Patent Publication Number: US-9839560-B2

Title: Wound dressing, ingredient delivery device and IV hold-down, and method relating to same

Description:
CLAIM OF PRIORITY 
     This application is a continuation of U.S. Pat. No. 7,888,546, issued on Feb. 15, 2011, entitled “WOUND DRESSING, INGREDIENT DELIVERY DEVICE AND IV HOLD-DOWN, AND METHOD RELATING TO SAME,” which is a 371 of PCT/US04/21521 filed on Jul. 2, 2004, claims the benefit of: U.S. Provisional Patent Application No. 60/570,666, filed on May 13, 2004; U.S. Provisional Patent Application No. 60/508,088, filed on Oct. 2, 2003; and U.S. Provisional Patent Application No. 60/484,711, filed on Jul. 3, 2003. All of the above-identified applications are incorporated herein by reference. 
     BACKGROUND OF THE INVENTION 
     The present invention relates to adhesive devices used as wound dressings, ingredient delivery devices and IV hold-downs. 
     Wound dressing and IV hold-downs in particular comprise a layer of polymeric film having an adhesive layer on one side thereof, which is protected during storage and handling by a release liner. United States Patent Publication 2002/0107466 A1 discloses such devices which also have a handling member adhered to the non-adhesive coated side of the polymeric film by means of a pressure sensitive adhesive. The pressure sensitive adhesive used between the handle and the polymeric film is less aggressive than the pressure sensitive adhesive used on the underside of the polymeric film, such that once the polymeric film is applied to a patient&#39;s skin or mucosa, the handle can be peeled away without peeling the polymeric film away from the patient&#39;s skin. 
     Experience has shown that regardless of differences in adhesive strength between the skin or mucosa adhesive and the handle adhesive, there is a tendency for the edge of the polymeric film to lift away from the user&#39;s skin or mucosa when the handle member is peeled away from the back of the polymeric film. This same tendency is observed in the wound dressing disclosed in U.S. Pat. No. 6,169,224, where the handling member is sealed to the polymeric film by a heat activated adhesive. 
     SUMMARY OF THE INVENTION 
     In the various aspects of the present invention, inadvertent edge release caused by peeling the handle member away from the polymeric film can be minimized by the following methods or combinations thereof:
         1. minimizing the electrostatic charge buildup in the localized area of the polymeric film beneath the handle, as the handle is peeled away from the film; and/or   2. decreasing the mechanical advantage of the handle relative to the thin film.       

     In various different preferred aspects of the invention, either or both of these are accomplished by:
         1. interrupting the continuity of contact between the handle and the underlying surface of the polymeric film to which the handle is adhered, said adherence either being due to electrostatic attraction or to the use of an adhesive layer on the underside of the handle;   2. placing an anti-static ingredient in one of, the adhesive coating on the underside of the polymeric film, or in an anti-static coating on the upper or lower surface of the polymeric film itself, with the anti-static agent preferably being located in an adhesive layer on the underside of the polymeric film;   3. removing at least a portion of the periphery of the handle layer, or of the adhesive layer on the underside of the handle if one issued, so that it does not extend to the periphery of the polymeric film layer upon which the handle layer resides; and/or   4. reducing the surface area of the adhesive coating disposed on the periphery of handle.       

     In another aspect of the invention, an inwardly-directed thumb tab, oriented at an obtuse angle with respect to the edge of the handle in the direction in which the handle is pulled, is provided to facilitate peeling of the handle away from the polymeric film. Such a thumb tab enhances the ease with which the handle is peeled away from the polymeric film. The thumb tab starts the peeling at such an angle that the tendency of the handle to lift the underlying polymeric film away from the patient&#39;s skin or mucosa is minimized. 
