Abstract:
A prosthesis for abdominal surgery and the method of using it, in which a two-sheet prosthetic is attached to the facia only at opposite sides of an incision. The sheets permit opening and reclosing of the incision and maintaining tension on the facia to bring the edges closer together with each opening and closing to allow for final fascia-to-fascia closure. The method of detoxifying the two-sheet facia prosthesis also is disclosed.

Description:
[0001]    This application claims priority based on Provisional Patent Application No. 0/230,202 filed Sep. 5, 2000. 
     
    
     
       FIELD OF THE INVENTION  
         [0002]    This invention relates to abdominal surgery devices and the method of using and detoxifying such devices.  
         BACKGROUND OF THE INVENTION  
         [0003]    There are a number of abdominal surgery emergencies especially for trauma and infectious conditions, which cannot be solved with a single operation and multiple re-operations are required. In these conditions, intra-abdominal pressure is often increased and closing the abdomen forcefully leads to multi-organ failure and death. Traditionally, the surgeon was always closing the abdomen by suturing the fascia. He would be reoperating when clinically the need for a re-operation became obvious. This, however, caused a delay in diagnosis which consequently resulted in a high mortality in such conditions. The need to treat increased intra-abdominal pressure to prevent abdominal compartment syndrome and multi-organ dysfunction was traditionally neglected until very recently (1995). To treat increased intra-abdominal pressure, the abdominal cavity was initially left open which lead to bowel fistulae and high incisional hernias that were extremely difficult to manage.  
           [0004]    To avoid the delay in diagnosis of postoperative intra-abdominal emergencies the conception of planned relaparotomy was designed. Temporary closure methods using retention sutures wires were employed and severe abdominal wall necrosis and necrotizing fasciitis were observed. Later other devices such as plastic meshes were introduced to act as fascial prostheses and cover abdominal content. Plastic meshes, however, need to be reopened and often replaced for abdominal re-entry. Reapproximation of the fasciae is rarely possible using prior art devices and high abdominal hernias develop in most cases.  
           [0005]    As treatment progresses, most of the prior art devices cannot accommodate decreases in abdominal distention and have to be replaced by a similar member and resutured.  
           [0006]    There is obviously a need for a method and fascial prosthesis for temporary bridging the fascial gap and permitting final fascial closure without leaving foreign material in situ at the same time.  
           [0007]    More precisely a need exists for a simple, effective, improved method and device use for decompressing abdominal hypertension; for protecting exposed abdominal contents; for opening and closing incisions without tissue damage; for permitting final fascial closure without leaving a foreign body in place; and for averting infectious risks during the entire prosess.  
         BRIEF SUMMARY OF THE INVENTION  
         [0008]    The objects of the present invention are to provide a simple, effective, improved method and fascial prosthesis device for bridging fascial gaps, decompressing increased abdominal pressure, protecting abdominal contents, temporary closing the incision so that it can be subsequently opened and re-closed as needed, and finally closing the abdomen fascia to fascia without need for prosthetic material and preventing bacterial contamination during the decompression and reclosure period at the same time.  
           [0009]    The device of the present invention basically comprises two flexible, trimmable sterile sheets. The first flexible, trimmable sheet has a relatively smooth bottom for covering the wound, and a top surface which will mate with or from a cohesive, releasable bond with the bottom surface of the second, flexible, trimmable sheet.  
           [0010]    In the preferred embodiment, the kit consists of a sterile package containing two sterile rectangular sheets of plastic Velcro-like material, each about 20×40 cm. One sheet is characterized by having “hooks” (micromushrooms) on the bottom, while the other sheet has a top with “loops” to which the “hooks” attach when the two pieces are placed one upon the other with the “hooks” on the “loops”. The “hooks” are not hooks in the classical sense. They consist of micromushrooms which functionally act as hooks. Once thus joined the sheets can only be disconnected by lifting and separating one sheet from the other. They cannot be separated by pulling the sheets apart edge to edge.  
           [0011]    In the methods of the present invention, one edge of the first sheet is attached with the top of the sheet with its mating surface with loops facing upward, and the relatively smooth bottom facing downward. The first sheet is sutured to the fascia and the free end is inserted between the opposite parietal peritoneum and the intentines so that the first sheet protects any exposed abdominal contents. The second flexible, trimmable sheet is then similarly sutured to the opposite fascia of the abdominal wound with the bottom-mating surface of micromushrooms facing downward. To temporarily close the wound a slight pulling is exerted on each of the two sheets to put the fascia under minimal tension, and the mating surfaces are brought together to close the incision. Intra-abdominal organs may be protected during the process by covering the mating surfaces of the second sheet with a towel, as long as the abdomen is open.  
           [0012]    Subsequently, when the abdominal re-exploration is performed, the bonds between the mating surfaces are broken and the sheets folded back to open the previously closed incision. If the wound is to be again temporarily closed, the process is reversed taking care to insure that both abdominal wall fasciae are again under minimal tension so that they do not retract. If, when the wound is recluse the edges of the fasciae are closer together than originally, the sheets can be tailored to the proper size by trimming them with scissors to an equivalent size to the distance between the opposed fascial edges and the excess material removed. The opening and closing can be repeated until the wound is ready to be permanently closed at which time the remainders of the two sheets are removed and the fascia joined by a continuous suture. During the entire procedure that may last several days, the abdominal opening with the fascial prosthesis is protected by the self adhesive plastic sheet cover and negative pressure applied to hermetically seal the abdominal aperture.  
           [0013]    The novel method of the present invention is cost effective as it better uses hospital resources and it reduces both mortality and morbidity by avoiding formation of bowel fistulae and high abdominal hernias.  
           [0014]    It will be apparent to those skilled in the art that the present invention fulfills the above-stated objects and also provides other advantages. 
       
