Abstract:
A method for applying pressure to skin with a dressing. The method including adhering at least a portion of the dressing to the skin and changing the shape of the dressing after application of the dressing to the skin wherein the changed shape applies pressure to the skin. The changing can include releasing a member from the dressing to allow the dressing to change the shape of the dressing; deforming at least a portion of the dressing to change the shape of the dressing or allowing the dressing to heat to above a transition temperature at which the dressing changes shape.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims the benefit of provisional application Ser. No. 60/872,190 filed on Dec. 2, 2006, the contents of which is incorporated herein by reference. 
     
    
     BACKGROUND 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates generally to dressings, and more specifically to shape and pressure adjustable dressings. 
         [0004]    2. Prior Art 
         [0005]    In many situations, dressings are desired to apply a certain amount of pressure on a wound or to apply a certain amount of force to close a wound or keep it closed, even over time as inflammation subsides. In other situations, it may be desired to increase the pressure or force over time to assist healing without a change in the dressing. In yet other situations it may be desirable to vary the pressure or force distribution over time. However, the currently available materials used for dressing wounds are difficult if not impossible to be used to achieve the above results in general, and to achieve it with ease and in a reliable manner in particular, even with the use of such aids as elastic components or tension fixtures. 
         [0006]    In other situations, the dressing may be required to cover certain surfaces over the body that due to the shape of the surfaces, it may be difficult to make a close fit and even more difficult to apply pressure to the surface and sustain the applied pressure over time. In such situations, the dressing has to not only conform to the covered surfaces, but at the same time may have to provide a certain pattern of pressure or force to achieve certain goals. 
         [0007]    A need therefore exists for a method to construct dressings that can be readily applied to the desired area, and then have the capability of its shape to be varied and/or apply a desired pattern of pressure or force to the covered area. The disclosed methods of varying the shape of the component just before use, is also advantageous in many applications since it can be used to reduce the size of the required packaging, e.g., a blister shaped component may be initially stored as a relatively flat sheet and then be turned to a blister just before application to the patient&#39;s skin. 
       SUMMARY 
       [0008]    It is an object of the present invention to provide methods and/or dressings that: a) can be readily applied to a desired area, including areas that are hard to cover due to their shape and geometry; b) can be manipulated to change its shape in a predetermined manner (before or after its application); c) can be made to apply pressure (or a pulling force) to the covered area; and/or d) can be made to apply a force, for example an opening or closing force, in certain direction to the covered area. 
         [0009]    Accordingly, a dressing for covering a wound is provided. The dressing comprising: a first component having a first shape; a second component releasably attached to the first component to maintain the first component in a second shape different from the first shape; and means for attaching a surface of the first shape to the wound such that the second component can be released from the first component to allow the first component to take the first shape to apply a pressure to portions of the skin surrounding the wound. 
         [0010]    The second shape can be flat. The first shape can be curved in at least a portion of the first component. 
         [0011]    The means for attaching the surface of the first shape to the wound can be an adhesive. 
         [0012]    The first component can further comprise one of a medicament and gauze. 
         [0013]    The first component can include discontinuities in the first shape and such discontinuities can be living joints. 
         [0014]    Also provided is a dressing for covering a wound. The dressing comprising: a component having a first shape and a surface for contact with the skin of a patient; means for attaching the surface to the skin of the patient; and means for changing the first shape to a second shape after attachment of the surface to the skin to apply a pressure to the skin. 
         [0015]    The means for attaching the surface to the skin of the patient can comprise an adhesive. 
         [0016]    The means for changing the first shape to a second shape can comprise the component having a portion not in contact with the skin which can be deformed to likewise deform the component into the second shape. 
         [0017]    The means for changing the first shape to a second shape can comprise the component at least in part being formed of a shape memory material wherein a change in temperature of the component due to contact with the skin causes the component to take the second shape. 
         [0018]    The first component can further comprise one of a medicament and gauze. 
         [0019]    Still yet provided is a butterfly for closing a wound of a patient. The butterfly comprising: a butterfly body having a narrowed portion and two wider end portions, at least a portion of the narrowed portion being formed of a shape memory material; and an adhesive for applying at least the two wider portions to skin surrounding the wound; wherein the shape memory material of the butterfly body having a first shape below a transition temperature and a second shape above the transition temperature, where the transition temperature is substantially equal to a body temperature of the patient. 