     These and other objects, features and advantages of the invention will be more fully understood and appreciated by reference to the written specification and appended drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a plan view of a wound dressing, ingredient delivery device, or IV hold-down in accordance with a first embodiment of the present invention; 
         FIG. 2  is a cross sectional view of the wound dressing, ingredient delivery device, or IV hold-down of  FIG. 1 , taken along line II-II of  FIG. 1 ; 
         FIG. 3  is a perspective view of a wound dressing, ingredient delivery device, or IV hold-down of  FIG. 1 , with the handle being removed; 
         FIG. 4  is an enlarged sectional view of a wound dressing, ingredient delivery device, or IV hold-down of  FIG. 2 , taken at section IV of  FIG. 2  with the release liner removed; 
         FIG. 5  is a plan view of a wound dressing, ingredient delivery device, or IV hold-down in accordance with a second embodiment of the present invention; 
         FIG. 6  is a cross sectional view of a wound dressing, ingredient delivery device, or IV hold-down of  FIG. 5 , taken along line VI-VI, with the release liner removed; 
         FIG. 7  is a plan view of a wound dressing, ingredient delivery device, or IV hold-down in accordance with a third embodiment of the present invention. 
         FIG. 8  is a cross sectional view of a wound dressing, ingredient delivery device, or IV hold-down of  FIG. 7 , taken along line VII-VII of  FIG. 7 ; 
         FIG. 9  is a plan view of a wound dressing, ingredient delivery device, or IV hold-down in accordance with a fourth embodiment of the present invention. 
         FIG. 10  is a cross sectional view of a wound dressing, ingredient delivery device, or IV hold-down of  FIG. 9 , taken along line X-X of  FIG. 9 ; 
         FIG. 11  is a cross sectional view of a wound dressing, ingredient delivery device, or IV hold-down in accordance with a fifth embodiment of the present invention; 
         FIG. 12  is a cross sectional view of a wound dressing, ingredient delivery device, or IV hold-down in accordance with a sixth embodiment of the present invention; 
         FIG. 13  is a cross sectional view of a wound dressing, ingredient delivery device, or IV hold-down in accordance with a seventh embodiment of the present invention; 
         FIG. 14  is a cross sectional of a wound dressing, ingredient delivery device, or IV hold-down in accordance with an eighth embodiment of the present invention; 
         FIG. 15  is a plan view of a wound dressing, ingredient delivery device, or IV hold-down of  FIG. 14 ; 
         FIG. 16  is a plan view of a wound dressing, ingredient delivery device, or IV hold-down; 
         FIG. 17  is a cross sectional view of the wound dressing, ingredient delivery device, or IV hold-down of  FIG. 16 , taken along line XVII-XVII of  FIG. 16 ; 
         FIG. 18  is a plan view of a wound dressing, ingredient delivery device, or IV hold-down in accordance with a tenth embodiment of the present invention; and 
         FIG. 19  is a plan view of a wound dressing, ingredient delivery device, or IV hold-down in accordance with an eleventh embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENT 
     Introduction 
     The term “dressing” as used herein is to be understood to include wound dressings, IV hold-downs and transdermal, dermal, transmucosal and mucosal delivery systems. The various preferred embodiments disclosed herein have many components or similar components in common, which are described in this Introduction using numbers which are common to all embodiments. The differing embodiments, and the similar elements thereof, are distinguished by adding the letters a-j. 
     In the various preferred embodiments, the basic elements of a device in accordance with the present invention comprise a handle  10  having either an adhesive coating  20  on the undersurface thereof or being electrostatically adhered to an underlying polymeric film  30 , and preferably having an inwardly-projecting thumb tab  11  ( FIGS. 1-3 ). Handle  10  is applied to the non-adhesive coated surface of a polymeric film  30  having a pressure sensitive adhesive layer  40  on the undersurface thereof. Adhesive layer  40  is protected during handling and storage by a release liner  50  having a silicone coating layer  51 . In use, release liner  50  is removed from the assembled polymeric film  30  and handle  10 , and handle  10  is then used to manipulate the polymeric film and place it on the patient. Once the polymeric film has been applied to the patient, the user grasps inwardly-projecting thumb tab  11  on handle  10  and peels handle  10  away from the applied polymeric film  30 . 
     Inadvertent edge release caused by removal of the handle  10  is minimized by any one or any combination of the following:
         1. the angle at which thumb tab  11  projects from handle  10 ;   2. by minimizing the build up of localized electrostatic charge on the polyurethane film as the handle is removed; and/or   3. decreasing the mechanical advantage of handle  10  relative to film  30 .       

