Abstract:
A system for wound closure has at least two closure elements. One closure element is detachably tethered to another closure element. Each closure element includes: a base member with an integral strap hingably connected to the base member, and a lock member slidably disposed on the strap and being lockable on the strap. Alternatively, the base member defines a plane and the strap being affixed to the base member at an angle to the plane. The system may further include a wound covering disposed between the straps and the wound. The wound covering may be a laminate having at least two layers; a first layer is a moisture impervious layer adapted to contain body heat, and a second hydrophilic layer is adapted to retain moisture.

Description:
RELATED APPLICATION 
       [0001]    This application claims the benefit of co-pending U.S. provisional application No. 61/765,385 filed Feb. 15, 2013, which is incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention is directed to a system and method for closing a wound. 
       BACKGROUND OF THE INVENTION 
       [0003]    Traumatic injuries typically occur away from medical facilities. Thus, the victim must be transported from the site where the injury occurred, such as a battlefield or a roadside, to the medical facility for treatment. During this ‘short term’ period, for example, transportation from the site to the facility, it may be best to keep the wound closed, as much as possible, and even covered, if possible, to prevent, for example, ingress of contaminants, or to facilitate treatment. 
         [0004]    Two such devices have been proposed, they are discussed below. 
         [0005]    U.S. Pat. No. 3,971,384 discloses a suture less closure device. The device has a tie strip with an anchor affixed at one end of the strip and a slide lockably engaged on the strip. The anchor is affixed to the skin on one side of the incision and the slide is affixed to the skin on the other side on the other side of the incision. The incision is closed by pulling the strip through the slide and locking the strip in the slide. 
         [0006]    U.S. Design Patent No. D652,145 discloses a wound closure device. The device has two wound closure clips and a strip therebetween. 
         [0007]    While these devices may be used in the situations discussed above, improvements are needed. Those improvements include, but are not limited to, ease of operation, compactness, reduced weight, fewer pieces, rapid deployment, and versatility, to mention a few. 
         [0008]    Accordingly, the invention, discussed below, addresses and improves upon, at least, the issues mentioned above. 
       SUMMARY OF THE INVENTION 
       [0009]    A system for wound closure has at least two closure elements. One closure element is detachably tethered to another closure element. Each closure element includes: a base member with an integral strap hingably connected to the base member, and a lock member slidably disposed on the strap and being lockable on the strap. Alternatively, the base member defines a plane and the strap being affixed to the base member at an angle to the plane. The system may further include a wound covering disposed between the straps and the wound. The wound covering may be a laminate having at least two layers; a first layer is a moisture impervious layer adapted to contain body heat, and a second hydrophilic layer is adapted to retain moisture. 
     
    
     
       DESCRIPTION OF THE DRAWINGS 
         [0010]    For the purpose of illustrating the invention, there is shown in the drawings a form that is presently preferred; it being understood, however, that this invention is not limited to the precise arrangements and instrumentalities shown. 
           [0011]      FIG. 1  is an illustration of one embodiment of the system for closure of a wound. 
           [0012]      FIG. 2 , taken generally along section lines  2 - 2  of  FIG. 1 , is an embodiment of the base member. 
           [0013]      FIG. 2A  is an enlarged view of a portion of the embodiment shown in  FIG. 2 . 
           [0014]      FIG. 3 , taken generally along section lines  2 - 2  of  FIG. 1 , is another embodiment of the base member. 
           [0015]      FIG. 4  is an illustration of the inventive system with the strap folded and releasably affixed to the base member and the lock mechanism of the lock member in an open position. 
           [0016]      FIGS. 5A and 5B  illustrate one embodiment of the lock mechanism in an open position and a closed position, respectively. 
           [0017]      FIG. 6  is an illustration of the inventive system in operation along with an optional wound covering. 
       
    
    
     DESCRIPTION OF THE INVENTION 
       [0018]    Referring to the drawings, where like elements have like numerals, there is shown in  FIG. 1  an embodiment of the system for closure of a wound  10 , for example, short term closure. Generally, system  10  comprises a closure element  12 . In one embodiment, several closures elements  12  may be joined together via a tether  14 . But, closure elements  12  may be independent, i.e., not tethered. Several, as used herein, may mean at least two, but may include up to  12 , or any whole number between  2  and  12 . 
