Abstract:
A pre-stressed pressure device for treating a wound or reducing scarring of a skin of a patient. the pre-stressed pressure device is composed of a pressure member having a curved state and a non-curved state, the pressure member having an inner surface and an outer surface. The pressure member has a central portion and first and second end portions, the central portion having a curved shape when the pressure member is in the curved state. The pre-stressed pressure device also contains a substrate assembly having a first surface side and a second surface side, the first surface side of the substrate assembly being secured to the inner surface of the pressure member and wherein the substrate assembly is no shorter than the pressure member. Further included is a treatment device connected to the second surface side of the substrate assembly, wherein the first and second end portions of the substrate assembly extend beyond a first and a second end of the treatment device; and an adhesive is located on the first and second end portions of the substrate assembly on the second surface side of the substrate assembly for applying the pre-stressed pressure device to the skin of the patient. The pressure member exerts end forces directed away from the patient and a central force directed towards the patient.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application is a division of U.S. patent application Ser. No. 13/934,600, filed Jul. 3, 2013, entitled “PRE-STRESSED PRESSURE DEVICE”, which is currently pending. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The invention relates to a device and system for treating a patient. Specifically, the invention relates to a pre-stressed pressure device that applies pressure to a wound and/or scar to promote healing and reduce the appearance of scars and to a system for making and using the pre-stressed pressure device. 
         [0004]    2. Description of the Related Art 
         [0005]    Applying pressure to a patient&#39;s wound is beneficial because pressure provides immediate hemostasis and decreases swelling and bruising associated with the wound. An added benefit for traumatic or surgical wounds that require sutures is diminished swelling resulting in less tension across the suture lines. This facilitates healing and improves the quality of the final scar by decreasing suture marks and irregularities formed in the skin as the tissue surrounding the wound heals. 
         [0006]    Wounds may take many forms. Herein, “wound” is intended to be as broadly inclusive as possible and means one or more injuries to at least the skin of a person. Wound may mean cuts and lacerations that are self-treated by a patient. It may also mean serious wounds caused by traumatic injuries that are treated in a medical setting; wounds caused by surgery; or vascular cutaneous puncture sites such as intravenous catheter, arterial catheter, or the like. 
         [0007]    As wounds heal, applying pressure prevents scarring. The skin at any site of the body comprises an intrinsic tension that stretches the marginal area of the skin surrounding the wound. The actual amount of tension may vary, depending upon the person, age, skin type, and wound location. Pre-existing skin conditions, such as scarring, may also affect the intrinsic tension. During the intermediate phase of a wound healing process (between 2 weeks and 12 weeks), the edges of a healing incision or wound, are pulled in different directions by surrounding skin, causing formation of the scar tissue. 
         [0008]    Even after scarring has formed, applying pressure is an integral component of a scar reduction regimen. Typically, a silicone gel sheet is fastened to a patient using a bandage wrapped tightly around the patient&#39;s limb or torso. When combined with glucocorticoid steroids, the result reduces the appearance of hypertrophic (thick) scars. 
         [0009]    Herein, “scar” and/or “scarring” is intended to be as broadly inclusive as possible and means at last one or more temporary or permanent deformations of any part of the skin due to injury to the skin. 
         [0010]    Unfortunately, to date, the various technologies available for providing pressure on a wound and/or scar require bulky or impractical devices. Thus, what is desired is a wound and scar treatment that provides pressure to a wound and/or scar and that is compact and a system for making and using that treatment. 
       SUMMARY OF THE INVENTION 
       [0011]    These and other objectives are met by the present invention. 
         [0012]    In accordance with one or more embodiments of the present invention, a pre-stressed pressure device is preferably configured as a pressure bandage for treating a wound or to reduce scarring of the skin of a patient. The pressure bandage includes a substrate assembly having a first surface, a pressure member having a curve in a central portion, the pressure member being secured to the substrate assembly; a treatment device for exerting a pressure on the wound or the scarring, the treatment device being connected to a first area of the first surface; and an adhesive for applying the pressure bandage to the skin, the adhesive being disposed on a second area of the first surface, the first and second areas being non-overlapping. 
