Abstract:
A surgical procedure bag allowing for rapid preparation of a surgical procedure while ensuring the sterility of the patient and the surgical instruments. The surgical procedure bag comprises a top layer and a bottom layer. The bottom layer is placed above and against the surgical site and, wearing gloves, the surgeon inserts his/her hands through the top layer and manipulates the pre-sterilized surgical instruments placed inside the bag to perform the surgical procedure.

Description:
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH 
       [0001]    Not Applicable. 
       FIELD OF INVENTION 
       [0002]    This invention relates generally to apparatus used to create a sterile environment during surgical procedures, and more specifically to medical-grade coverings that eliminate the need for a surgeon and his/her assistant(s) to wear a hat, mask or sterile gown. 
       BACKGROUND 
       [0003]    A surgical procedure is a procedure done on a patient or an animal. It may be a minor procedure such as the closure of a wound or the placement of central line catheter or dialysis catheter. Alternatively, it may be a major operation such as an intra-abdominal or intra-thoracic operation. A major risk in all types of surgical procedures is infection. In order to reduce the risk of infection, surgical procedures are to be performed under strict sterile conditions, which include the preparation of the surgical site with a disinfectant solutions and the covering of the unsterile parts of the patient, the surgeon and the medical staff with sterile coverings. 
         [0004]    Typical coverings used by surgeons and medical staff include masks, hats, sterile gowns, and sterile gloves. The donning of all of this apparel is not only time consuming, but there are situations when the surgeon is unable or unwilling to comply with all aseptic requirements due to lack of time in emergency situations or, as happens with many minor surgical procedure or central line placement, due to lack of interest on the part of the surgeon in observing all sterility precautions. With the growing popularity of using ultrasound devices for central venous access procedures, the risk of contaminating a surgical site with an ultrasound probe increases. 
         [0005]    Moreover, as is currently done with minor surgical procedures and central line placements outside of hospital operating rooms, sterile packages containing the instruments to be used during the surgical procedure are opened and placed within reach of the surgeon, usually on a table next to the patient. It is not uncommon for the sterilized instruments to then touch unsterile objects or surfaces when they are removed from the packaging to the surgical site. 
         [0006]    There is therefore a need in the art for an apparatus that ensures surgical instruments will remain sterilized throughout an entire surgical procedure, thereby reducing the risk of patient infection, while at the same time allowing a surgeon and his/her assistant to quickly prepare for and begin the surgical procedure. 
       SUMMARY 
       [0007]    The invention relates to an apparatus that ensures surgical instruments will remain sterile throughout an entire surgical procedure, thereby reducing the risk of patient infection, while at the same time allowing a surgeon and his/her assistant to quickly prepare for and begin the surgical procedure. A bag is constructed of transparent, flexible, medical-grade material, such as polyurethane film. The bag comprises a bottom layer and a top layer. The instruments needed to perform the surgical procedure are placed inside the bag and the bag is sterilized and packaged at the manufacturing facility. The bag&#39;s bottom layer has an opening, this opening on the periphery of its outside surface, is covered with medical-grade adhesives, such as an acrylic adhesive. This opening will be positioned against the patient&#39;s body at the surgical site with the adhesive layer attaching to patient&#39;s body and holding the bag in place. The top layer has at least two openings for insertion of the surgeon&#39;s hands into the bag. Once the surgeon&#39;s hands, covered with sterile gloves, have been inserted into the opening, the surgeon may access the sterilized instruments, and perform the surgical procedure on the patient. The top layer may also include a window covered and sealed with a flap door. This window can be accessed to add or remove surgical instrument throughout surgical procedure. After the surgical procedure is complete, the surgeon withdraws his/her hands from the bag, the bag is removed from the patient, and the bag then disposed of, either with the instruments still inside or after the instruments have been removed from the bag. 
         [0008]    The invention can be customized to accomplish a variety of surgical procedures. For major surgeries, larger bags with additional openings for the insertion of one or more assistants&#39; hands or the insertion of extra instruments/equipment may be needed. In one embodiment of the invention customized to provide central venous access in order to place central venous catheters, hemodialysis catheters or pacemakers and so forth, a pouch for insertion of an ultrasound probe is added to the top layer of the bag. This pouch will allow for the placement of the probe directly over the surgical site in order to visualize the vessels underlying the skin while at the same time preventing contamination of the surgical site by the probe. The pouch can be made of any thin flexible, medical-grade material, such as polyurethane film, which is impermeable and allows passage of ultrasound signals from and to the probe. The embodiment with the ultrasound pouch also can be used for regional anesthesia techniques or any other procedure which may require ultrasound visualization of underlying tissues. 