     Objects  2  and  3  are accomplished by any one or any combination of the following:
         1. interrupting the continuity of contact between the handle and the underlying non-adhesively coated surface of the polymeric film;   2. placing an anti-static ingredient in one of, the adhesive coating on the underside of the polymeric film, or in an anti-static coating on the upper or lower surface of the polymeric film itself, with the anti-static agent preferably being located in the adhesive layer on the underside of the polymeric film;   3. removing at least a portion of the periphery of the handle layer, or of the adhesive layer on the underside of the handle, if one issued, so that it does not extend to the periphery of the polymeric film layer upon which the handle layer resides; and/or   4. reducing the surface area of the adhesive coating disposed on the periphery of handle.       

     Handle  10  is preferably made of a stiffer and generally thicker material than that of polymeric film  30 . Typical of such materials are plastic or paper material. Useable plastics include polyesters, polycarbonates, PVC&#39;s, polyurethanes, polyethylene vinyl acetates, polyester copolymers, polyethylenes, and polypropylenes. In the preferred embodiment a silicone coated paper  50 , with a silicone coating  51  on the upper surface thereof, is used. 
     In  FIG. 2 , the undersurface of each handle  10  is coated with an optional adhesive layer  20 , preferably a pressure sensitive adhesive which is moderately aggressive with respect to polymeric film  30 , but which does not adhere or adheres less aggressively to either the silicone coating  51  on release liner  50  or to human skin. In this way, a user can readily fold back an end portion of release liner  50  to expose an end of handle  10 , and the exposed end can then be used to peel film  30  away from release liner  50 . The adhesive of layer  20  is “moderately aggressive” in that handle  10  remains attached to polymeric film  30  when it is peeled away from release liner  50 , and while it is being handled and applied to the patient&#39;s skin. However, adhesive  20  is less aggressive with respect to its adhesion to polymeric film  30 , than is the adhesion of layer  40  on the undersurface of polymeric film  30  toward human skin or mucosa. As a result, handle  10  can be peeled away from polymeric film  30 , once film  30  is applied to the patient. 
     One type of adhesive which we have found useful for layer  20  on the undersurface of handle  10  is a low tack removable acrylate-based adhesive with a peel adhesive level of approximately three ounces. Other useful adhesives include, but are not limited to, silicone, urethane, synthetic rubber and natural rubber. Adhesives of this type can be formulated to have essentially no or very little adhesion to the human skin or to the silicone coating  51  on the release liner  50 , but still adhere firmly but releasably to film  30 . 
     Alternatively, handle  10  can be electrostatically adhered to polymeric film  30 , rather than through the use of an adhesive layer on the undersurface of handle  10 . In such an embodiment, handle layers  10  and  20  as shown in the drawings comprise a layer of non-conductive material  10 , e.g., a layer of polymeric film, and a layer of conductive material  20  (rather than a layer of adhesive). For example, a layer of aluminum  20  might be vapor deposited onto non-conductive polymeric film layer  10 . 
     Optionally, conductive layer  20  may be disposed between two layers of non-conductive polymeric films, rather than having a single layer on only one side. However, only one non-conductive layer  20  is required, and handle  10 - 20  can be applied to polymeric film  30  with either conductive layer  20  applied directly against film  30 , or with non-conductive layer  10  lying against film  30 . The static change generated during handling of the materials in manufacture is sufficient to electrostatically bond handle  10 - 20  to film  30 . An optional corona treatment may be used as a way to increase the electrostatic surface adhesion of the polymeric film, but it is not necessary. 
     A second electrostatic charge is created during the application process which enhances the electrostatic bond between handle  10 - 20  to polymeric film  30 . This second electrostatic charge is generated when release liner  50  is peeled away from the adhesive layer  40  on the undersurface of film  30 . Though not wishing to be bound by theory, when these two materials are separated, a positive charge will accumulate on the surface of the polyurethane and a negative charge on the release liner. Since two oppositely charged surfaces will attract each other, the positive static charge of polymeric film  30  is then attracted to the electron rich, negatively charged, conductive material  20 . Therefore, this additional statically attractive force adds to the retention of handle  10 - 20  to polymeric film  30 , and tends to remain until the user applies the system to the patient, at which time the system is grounded, thereby removing or at least diminishing the electrostatic attractive force. 