         [0013]    In accordance with one or more embodiments of the present invention, a pre-stressed pressure device is preferably configured as a pressure bandage for treating a patient. The pressure bandage includes a substrate assembly, a treatment device mounted on the substrate assembly, an adhesive disposed on the substrate assembly, the adhesive for securing the pressure bandage to the patient, and a pressure member secured to the substrate assembly. Therein, the pressure member is in a substantially curved state when the pressure bandage is not secured to the patient. 
         [0014]    The pressure member includes a center portion and an end portion, which have a different thickness or a different width from each other. 
         [0015]    The pressure member includes a plurality of disconnected portions disposed in a plurality of planes. 
         [0016]    A system for treating a wound or scarring of a patient includes a pressure bandage comprising a pressure member having a pre-tension, a 3D printer for printing the pressure member, and a heater for selective heating an area of the pressure member to impart the pre-tension. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0017]      FIG. 1   a  is a schematic plan view of a wound and scar being treated by the present invention. 
           [0018]      FIG. 1   b  is a cross-sectional area view of the wound of  FIG. 1   a  being treated by the present invention and a pressure diagram associated with the present invention. 
           [0019]      FIG. 2   a  is a top plan view of a pre-stressed pressure device that is configured as a bandage in accordance with one or more embodiments of the present invention. 
           [0020]      FIG. 2   b  is a bottom plan view of the bandage of  FIG. 2   a.    
           [0021]      FIG. 2   c  is a longitudinal side view of the bandage of  FIG. 2   b.    
           [0022]      FIG. 2   d  is a first transverse cross-sectional view of the bandage of  FIG. 2   a.    
           [0023]      FIG. 2   e  is a second transverse cross-sectional view of the bandage of  FIG. 2   a.    
           [0024]      FIG. 2   f  is a longitudinal cross-sectional view of the bandage of  FIG. 2   a.    
           [0025]      FIG. 3   a  is a schematic view of the bandage of the present invention of  FIG. 2   a  prior to being applied to the wound of  FIGS. 1   a  and  1   b.    
           [0026]      FIG. 3   b  is a detail view of the treatment device of the present invention of  FIG. 2   a  after being applied to the wound of  FIGS. 1   a  and  1   b.    
           [0027]      FIG. 3   c  is a schematic view of the present invention of  FIG. 2   a  after being applied to the wound of  FIGS. 1   a  and  1   b  and pressure diagrams associated with the present invention. 
           [0028]      FIG. 4   a  is a longitudinal cross-sectional view of the pressure member of the bandage of  FIG. 2   a.    
           [0029]      FIG. 4   b  is a first transverse cross-sectional view of the pressure member of  FIG. 4   a.    
           [0030]      FIG. 4   c  is a second transverse cross-sectional view of the pressure member of  FIG. 4   a.    
           [0031]      FIG. 5   a  is a top plan view of a bandage in accordance with one or more embodiments of the present invention. 
           [0032]      FIG. 5   b  is a bottom plan view of the bandage of  FIG. 5   a.    
           [0033]      FIG. 5   c  is a longitudinal side view of the bandage of  FIG. 5   b.    
           [0034]      FIG. 6   a  is a top plan view of a bandage in accordance with one or more embodiments of the present invention. 
           [0035]      FIG. 6   b  is a bottom plan view of the bandage of  FIG. 6   a.    
           [0036]      FIG. 6   c  is a longitudinal side view of the bandage of  FIG. 6   b.    
           [0037]      FIG. 7   a  is a plan view of a pressure member in accordance with one or more embodiments of the present invention. 
           [0038]      FIG. 7   b  is a cross-sectional view of the pressure member of  FIG. 7   a.    
           [0039]      FIG. 7   c  is a first alternate cross-sectional view of the pressure member of  FIG. 7   a.    
           [0040]      FIG. 7   d  is a second alternate cross-sectional view of the pressure member of  FIG. 7   a.    
           [0041]      FIG. 7   e  is a plan view of a pressure member in accordance with one or more embodiments of the present invention. 
           [0042]      FIG. 7   f  is a plan view of a pressure member in accordance with one or more embodiments of the present invention. 
           [0043]      FIG. 8   a  is a plan view of a pressure member in accordance with one or more embodiments of the present invention. 
           [0044]      FIG. 8   b  is a longitudinal cross-sectional view of the pressure member of  FIG. 8   a.    
