Abstract:
A wound ( 50 ) is closed using a first adhesive shoe ( 10 ) adhesively affixed adjacent to a first edge ( 51 ) of the wound, a second adhesive shoe ( 20 ) adhesively affixed adjacent to a second opposite edge ( 52 ) of the wound, a forceps device ( 100 ) comprising a first leg ( 101  ) adapted to couple with the first adhesive shoe and a second leg ( 102 ) adapted to couple with the second adhesive shoe; and a locking mechanism ( 150 ) adapted to draw the first and second forcep legs together and hold legs in the desired closed position after they are drawn together.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    1. Technical Field 
         [0002]    The present invention relates to an apparatus and method for closing a skin wound and more specifically to the art of using tissue glue in combination with tissue approximation forceps to glue wound edges together. 
         [0003]    2. Background Art 
         [0004]    In recent years, tissue adhesives such as the cyanoacrylates have become widely used for closing skin wounds, both those caused by trauma and those made as surgical incisions. In many cases, the use of tissue adhesives instead of skin sutures or staples allows wounds to be closed without the need for injecting local anesthetic into a wound, thereby expediting the procedure and sparing the patient the pain of an injection. 
         [0005]    When a wound is closed using sutures, the process of placing the sutures and tying the associated knots brings the wound edges into proper alignment at the same time that it closes the wound and secures that alignment. Thus it is not necessary to hold the wound edges together during suturing. 
         [0006]    When tissue adhesives are used appropriately, they yield cosmetic results typically better than the results achieved using sutures. The chief difficulty with using adhesives to close a wound is that the edges of the wound must be brought into alignment and held there as the liquid adhesive is applied. Unlike sutures, the wound edges must be held and kept in alignment while the adhesive cures. To assist in the process of keeping the wound edges aligned while the adhesive cures, there have been attempts to use prior art tissue forceps. However prior art forceps are not well suited to this task. 
         [0007]    Prior art tissue forceps come in a variety of types, each with various tissue mating surfaces adapted for the purpose of grasping the tissue adjacent the edges of a wound in a secure manner. These mating surfaces give only a limited degree of control over the wound edges. Prior art forceps indent the skin and evert the wound edges during closure. This is most desirable for suturing a wound because the edges eventually flatten and give a cosmetically acceptable result. However it is not desireable for wound closure when using a tissue adhesive material in place of sutures. 
         [0008]    Prior art forceps also require that one of the treating surgeon&#39;s hands be used to secure the forceps in position during the wound closure procedure due to the fact that the forceps will not remain on the skin if one hand does not remain on the forceps. Such limitations in the prior art therefore did not allow the use of two hands to stitch or apply the tissue glue. It is more desirable if the surgeon has his second hand available. The surgeon could then use that second hand to steady the patient rather than keeping it on the forceps in order to keep the wound edges together. 
         [0009]    Also In the prior art, if the patient moves then the forceps will move and the wound edges will not maintain registration. When the forceps slip out of position, the wound may open and allow tissue glue to enter the wound. If such forceps were capable of remaining attached to the skin in the closed position, then they would also be free to move with the patient&#39;s movement without a loss of wound edge closure. 
         [0010]    To solve the aforementioned problems associated with wound closure, the present invention is a unique system for simple and reliable closing of the edges of a wound allowing for optimal application of tissue glue. 
         [0011]    The new and improved tissue forceps, according to the present invention, have independent and detachable tissue mating surfaces which adhesively engage the skin adjacent to a wound in a manner which approximates the wound edges. The forceps may also include a locking mechanism which, in many cases, allows the operator to let go of the forceps once the wound edges have been positioned, thereby freeing up one hand. 
       SUMMARY OF THE INVENTION 
       [0012]    The following summary of the invention is provided to facilitate an understanding of some of the innovative features unique to the present invention. A full appreciation of the various aspects of the invention can only be gained by taking the entire specification, claims, drawings, and abstract as a whole. 
         [0013]    The present invention is directed to improved wound closure using a forceps device, such as tissue approximation forceps, with detachable adhesive shoes that are adhesively affixed to the edges of the wound. The present invention can be used in combination preferably with applied tissue glue. 