         [0019]    The tether  14  may be breakable or cuttable, so that the number of closures  12  may be tailored to a suitable number for closure of the wound. Tether  14  may be positioned on an upper portion of the closure elements  12 , so that the tether  14  does not touch the skin. 
         [0020]    The system  10  may be made of one or more injection moldable thermoplastic materials, alone or in combination. Such thermoplastic materials include, but are not limited to, polyolefins (for example, polyethylene and polypropylene), polyesters (for example, polyethylene terephthalate), polyamides (for example, nylon), or the like. 
         [0021]    Closure element  12  generally includes a base member  16 , a strap  18 , and a lock member  20 . The base member  16  may be integral with the strap  18 . The lock member  20  may be slidably and/or removably engaged with strap  18 . 
         [0022]    Referring to  FIGS. 1-4 , the base member  16  will be discussed in greater detail hereinafter. Base member  16  generally includes a strap fastener  22  and a bottom plate  24 . Base member  16  optionally includes at least one pair of staple holes  26  through the bottom plate  24 . Any number of pairs of staple holes may be used, for example, 1-4 pairs of staple holes including any whole number between 1 and 4. The staple holes  26  may be used so that the base member may be stapled to the skin surrounding the wound. The base member may also optionally include at least one pair of staple guides (e.g., teeth)  28 , for example, upstanding from the lateral edges of the bottom plate  24 . Additionally, the staple guides  28  allow the base member  16  to be more flexible therebetween. Any number of pairs of staple guides may be used, for example, 1-6 pairs of staple guides including any whole number between 1 and 6. 
         [0023]    As shown in  FIG. 4 , strap fastener  22  may be used to releasably secure strap  18 , so that the strap  18  may be held away for the wound. Strap fastener  22  may be any mechanism that can releasably hold strap  18 . The strap fastener  22  may be generally located on the base member  16  at an end of the bottom plate  24  distal the strap  18 . In one embodiment, shown in  FIGS. 1 ,  2 , and  4 , strap fastener  22  may comprise a pair of lateral clips  30 , each clip  30  spaced from the other so as to releasably secure strap  18  therebetween. The strap fastener  22  may optionally include strap engagement member  31 . Strap engagement member  31  working with clips  30  may more securely hold the folded strap  18  in strap fastener  22 . In another embodiment (not shown), strap fastener may be a post with mushroom head upstanding from bottom plate  24  for releasable engagement with one or more holes (not shown) through the strap  18 . 
         [0024]    Referring to  FIG. 2A , base member  16  may include an adhesive  32  for releasably securing base member  16  to the skin adjacent the wound. In one embodiment, the adhesive  32  may be affixed to a bottom surface of the bottom plate  24 . Adhesive  32  may be any adhesive suitable for releasably adhering the base member  16  to the skin adjacent the wound. The adhesive  32  may be a hydrocolloid dressing (for example, commercially available under such tradenames as Duoderm, Granuflex, Ultec, and 3M Tegaderm Hydrocolloid) and/or pressure sensitive adhesive. In one embodiment, the adhesive  32  covers all or a portion of the bottom surface of bottom plate  24 . In one embodiment, the adhesive  32  may be protected, prior to use, by a release layer  34 . In another embodiment, adhesive  32  may include a mesh (not shown) throughout the adhesive  32  and may extend beyond the peripheral edge of the adhesive  32 . 
         [0025]    The base member  16  may be integral with strap  18 . Integral, as used herein, may refer to the base member  16  and the strap  18  being molded as a single unit. The joint between the base member  16  and strap  18  should be flexible (i.e., capable of bending to allow fastening of the free end of the strap  18  to the base member  16  as shown in  FIG. 4 ). The strap  18  may be hingably connected with the base member  16 . In one embodiment, see  FIG. 2 , a hinge  36  joins the base member  16  with strap  18 . Hinge  36 , as shown in  FIG. 2 , may be formed by a thinning of material between the base member  16  and strap  18  (e.g., a living hinge). In another embodiment, see  FIG. 3 , the strap  18  is joined to the base member  16  at an angle  38 . Angle  38  may be any angle greater than 0° and less than 90°. The angle  38  may be in the range of 10°-45°, or 15°-35°. In one embodiment, the angle  38  may be about 30°. 