     
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         [0009]      FIG. 1  is a perspective view of a surgical bag according to an embodiment. 
           [0010]      FIG. 2  is a side sectional view of a surgical bag according to an embodiment. 
           [0011]      FIG. 3  is a side sectional view of a surgical bag according to an embodiment. 
       
    
    
     DETAILED DESCRIPTION 
       [0012]    Referring to  FIG. 1 , a surgical bag  10  according to the present invention is shown. The bag  10  has a bottom layer  4  and top layer  2 . The top layer  2  has a plurality of openings  6  that allow for the insertion of a surgeon&#39;s hands into the bag  10 . The openings  6  may be provided with sleeves  8 . The sleeves  8  are sealed to the edges of openings  6  and placed inside the bag  10 . The sleeves  8  will cover the surgeon&#39;s wrist, and forearm and provides flexibility of hand movement inside the bag  10  while maintaining the sterility of the bag&#39;s  10  interior. The sleeves  8  may be constructed out of an elastic and stretchable material, such as polyurethane film. The openings  6  may also have a protective cover  7  that covers the openings  6  from outside of the bag&#39;s  10  top layer  2 . The protective cover  7  isolates, and protects the sterility of, the interior of bag  10 . 
         [0013]    The protective cover  7  needs to be released from the top layer  2  and removed from the openings  6  before the surgeon inserts his/her hands into the openings  6 . The bottom layer  4  has at least one (1) opening  12 . The opening  12  is sized to fit over the surgical site of the patient and to allow the surgeon to access the patient&#39;s body so that the surgical procedure may be performed. The opening  12  is provided with a layer of medical grade adhesive  9   a  on periphery of its exterior surface. The adhesive  9   a  will attach to the patient&#39;s body, at the surgical site, and maintain the bag  10  in place. The opening  12  may be provided with protective cover  9   b . Cover  9   b  will attach to adhesive  9   a  and cover the opening  12  from outside. Cover  9   b  needs to be removed before the bag  10  is positioned against the surgical site. 
         [0014]    In certain embodiments of the invention, the bag  10  may also comprise an access window  14 . The access window  14  is an opening in the top layer  2  that provides access to the interior of the bag  10 . The access window  14  is covered with a lid  16 . The lid  16  may be resealable against the top layer  2 . The lid  16  is comprised of a tab  16   b . The tab  16   b  can be used by an assistant to lift the lid  16 . By lifting the lid  16 , an assistant can insert additional sterile items into the interior of the bag  10  as needed by surgeon. Used items can be removed from the bag  10  through the access window  14  as well. Care must be taken not to contaminate the interior of the bag  10  when adding items thereto or removing items therefrom through the access window  14 . 
         [0015]    In certain embodiments, a plurality of surgical instruments  20  are fastened to an interior surface of the bag  10  in releasable manner. Each instrument  20  can be removed from its attachment and put back in place easily. The type of instruments  20  placed inside the bag  10  depends on the type of surgical procedure the bag  10  has been customized to accommodate. The instruments  20  can include needles, syringes, central line catheters, hemodialysis catheters, guide wires, regional anesthesia needles and catheters, scalpels, sharp containers, gauzes, surgical sutures, alcohol preps and other disinfectants, packs of conductive gels, bottles of local anesthetics, or other medications or any other items needed to perform the particular surgical procedure. The bag  10  can be made of any transparent medical grade material or plastic that allows the interior of the bag  10  to be visible, such as polyurethane film. 
         [0016]    After the surgical site is prepped in the usual manner, the covering  9   b  is removed and the bag  10  is positioned on top of the surgical site in such a way that the opening  12  sits directly over and around the surgical site. The cover  7  is then removed and the surgeon&#39;s hands, covered with sterile gloves, are placed inside the bag  10  through the openings  6 , and the surgical procedure performed in a sterile environment. As can be seen in  FIG. 1 , because the surgical environment created inside the bag  10  is separated from outside exposure, there should be no need for the surgeon and any assistants to wear a gown, hat or mask. 
