Abstract:
The invention relates to a wound treatment device with at least one elastically deformable vacuum-generating element which can be actuated directly by hand and which is arranged on and connected directly to a film-like wound-covering element that covers the wound chamber. The vacuum-generating element is a hollow body whose cavity, in the state with the device applied to the patient&#39;s body, communicates directly with the wound chamber via an opening formed on the wound-covering element. At least one absorption body that absorbs the wound secretions is positioned in the wound chamber and is surrounded by a finely porous sleeve that is permeable to liquid. The hollow body is provided with at least one valve.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of application Ser. No. 12/096,264, filed Jul. 31, 2008, which application was a U.S. National Stage of International Application No. PCT/EP2006/012041, filed Dec. 14, 2006, and claims priority to German Patent Application No. DE 20 2005 019 670.3, filed Dec. 14, 2005. 
     
    
     BACKGROUND OF INVENTION 
       [0002]    1. Field of Invention 
         [0003]    The invention concerns a wound treatment device with at least one elastically deformable vacuum producing element, which can be operated directly by hand, being arranged on a film-like wound cover element, covering the particular wound cavity, and being connected to the latter tubelessly. 
         [0004]    2. Description of Related Art 
         [0005]    A wound treatment device of the above mentioned kind is found in DE 198 44 355 A1. The vacuum producing element shown in  FIG. 2  is glued directly to the wound cover film. The vacuum producing element is a bell-shaped hollow body, filled with a pre-compressed sponge, which swells up during the suction process only when a water-soluble plate located between the sponge and the wound surface dissolves. The pre-compressed sponge also presses against the entire inner surface of the hollow body. The compression and subsequent expanding of the sponge in the direction of the wound can also occur without a water-soluble plate if the sponge is compressed only when the bandage is put in place and the sponge is accommodated in the hollow body. The drawback in both instances is that the compressed sponge upon expanding presses against the sensitive wound surface. 
         [0006]    The problem of the invention is to design an improved wound treatment device with vacuum producing element, integrated with the wound cover film, wherein the pre-compressed filling can be done away with. 
       BRIEF SUMMARY OF THE INVENTION 
       [0007]    This problem is solved by a wound treatment device of this kind, wherein
       the vacuum producing element is a hollow body, whose cavity in the condition placed on the patient&#39;s body is in direct contact with the wound cavity via an opening worked into the wound cover element, and   at least one absorption body to absorb the wound secretions is placed in the wound cavity, being surrounded by a fine-pore, liquid-permeable envelope.       
 