    
    
     BRIEF DESCRIPTIONS OF THE DRAWINGS  
       [0015]    [0015]FIG. 1 is a perspective view of a kit of the present invention;  
         [0016]    [0016]FIG. 2 is a perspective view showing the present invention closing an abdominal incision;  
         [0017]    [0017]FIG. 3 is a view taken along lines  3 - 3  in FIG. 2;  
         [0018]    [0018]FIG. 4 is another view like FIG. 2 showing the device of the invention being trimmed with scissors to remove excess material;  
         [0019]    [0019]FIG. 5 is a view like FIG. 2 showing the abdominal incision closed after trimming; and, FIG. 6 is a view similar to FIG. 3 showing the final stage of applying the wound shield. 
     
    
     DESCRIPTION OF PREFERRED EMBODIMENT  
       [0020]    In the preferred embodiment of the invention shown in FIG. 1, the prosthesis or device  10  is stored in a sealed outer package  11  with a sterile interior which contains a sterile loop sheet  12  and a sterile micromushroom sheet  13 .  
         [0021]    As seen in FIG. 3, the sheet  12 , has a smooth bottom  14 , and a top  15 , which is adapted to mate with the bottom  16 , of the male sheet  13 . Sheets  12  and  13  mate. The top  15 , of the female sheet  12 , is covered with “loops” and the bottom  16 , of the male sheet  13 , is provided with a multitude of “hook-like” protuberances (micromuchrooms) that mate  15  with the looped surface to releasable bond the sheets  12  and  13  together.  
         [0022]    The sheets  12  and  13  should be made of a biocompatible, easily sterilized fabric which can be easily and securely sutured, and easily trimmed using conventional operating room instruments. Preferably, the sheets  12  and  13  are of a polyester material, and they are of contrasting colors to avoid confusion. The loop sheet  12  is made of a 20 polymer and the micromushroom sheet  13  is made of a polymer, polypropylene, polyurethane and polyacrylate.  
         [0023]    The preferred method of using the device or implant of the present invention will be described in conjunction with FIGS.  2  to  5 .  
         [0024]    When it is desired to close an incision, as for example at the end of a laparotomy, one edge of the loop sheet  12 , is attached with a runring suture  17 , to one fascia  18  with the top or loop side  15  up, i.e., so that the loop side does not contact bowel wall, omentum, or other intraperitoneal organs. The smooth biocompatible bottom of the loop sheet  12  protects the exposed abdominal contents and the free end of the loop sheet is inserted between the parietal peritoneum and the intestines at the opposite edge of the wound. One edge of the hook sheet  13 , which is preferably of a contrasting color, is similarly sutured to the opposite fascia  19  so that the bottom or hooks side  16  will face toward the loop side  15  of sheet  12 , which is covering the abdominal organs. Then the fascial edges are approximated by pulling the free edges of both of the sheets  12  and  13  toward each other to exert a minimal positive tension on the fascia and the cohesive surfaces are mated to close the incision and make a temporary abdominal closure.  
         [0025]    In FIG. 3, the sheets  12  and  13  can be seen overlapped and bonded together by the mating of the micromushroom top  15  and bottom  16 . When thus mated the sheets  12  and  13  cannot be separated except by lifting the male sheet  13  of the female sheet  12 .  
         [0026]    Gauze  32  is utilized to cover the hook sheet  12  and subcutaneous tissue up to the level of the skin. A suction drain tube  34  is imbedded into the gauze  32 . Following this, a plastic drape  36  having an adhesive side is applied to the skin to cover the entire abdominal wall and the wound, leaving a tunnel for the drain tube. This seals the abdominal cavity and keeps it sterile. The area of the skin covered by the plastic drape  36  should cover a distance of at least 20 cm from any edge of the abdominal wound. This plastic drape seals off the abdominal cavity and a suction is applied to the drain tube  32  by a pump  38  to provide a sealing negative pressure and to collect abdominal fluid for measurement of protein losses and other factors for possible replacement.  
         [0027]    The interval between two operations of a series of planned abdominal re-entries or staged abdominal repairs should not exceed thirty-six hours after the ending of the previous abdominal entry. It is important to definitively close the abdomen as early as possible when most of the peritoneal edema has disappeared. With every abdominal reentry the fascial edges should be pulled together to decrease the gap between the fascias.  
         [0028]    The abdominal cavity can be finally closed once the problem within the abdominal cavity is solved. The sheets  12  and  13  are removed by taking out the running sutures. The hook sheet  13  is first removed from one side and then the loop sheet  12  from the other side. Subsequent to this, the fascia is closed by conventional suture technique.  
         [0029]    The device  10  incorporating sheets  12  and  13  must be detoxified for use in abdominal surgery. For that purpose, the sheets  12  and  13  of hook and loop material are cut to a predetermined size to accommodate the largest of sizes of expected incisions and are measured for compliance. The sheets are easily trimmed to a smaller size at the time of surgery.  
         [0030]    The sized sheets are immersed in an alcohol solution and remain immersed for an extended predetermined time. Upon removal from the alcohol solution the sheets are drained and rinsed with purified water.  
         [0031]    The components subsequently are laid out in an orderly pattern in a room or hooded area and subjected to laminar airflow until the components are completely dry.  
         [0032]    The dried components are packaged in an internally sterile package such as a transparent plastic bag for storage until use.