         [0014]    According to a first aspect, in which specially adapted bandages are used as the adhesive shoes, the present invention provides a wound closure system comprising a first bandage with an open pocket portion, a second bandage with an open pocket portion, a forceps device, and a locking mechanism. The first bandage is adhesively adjacent to a first longitudinal edge of the wound, with its open pocket portion facing away from the wound. The second bandage is adhesively affixed adjacent to a second longitudinal edge of the wound, with its open pocket portion facing away from the wound. The forceps device includes a first leg adapted to fit within the open pocket portion of the first bandage and a second leg adapted to fit within the open pocket portion of the second bandage. The locking mechanism is adapted to hold the first and second legs in position when they are drawn together by closing the forceps device. 
         [0015]    In a further embodiment, tissue glue is applied directly to the edges of the wound when they are drawn together and locked into position. 
         [0016]    According to a second aspect, the present invention provides a wound closure system comprising a first adhesive shoe adhesively affixed adjacent to a first longitudinal edge of the wound, a second adhesive shoe adhesively affixed adjacent to a second longitudinal edge of the wound, a forceps device comprising a first leg adapted to couple with the first adhesive shoe and a second leg adapted to couple with the second adhesive shoe; and a locking mechanism adapted to hold the first and second legs in position when they are drawn together by closing the forceps device. 
         [0017]    According to a third aspect, the present invention provides a method for closing a wound using a forceps device and tissue glue including the steps of: affixing a first adhesive shoe adjacent to a first longitudinal edge of the wound, affixing a second adhesive shoe adjacent to a second longitudinal edge of the wound, coupling a first leg of said forceps device to said first adhesive shoe, coupling a second leg of said forceps device to said second adhesive shoe, closing the forceps device, thereby drawing the first and second longitudinal edges of said wound substantially together, locking the forceps device such that legs thereof remain fixed in position thereby holding the edges of said wound substantially together, applying tissue glue directly to the edges of said wound, waiting a predetermined period of time for said tissue glue to set, unlocking said forceps device, and decoupling the legs of said forceps device from said first and second adhesive shoes to complete the closing of said wound. 
         [0018]    The present invention seeks to overcome or at least ameliorate one or more of several problems with wound closure when using tissue adhesive, including but not limited to unsatisfactory results yielded by using prior art forceps. The present invention frees both of the surgeon&#39;s hands during a wound closure procedure so that he will be free to use two hands to apply tissue glue (or sutures, staples or other method, if desired) to join the wound edges together. 
         [0019]    When tissue adhesives are used to close a wound, the edges of the wound must be brought into alignment and held there as the adhesive is applied and for long enough for the adhesive to set. With commonly used adhesives such as cyanoacrylates, the wound edges must be held tightly enough together to keep the adhesive from flowing into the wound, as the presence of the adhesive in the wound is injurious to the tissue. Achieving correct alignment of wound edges is important, as misaligned wound edges can result in a poorly formed and unsightly scar. Often, bringing wound edges into alignment is made much more difficult when the patient, who may be a young child, is unable to cooperate with the procedure. 
         [0020]    The most common method for bringing wound edges into alignment for application of tissue adhesive is the use of fingers. The user places gloved fingers of one hand on either side of the wound and squeezes the edges together. This method is limited by the amount of friction obtainable between the medical operator&#39;s gloved hand and the patient&#39;s skin. The medical operator&#39;s fingers must also apply downward pressure to either side of the wound in order to obtain friction, and this pressure can be painful for the patient. It is easily possible for the adhesive to flow to the medical operator&#39;s glove, sticking the glove to the patient&#39;s skin. 
         [0021]    In another method, standard surgical forceps are placed with one leg of the forceps on either side of the wound, the forceps pressed down and squeezed together. However, there is typically not enough friction available to bring the wound edges together, and the downward pressure applied can be painful to the patient. Finally, as with the use of fingers, the forceps like the glove can inadvertently be glued to the patient&#39;s skin. 
         [0022]    In a third method, specially adapted forceps whose tips have flat surfaces with one or more pointed protrusions for increasing friction can be used to approximate the wound edges. With this method, the protrusions can cause pain as they are pressed into the skin, and the forceps can slip out of position during the application of the adhesive. All of the above methods can often be defeated by the movements of an uncooperative patient such as a young child. 
         [0023]    In each of the above present methods, it is important to recognize that while the tissue glue sets, the medical practitioner must maintain the wound edge alignment by holding the wound edges together. The present invention can eliminate this problem because the adhesive shoes allow the forceps to remain properly positioned on the skin surface even without the aid of the medical practitioner&#39;s hand holding them in place. The locking mechanism of the forceps holds the wound edges aligned. Thus the combination of the adhesive shoes and locking mechanism gives the medical practitioner the option to remove their hands from the forceps. 
