Patent Publication Number: US-2005125033-A1

Title: Wound closure apparatus

Description:
BACKGROUND  
      Since their first introduction on the U.S. market, tissue adhesives have been gaining acceptance in the operating room as an attractive alternative to the use of sutures for closing skin lacerations. This technology takes less time to apply and causes less pain than suturing, and requires no dressing or needle use. This is especially useful in the case of children, or when small-caliber sutures must be removed from sensitive areas of the face. In addition, the risk of needle-stick injury and transmissible infections for operating room personnel is removed.  
      Surgical adhesives such as cyanoacrylate glues have the advantage that they are generally easy to dispense. However, application of adhesives during any surgical procedure can be cumbersome. Because of their liquid nature, these adhesives are difficult to precisely position on tissue and thus require adept and delicate application if precise positioning is desired. Cyanoacrylates also harden rapidly; therefore, the time available to the surgeon for proper tissue alignment is limited.  
      Improvements to currently available biologic and synthetic adhesives are addressed in a co-pending U.S. patent application: Non-Light Activated Biological Adhesive Device, System, and Methods of Use Thereof, Ser. No. 10/610,068, filed June 2003 (to co-inventors McNally-Heintzelman K M, Heintzelman D L, Bloom J N and Duffy M T). The present application describes locking wound closure clamps designed to facilitate the use of the adhesive described in the above mentioned U.S. patent application, as well as other surgical adhesives and adhesive-enhanced repair techniques.  
     SUMMARY  
      One aspect of the present invention relates to a locking wound closure apparatus, system and method for placing wound edges in close apposition to allow for a proper closure. In accordance with the present invention, a wound closure apparatus is provided, which includes first and second clamp arms coupled together at one end. Each clamp arm includes a blade. Each blade includes a gripping surface. The blades on the clamp are separated by a well for placement of an adhesive material. The clamp is configured to isolate the wound field and align the wound edges to allow for precise placement of the adhesive material.  
      Another aspect of the present invention relates to a locking mechanism that allows a single user to both clamp and set an adhesive material in place. Thus, in an alternative embodiment, the wound closure apparatus further includes a locking mechanism. In the illustrated embodiment, the locking mechanism includes a pair of spaced apart locking members configured to engage one another. In the illustrated embodiment, a first locking member is coupled to the first clamp arm and a second locking member is coupled to the second clamp arm. In certain embodiments, the locking mechanism has a variable width to allow for customized selection of the size of the adhesive material.  
      Yet another aspect of the present invention relates to a plurality of interchangeable blades, manufactured, for example, with variable length and weight, to suit a broad range of wound closures. Accordingly, a wound closure system is also provided, which includes a wound closure apparatus and a plurality of blades.  
      Still another aspect of the present invention involves a separate instrument to provide custom curvilinear bending of the blades such that they can be contoured to suit non-linear wounds. Accordingly, an alternative wound closure system is provided, which includes a wound closure apparatus and a blade adjustment apparatus.  
      A further aspect of the present invention relates to a locking wound closure apparatus configured to facilitate closure of higher tension wounds. In one embodiment, the clamp of the wound closure apparatus has a heavier weight. In another embodiment, the blades include dentals or dental-like protrusions configured to engage thicker skin and/or skin under high tension. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       FIG. 1   a  is a perspective view of an embodiment of a wound closure apparatus used to place wound edges in close apposition for proper closure;  
       FIG. 1   b  is a side view of a first embodiment of a blade and gripping portion for use with the wound closure apparatus of  FIG. 1   a;    
       FIG. 1   c  is a side view of a second embodiment of a blade and gripping portion for use with the wound closure apparatus of  FIG. 1   a;    
       FIG. 1   d  is a top view of the apparatus of  FIG. 1   a,  while in use holding a wound closed;  
       FIG. 1   e  is a side view of a third embodiment of a blade and gripping portion for use with the apparatus of  FIG. 1   a;    
       FIG. 1   f  is a top view of the apparatus of  FIG. 1   a,  with the blade and gripping portion of  FIG. 1   e,  while in use;  
       FIG. 2   a  is a perspective view of a first alternative embodiment of a wound closure apparatus used to facilitate closure of high tension wounds;  
       FIG. 2   b  is a perspective view of a second alternative embodiment of a wound closure apparatus used to facilitate closure of high tension wounds;  
       FIG. 2   c  is a perspective view of a third embodiment of a wound closure apparatus used to facilitate closure of high tension wounds;  
       FIG. 2   d  is a top view of the blades of the apparatus of  FIG. 2   a  in use, closing around an incision; and  
       FIG. 2   e  is a side view of the blade shown in  FIG. 2   a.   