         [0010]    The aim is to achieve a new kind of wound treatment device, in which the wound exudate is taken up by the absorption body, while at the same time the suction function is supported by a simplified vacuum system which can be activated by hand. The absorption body can be a sheet-like shape, whose final volume increases greatly in the course of the absorption process, without exerting a noteworthy pressure on the wound surface. However, if a pressure is to be exerted on the wound, one can at least resort to an additional absorption body, encased or not, which can be placed directly on the wound surface, i.e., underneath the mentioned flat absorption body. The additional absorption body can also take on the function of a trapping layer for the coarse, clumplike secretions. The absorption body can be placed dry or slightly pre-moistened on the wound surface. 
         [0011]    The additional absorption body can be a perforated pouch containing absorbent particles, a shaped piece of foam plastic or fleece, possible with superabsorbent particles. Superabsorbing foam plastic beads can be poured into the pouch. 
         [0012]    The encased absorption body can be one which is interspersed with superabsorbents. The envelope can have pores whose size does not greatly exceed that of the superabsorbing particles. In this way, the wound secretions sucked up remain inside the envelope until the absorption body is removed from the wound and help improve the climate of the wound space, i.e., maintain the moist surroundings. The wound exudate does not necessarily have to be taken away through an additional conduit, unless there is an excess of wound exudate. 
         [0013]    The absorption body can be made from various medically safe materials, such as open-cell foam plastic, gel or textile. Preferably, it consists of at least one layer of a fleece-like textile material containing cellulose and having superabsorbent particles, which is easy to work and make ready. The absorption body can consist of or contain alginate fibers. It is expressly pointed out that the absorption body (or bodies) placed in the wound cavity or in the cavity of the hollow body is (are) not pre-compressed. 
         [0014]    Finally, the shaped absorbing piece or the pouch with absorber particles contained therein can be placed directly on the wound, without having to use the mentioned encased sheet-like absorption body. 
         [0015]    In order to kill germs, the encased absorption body and/or the additional absorption body of fleece or foam plastic or an anti-adhesive film element which can be placed directly on the wound can be provided with substances containing silver or copper, for example, in nanocrystalline form. As the anti-adhesive film element, one can use a perforated so-called wound spacer grid, which is arranged between the wound surface and the absorption body. Substances containing zinc are also possible, and can support the wound healing process. 
         [0016]    Furthermore, the absorption body can contain carboxymethylcellulose, natural or synthetic hyaluronic acid, honey and/or its derivatives, propolis and/or pharmaceutically active plant extracts, such as Aloe vera. 
         [0017]    The compressible hollow body can have any desired external shape, provided that it is connected tubelessly to the wound cover element and sits stable thereupon. The hollow body can have the shape of a prism, such as a cuboid. Preferably, the hollow body is configured as an elastically deformable solid of revolution, such as one made of elastomer. The hollow solid of revolution can be spherical, cylindrical or conical, but it can also have the shape of a pear or oval cylinder. An especially advantageous configuration of the hollow body is a cuboidal or somewhat cylindrical bellows, which can be deformed essentially only in one direction, say, perpendicular to the emplaced would cover element. 
         [0018]    Preferably, the hollow body is joined to a circumferential flat collar, which can be joined to the wound cover element directly or via a cushion ring. The cushion ring can have a flat to round or toroidal cross section. The task of the cushion ring is to gently transfer the pressure on the hollow body when pressed by hand against the patient&#39;s skin and to distribute it evenly. The cushion ring can be made from any desired deformable and especially elastomeric material, such as rubber or plastic. 
         [0019]    The hollow body can also be designed as a single piece with the wound cover element. This can be the case, in particular, for the smaller sizes of wound cover element. A single-piece configuration can furthermore pertain to a product which is assembled from the hollow body, the wound cover element, and the encased absorption body. Here, “single-piece” refers to a one-part design, e.g., a molded piece. 
         [0020]    The wound treatment device can be provided with at least one window arranged on the wound cover element and able to be removed or swiveled, on which the mentioned hollow body sits. In this case, the wound cover element has at least one recess to accommodate the window. 
         [0021]    A vacuum indicator can be connected or connectable to the valve, by which the patient himself or the doctor can read off the vacuum level and change it if necessary by activating the hollow body or the valve. The vacuum indicator can be part of an external pump. The vacuum producing element itself, i.e., the hollow body, can take on the supplemental function of a vacuum indicator if it is appropriately scaled. For example, the vacuum indicator can be a scaled glass tube with piston, connected directly to the valve. 
         [0022]    With the wound treatment device according to the invention, the following kinds of wounds can be treated:
       mechanical wounds such as cuts and puncture injuries, bite wounds, gunshot wounds, abrasions;   iatrogenic wounds;   thermal wounds, such as burns;   chemical wounds, such as acid or alkali burns;   open wounds; and   perforating wounds and others.       
 