     Polymeric film  30  is preferably comprised of any breathable and waterproof material. In the preferred embodiment, a polymeric film on the order of from about 0.5 to about 4 mils (0.0005 to 0.004 inches) is preferred. The film is preferably very flexible, allowing it to conform readily to the user&#39;s skin or mucosa. The film must have sufficient strength to afford resistance to damage in handling and in use. It also preferably allows the passage of oxygen, thereby allowing the skin or mucosa to breathe. The polymeric film material preferably is a polyurethane film such as a Pebax® film (MediFilm 810, 2 mils, Mylan). Additionally, copolymers of polyethylene and vinyl acetate are also preferable. 
     The adhesive layer  40  may be any adhesive that bonds well to skin or mucosa. Preferably, a pressure sensitive adhesive is used. A type of adhesive found useful for adhesive layer  40  is a permanent acrylate-based pressure sensitive adhesive designed for skin, with a peel adhesion level of approximately 50 ounces. Other useful adhesives include, but are not limited to, silicone, urethane, synthetic rubber and natural rubber. Such adhesives can be formulated to adhere releasably to the silicone coated surface  51  of a release liner  50 . At the same time, they can be formulated to adhere firmly to the patient&#39;s skin or mucosa such that polymeric film  30  will not peel away unless someone intends to do so. For example, one can use an acrylate derivative adhesive such as copolymers of alkyl acrylate/vinyl acetate containing —OH or/and —COOH functional groups, or hydrophobic styrenic rubber polymer or PIB containing 1 to 20% hydroattractants such as PVP, PVA, and cellulose derivatives such as Duro-Tak 87-2516 (National Starch), and PIB containing 20% Kollidong® CL-M (BASF). 
     The entire assembly of handle  10 , adhesive layer  20 , polymeric film  30  and adhesive layer  40  is releasably adhered to a release liner  50 . Release liner  50  may be comprised of any material that will releasably adhere adhesive layer  40 . However, in the preferred embodiment, release liner  50  is a paper material with a silicone coating  51  on the top surface thereof. 
     The very properties of polymeric film  30  which make it desirable in use make it difficult to handle in application. The drape and flexibility properties of polymeric film  30  may cause it to fold over onto itself and self-adhere relatively easily when one is trying to apply the system to the user&#39;s skin. The thicker handle  10  disclosed in the preferred embodiment reduces these shortcomings and makes the systems relatively easy to apply without fouling polymeric film  30 . However, the structural characteristics of the stiffer and generally thicker material of handle  10  which aid in the application is compromised when a cut line  13  is made to handle  10  ( FIG. 1 ). Cut line  13 , which aids the applicator in the removal of handle  10 , compromises the structural integrity of handle  10  and allows the polymeric film  30  to fold over and adhere to itself. 
     Edge release typically occurs with these systems when handle  10  is removed from polymeric film layer  30 . The generally thicker material of handle  10  creates a lever arm out of handle  10  when handle  10  is being peeled off of film  30 . This lever arm created by handle  10  acts to pry up film  30  from the patient&#39;s skin. If this force is great enough the edge of film  30  can separate from the patient&#39;s skin (e.g., edge release occurs). In general, as the stiffness of the material of handle  10  increases, the less flexible it becomes. The less flexible the handle becomes, the longer the lever arm becomes and this in turn creates higher forces which act upon film layer  30  causing more significant edge release. In addition, it is believed that as handle  10  is removed from polymeric film layer  30 , it causes an electrostatic buildup in film layer  30 , which contributes to the tendency of the edge of film  30  to release from and be pulled away from a patient&#39;s skin or mucosa. Therefore, the properties that make handle  30  useful, namely its stiffness, also create edge release. 
     The Angled Thumb Tab 
     Tab  11  is provided on handle  10  to minimize the tendency of film  30  to fold over at cut line  13 , as well as aid in the removal of handle  10 . Inwardly-projecting thumb tab  11  includes a distal portion  12 . Preferably, the underside of thumb tab  11  is not coated with adhesive. In the preferred embodiment, the leading edge A of thumb tab  11  is disposed at an angle greater than 90 degrees with respect to the edge of the handle in the direction “B” in which the handle is pulled, and distal portion  12  extends beyond cut line  13  into window  15  of handle  10 . Preferably, the angle is between about 120 degrees and about 150 degrees, and most preferably about 135 degrees. This placement of distal portion  12  provides more support for polymeric film  30  and handle  10  and it is therefore less likely that polymeric film  30  will fold at cut line  13 . However, this is merely the preferred embodiment and tab  10  may also be disposed outwardly. Similarly, it is preferably that cut line  13  extends between the edges of handle  10  at between about 130 degrees and about 150 degrees, most preferably about 135 degrees, with respect to the direction in which handle  10  will be initially peeled away from film  30 . This also helps prevent film  30  from buckling across the cut through the handle. 