           [0045]      FIG. 8   c  is an alternate longitudinal cross-sectional view of the pressure member of  FIG. 8   a.    
           [0046]      FIG. 9   a  is a plan view of a pressure member in accordance with one or more embodiments of the present invention. 
           [0047]      FIG. 9   b  is a plan view of a pressure member in accordance with one or more embodiments of the present invention. 
           [0048]      FIG. 9   c  is a longitudinal cross-sectional view of the pressure member of  FIG. 9   b.    
           [0049]      FIGS. 10   a - 10   c  and  11   a - 11   c  are, respectively, plan, side, and side on skin views of a bandage in accordance with one or more embodiments of the present invention. 
           [0050]      FIG. 12   a  is a longitudinal side view of a pre-stressed pressure device that is configured as a stress guard prior to being applied to a patient in accordance with one or more embodiments of the present invention. 
           [0051]      FIG. 12   b  is a longitudinal side view of the stress guard of  FIG. 12   a  applied to a patient when initially applied to an open incision site. 
           [0052]      FIG. 12   c  is a longitudinal side view of the stress guard of  FIG. 12   a  after being stressed. 
           [0053]      FIG. 12   d  is a first detail view of the stress guard of  FIG. 12   a.    
           [0054]      FIG. 12   e  is a second detail view of the stress guard of  FIG. 12   a.    
           [0055]      FIG. 13  is a diagram illustrating a treatment system for making a pre-stressed pressure device for treating a wound and/or reducing scarring in accordance with one or more embodiments of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0056]    The following detailed description is of the best mode or modes of the invention presently contemplated. Such description is not intended to be understood in a limiting sense, but to be an example of the invention presented solely for illustration thereof, and by reference to which in connection with the following description and the accompanying drawings one skilled in the art may be advised of the advantages and construction of the invention. In the various views of the drawings, like reference characters designate like or similar parts. 
         [0057]      FIG. 1   a  is a schematic plan of a wound and scar being treated by the present invention.  FIG. 1   b  is a cross-sectional area of the wound of  FIG. 1   a  being treated by the present invention and a pressure diagram associated with the present invention. 
         [0058]    Therein, a patient  100  has sustained a wound  110  as is commonly understood and at least as defined in the Description of the Related Art. The wound  110  has a wound area  112  that is determined by the type and cause of the wound and a treatment area  114 . The treatment area extends from a regularized margin  116  of the wound to encompass the wound and an area most likely to be scarred by scarring  118 , such as hypertrophic, as determined by a patient, but preferably by a qualified medical practitioner. A “regularized margin” herein means a theoretical margin of the wound that extends in a regular geometric pattern of an ellipse or a circle about the wound and touches the furthest extent of the actual margin of the wound at at least three points. To treat the wound  110  and prevent likely scarring  118 , a pressure P, shown as exemplary pressure  190  in the pressure diagram of  FIG. 1   b , is applied by a treatment device (not shown) on at least the treatment area  114  using a pressure bandage  10 . 
         [0059]    It should be understood that the present invention may also be applied to only a scar. Therein, the wound area  112  is nil and the treatment area  114  extends to encompass the area scarred by scarring  118 , such as hypertrophic scarring, as determined by a patient, but preferably by a qualified medical practitioner. To treat scarring  118 , pressure P, is applied by a treatment device on at least the treatment area  114  using a pressure bandage  10 . 
         [0060]    Pressure P is preferably non-uniform and is greater over the treatment area  114  than in other areas where the pressure bandage is applied. The particular diagrammatic shape and/or amount of pressure P are dependent on the shape of a pressure member in plan view, thickness, and amount, i.e., degree of pre-stressing. 
         [0061]      FIG. 2   a  is a top plan view of a pre-stressed pressure device that is configured as a bandage in accordance with one or more embodiments of the present invention.  FIG. 2   b  is a bottom plan view of the bandage of  FIG. 2   a .  FIG. 2   c  is a longitudinal side view of the bandage of  FIG. 2   b .  FIG. 2   d  is a first transverse cross-sectional view of the bandage of  FIG. 2   a .  FIG. 2   e  is a second transverse cross-sectional view of the bandage of  FIG. 2   a .  FIG. 2   f  is a longitudinal cross-sectional view of the bandage of  FIG. 2   a.    