         [0026]    Strap  18 , see  FIGS. 1 ,  4 ,  5 A, and  5 B, is a elongated member extending away from the base member  16 . The strap  18  is flexible. The strap may have a plurality of teeth  40  along a surface of strap  18  (for example, the upper surface). These teeth  40 , in one aspect of the invention, may work with strap engagement member  31  of the strap fastener  22  (discussed above); and in another aspect of the invention, these teeth  40  may engage with strap engagement member  54  to hold the strap  18  fast in locking mechanism  42  (discussed below). The strap  18  may be any length. In one embodiment, the length may range from 12 inches to 36 inches. Strap  18  may be severable. For example, the strap may be severed (for example, with a knife or scissors) along its length so that the strap length may be tailored to a suitable length for closure of the wound. In one embodiment (not shown), the strap  18  may include one or more notches at regular intervals (for example, 1 or 2 inches) along the length of the strap  18  to facilitate severability. The notch may run across the width of the strap  18  (i.e., generally perpendicular to the longitudinal axis of the strap  18 ) and may be an area of the strap that may be generally thinner in depth than other areas of the strap, so that the notch acts as a guide for a knife to facilitate strap cutting in the dark as may be necessary under battle field conditions. 
         [0027]    Lock member  20 , see  FIGS. 5A and 5B , may be slidably releasable on strap  18 . Lock member  18  may be slid along strap  18  to facilitate closure and access to the wound. Lock member generally includes a locking mechanism  42  for releasably engaging strap  18 . In one embodiment, the lock member  20  may include a bottom plate  44  with the locking mechanism  42  joined to an upper surface of the bottom plate  44 . 
         [0028]    Lock member  20  optionally includes at least one pair of staple holes  26  through the bottom plate  44 . Any number of pairs of staple holes may be used, for example, 1-4 pairs of staple holes including any whole number between 1 and 4. The staple holes  26  may be used so that the base member may be stapled to the skin surrounding the wound. The base member may also optionally include at least one pair of staple guides (e.g., teeth)  28 , for example, upstanding from the lateral edges of the bottom plate  44 . Additionally, the staple guides  28  allow the lock member  20  to be more flexible therebetween. Any number of pairs of staple guides may be used, for example, 1-6 pairs of staple guides including any whole number between 1 and 6. 
         [0029]    The locking mechanism  42 , in one embodiment, may include a foldable lid  46  mounted via a hinge  48  to wall  50 . The lid  46  is movable from an open position, FIG.  5 A, to a closed position,  FIG. 5B . The lid  46  may include a clasp  52  which is releasably engagable with wall  50 . Optionally, the lid  46  may include strap engagement member  54  for holding the strap in a non-slidable manner when the lid  46  is in the closed position. Optionally, the locking mechanism  42  may include a mechanism (not shown) so that when lid  46  is in the closed position, the strap  18  may be pulled therethrough, thereby closing the wound by drawing the base member  16  and lock member  20  together. This mechanism may only allow the strap to be pulled through in one direction and hold fast in the opposite direction. 
         [0030]    Lock member  20  may include an adhesive for releasably securing lock member  20  to the skin adjacent the wound. In one embodiment, the adhesive may be affixed to a bottom surface of the bottom plate  44 . The adhesive may be any adhesive suitable for releasably adhering the lock member  20  to the skin adjacent the wound. The adhesive may be a hydrocolloid dressing (for example, commercially available under such tradenames as Duoderm, Granuflex, Ultec, and 3M Tegaderm Hydrocolloid) and/or pressure sensitive adhesive. In one embodiment, the adhesive covers all or a portion of the bottom surface of bottom plate  44 . In one embodiment, the adhesive may be protected, prior to use, by a release layer. In another embodiment, adhesive may include a mesh (not shown) throughout the adhesive and may extend beyond the peripheral edge of the adhesive. The adhesive may be positioned on the lock member  20  in the same fashion as the adhesive  32  is employed with the base member  16 , and shown in  FIG. 2A . 