         [0020]    The first shape can be flat. The second shape can be curved in at least the narrowed portion. 
         [0021]    The first component can further comprise one of a medicament and gauze disposed on a surface corresponding to the narrowed portion. 
         [0022]    Still yet further provided is a method for applying pressure to skin with a dressing. The method comprising: adhering at least a portion of the dressing to the skin; and changing the shape of the dressing after application of the dressing to the skin wherein the changed shape applies pressure to the skin. 
         [0023]    The changing can comprise releasing a member from the dressing to allow the dressing to change the shape of the dressing. 
         [0024]    The changing can comprise deforming at least a portion of the dressing to change the shape of the dressing. 
         [0025]    The changing can comprise allowing the dressing to heat to above a transition temperature at which the dressing changes shape. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0026]    These and other features, aspects, and advantages of the apparatus and methods of the present invention will become better understood with regard to the following description, appended claims, and accompanying drawings where: 
           [0027]      FIG. 1(   a ) illustrates a first embodiment of a dressing having a first layer and a second layer. 
           [0028]      FIG. 1(   b ) illustrates the dressing of  FIG. 1(   a ) in which the first and second layers are separated. 
           [0029]      FIG. 1(   c ) illustrates the first layer of  FIG. 1(   b ) after the second layer has been separated therefrom. 
           [0030]      FIG. 2(   a ) illustrates the dressing of  FIG. 1(   a ) attached to the surface of skin. 
           [0031]      FIG. 2(   b ) illustrates the dressing of  FIG. 2(   a ) after the second layer has been removed. 
           [0032]      FIG. 3(   a ) illustrates two component sheets of a second embodiment of a dressing. 
           [0033]      FIG. 3(   b ) illustrates the two component sheets of  FIG. 3(   a ) attached into an assembly. 
           [0034]      FIG. 3(   c ) illustrates one of the components of  FIG. 3(   b ) attached to the skin of a patient and the other of the components separated therefrom. 
           [0035]      FIG. 4(   a ) illustrates another embodiment of a dressing. 
           [0036]      FIG. 4(   b ) illustrates the dressing of  FIG. 4(   a ) attached to skin of a patient. 
           [0037]      FIG. 4(   c ) illustrates the dressing of  FIG. 4(   b ) being compressed together. 
           [0038]      FIG. 5(   a ) illustrates a top view of yet anther embodiment of a dressing. 
           [0039]      FIG. 5(   b ) illustrates a side view of the dressing of  FIG. 5(   a ) when at a temperature lower than a threshold temperature. 
           [0040]      FIG. 5(   c ) illustrates the dressing of  FIGS. 5(   a ) and  5 ( b ) attached over a cut in skin. 
           [0041]      FIG. 5(   d ) illustrates the dressing of  FIG. 5(   c ) after the dressing has attained a temperature greater than the threshold temperature to close the cut in the skin. 
       
    
    
     DETAILED DESCRIPTION 
       [0042]    A schematic of a basic design based on a first embodiment is shown in the  FIG. 1(   a ) to  1 ( c ). In  FIG. 1(   a ), the cross-section of a plane assembly  100  is shown, and consists of a first layer  101  and a second layer  107 . The two layers are attached together using any methods known in the art, such as with adhesives, so that the user could readily separate them. The layer  101  consists of components  102  and  104 , which are attached together with an intermediate component  103 . Similarly, the components  104  and  106  are attached together with an intermediate component  105 . The components  102 ,  104  and  106  are considered to be relatively devoid of internal stresses, while the components  103  and  105  have been originally shaped as shown in  FIG. 1(   c ), but have been elastically flattened and held in the flattened configuration by the component  107 , as shown in  FIG. 1   a , to form the assembly  100 . Obviously, if the component (layer)  107  is separated from the assembly  100 , as shown in  FIG. 1(   b ), the components  103  and  105  would return to their original shape, and the layer  100  will take the shape shown in  FIG. 1(   c ). 