     As described above, edge release typically occurs with these systems when handle  10  is removed from polymeric film layer  30 . Tab  11  minimizes this tendency by reducing the mechanical advantage that handle  10  has over polymeric film  30  when handle  10  is being peeled off. The mechanical advantage is reduced by the angle at which thumb tab  11  projects from handle  10  and subsequently, the angle at which handle  10  is removed from polymeric film  30 . 
     Interrupting the Continuity of Contact Between the Handle and the Polymeric Film 
     In addition to the mechanical advantages of thumb tab  11 , edge release can also be minimized by interrupting the continuity of contact between the adhesive coated surface of handle  10  and the underlying non-adhesively coated surface of the polymeric film  30 , at least in the vicinity of at least a portion of the edge of handle  10 . Although not wishing to be bound by theory, it is believed that this interruption helps to minimize edge release in three ways:
         1. less contact area means handle  10  can be removed more easily;   2. the mechanical advantage of the handle relative to the film  30  edge is reduced; and   3. localized electrostatic build up when handle  10  is peeled away from film  30  is reduced.       

     Interrupting the contact between the adhesive layer  20  of handle  10  and film  30  reduces the contact area. We have found it helpful to reduce the contact area by from about 10% to about 70%, preferably about 10% to about 50%, and most preferably from about 10% to about 30%, as compared to the contact area without such interruptions in continuity. If a greater reduction in contact area is desired, a more aggressive adhesive can be used in adhesive layer  20 . 
     One technique for interrupting the adhesive layer of the handle and the non-adhesively coated surface of polymeric film  30  is to texture handle  10 , at least at adhesive layer  20  on handle  10  which faces and is adhered to polymeric film  30 . Preferably, this texturing is done by piercing slots  16  through handle  10  and adhesive coating layer  20  ( FIGS. 1-6 ). Other techniques include placing pin holes through handle  10  ( FIGS. 7, 8 ); knurling handle  10  ( FIGS. 9, 10 ); embossing or debossing handle  10 ; printing adhesive layer  20  in a pattern ( FIG. 11 ); and employing a handle material having a relatively rough surface facing polymeric film layer  30 . Alternatively, the polymeric film  30  may be textured on the side facing handle  10  ( FIG. 12 ). Preferably, the texturing is done in such a way as to break the adhesive coating layer itself, as distinguished from merely making it irregular in shape (see e.g.,  FIGS. 2, 4 and 8 ). 
     As depicted in  FIG. 1 , a first embodiment is shown utilizing a plurality of piercing slots  16  completely surrounding and angularly disposed with respect to window  15 . The slots  16  may be pierced from the either side. However, in the preferred embodiment the slots are pierced from the top surface and through adhesive layer  20  on handle  10  as shown in  FIG. 2 . 
     In response to the piercing action, material of handle  10  at the pierced location is deflected toward polymeric film layer  30  resulting in a raised portion  17  of slot  16  ( FIG. 2 ). Film  30  tends to bridge over raised portions  17  of slots  16 , creating a “tunnel” at which film  30  is separated from handle  10 . Raised portion  17  thereby effectively reduces the area of contact between film  30  and adhesive layer  20  of handle  10 . This reduces the adhesive retention of handle  10  to polymeric film  30 . 
     Also when handle  10  is removed from polymeric film  30  an atmospheric venting effect  21  occurs in the tunneling area ( FIG. 4 ). This venting effect enhances the ease of removal of the handle. The result is less inadvertent edge release. 
     Additionally, raised portion  17  which is in contact with polymeric film  30  provides a conductive pathway between polymeric film  30  and handle  10 . This pathway interrupts the continuity of contact between the adhesive coated surface  20  of handle  10  and the underlying non-adhesively coated surface of polymeric film  30  thereby minimizing the electrostatic buildup of localized electrostatic charge on the polyurethane film during the removal of handle  10 . This minimization of electrostatic build up contributes towards the reduction in edge release. 