         [0062]      FIG. 3   a  is a schematic view of the bandage of the present invention of  FIG. 2   a  prior to being applied to the wound of  FIGS. 1   a  and  1   b .  FIG. 3   b  is a detail view of the treatment device of the present invention of  FIG. 2   a  after being applied to the wound of  FIGS. 1   a  and  1   b .  FIG. 3   c  is a schematic view of the present invention of  FIG. 2   a  after being applied to the wound of  FIGS. 1   a  and  1   b  and pressure diagrams associated with the present invention. 
         [0063]      FIG. 4   a  is a longitudinal cross-sectional view of the pressure member of the bandage of  FIG. 2   a .  FIG. 4   b  is a first transverse cross-sectional view of the pressure member of  FIG. 4   a .  FIG. 4   c  is a second transverse cross-sectional view of the pressure member of  FIG. 4   a.    
         [0064]    In accordance with one or more embodiments of the present invention, a pre-stressed pressure device is configured as a pressure bandage  10 . The pressure bandage  10  is preferably used for treating the wound  110  and comprises a pressure member  14 , a substrate assembly  16 , and a treatment device  22  joined to the substrate assembly. The pressure member  14  is secured to the substrate assembly  16  and applies a force to the treatment device  22 . In turn, the treatment device  22  applies pressure P, i.e., the pressure  190 , within at least the treatment area  114  of patient  100  to promote healing and/or reduce scarring when the bandage  10  is secured to the skin of the patient  100 . 
         [0065]    The pressure member  14  comprises one or more layers of one or more pressure materials. 
         [0066]    A pressure material may be any suitable material that is elastic and capable of holding an initial non-flat shape, preferably a curved shape. However, preferably, the pressure material is a polymer material. More preferably, the pressure material is selected from the group of polyvinyl chloride (PVC), acrylonitrile butadiene styrene (ABS); nylon polymers including polyamide 6, polyamide 66, homopolymers, and co-polymers; polyester resin; low-density polyethylene terephthalate (PET); low-density polyethylene, high-density polystyrene; high-density polyethylene; and rubberized and/or plasticized PVC. 
         [0067]    The pressure member  14  comprises, but not necessarily, a generally rectangular shape in plan view having end portions  14   a  (each defined as being generally, but not necessarily, the one-third end area in plan view of the pressure member) spaced distal from a central portion  14   b  (defined as being generally, but not necessarily, the center one third area in plan view of the pressure member) and has a thickness  14   c . The thickness  14   c  is preferably sufficient to prevent the longitudinal edges of the pressure member  14  from curling inwards towards the longitudinal centerline of the pressure member. That is, the thickness  14   c  is chosen such that the pressure member remains rigid in a cross-section perpendicular to the longitudinal centerline of the pressure member. 
         [0068]    Therein, the thickness  14   c  may be varied as needed for the specific embodiment of the bandage  10  and may be non-uniform and variable in thickness across the width and/or along the length of the pressure member  14 . The thickness preferably also provides the bandage  10  with sufficient load carrying capacity to achieve the desired pressure strains needed for the therapeutic effect on the wound  110  and/or the scarring  118 . The thickness  14   c  of the pressure member  14  may be tapered near the edges for added comfort and/or safety of use. 
         [0069]    The pressure member  14  normally has a curved shape in at least part of the central portion  14   b  while the end portions  14   a  are straight. In other words, the pressure member  14  has a normally curved state  15   a , i.e., first state. This state occurs prior to the pressure bandage  10  being applied to the skin of the user. 
         [0070]    The curved shape in at least part of the central portion  14   b  may be achieved by casting, extruding, and/or forming central portion to be curved. Therein, the central portion  14   b  may have any suitable curve while the end portions  14   a  are straight. 
         [0071]    The curved shape may also be made by pre-stressing the pressure member in a pre-stressed area  14   d  ( FIG. 4   a ), such as being heat-treated. Therein, the pre-stressed area  14   d  is preferably disposed in the central portion  14   b . In the pre-stressed area, the pressure member has been stressed increasing the compression side  14   e , moving the neutral axis  14   f  in the pre-stressed area  14   d , and causing the tension side  14   g  to be reduced. 
