Abstract:
The invention is an apparatus comprising a garment that prevents wrong site surgery. The garment comprises a garment portion, a warning, a patient information indicator, and a verification. The warning, patient information indicator and verification can be integral with the garment portion or printed on a separable medium. The method of the present invention comprises steps to prevent wrong site surgery including placing a garment on a non-operative body part, placing a warning on said garment, placing patient information on said garment, and requiring the patient or an authorized individual to verify that the patient is willingly undergoing the surgery. The above pieces of information can be removed from the garment and placed in the patient&#39;s medical record.

Description:
CLAIM OF PRIORITY  
       [0001]     This application claims the benefit of U.S. provisional Application No. 60/545,667 filed Feb. 19, 2004. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The invention is an apparatus and method designed to reduce the likelihood of wrong site surgery. One example of an operation being performed on a wrong body part occurs when, in the instance where there is an identical body part on either side of the body, an operation is performed on the incorrect side. The most obvious example is in the case of surgery that is performed on an extremity (arm or leg).  
       BACKGROUND OF THE INVENTION  
       [0003]     Wrong site surgery (WSS) is defined as: a) the wrong operation performed on a patient, b) an operation performed on the wrong patient or c) an operation performed on the wrong body part. Wrong site surgery is characterized as a preventable medical error and thus great efforts are being made to reduce the incidence of WSS.  
         [0004]     Current methodologies to prevent WSS include the use of indelible markers and adhesive labels to identify appropriate surgical sites. These methodologies have inherent deficiencies and wrong site surgery continues to occur. A zero-tolerance policy for wrong site surgery has been mandated by major agencies and professional organizations that accredit health care providers. Therefore, a need exists for better methods to further reduce the likelihood of wrong site surgery.  
       SUMMARY OF THE INVENTION  
       [0005]     In one embodiment, the apparatus comprises a garment portion. The garment portion can be a sleeve, a partial sleeve or gown that is placed on a patient or worn by a patient during an operation. The garment portion is constructed from any material that would be suitable to come in contact with human tissue and would meet the operating room safety criteria. For example, the garment portion would be preferably made of a hypoallergenic and fire proof material. The sleeve embodiment of the garment is designed to be placed on and cover an entire extremity such as an arm or a leg. The partial sleeve embodiment of the garment is designed to be placed on and cover only a portion of an extremity such as a shoulder, elbow or wrist on the arm or a hip, knee or ankle on the leg.  
         [0006]     In the instance where a surgeon is to perform an operation on a body part of which there are two, one on either side of the body, the garment is placed on the non-operative body part (“the non-operative body part”). An example is surgery to be performed on an extremity such as an arm or a leg. The presence of the garment on the non-operative side will prevent the creation of a sterile surgical field, and thus a wrong site surgery, on that part of the body.  
         [0007]     The garment has several components that serve to collect, record, and convey important information regarding the surgery. A patient information indicator correctly identifies the patient name, surgery to be performed including the correct side, and the operating surgeon. A verification component confirms that the patient was an active participant in placing the garment on the non-operative body part. Said components can comprise data that is recorded on paper or other media suitable for printed information. In another embodiment, this information is recorded on material that has been integrated into the structure of the garment portion. Alternatively, the information may be recorded on paper or other media that is not integral to the garment. In this embodiment, the patient information indicator and the verification is recorded on separate material and then displayed by placing it into an information display means. In one embodiment, this display component is preferably a “pocket” with a transparent face that allows the information to be viewed by all who come into contact with the patient. The display means is placed on a visible area of the garment portion. The patient information indicator and the verification may be recorded on a suitable media, such as paper, that can be removed from the display means and then incorporated into the patient medical record.  
         [0008]     Another feature of the garment communicates a warning, i.e., a message that the body part on which the garment is placed is not a surgical site and that the garment is to be removed only in the case of an emergency. The exact wording of this warning is discretionary and may be determined by medical staff, medical professionals or other personnel performing the surgery. One embodiment would result in the message being printed directly on the material that comprises the garment. Alternatively, the warning can be displayed in a display means as described above.  