       FIG. 5  shows a second embodiment including slots  16   a  which are parallel to window  15   a  along its sides, and angularly disposed with respect to the top and bottom surface. In this configuration, after the release liner  50   a  is removed, atmospheric venting effect  21   a  again occurs ( FIG. 6 ). 
     A third embodiment is shown in  FIG. 7  and is similar to the first two embodiments except that it utilizes a puncture or pinhole to interrupt the continuity between the handle  10   b  and the polymeric film  30   b . As shown in  FIG. 8 , pinholes  16   b  minimize edge release by reducing the adhesion of handle  10   b  to the polymeric film  30   b  and also providing a conductive pathway between polymeric film  30  and handle  10  in order to minimize electrostatic buildup as described above. 
     A fourth embodiment using a knurled pattern is depicted in  FIG. 9 . The knurled pattern may take any geometrical shape and be either embossed or debossed on handle  10   c . Additionally, the pattern may be varied thereby increasing or decreasing the contact area to accommodate the application requirements. Unique to this embodiment is the feature that the knurls  16   c  do not puncture handle  10   c . Instead, the reduction in adhesion is accomplished through the bottom of knurls  16   c  residing directly on polymeric film layer  30   c  and therefore reducing the adhesive contact surface of polymeric film  30   c , as shown if  FIG. 10 . However, this is not meant to be limiting and knurls  16   c  may puncture handle  10   c  if required. Embossing or debossing handles  10  is similar to knurling, though the raised portion would probably be larger in area than the knurl projections. 
     Additionally, a fifth embodiment is shown in  FIG. 11 . This embodiment reduces the adhesion between handle  10   d  and polymeric film layer  30   d  by patterning the adhesive layer. As described above, the pattern may be varied thereby increasing or decreasing the contact area according to the specific requirements of the application. 
     Still further, it is possible to accomplish this reduction in continuity through the use of a rough surface or handle  10 , facing polymeric film layer  30 . This can be done, for example, through the use of a rough or non-smooth paper for handle  10 . 
       FIG. 12  shows a sixth embodiment which uses a polymeric film layer  30   e  having at least a textured upper surface to reduce the continuity of contact between handle  10   e  and polymeric film  30   e . The pattern may take any geometrical shape and be either embossed or debossed on polymeric film layer  30   e . Additionally, as described above, the pattern may be varied thereby increasing or decreasing the contact area to accommodate the application requirements. The patterning of polymeric film layer  30   e  may be accomplished mechanically or chemically. 
     While the embodiments described above are wound dressings or IV hold-down devices, the various aspects of the present invention are also applicable to devices designed to deliver active ingredients to or through the dermal or mucosal layers. Such delivery systems typically deliver the active via a gel modulated system, membrane modulated system, or an adhesive modulated system. All of the embodiments of  FIGS. 1-19  can be made to be ingredient delivery devices by incorporating an active ingredient into adhesive layer  40 - 40   j , for example. 
     The delivery system depicted in  FIG. 14  includes a breathable and waterproof polymeric film  30   g . Layered to a first side of film  30   g  is adhesive layer  40   g . Adhered to adhesive layer  40   g  of film  30   g  is an active ingredient containing island  60   g . Island  60   g  comprises a thin or ultra thin polymeric backing film  62   g . Layered to backing film  62   g  is an active ingredient layer  63   g  that may or may not be incorporated into an adhesive. 
     Incorporating an Anti-Static Ingredient 
     Edge release can also be minimized by utilizing an anti-static coating to minimize the electrostatic buildup that occurs when handle  10  is removed. A seventh embodiment using an anti-static coating  61  is shown in  FIG. 13 . The anti-static coating layer  61  on polymeric film layer  30   f  acts to minimize the electrostatic buildup of localized electrostatic charge on polyurethane film  30   f  during the removal of the handle  10   f . The minimization of electrostatic build up contributes towards the reduction in edge release. 
     Alternatively, or in addition, anti-static material may be incorporated onto the lower surface of polyurethane film  30   f  or into adhesive layer  40   f  of polyurethane film  30   f.    