         [0072]    In the curved state  15   a , the pressure member  14  is curved in the pre-stressed area  14   d , i.e., at least part or all of the central portion  14   b , while the end portions  14   a  are straight. Therein, the end portions  14   a  are preferably, but not necessarily, equidistant from the central portion  14   b  in lateral and offset directions and are curved in the same direction. When the pressure member  14  is in the curved state  15   a , the bandage  10  generally follows the same curved contour as the pressure member  14  and also is in the curved state  15   a.    
         [0073]    When the bandage  10  has been applied to the patient  100 , the pressure member  14  will be in a non-curved, substantially non-curved state  15   b , i.e., second state. When the pressure member  14  is in substantially the non-curved state  15   b , the bandage  10  generally follows the same contour as the pressure member  14  and also is in substantially the non-curved state  15   b . The non-curved state  15   b  may be a flat state or contour, and/or may be one where the pressure member, i.e., pressure bandage, follows the contour of the skin. 
         [0074]    In the substantially non-curved state  15   b , the pressure member  14  exerts a force F 1 . The force F 1  has end forces F 1   a  and F 1   b  directed away from the patient  100  and a central force F 1   c  directed toward the patient  100  and forcing the treatment device  22  onto at least the treatment area  114 . That is, when the pressure member  14  is straightened, the region of the pressure member  14  that has not been pre-stressed will pull upwards with forces F 1   a  and F 1   b  in an evenly dispersed manner while the force F 1   c  in the region that has been pre-stressed, i.e., the central portion  14   b , will be applied downward with a force equal to the sum of the forces F 1   a  and F 1   b . The force F 1   c  will be at maximum at the center the pressure member vary along the central portion  14   b.    
         [0075]    Advantageously, the pressure material may be pre-stressed to a predetermined amount, and thus, the amount of curvature may be selectively predetermined to the pressure member  14 . In turn, by varying the curvature, the central portion  14   b  can be predetermined to exert a specific force F 1   c  on the wound  110 . In addition or in the alternative, the shape and/or the thickness  14   c  of the pressure member may be selected, as taught further herein, to provide further predetermined refinement of the force F 1   c . For example, by increasing the size of the edge portions  14   a  relative to the central portion  14   b , a greater force F 1   c  will be generated. The force F 1   c  is transferred as pressure to the patient via the treatment device, since pressure is force per unit area. 
         [0076]    Therein, increasing the force F 1   c  will yield an increase in pressure applied to at least the treatment area  114  via the treatment device. 
         [0077]    The pressure member  14  may have a thickness of 100 microns to at least 1 mm, but preferably with a range of about 220 microns to about 500 microns, or more preferably 300 microns to 400 microns. 
         [0078]    The substrate assembly  16  comprises at least two substrate members  18   a ,  18   b  and an adhesive  20   a  applied in an adhesive area  20   b  of the substrate assembly  16 . Substrate members  18   a ,  18   b  may be made of any suitable material  19   a  that is durable, stretchable, and resiliently flexible as is known in the art for adhesive bandages. 
         [0079]    However, preferably, each substrate member, when made of a single layer, comprises or consists of a material  19   a  and, when made of a multilayer structure, comprises a covering made of a material  19   a  and one or more support layers made of a material  19   b . The material  19   a  used may be made entirely of or comprise a woven material such as cloth in any suitable weave strength and may metal-detectable fabric, such as metal fibers, to permit the use of the bandage  10  in food service and/or processing industry. The material  19   a  may also be a light woven material for comfort or a heavy woven material for protection. The material may be chosen such that it is air permeable to permit air to access the wound  110  and/or the treatment area  114 . 
         [0080]    The material  19   a  may also be made entirely of or comprise a plastic material or rubber material as is known in the art for adhesive bandages due to their excellent stretchability, costs, and/or wearability. 
         [0081]    The substrate members  18   a  and  18   b  may also comprise a multilayer structure. Therein, one or more material layers comprise or consist of a material  19   b , which may be cotton, artificial and/or natural fibers, artificial and/or natural gel materials, natural or artificial foamed rubber and/or vinyl, or a combination thereof may be added to the covering. 