         [0024]    Unless the context clearly requires otherwise, throughout the description and the claims, the words ‘comprise’, ‘comprising’, and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to”. 
       BRIEF DESCRIPTION OF DRAWINGS 
       [0025]    The accompanying figures further illustrate the present invention. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING 
         [0026]      FIG. 1  shows a wound closure system that uses bandages with open pocket portions in accordance with a first illustrative embodiment of our invention. 
           [0027]      FIG. 2  depicts an illustrative method of closing a wound in accordance with with our invention. 
       
    
    
     LIST OF REFERENCE NUMBERS FOR THE MAJOR ELEMENTS IN THE DRAWING 
       [0028]    The following is a list of the major elements in the drawings in numerical order.
         10  first adhesive shoe (e.g. specially adapted bandage)     11  open pocket (of bandage  10 )     20  second adhesive shoe (e.g. bandage)     21  open pocket (of bandage  20 )     50  wound     51  first longitudinal edge (of wound  50 )     52  second longitudinal edge (of wound  50 )     100  forceps device     101  first leg (of forceps device  100 )     102  second leg (of forceps device  100 )     105  wings     150  locking mechanism     151  push top (part of locking mechanism  150 )     201  (step of) affixing a first adhesive shoe     202  (step of) affixing a second adhesive shoe     203  (step of) coupling a first forceps leg to the first adhesive shoe     204  (step of) coupling a second forceps leg to the second adhesive shoe     205  (step of) closing the forceps device     206  (step of) locking the forceps device     207  (step of) applying tissue glue     208  (step of) waiting for tissue glue to dry     209  (step of) unlocking the forceps device     210  (step of) decoupling the legs of the forceps device       
 
       DESCRIPTION OF THE INVENTION 
       [0052]    The present invention is designed for use within a medical treatment environment for the purpose of closing skin wounds in place of more traditional stitches. 
       MODE(S) FOR CARRYING OUT THE INVENTION 
       [0053]    Refer first to  FIG. 1 , which shows a first illustrative embodiment of the present invention. A patient has an open wound  50  that a surgeon is working to close with a forceps device  100 , such as tissue approximation forceps. A left adhesive shoe, such as a first bandage  10 , is applied to the patient&#39;s skin adjacent to a first longitudinal edge  51  of wound  50 . A right adhesive shoe, such as a second bandage  20 , is applied to the patient&#39;s skin adjacent to a second opposing longitudinal edge  52  of wound  50 . Next, the forceps legs  101  and  102  are slipped into the respective left and right shoes, such as open pocket portions  11  and  21  of the first and second bandages  10  and  20 . 
         [0054]    Other embodiments of the present invention use different configurations in place of adhesive shoes for attaching the forceps to the skin surface, such as detachable portion of the forceps legs or even magnets that are affixed to edges of the wound. Another embodiment of the invention uses a weak adhesive applied directly to the legs of the forceps. In this embodiment, the ends of the forceps adhere directly to the skin surface, without the use of adhesive shoes. The adhesive is just strong enough to allow the forceps to control the wound edges but is weak enough to allow the legs of the forceps to be removed easily from the skin surface after the tissue glue has been applied and has cured. 
         [0055]    In yet another embodiment, the adhesive shoes are slipped onto the respective left and right forceps legs and then the forceps are pressed across the injury area to straddle the wound  50 . The adhesive shoes attach to the skin when the forceps are pressed down onto the skin. This embodiment does not require the surgeon to press down hard on the wound  50 , thus avoiding a source of pain and giving much greater control over the skin. 
         [0056]    The forceps legs  101  and  102  can then be drawn together by the surgeon to bring the edges  51  and  52  of the wound  50  together into proper registration. In new inventive forceps, the surgeon&#39;s fingers provide the force needed to close the jaws of the forceps. The new improved forceps come in contact with only the skin surface such that there is no actual clamping of any tissue. The closing of the jaws of our forceps is done without the mechanism grasping the skin. Advantageously, our invention does not have any protrusions that poke into the skin of the patient, avoiding this source of pain. 