     Removing a Portion of Handle or Adhesive at the Periphery 
     Removing a portion of handle  10 , or its underlying adhesive layer  20 , from over at least a portion of the edge area of film layer  30  helps to minimize edge release. Although not wishing to be bound by theory, it is believed that this is accomplished in three ways:
         1. less adhesive contact area means handle  10  can be removed more easily;   2. reducing the ability of handle  10  to act as a lifting lever relative to film  30 , at least when a portion of the handle per se is removed; and   3. minimizing the localized electrostatic build up at the periphery of film  30  when handle  10  is peeled from film  30 , by moving the periphery of handle  10  away from the edge of film  30 .       

     One way to move at least a portion of the edge of said handle away from the periphery of said polymeric film is to pattern the handle layer with a scalloped pattern as shown in  FIGS. 16 and 17 . In this embodiment, the scalloping extends around the entire perimeter of handle  10 . The scalloped edge reduces the mechanical advantage of handle  10  primarily in two ways. The first is by reducing the surface area of adhesive coating  20  disposed on the periphery of handle  10 , and the second is by reducing the ability of handle  10  to act as a lever. In the first mode, a portion of the periphery of handle  10  is removed resulting in scalloped edge  15 . Simultaneous to this removal of a portion of handle  10  is the removal of a corresponding portion of adhesive coating  20  attached thereto. This removal of adhesive  20  on the periphery of handle  10  reduces the upward force exerted on the periphery of polymeric film  30  by adhesive coating  20  during its removal. Reducing the upward force exerted on the periphery of polymeric film  30  reduces edge lift. In the second mode, scalloped edge  15  reduces the ability of the generally thicker material of handle  10  to act as a lever arm. 
     When the peripheral interaction between adhesive layer  20  and polymeric film  30  is removed, the localized electrostatic buildup on film  30  is also reduced. This is because the interaction between adhesive layer  20  and film layer  30 , during their separation, causes the electrostatic buildup. The removal of a portion of the peripheral edge of handle  10 , and subsequently adhesive layer  20 , or the removal of some of the adhesive at the edges of handle  10  minimizes the electrostatic buildup on the peripheral edge of polymeric film  30  by removing this interaction and therefore, reduces edge lift. 
     The scalloped edge ( 15 ) of handle  10  is depicted in  FIG. 16  as having a wave like or sinusoidal like pattern, leaving projecting portions  16  extending to the edge of film layer  30 . Other geometrical forms may be used which reduce the interaction between the periphery of handle  10  and the periphery of film  30 . While a handle could be made that simply does not extend to the edge of film layer  30 , thereby reducing edge lift, the scalloped pattern has the advantage of having end portions  16  that extend to the edge of film  30 . End portions  16  act to support thin film  30  and keep it from folding over onto itself during application. Therefore, scalloped edge  15  retains the benefits of a handle layer (e.g., ease of application) while minimizing the negative effects of a handle layer (e.g., edge lift). 
     In the  FIG. 18  embodiment, the edge portion of handle  10  along two opposite sides thereof, preferably the longest sides, have been substantially removed as a continuous, uninterrupted strip. This leaves the longest edge portions  31  of polymeric film but retains a portion of handle  10  along two other sides which extends to the film periphery sides to support film  30  during application. Preferably, only the central portion of the edge of handle  10  is removed, such that end or corner portions  11  of handle  10  extend out to the edges or corners to give stability. The  FIG. 19  embodiment is similar to the  FIG. 18  version, but also incorporates a window of removed handle material which is centrally located on the dressing, leaving the central portion  32  of film  30  also exposed. 
     Although only a few preferred embodiments have been shown and described it is envisioned that there are numerous geometrical patterns that may used. Additionally, there are supplementary methods which can be combined with the various edge geometries for reducing the edge lift even further. For example, the preferred embodiment may include additional features such as texturing handle  10 , texturing adhesive layer  20 , texturing polymeric film layer  30  and/or using an anti-static ingredient in one of, the adhesive coating on the underside of the polymeric film, or on the upper or lower surface of the polymeric film itself. Additionally, texturing may be done by piercing slots, placing pin holes, knurling, embossing or debossing, or creating a relatively rough surface on handle  10 . 
     CONCLUSION 
     The embodiments described above minimize the problem of edge release which typically occurs in adhesive devices used as wound dressings, ingredient delivery devices and IV hold-downs. Of course it is understood that the above are preferred embodiments only, and that various changes and alterations can be made without departing from the spirit and scope of the invention as set forth in the appended claims, as interpreted in accordance with the principles of patent law.