         [0082]    The adhesive  20   a  may be one or more suitable pressure-sensitive adhesives as is known in the art for adhesive bandages. Due to their excellent adhesion strength, usability, costs, and/or length of use, the adhesive  20   a  is preferably selected from the group of acrylic, silicone, butyl rubber, nitrile, styrene block copolymers (SBC), ethylene-vinyl acetate (EVA), or a combination thereof. In addition or in the alternative, the adhesive  20   a  may be a polyacrylate-based, polyisobutylene-based, and/or silicone-based pressure-sensitive adhesive; or a synthetic rubber, acrylic, hydrocolloid, or a like compound adhesive. In addition or in the alternative, the adhesive  20   a  may also be a light-curable or heat-curable adhesive. 
         [0083]    Preferably, regardless of type, the adhesive  20   a  comprises a T-peel release force of in the range of 0.45 N/cm to at least 19 N/cm. Therein, the T-peel release force and blunt probe tack force of pressure-sensitive adhesives is in accordance with ASTM D1876 and ASTM D2979 or other appropriate methods. 
         [0084]    The adhesive  20   a  is applied in the adhesive area  20   b  to the substrate assembly. Therein, the adhesive area  20   b  is preferably a marginal area of the substrate assembly  16  that surrounds the treatment device  22  and is non-overlapping with the treatment device  22 , which is also attached to the substrate assembly  16 , to provide maximum adhesion to the skin of the patient  100 . 
         [0085]    The substrate members  18   a  and  18   b  are preferably sized similarly and define the maximum extent of both the bandage  10  and the substrate assembly  16  in plan view. In accordance with one or more embodiments of the present invention, a pressure bandage  10  exerts a pressure P having a pressure component  190  and one or more pressure components  191 . The pressure component  190  is the result of the force F 1  and F 2  and each pressure component  191  is the result of only the force F 2 . 
         [0086]    The minimum size of the substrate assembly  16  is determined by the size of the adhesive area  20   b  needed for an adhesive  20   a  to create the force F 2  to overcome the forces F 1   a  and F 1   b  of the pressure member and to adhere the bandage  10  to the skin with sufficient forces to overcome unintended removal of the bandage  10  from the skin. Thus, when the bandage  10  has been applied to the patient  100 , at least the force F 1   c  is exerted onto the treatment device  22 , in turn, creating the pressure  190  onto at least the treatment area  114 . 
         [0087]    In accordance with one or more other embodiments of the present invention, the size of the substrate assembly  16  may be determined by the size of adhesive area  20   b  needed for the adhesive  20   a  to create the force F 2  to overcome at least the forces F 1   a  and F 1   b  of the pressure member, to adhere the bandage  10  the skin of the patient with sufficient forces to overcome unintended removal of the bandage  10  from the skin, and, further to add to the pressure applied by the pressure member  14  to the treatment device. Thus, preferably, the adhesive placed in the adhesive area  20   b  exerts a force F 2  onto the substrate assembly  16 , or more specifically, to the pressure member  14  to prevent the pressure member from removing the bandage from the skin of the patient. Thus, when the bandage  10  has been applied to the patient  100 , the force F 1   c  and a portion of the force F 2  is exerted onto the treatment device  22 , in turn, creating the pressure  190  onto at least the treatment area  114 . 
         [0088]    The pressure member  14  may be disposed in the substrate assembly  16  by being embedded or sandwiched between the substrate members  18   a  and  18   b  and additionally may be secured as described below. However, the pressure member  14  may also be disposed or embedded solely within one of the substrate members or may be embedded such that a longitudinally-extending or laterally-extending portion of the pressure member is embedded solely in one substrate member. The other longitudinally-extending or laterally-extending portion of the pressure member is then embedded in the other substrate member or when three or more substrate members are present in one or more of the other substrate members. 
         [0089]    In addition, the pressure member  14  may be joined to, joined with, disposed in, or disposed on, or embedded in the substrate using an adhesive, sonic welding, heating, stamping, or any other suitable means that aids in avoiding unintended movement of the pressure member  14  relative to the substrate assembly  16 . 
         [0090]    Regardless of how the pressure member  14  is disposed in the substrate assembly  16 , the substrate assembly  16  comprises a marginal edge area  18   c  in plan view between a perimeter of the pressure member and a perimeter of the substrate assembly. The marginal edge area  18   c  also advantageously aids in keeping the pressure member  14  securely located relative to the substrate assembly  16 . 