         [0009]     In another embodiment, a step of the inventive method is to place the garment on the side of the body on which surgery is not to be performed (“non-operative side”) or the non-operative body part. Patient information is also provided. Such information could preferably include the patient&#39;s name, the surgery to be performed including the correct side of the body, the surgeon who will be performing the operation as well as any additional information that may be necessary for patient safety. As described above, this information is recorded either on material integral to the garment or recorded on material that can be secured to the garment, for example, on paper that is inserted into a display means. Another step in the method is the verification step in which the patient or authorized individual verifies through a process such as a signature or an equivalent, that the patient is an active participant in the placement step and/or the patient identification step. In some embodiments, a witness may be required to verify the placement of the garment as well as the completion of the patient identification and/or verification steps. Preferably, copies of the patient information indicator and verification are made available for the health care provider.  
         [0010]     In this way, the garment portion is visible to those involved with the surgery. The part of the body that is not scheduled for surgery is covered with the garment. As an example, if the operating surgeon mistakenly approaches the wrong body part to begin to prepare for the surgery he/she will encounter the garment. The presence of the garment will prevent the surgeon from preparing the body part for surgery. One of the invention&#39;s features will clearly inform the surgeon of the intent of the garment with a message such as “THIS IS NOT A SURGICAL SITE. REMOVE ONLY IN THE CASE OF AN EMERGENCY.” The surgeon can confirm all the important patient identification information from the area of the garment designed to display said information. An embodiment of the garment and method allows for the surgeon to confirm, by means of a signature or an equivalent, that he/she reviewed the important patient identification information prior to the start of the surgery.  
         [0011]     One embodiment of the method allows for a copy of the patient identification and verification data to be removed from the garment at the end of the case and be incorporated into the patient medical record.  
     
    
     BRIEF DESCRIPTION OF DRAWINGS  
       [0012]      FIG. 1A  shows the full sleeve embodiment on a patient&#39;s left arm.  
         [0013]      FIG. 1B  shows the full sleeve embodiment on a patient&#39;s left arm with openings and cut-outs shown.  
         [0014]      FIG. 1C  shows the partial sleeve embodiments for the shoulder, elbow, and hand/wrist.  
         [0015]      FIG. 2A  shows the full sleeve embodiment on a patient&#39;s left leg.  
         [0016]      FIG. 2B  shows the partial sleeve embodiments on the hip, knee, and foot of a patient.  
         [0017]      FIG. 3A  is a view of the partial sleeve embodiment for the shoulder.  
         [0018]      FIG. 3B  is an alternative view of the partial sleeve embodiment for the shoulder looking into the first opening.  
         [0019]      FIGS. 4A and 4B  show the partial sleeve embodiment for the elbow.  
         [0020]      FIGS. 5A and 5B  show partial sleeve embodiments for the hand/wrist.  
         [0021]      FIGS. 6A and 6B  show the partial sleeve embodiments for the foot.  
         [0022]      FIGS. 7A and 7B  show the display means, which can be incorporated into the embodiments described herein.  
         [0023]      FIG. 7C  shows an embodiment where in the display means is used with the garment. 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0024]      FIG. 1  illustrates an embodiment of the invention wherein the garment  100  is a full sleeve to be used with an arm. As used herein the term “sleeve” will enjoy its ordinary and accustomed meaning. Though not limited by the following definition, “sleeve” can mean an open-ended flat or tubular covering able to be placed over an extremity. Appropriately sized, the sleeve can accommodate any body extremity including an arm, a leg, a hand, a foot, individual or combinations of fingers and toes. The sleeve could be made form-fitting by being comprised of an elastic or stretch material. The skilled artisan will appreciate that the above list is not exhaustive and that the sleeve could be used with any extremity. Note that the garment portion may comprise a wrap, i.e., a flat piece of material that is able to be wrapped around an extremity and secured thereon by means of securing elements at the ends of said piece of material. For example, the wrap could be wrapped around an extremity and secured by securing elements, which are on the ends of the wrap, the male portion of the element on a first end and a first surface of the wrap and a female version of the element on a second end and second surface of the wrap. In the above embodiment, the securing element could be Velcro® or snaps. In another embodiment the securing element could be band-like fabric strips functioning as ties as is commonly used on conventional hospital gowns. Once secured, the wrap would function similar to a sleeve, although a sleeve configuration is the preferable one since it can be slid on and off without the step of securing. The sleeve embodiment is also preferable because it has been found that a sleeve is able to stay on an extremity better than the aforementioned stickers, and better than material that is simply strapped on to or around the extremity.  