    
    
     DETAILED DESCRIPTION  
       FIGS. 1   a - 1   f  show various features and alternative designs of portions of a wound closure apparatus in accordance with the present invention.  FIG. 1   a  shows one embodiment of the wound closure apparatus.  
      The wound closure apparatus  100  of  FIG. 1   a  includes first and second clamp arms  102 ,  104  coupled together at a joint  126  by an adhesive, solder, fastener, or any other suitable coupling means known in the art. Clamp arms  102 ,  104  include locking members  108 ,  110  of locking mechanism  106 . Clamp arms  102 ,  104  also include blade portions  116 ,  118  located on the ends of clamp arms  102 ,  104  opposite joint  126 .  
      The various portions of wound closure apparatus  100  are made of surgical steel or other suitable material known in the art. Portions of clamp arms  102 ,  104  may be coated or enclosed in a synthetic material such as a foam, rubber or other suitable high-friction material to provide for easier maintenance and handling by the medical professional.  
      Locking mechanism  106  operates to hold blades  116 ,  118  in place after application to a wound area. In particular, locking mechanism  106  allows the medical professional to remove his/her hand from wound closure apparatus  100  after a wound has been closed, so that the hand is free to apply an adhesive to the wound site or perform other tasks.  
      First locking member  108  includes at least one coupling portion  112 , e.g., gradation, ridge, hook, or the like that is sized to mate with a corresponding coupling portion (not shown), e.g., depressions, catches, rings, or the like of second locking member  110 . It is understood that any suitable coupling mechanism known in the art may be used to couple locking members  108 ,  110  together.  
      In addition, locking members  108 ,  110  preferably include at least two such coupling mechanisms, so that wound closure apparatus  100  is adjustable to wounds of varying widths or thicknesses.  
       FIG. 1   d  shows an example of wound closure apparatus  100  in a locked position, holding a wound closed with the wound edges aligned. Through the use of an adjustable locking mechanism  106  and various alternative blades  116 ,  118 , the amount of force or tension exerted on the wound site can be controlled and adjusted to achieve the desired alignment of the wound edges.  
      As noted above, blades  116 ,  118  are configured with a gripping portion  122 . The characteristics of the gripping portion are selected as appropriate based on the type, size, or location of the wound, the type of adhesive or method of wound closure being used, or other criteria.  
       FIG. 1   b  shows one variation of a gripping portion. Interior surface  128  of at least one of blades  116 ,  118  has an irregular character, for example, including alternating raised areas (shown as shaded squares) and flat or depressed areas (unshaded squares). Protrusions  130  are coupled to outer surface  124  of blades  116 ,  118  by solder, adhesive or other coupling means, or are molded with each blade  116 ,  118 . As shown in  FIG. 1   b,  protrusions  130  are essentially cone-like in shape.  
       FIG. 1   c  shows another variation of gripping portion  122 , including bumps  132  coupled thereto in an alternating pattern to provide an irregular surface. Bumps  132  are coupled to gripping portion  122  via any suitable coupling means mentioned above or otherwise known in the art, or are molded into gripping portion  122  by known techniques. Protrusions  134  generally have a smaller diameter or thickness than the protrusions  130  shown in  FIG. 1   b  and are essentially pin- or needle-like in shape.  