         [0017]    The present invention has important implications and uses for surgical procedures done in emergency situations or outside of operating rooms, such as surgical procedures done in military zones and so forth where dust from the environment may prevent a sterile procedure from being performed. Even in controlled hospital environments, the isolation from contaminants provided by the present invention will make all medical staff present for the procedure compliant with sterility requirements. Because all the instruments  20  needed for the surgical procedure are organized and accessible inside the bag  10 , the surgical procedure can often be done faster and the risk of accidental contamination of the surgical site and the instruments  20  is significantly reduced. 
         [0018]    The size of the bag  10  should be customized to suite the surgical procedure intended to be accomplished. As mentioned earlier, the bag  10  can be customized for different surgical procedures and can have multiple openings  6  for the insertion of assistants&#39; hands and other equipment. 
         [0019]    The top layer  2  of the bag  10  should be made of transparent medical-grade material, such as polyurethane film. Although the top layer  2  can be made out of material with different rigidity, making it out of soft flexible material has the advantage of having more flexibility for hand movement inside the bag  10 . Being soft and collapsible also makes packaging and storing the bag  10  simpler. The bottom layer  4  should be soft and flexible to follow the contour of the patient&#39;s body. The bottom  4  should also be impermeable to prevent patient&#39; body fluids from leaking into the bag  10  and contaminating the sterile environment. 
         [0020]    In one embodiment shown in  FIG. 2 , the bag  10  is comprised of a pouch  18 . The pouch  18  is attached to the top layer  2  and is shaped to allow the insertion of an ultrasound probe. The pouch  18  can be made of any thin medical-grade material or plastics that is impermeable to liquids, which allows for easy penetration of an ultrasound signal to and from the ultrasound probe. The pouch  18  is sized to accept a plurality of commercially-available ultrasound probes. The pouch  18  has an open end  18   a  and a closed end  18   b  and is attached to the top layer  2  at the open end  18   a.    
         [0021]    The patient&#39;s skin over the target vessel is prepped and the opening  12  of the bag  10  is positioned over the target vessel. The ultrasound probe is then placed inside the pouch  18  and the surgeon places his/her hands, covered with sterile gloves, through the openings  6  and inside the bag  10 . Conductive gel may be placed inside the pouch  18  prior to probe insertion. The surgeon can hold the ultrasound probe from inside the bag  10  with one hand to visualize the target vessel without contaminating the surgical field. The other hand is used to perform the endovascular procedure (e.g., advance needles and guide wires into the vessels under direct ultrasound vision). Alternatively, an assistant can hold the ultrasound probe from the outside of the bag  10  without contaminating the patient or the instruments being handled by the surgeon. 
         [0022]    In certain embodiments, the pouch  18  can hang free underneath the top layer  2  with the closed end  18   b  freely moving inside the bag  10 . Alternatively, the pouch  18  may be anchored to the bottom layer  4  at the periphery of the opening  12 . This anchoring is intended to maintain the head of ultrasound probe over the skin on the target vessel. This anchoring may be rigid, semi-rigid, or even may include flexible anchors or joints to allow the ultrasound probe position and the angle against the patient&#39;s skin to be adjustable. 
         [0023]    In one embodiment shown in  FIG. 3 , surgical gloves  22  are placed inside the bag  10 . The surgical gloves  22  are attached to top layer  2  and positioned inside the bag  10  as shown in  FIG. 3 . The proximal ends  22   a  of the surgical gloves  22  are sealed at the edges of the openings  6 . This embodiment can be made with different glove sizes for different hand sizes. One advantage of having surgical gloves  22  incorporated into the bag  10  is that the surgeon can frequently remove his/her hands in and out of the bag  10  without contaminating the interior of the bag  10 . 
         [0024]    In smaller embodiments customized for minor operations or central vascular access, the bag  10  may be made of a material that, while soft and flexible, allows the bag  10  to naturally maintain its three-dimensional shape to create the space necessary for free movement of the surgeon&#39;s hands inside the bag  10 . Placement of the hands inside the bag may help to maintain this space. In larger bags, or bags made with very thin walls, means to prevent the bag  10  from collapsing may be needed. These means may include a variety of lightweight skeletons placed inside or outside of the bag  10 . The skeleton may be flexible or collapsible to allow easy packaging and storage. Alternatively the bag may be made out of more rigid material or pressurizing the inside of the bag  10  to maintain interior space may be needed in some embodiments. The pressurizing may be accomplished by insufflations of CO 2 , air or any other medically approved gas.