         [0025]      FIG. 1  shows the garment  100  on the left arm of a human body. As with all figures herein, the body is shown in phantom. When the garment  100  is used on the arm, it is as a sleeve. The full sleeve embodiment of the garment  100  comprises a garment portion  20 . The garment portion  20  covers the arm  30  from shoulder  40  to hand  50  thus preventing a wrong site surgery. Referring to  FIG. 11B , the arm  30  is inserted into a first opening  16  in the garment portion  20  and the hand  50  exits at a second opening  18  so that the entire extremity is covered. The garment portion  20  comprises a warning  60  that, in the preferred embodiment, informs individuals, including medical staff and professionals, that no surgery is to be performed on the body part covered by the garment  100  and that the garment  100  should only be removed in the case of an emergency. Preferably, this warning  60  is printed directly on the garment portion  20 . The garment portion  20  also comprises a patient information indicator  70 , which preferably comprises the name of the patient, the surgery to be performed (including the correct location of the surgery), and the name of the operating surgeon. The patent information indicator  70  also comprises a verification  75 , which can include any verification information such as the patient&#39;s signature verifying that he or she was an active participant in placing the garment  100 . The verification  75  is represented as a signature line through the figures. In one embodiment of the method the warning  60 , patient information indicator  70 , and verification  75  are recorded on material that is integral to the garment portion  20 . In another embodiment of the garment this information is recorded on separate material and then placed in a display means, which will be discussed in more detail with reference to  FIGS. 7A-7C  below. The skilled artisan will appreciate that the warning  60 , patient information indicator  70  and verification  75  can be placed at any location on the garment. Preferably, the patient information indicator  70  comprises the verification  75 .  
         [0026]     Also shown in  FIG. 1B  is an opening  172 , which allows access to the underlying body part, which in this figure is an arm  30 . Access may be necessary, for example, for administration of intravenous solutions, medicine, or food. The opening  172  can exist on any of the embodiments herein and can be located anywhere that will appropriately provide access as described above. Some embodiments may have more than one opening. The opening  172  can be of any size or shape.  
         [0027]     Other embodiments of the garment involve the use of partial sleeves rather than full sleeves as shown in  FIG. 1C . The partial sleeve embodiments  200 ,  300 ,  400  for the shoulder  40 , elbow  310  and wrist/hand  50  are shown. As with the full sleeve embodiment shown in  FIGS. 1A and 1B , each partial sleeve  200 ,  300 ,  400  comprises a garment portion  20  that is designed to cover a part of the body and prevent wrong site surgery. As with the full sleeve embodiment, the partial sleeve embodiments  200 ,  300 ,  400  each comprise a warning  60  preferably indicating that no surgery is to be performed on the body part on which the garment is placed as well as that the garment is to be removed only in the case of an emergency. In addition, as in the case of the full sleeve embodiment, the partial sleeve embodiments  200 ,  300 ,  400  comprise the patient information indicator  70 . Also as in the full sleeve embodiment, the patient information indicator  70  can comprise a verification  75 . Also similar to that which is described above, the warning  60 , patient information indicator  70 , and verification  75  can be placed on material that is integral to the garment or on material that is separate from the garment which is then secured to said garment portion  20 . The warning  60 , patient information indicator  70  or verification  75  can be placed at any location on the garment.  
         [0028]      FIGS. 2A and 2B  illustrate the full sleeve and the partial sleeve embodiments of the garment on a lower extremity. The Figures represent the left leg  65  and the left hip  34  viewed from the front. The structure of the embodiments in  FIGS. 2A and 2B  is essentially the same as the above-described embodiments. But for clarity, some of the structure of the embodiments in  FIGS. 2A and 2B  will be discussed in detail below.  
         [0029]     The full sleeve embodiment of the garment  500  on a lower extremity comprise a garment portion  20  that covers the leg  65  from hip  34  to foot  36  thus preventing a wrong site surgery. The leg  65  is inserted into a first opening  501 , and the foot  36  exits at a second opening  502  so that the entire extremity is covered. The garment portion  20  comprises a warning  60  that preferably indicates that no surgery is to be performed on the body part covered by the garment  500  and that the garment  500  should only be removed in the case of an emergency. The garment portion  20  also comprises a patient information indicator  70 , which comprises information such as the name of the patient, the surgery to be performed including the correct location and the name of the operating surgeon. The patient information indicator  70  preferably also comprises verification  75  information such as the patient&#39;s signature verifying that he or she was an active participant in placing the garment  500 .  