      In the alternative design of  FIG. 1   e,  gripping portion  122  is more or less smooth, but dentals or other tooth-like protrusions  138  are coupled to outer surface  124 . As shown, each protrusion  138  has an irregular edge  140 .  FIG. 1   f  shows the embodiment of  FIG. 1   e,  in use to hold wound  136  closed.  
       FIGS. 2   a,    2   b,  and  2   c  show alternative embodiments of a wound closure apparatus  200  in accordance with the present invention.  
      As shown in  FIG. 2   a,  wound closure apparatus  200  includes clamp arms  202 ,  204 , blades  210 ,  212  coupled to or molded from clamp arms  202 ,  204 , and locking members  206 ,  208  as described above. Clamp arms  202 ,  204  are coupled together at end  220 .  
      In the embodiment of  FIG. 2   a,  blades  210 ,  212  each have a gripping member which includes a center portion  214  and end portions  216 ,  218  adjacent each end of center portion  214  as shown. End portions  216 ,  218  are angled inwardly away from the blades  210 ,  212  to which they are attached. In the illustrated embodiment, the angles  238  formed by the intersection of the end portions  216 ,  218  with a longitudinal axis  242  of the clamp arm is greater than 90° as best shown in  FIG. 2   e.    
      The inner surfaces of end portions  216 ,  218  and center portion  214 , i.e., the surfaces facing toward the gripping surface of the opposite clamp arm, are illustratively smooth. However, it is understood that one or more of such inner surfaces may have an irregular or rough character. For example,  FIG. 2   b  shows a center portion  214  with at least one dental-like protrusion  222 .  
      End portions  216 ,  218  are configured to form a “well” around the wound when apparatus  200  is in use. The well is designed to hold a volume of adhesive in the area of the wound.  
      The embodiment of  FIG. 2   c  includes an alternative form of gripping mechanism. This embodiment is configured to enable the medical professional to position, move or manipulate a scaffolding or adhesive composite while still holding the edges of a wound in the desired alignment.  
      The alternative gripping mechanism of  FIG. 2   c,  referred to as the “reverse action grip,” includes an adjustment member  226  coupled to or molded with a cross member  228 . Cross member  228  is coupled to or molded with side members  230  which run along the outer edges of clamp arms  202 ,  204 .  
      Adjustment member  226  includes a curved portion  232  which controls movement of reverse action grips  224 . When pressure is applied to adjustment member  226  in the direction of arrow  236 , reverse action grips  224  move in the corresponding direction of arrow  234 . For example, if adjustment member  226  is moved downwardly toward blades  210 ,  212 , reverse action grips  224  will move downwardly away from blades  210 ,  212 , thus creating a gap between grips  224  and blades  210 ,  212 . If adjustment member  226  is moved upwardly toward end  220 , reverse action grips  224  move upwardly toward blade portions  210 ,  212 , thus closing the gap between grips  224  and blades  210 ,  212 . Operation of adjustment member  226  can be performed independently of locking mechanism  206 ,  208 . In the illustrated embodiment, adjustment member  226  controls the action of both grips  224  simultaneously. In an alternative embodiment, grips  224  are independently controllable.  
      In the illustrated embodiment, cross member  228  is sufficiently flexible or resilient so that when clamp arms  202 ,  204  move toward or away from each other (e.g., to engage locking mechanism  206 ,  208 ), cross member  228  flexes inwardly or outwardly as needed.  
      In  FIG. 2   c,  curved portion  232  is sized to accommodate a human finger, such as an index finger, for ease of use by the medical professional. With end  220  proximate to the palm of the hand, and the index finger curled around curved portion  232 , the action of retracting index finger backwardly toward the palm accomplishes upwardly movement of reverse action grips  224  toward blades  210 ,  212 .  
       FIG. 2   d  shows the embodiment of  FIG. 2   a  while in use to surround a wound site  240  and keep the wound edges aligned.  
      Although the present invention has been described in detail with reference to certain exemplary embodiments, it is understood that variations and modifications exist and are within the scope and spirit of the present invention.