         [0029]    Some additional selected usage possibilities are listed below:
       as a dressing to treat an edematous or inflammatory altered wound region;   as a dressing to treat a microbially laden wound surface, by using the suction force to take germs or cell fragments into anaerobic regions of the swollen absorption body;   as a dressing to remove inflammatory cytokins, matrix metalloproteases, TIMPs, degraded fibronectin (holds the tissue together) or other substances causing chronicity;   as a dressing to regulate the air humidity, since the absorption body releases the aqueous components back into the air through their vapor pressure;   as a dressing on top of a primary applied wound spacer grid or a gauze as a secondary dressing having no immediate sheet-like contact with the wound;   as a dressing beneath a film permeable to water vapor to achieve a breathable dressing;   as a dressing during a compression therapy; and   as a dressing during a maggot therapy promoting epithelial cell migration and granulation, in which the larvae of  Lucilia sericata  are used; this involves, in particular, acute and chronic wound infections. Instead of larvae, a substance secreted by the maggots can be used, namely, their saliva.       
 
         [0038]    The benefits of the invention consist, in particular, in that:
       thanks to the use of the encased absorption body, the moist environment within the wound cavity can be maintained;   the absorption process can be supported by the air evacuation;   the air evacuation can be done by the patient; it is enough to exert a pressure by hand or finger on the bellows or the ball of the hollow body;   the absorption body can serve as a storeroom for the wound exudate; the liquids need not be carried away from the wound region; instead, they can be gathered close to the wound; and   the time and the costs of the wound treatment can be reduced.       
 