         [0030]      FIG. 2B  shows partial sleeves on the lower extremity. The partial sleeve embodiments  125 ,  225 ,  325  for the hip  34 , knee  35  and foot  36  are shown. The structure of the partial sleeve embodiments shown in  FIG. 2B  is essentially the same as the above partial sleeve embodiments, except that garments  125 ,  225  and  325  are used with the hip  34 , knee  35  and foot respectively. Therefore, reference should be had to the discussion above, and in particular, to the discussion with reference to  FIG. 1C  with the understanding that the body parts to which the  125 ,  225 ,  325  apply are different than in  FIG. 1C .  
         [0031]      FIGS. 3A and 3B  further illustrate the garment  200  used with a shoulder  40 . All elements as described herein are present in this embodiment. A first opening  16  and second opening  18  are shown, which allow the upper arm and shoulder  40  to pass through.  FIG. 3A  shows that the arm is placed into the garment though the first opening  16  and exits through the second opening  18  so that the garment  200  rests on the shoulder  40 . First  17  and second  19  ends are shown.  FIG. 3B  shows a side view of the garment  200  as it would appear to a patient preparing to place it on. The first opening  16  for placing the arm through is viewed face on. The second opening  18  through which the arm exits the garment  200  is seen at the lower end of the garment  200 . In one embodiment, elastic material is secured to the ends  17 ,  19  which is represented by the bunched appearance of the ends in  FIG. 3A .  
         [0032]      FIG. 4A  shows a side view of the partial sleeve embodiment  300  for an elbow.  FIG. 4B  shows a face on view of the garment  300  (from first opening  16  to second opening  18 ), i.e., looking into the long axis from first opening  16  through to the second opening  18 . Refer to the discussion above, specifically with reference to  FIG. 1C , for a description of the garment on the elbow  310 .  FIG. 4A  shows that the arm is placed into the garment  300  through a first opening  16  and exists through a second opening  18  so that the garment rests on the elbow (not shown in  FIG. 4A ).  
         [0033]      FIGS. 5A and 5B  illustrate a top view and a side view respectively, of the partial sleeve embodiment for the hand and wrist  50 . Refer to the discussion above, and specifically to the discussion in  FIG. 1C , for a description of the elements of the garment  400  on the wrist.  FIG. 5A  shows that the hand  50  is placed into the garment though a first opening  16 . The fingers  411  then exit through a plurality of openings, one of which is shown as  412 , so that the garment  400  rests on the wrist and hand  50 . As with most above embodiments, it will be seen that the warning  60 , patient information indicator  70 , and verification  75  are present. Note that they are partially viewable in  FIG. 5B  due to the perspective of the figure.  
         [0034]      FIG. 6A  illustrates a side view of an embodiment of the garment  325  on a foot  36 .  FIG. 6A  shows that the foot  36  is placed into the garment  325  though a first opening  16 . The foot  36  then exits through a second opening  18  so that the garment rests on the ankle  33  and foot  36 . Note also a third opening  18 A for the heel to exit. Refer to the discussion above for a description of elements of the garment  325 , e.g., warning  60 , patient information indicator  70 , and verification  75 .  
         [0035]      FIGS. 7A, 7B  and  7 C illustrate the display means  134  of the garment that may be used to display the important patient information  70 , warning  60 , and/or verification  75 . The display means  134  is designed to be affixed to the garment portion  20  of the garment by means of sewing Velcro® adhesive or any other convention means. As shown in  FIGS. 7A and 7B , the patient information indicator  70 , and verification  75  are recorded on paper or any similar material and placed into the display means  134  so that it may be viewed by any person involved in the surgical procedure. The display means  134  will be used when the paper or suitable media is itself not integral to the garment. The display means  134  comprises a transparent face  135  so that the patient information indicator  70  and the verification  75  can be visualized (or in some embodiments, warning  60 ). On one side of the component  134  is an opening  136  that will allow the patient information indicator  70  and verification  75  to be placed into the means  134 . In  FIG. 7A , the patient information indicator  70  is partially removed from the means  134 .  FIG. 7C  shows the display means  134  on a full sleeve embodiment of invention on the leg. Note that the display means  134  can be used in conjunction with any embodiment described herein.  
         [0036]     While the invention has been illustrated and described in detail in the drawings and the foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes, equivalents, and modifications that come within the spirit of the invention defined by the following claims, are desired to be protected.