         [0057]    A locking mechanism  150 , such as a collar, serves to maintain a position of the closure of the forceps that has already been attained. Advantageously, once the forceps are locked in place with the wound edges  51  and  52  in registration, the forceps are retained “hands free” on the patient. In certain embodiments, wings  105  are mounted on the legs of the forceps device to allow the surgeon&#39;s fingers to resist the force of the locking device and to allow the surgeon added degree of control in applying a lifting movement to one or both wound edges 
         [0058]    The surgeon is then free to use both hands during the remainder of the wound closure procedure. Advantageously, the use of adhesive shoes allows a greater ability to position the wound edges  51  and  52  into a desired registration of tissue movement because such adhesive shoes allow both lateral movement and a vertical lifting movement to be applied to one or both of the wound edges, which can facilitate better positioning of some wound edges. Certain embodiments of the present invention incorporate an additional degree of freedom in the forceps device to allow a small additional amount of longitudinal movement perpendicular to the direction of closing the wound. 
         [0059]    Finally, tissue glue is applied to hold the edges  51  and  52  of the wound  50  together. Note that the inventive forceps can be used not only with tissue glue but also with conventional wound closure methods, such as staples, sutures or stitches, since they help keep the wound edges in position and keep both of the treating surgeon&#39;s hands free. 
         [0060]    The invention provides much greater control in manipulating the wound edges. It also keeps the space over the wound open, not blocked, such as by a covering pad. Advantageously, this allows for better visualization of the wound, allows the wound to be blotted dry after the edges have been positioned, and allows the adhesive to be applied directly to the wound surface, without the use of a pad. 
         [0061]    Refer now to  FIG. 2  which illustrates a method of closing a wound in accordance with an illustrative embodiment of the present invention. First, the surgeons affixes (step  201 ) a first adhesive shoe adjacent to a first longitudinal edge  51  of the wound  50 , as shown in  FIG. 1 . Next, the surgeon affixes (step  202 ) a second adhesive shoe adjacent to a first longitudinal edge  52  of the wound  50 , as shown in  FIG. 1 . 
         [0062]    The surgeon couples (step  203 ) a first leg of a forceps device, such as forceps, to the first adhesive shoe and then couples coupling (step  204 ) a second leg of said forceps device to the second adhesive shoe. As noted above, in alternate embodiments, the adhesive shoe can be first coupled to the legs of the forceps and then pressed onto the patient&#39;s skin. Also, the present invention contemplates several coupling schemes, including, but not limited to pocket portions of bandages, detachable portions of forceps legs, rigid adhesive shoes and adhesive magnets. 
         [0063]    The surgeon closes (step  205 ) the forceps device, such as forceps, and thereby draws the first and second longitudinal edges of said wound substantially together. Next, the surgeon locks (step  206 ) the forceps device such that legs thereof remain fixed in position thereby holding the edges of said wound substantially together and applies (step  207 ) tissue glue directly to the edges of the wound 
         [0064]    Finally, after waiting (step  208 ) a predetermined period of time for the tissue glue to set, the surgeon unlocks (step  209 ) the forceps device; and decouples (step  209 ) the legs of the forceps device from the first and second adhesive shoes to complete the closing of the wound. 
         [0065]    In the present inventive forceps, the medical practitioner&#39;s fingers provide the force needed to close the jaws of the forceps. The collar only serves to maintain a position of the jaws that has already been attained. 
         [0066]    With the present invention there is no actual clamping of any tissue. The closing of the jaws of the forceps is done without the forceps grasping or pinching the skin. 
       Alternate Embodiments 
       [0067]    Alternate embodiments may be devised without departing from the spirit or the scope of the invention. 
         [0068]    By way of example, rather than affixing the adhesive shoes to the respective edges of the wound and then coupling one of each of the legs of the forceps to an adhesive shoe, the legs can first be coupled to the adhesive shoes prior the adhesive shoes being affixed to the edges of the wound. 
         [0069]    Yet another embodiment may incorporate an additional degree of freedom of the jaws to allow a small amount of lateral movement. By providing a pivot ( 160 ) where the first and second forceps legs connect, each individual leg may be rotated to align with opposing wound edges that are not parallel. The locking mechanism ( 150 ) is replaced with locking nut or thumbwheel attached to the pivot point which allows holding the forceps in the desired closed position. 
         [0070]    The pivot could be a swivel joint, a ball joint or other similar assembly well known in the art that provides the ability for each forceps leg to move in a rotational fashion in relationship to the opposite leg.  FIG. 3  shows the alternative forceps with the flexible pivot ( 160 ). 
         [0071]    It would be apparent to one skilled in the art to alter the sequence of steps in other similar fashions without altering the results achieved with the invention.