         [0043]    The first layer  101  can be formed of any material which can be fabricated into a certain (original) shape and elastically deformed into another shape, such as a plastic or metal or combination thereof. Furthermore, plate  107  can be formed of any material rigid enough to prevent the first layer  101  from taking the original shape while attached to the first layer. 
         [0044]    In the schematic of  FIGS. 1(   a )- 1 ( c ), the assembly  100  is shown to be in the shape of a flat plate. It is, however, appreciated by those skilled in the art, that the assembly may form a curved surface; more stressed (preloaded or elastically deformed) and essentially unstressed (preloaded or elastically deformed) components may be used in the assembly; and in their unstressed state, the stressed (preloaded or elastically deformed) component(s) may have been constructed to assume a variety of shapes (configurations), including complex shapes and curvatures. In general, upon the removal of the constraining component(s), the stressed (preloaded or elastically deformed) component(s) will tend to return to their unstressed (natural) state. It is appreciated that the stressed component(s), while tending to return to their unstressed (natural) state (shape or configuration), may still retain part of their induced internal stresses. 
         [0045]    The dressing assembly  100  may be applied to the body surface  110 , e.g., via an adhesive layer on the free surface of the layer  101  (not shown), as can be seen in  FIG. 2(   a ). Once the assembly  100  is securely attached to the body surface, the layer  107  (wholly or partially) is removed.  FIG. 2(   b ) shows the case in which the layer  107  is removed. At least part of the preloading stresses in the components  103  and  105  are then released. As a result, the layer  101  tends to its natural (stress-free) state. The components  102  and  106  are then pulled towards each other in the direction  112 , and the underlying skin is pulled together. Thereby if a cut was present in the section of the skin  111  between the  102  and  106  components, the above action would tend to force it closed. The component  104  of the layer  107  is also pushed away from the skin. 
         [0046]    In the schematics of  FIGS. 1(   a )- 1 ( c ), for the sake of simplicity, only two distinct layers are used and only one of the layers is provided with the preloaded components. However, more than one layer can be utilized, and layers with partially preloaded components may also be used to construct the dressing components. It is also possible to construct devices that are constructed with at least two layers of fully preloaded components. In addition, the final assembly (assembly  100 ) does not have to be flat, and may assume any appropriate shape and configuration as dictated with the particular application. 
         [0047]    It should also be noted that in the schematics of  FIGS. 1(   a )- 1 ( c ), and in the remaining illustrations, only living joints are illustrated at discontinuities in the first layer  101 . It is, however, appreciated that regular joints, such as pin joints and/or sliding joints, may also be used in the construction of the present devices. 
         [0048]    Another embodiment of a dressing is shown schematically in  FIGS. 3(   a )- 3 ( c ). The dressing assembly  200  shown in  FIG. 3(   b ), consists of at least two components (sheets)  201  and  202 , which in their free (natural) form are curved as shown in  FIG. 3(   a ). The dressing  200  is assembled by deforming the components  201  and  202  to their assembly configuration and attaching them together, preferably using adhesives, to achieve their final (assembled) configuration. In  FIG. 3(   a ), and for the sake of simplicity, the two components  201  and  202  are shown to be deformed in a symmetrical manner, which upon bending in the directions  203  and  204 , respectively, could be nearly flattened to their final shape in the assembly. In this particular case, since the two components  201  and  202  are considered to be identical and with symmetrical initial deformation, then upon their assembly after being flattened would assume a flat configuration. It is readily seen that by using two or more components with varying shape, and/or size, and/or materials, and/or initial (free or natural) configuration, one could construct infinite number of assemblies, which upon partial or full removal of one or more of the components, the desired final shape, size, configuration, and when appropriate applied force (moment or torque) to the attached member, could be achieved. 
         [0049]    In certain assemblies, it may be necessary to use less strong adhesives for assembling certain components of the assembly for reasons such as ease of removal. In such cases, it may be necessary to provide mechanical locking action, such as by bending sides or corners of one component over the other, or by using attachment methods such as sewing or stapling or by using one or more clipping elements, etc., which is/are readily removable before applying the dressing to the patient or following its application.  FIG. 3(   c ) illustrates the dressing  200  attached to a surface of the skin and sheet  202  removed, in which case sheet  201  is deformed towards its original shape and the skin takes the shape of the sheet  201  and is pulled together. 