         [0044]    The foregoing and other features of the invention are hereinafter more fully described and particularly pointed out in the claims, the following description setting forth in detail certain illustrative embodiments of the invention, these being indicative, however, of but a few of the various ways in which the principles of the present invention may be employed. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0045]    Sample embodiments of the invention are explained more closely hereafter by means of the drawing. The figures show: 
           [0046]      FIG. 1 , a wound treatment device with a bell-shaped hollow body, glued onto the skin of the patient, in a schematic representation; 
           [0047]      FIG. 2 , the wound treatment device per  FIG. 1  in a perspective view; 
           [0048]      FIG. 3 , the wound treatment device per  FIG. 1  with a thickening arranged in its apex region, in a schematic representation; 
           [0049]      FIG. 4 , the wound treatment device per  FIG. 1  in use; 
           [0050]      FIG. 5 , the wound treatment device per  FIG. 1  in a top view of the wound cover element; 
           [0051]      FIG. 6 , the wound treatment device per  FIG. 1 , with a cushion ring, in a schematic representation; 
           [0052]      FIG. 7 , the cushion ring in top view of its flat side; 
           [0053]      FIG. 8 , a cross section A-A per  FIG. 7 ; 
           [0054]      FIG. 9   a , a second embodiment of the bell-shaped hollow body, with inward pointing projections, in a schematic view; 
           [0055]      FIG. 9   b , the hollow body per  FIG. 9   a  with swollen absorption body; 
           [0056]      FIGS. 10   a  to  10   c , a further, single-piece embodiment of the wound treatment device, likewise in a schematic representation; 
           [0057]      FIGS. 11   a  to  12 , a fourth, bellows-like embodiment of the wound treatment device, in a schematic representation; 
           [0058]      FIG. 13 , a wound treatment device with a cuboidal, bellows-like hollow body, in a perspective view; 
           [0059]      FIG. 14 , the wound treatment device per  FIG. 11 , with a cushion ring, in a schematic representation; 
           [0060]      FIG. 15 , a wound treatment device with a ball-shaped hollow body, in a schematic representation; and 
           [0061]      FIG. 16 , a hollow body with bottom plate element, likewise in a schematic representation. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0062]      FIGS. 1 and 2  show a first embodiment (reference number  100 ) of the wound treatment device, consisting of a film-like wound cover element  2 , a bell-shaped hollow body  4 . 1  and an absorption body  5 . The hollow body  4 . 1  is made as a molded piece of polyethylene in the deep drawing process. The wall thickness of the translucent hollow body is 0.8 mm. The spherical molded piece passes into a peripheral flat collar  14 , which is glued onto the wound cover element  2  by means of a medically safe adhesive. The wall of the hollow body bounds a cavity  7 , which is in direct contact with a wound cavity  1  via an opening  3  made in the wound cover element  2 . The wound cavity  1  is defined by a wound surface, designated as  24 , and the wound cover element 2. 
         [0063]    The hollow body  4 . 1  is provided with a one-way valve  12 , which allows the flow through of air and—if necessary—excess wound secretions, if the hollow body is connected via an additionally provided conduit  19  to a corresponding mechanical or electrical suction device (not shown), in one direction (arrow R). Thus, a return flow from the outside is prevented. Even so, another one-way valve  13  (see  FIG. 2 ) can be provided, with which the pressure inside the hollow body and thus in the wound cavity  1  can be regulated. Medications can be dispensed via a conduit  23 , indicated by broken line. 
         [0064]      FIGS. 1 ,  3  and  4  shows the wound treatment device  100  in use. First, the opening  3  on the film-like wound cover element  2  is cut out according to the wound size and the wound cover element  2  is glued onto the skin of the patient. The absorption body  5  is laid flat in the wound cavity  1  underneath the wound cover element  2  and only then is the hollow body  4 . 1  installed with its flat collar  14 .  FIGS. 1 and 3  show this condition. The absorption body  5  is surrounded by a perforated envelope  6 , whose dimensions (width and length, or diameter) are much larger than those of the absorption body. In the present case, the absorption body  5  is around 5.5 cm×5.5 cm in plan view on its flat side and the envelope is around 7.0 cm×7.0 cm in size. 
         [0065]    According to  FIG. 3 , the hollow body 4.1 has a thickening 17 in the region of its apex  18 , which can facilitate the deformation of the hollow body when pressing on it by hand, as shown in  FIG. 4 . 
         [0066]    The embodiment per  FIG. 5  calls for arranging the hollow body  4 . 1  on a round window  15 , which can swivel via a film hinge  20 . The window  15  is coated peripherally on its underside with a release glue  21 , so that it can be opened and glued back again as needed, for example, in order to take out the swollen absorption body. A pull flap  11  facilitates the handling of the window. 
         [0067]    The hollow body  4 . 1 , as shown in  FIG. 6 , can be braced against a cushion ring  8  by its flat collar  14 . The cushion ring  8  (see  FIGS. 7 and 8 ) is made from an elastomeric material, which allows the pressing forces exerted by hand to be distributed over its entire surface. It is beneficial that the cushion ring  8  can increase the effective volume of the cavity  7  of the hollow body  4 . 1 . 
         [0068]      FIGS. 9   a  and  9   b  show a similar embodiment (designated  200 ) of the wound treatment device, in which several spacers  22  are provided on the inside of the hollow body  4 . 2 . A perforated pouch  10  with a somewhat lens-shaped absorption body  9  contained therein is laid in the wound cavity  1 . When the absorption body  9  swells to its maximum volume (see  FIG. 9   b ), the spacers  22  prevent the absorption body  9  from taking up the entire cavity  7 , since some free spaces  16  remain between the envelope  6  and the inner surface of the hollow body  4 . 2 , making it possible to dispense liquid medications via the conduit  23  (see  FIG. 2 ) even before removal of the absorption body  9 . 
         [0069]    Optionally, the absorption bodies  5 ,  9  can contain a quantity of nanoparticles of silver, copper or zinc, which are useful as antibacterial agents. 
         [0070]      FIG. 16  shows a hollow body whose ball-shaped, compressible part  29  passes into a plate-like bottom element  28 , on which is arranged an opening  27 , situated in the middle, and making contact with the wound cavity  1  (not shown). The bottom element  28  makes possible a uniform distribution of pressure when exerting pressing force by hand. 
         [0071]      FIGS. 10   a,    10   b  and  10   c  show a one-piece wound treatment device  300 , consisting of a hollow body  4 . 1  or  4 . 2  with a film segment of the wound cover element, an absorption body  5  glued to this, and a removable, peripherally arranged, ring shaped protective film  25 . The collar  14  of the hollow body  4 . 1  is firmly glued or welded to the wound cover element. Before putting the wound cover element in place, the protective film  25  is pulled off, so that a glue layer  26  located on the underside of the wound cover element is exposed (see  FIG. 10   b ) and the device can be glued onto the patient&#39;s skin all around the wound (see  FIG. 10   c ). The wound treatment device  300  is designed as a prefabricated disposable product, which can be made in various sizes. 
         [0072]      FIGS. 11   a,    11   b  and  12  show a wound treatment device  400 , which is basically similar to that shown in  FIG. 5 , with the difference that its hollow body  4 . 3  has the shape of a cylindrical bellows, which can be deformed basically only in one direction, corresponding to a pressing force designated as P (see  FIG. 11   b ). The bellows can be compressed very easily by hand or by finger.  FIG. 12  shows, in turn, the bellows-like hollow body  4 . 3  in two positions. The hollow body  4 . 3  can be swiveled through a very wide angle a by the film hinge  20 . 
         [0073]    The embodiment of  FIG. 13  is a wound treatment device  500  having a film-like rectangular window  15 , on which a cuboidal hollow body  4 . 4  is arranged. The design principle of the wound treatment device  500  is identical to that of the wound treatment device  400 . 
         [0074]    As  FIG. 14  shows, the two hollow bodies  4 . 3 ,  4 . 4  can likewise be braced against the cushion ring  8  by their flat collar  14 . Preferably, the bellows of the hollow body is configured such that its portion extending from the flat collar  14  has smaller dimensions (diameter or width) than those of the compressible part. This configuration makes it possible to shove the finger of the hand underneath the upper, compressible part and press the bellows with the thumb, without having to exert pressure on the wound cover element  2 . 
         [0075]    Finally,  FIG. 15  shows a wound treatment device  600  whose hollow body  4 . 5 , provided with the flat collar  14 , is roughly pear shaped. The one-way valve  12  can be seen in the apex region. 
         [0076]    All wound treatment devices  100  to  600  described, and their parts, come in sterile packaging. 
       TABLE OF REFERENCE SYMBOLS USED IN THE DRAWING FIGURES 
       [0077]    Table of reference symbols: 
         [0000]    
       