         [0031]    In operation, referring to  FIG. 6 , system  10  is removed from a sterile packaging (not shown). The system  10  is spread, as necessary, so that the base member  16  is on one side of the wound, the lock member  20  is on another side of the wound, and the strap  18  traverses the wound. With the locking mechanism  42  in the open position ( FIG. 5A ), the base member  16  and lock member  20  are affixed to the skin adjacent the wound, via the adhesive. Staples (not shown) may be used to further secure the base member  16  and lock member  20  to the skin adjacent the wound. Strap  18  is inserted into the open locking mechanism  42 . The base member  16  and lock member  20  may be drawn together, whereby the wound may be closed (closure may only be sufficient to prevent internal organs from spilling from the wound during transportation, full closure of the wound may not be necessary or possible). Thereafter, the lock mechanism  42  may be closed ( FIG. 5B ), so that the strap  18  is fixed in place. Excess strap  18  (e.g., strap  18  extending beyond lock member  20 ) may be trimmed, as desired. If necessary to gain access to the wound after closure with system  10 , the locking mechanism  42  may be released ( FIG. 5A ) for access and then reclosed ( FIG. 5B ). 
         [0032]    Optionally, wound covering  60  may be included with system  10 . Wound covering  60  adds, among other things, further protection to the wound. Wound covering  60  may also, without limitation, prevent ingress of contaminants into the wound, prevent spillage of internal organs from the wound, assist in retaining body heat, assist in retaining moisture that may escape from the wound, and provide a vehicle through which medicines and/or fluids may be administered to, or through, the wound. Wound covering  60  may be any size. For example, the wound covering  60  may have dimension of 12 inches by 12 inches by 3 mm. 
         [0033]    Wound covering  60 , in one embodiment, may be a laminate. The laminate may have at least two layers. A top layer  62  may be for preventing escape of heat and moisture through the wound and preventing ingress of contaminants to the wound. Top layer  60 , in one embodiment, may be an aluminized plastic sheet. The aluminized surface faces toward or away from the wound. A middle layer  64  may be for administering fluids and/or medicines to the wound. Middle layer  64  may be a hydrophilic foam and/or an opened cell foam. Middle layer  64  may be affixed to top layer  62 . Additionally, wound covering  60  may include a third layer. Bottom layer  66  may be a perforated plastic film, so that fluids and/or medicines fed into the middle layer  64  may be distributed into the wound. Top layer  62  may be joined to bottom layer  66  via a weld seam  68 . Weld seam may be made by any suitable technique (for example, thermal weld, ultrasonic weld, adhesive, radio-frequency weld, and the like). Wound covering  60  may further include a fluid ingress port  70 . Port  70  may be coupled with, for example, a saline bag (not shown). Port  70  is in fluid communication with middle layer  64  and extends beyond the weld line  68 . Fluids and/or medicines may be administered from the saline bag through the port  70  to middle layer  64 , and then into the wound from the middle layer  64  and through the bottom layer  66 . Port  70  may be a luer lock-type device. Wound covering  60  may be supplied with system  10  folded and packaged in a sterile packaging or can be opened and worn on the inside of a battlefield helmet. 
         [0034]    In operation, the wound covering  60  is spread over the wound, and then system  10  may be deployed as described above. 
         [0035]    The system  10  may be compressed into a relatively small sterile package and is light-weight. Thus, it may be easily carried into a battlefield situation. 
         [0036]    While, originally intended for short term closure, the system  10  may also have benefit in other surgical-type procedures, including, for example, any hospital/medical environment, such as an operating theater, emergency room, trauma center, or the like. 
         [0037]    The present invention may be embodied in other forms without departing from the spirit and the essential attributes thereof, and, accordingly, reference should be made to the appended claims, rather than to the foregoing specification, as indicating the scope of the invention.