         [0050]    Yet another embodiment of a dressing is shown in  FIGS. 4(   a )- 4 ( c ). The schematic of the side view of a plate formed with two flat sides  231  and a middle side  232 , forming a simple example of a dressing element  230  is shown in  FIG. 4(   a ). The adhesives that are preferably provided on these surfaces may then apply the dressing element  230  to the surface of the skin  233  as shown in  FIG. 4(   b ), via the surfaces  231 . The part  232  is then compressed together (or twisted or otherwise deformed) in the direction of bringing the surfaces  231  together (direction  235 ), such as with a tie-wrap, string wire or the like. As a result, the underlying skin is pulled together in the direction  234 , thereby closing a wound or providing a desired compressive pressure, or in short the desired effect. 
         [0051]    In all the disclosed embodiments, appropriate dressing components such as gauzes, medications, etc., may be disposed (preferably in the middle regions) of the dressing assemblies to cover the wound. Ventilation or drainage ports may also be provided when appropriate in these regions. Elastic or removable elements may also be provided over or around such regions for administering medication. In certain cases, it may also be desirable to construct one or more components of the assembly with transparent materials so that the affected region could be observed. 
         [0052]    In addition, in all the disclosed embodiments, the applied pressure or would closing action of the dressing element may be increased or decreased over time by removing, e.g., a larger piece of the shape/configuration affecting components or by further deformation of the shape/configuration affecting components. You can also vary the pressure applied by the dressing so that the skin can be “pushed” and “pulled.” 
         [0053]    Referring now to  FIGS. 5(   a )- 5 ( d ), the component  101 ,  201  disposed on the skin can be formed, at least in part, of a shape memory material. Thus, when disposed on the skin, the component  101 ,  201  can change shape, in whole or in part, due to a shape memory effect upon being heated by the temperature of the skin to at or above a transition temperature of the shape memory material. Such materials are well known in the art and can be either metals or plastics which exhibit the shape memory effect. A dressing having such a configuration can eliminate the second component  107 ,  202  since the shape memory material can take one form, such as flat, at a first temperature ( FIG. 5(   b )) and take another shape, such as that shown in  FIG. 5(   d ) at a second temperature. Thus, the plate  107 ,  202  is not needed to maintain the sheet  101 ,  201  in the shape shown in  FIGS. 5(   a ) and  5 ( b ). In this configuration, the dressing component can be shaped as shown in  FIG. 5(   d ) when subjected to a temperature above the threshold temperature (e.g., body temperature) and can be flat when subjected to a temperature lower than the threshold temperature. 
         [0054]    This dressing has particular utility when used as a butterfly type dressing for closing wounds that may otherwise require stitches. In this regard, the plan or top view shape of the dressing  101 ,  201  can be shaped like a conventional butterfly bandage having a narrowed section in the middle thereof, as shown in  FIG. 5(   a ). Once placed over a cut  300  on the skin  302 , such as with adhesive on a face  303  of the dressing  101 ,  201 , as shown in  FIG. 5(   c ), preferably disposed on the surface outside of the narrowed portion. After the dressing  101 ,  201  is warmed by the body heat of the skin, the shape memory material changes its shape to another shape, such as that shown in  FIG. 5(   d ) to close the cut  300  by applying pressure in the direction of arrows  304 . The portion of the dressing  101 ,  201  contacting the cut  300  may have a gauze and/or a medicated layer. 
         [0055]    In a variation of such embodiment, the shape memory material dressing can be kept cool and applied to the skin while it is cold. Then the room temperature will activate it to change its shape so that you are not limited to activation with body temperature, which might be very close to the environmental temperature. 
         [0056]    Other active materials that could be employed for the dressing could be active polymers, which would require a voltage to get them to pull. 
         [0057]    While there has been shown and described what is considered to be preferred embodiments of the invention, it will, of course, be understood that various modifications and changes in form or detail could readily be made without departing from the spirit of the invention. It is therefore intended that the invention be not limited to the exact forms described and illustrated, but should be constructed to cover all modifications that may fall within the scope of the appended claims.