         
               
               
             
           
               
                   
               
             
             
               
                 1 
                 wound cavity 
               
               
                 2 
                 wound cover element 
               
               
                 3 
                 opening 
               
               
                 4.1 to 4.5 
                 hollow body 
               
               
                 5 
                 absorption body 
               
               
                 6 
                 envelope 
               
               
                 7 
                 cavity 
               
               
                 8 
                 cushion ring 
               
               
                 9 
                 absorption body 
               
               
                 10 
                 pouch 
               
               
                 11 
                 pull flap 
               
               
                 12; 13 
                 one-way valve 
               
               
                 14 
                 flat collar 
               
               
                 15 
                 window 
               
               
                 16 
                 space 
               
               
                 17 
                 thickening 
               
               
                 18 
                 apex 
               
               
                 19 
                 conduit (additional) 
               
               
                 20 
                 hinge 
               
               
                 21 
                 release glue 
               
               
                 22 
                 spacer 
               
               
                 23 
                 one-way valve 
               
               
                 24 
                 wound surface 
               
               
                 25 
                 protective film 
               
               
                 26 
                 glue layer 
               
               
                 27 
                 bottom element 
               
               
                 28 
                 opening 
               
               
                 29 
                 part 
               
               
                 α 
                 angle 
               
               
                 P 
                 pressing force 
               
               
                 R 
                 direction 
               
               
                 100; 200; 300; 
                 wound treatment 
               
               
                 400; 500; 600 
                 device 
               
               
                   
               
             
          
         
       
     
         [0078]    Additional advantages and modifications will readily occur to those skilled in the art. Therefore, the invention in its broader aspects is not limited to the specific details and illustrative examples shown and described herein. Accordingly, various modifications may be made without departing from the spirit or scope of the general inventive concept as defined by the appended claims and their equivalents.