at the fenestration  36 , and the existence of properly completed data on the incise material  10  provides validation to the surgical team that the surgical site  12 , the incise material  10 , and the drape  34  have been correlated.  
         [0040]    In other embodiments, not depicted, the incise material  10  may be eliminated altogether and the surgical site  12  may be labeled by applying a visible pattern to the surgical site  12 . The visible pattern may comprise an ink pattern transferred to the surgical site  12 . Such an ink pattern may contain any portion or all of the data enumerated above and may also be endorsed as described.  
         [0041]    Whether the invention includes a specific drape, a general drape, or no drape at all, means for labeling the surgical site  12  with data should help minimize the occurrence of wrong-site surgery. Such means for labeling may include: incise materials; labels, decals, mesh, membranes, films, patches, tattoos, inked patterns, ultraviolet patterns, projected images, electronically scannable components; and similar marking systems  
         [0042]    The various embodiments described above are intended to describe possible aspects of the same invention. The elements described in each individual example are intended to be capable of substitution in whole or in part in any of the other examples. For example, the decal  26  may also be used with the material  28 ; the scannable code  30  and/or chip  32  could be in the form of the decal  26 ; the use of a drape  34  with an incise material  10  or the use of the incise material  10  alone may be utilized with any form of data, decal  26 , and/or material  28 ; etc.  
         [0043]    Furthermore, as used herein and in the claims, the term “comprising” is inclusive or open-ended and does not exclude additional unrecited elements, compositional components, or method steps. Additionally, as used herein and in the claims, the terms “a patient” or “the patient” refer to the particular patient undergoing the surgical procedure. Likewise the terms “a surgical team” or “the surgical team” refer to the specific surgical team performing the surgical procedure.  
         [0044]    The invention may be embodied in other specific or equivalent forms without departing from the scope and spirit of the inventive characteristics thereof. The present embodiments therefore are to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.