         [0091]    The substrate members  18   a  and  18   b  may be secured to each other by using an adhesive, sonic welding, heating, stamping, or any other suitable means that aids in avoiding unintended movement of the substrate members relative to each other. Moreover, the perimeter and/or a perimeter margin of the substrate assembly  16  may have a finished and reduced thickness relative to other portions of the substrate assembly  16  by crimping, flattening, sonically welding, and/or stamping the perimeters of the substrate members  18   a ,  18   b . This advantageously prevents the unintended separation of the substrate members from each other. 
         [0092]    The treatment device  22  is joined to the substrate assembly  16  using an adhesive, sonic welding, heating, stamping, or any other suitable means that aids in avoiding unintended dislocation of the treatment device relative to the substrate assembly. 
         [0093]    In accordance with one embodiment of the present invention, the treatment device  22  may comprise or consist of an absorbent pad made from cotton gauze or fabric, but the treatment device  22  may also comprise or consist of an absorbent material impregnated with one or more anti-bacterial agents or substances generally known in the art. 
         [0094]    The treatment device  22  may also may comprise or consist of one or more scar reducing materials such as silicone formed into a pad. 
         [0095]    The treatment device  22  may also comprise or consist of a combination pad wherein a skin proximal layer is an absorbent material joined to a skin distal layer made of one or more scar reducing materials. This advantageously immediately permits hemostasis and initiates a regimen of scar reduction. 
         [0096]    In accordance with one or more embodiments of the present invention, the treatment device  22  for a wound may comprise an absorbent material and may have a thickness of approximately 220-500 microns at a center of the pad for maximum comfort and absorbency while marinating a clinically suitable pressure on the wound. The treatment device  22  may have a silicone pad for scar reduction and may achieve a pressure of 10 to 25 mm Hg, i.e., 10 to 25 Torr, of pressure under the pad for a clinically suitable pressure to reduce scarring. 
         [0097]    In accordance with one or more embodiments of the present invention, the treatment device  22  may comprise one or more therapeutic agents beneficial to wound healing and/or scar reduction that may be disposed in or on the absorbent pad of the treatment device, but also packaged with bandage  10  in a kit. For example, therapeutic agents may be Vitamin E and/or one or more hemostatic and/or coagulative agents. Hemostatic and/or coagulative agents may comprise epinephrine, calcium alginate, calcium-loaded zeolite, cellulose, microfibrillar collagen, fibrinogen, glucosamine, thrombin, coagulation factors (e.g. II, VI, VII, X, XIII, VWF), procoagulants, antifibrinolytics (e.g. epsilon aminocaproic acid), and/or similar compounds. 
         [0098]    A therapeutic agent may also be an antibiotic disposed in or on the treatment device, but also packaged with the bandage  10  in a kit. A therapeutic agent may be, but is not limited to, cephalosporins, polymyxin B sulfate, bacitracin, neomycin, polysporin), antiseptics (such as iodine solutions, silver sulfadiazine, chlorhexidine) and/or other treatments (e.g. botulism toxin, growth factors). 
         [0099]    The bandage  10  preferably includes a pair of protective sheets disposed on the side proximal to the treatment device as are generally known in the art. 
         [0100]    The bandage  10  may also be packaged in a sterile packaging that is easily removable by peeling two protecting sheets apart as is generally known in the art. 
         [0101]    Since the bandage  10  generally follows the same curved contour as the pressure member  14  in the curved state  15   a , the curved shape of the bandage, advantageously, permits nested packaging. 
         [0102]    A plurality of the bandages  10  may be packaged to have treatment regimen starting with control of the wound using the bandages having treatment devices consisting of absorbent pads to bandages having treatment devices consisting of combination pads and ending with bandages having treatment devices having only scar reducing materials. 
         [0103]    In accordance with one or more embodiments of the present invention, the bandage  10  may also be used for treatment of skin-related conditions such as skin injuries, including for example, incisions, acute or chronic wounds, ulcers, and venopuncture areas; preventing or reducing the incidence of wound infections, swelling and hematoma formation; treatment of skin irritation and sensitivity, skin paresthesia, allodynia, dermatitis, warts, rashes, acne, and psoriasis; management of arteriovenous malformations; treatment or improvement of wrinkles, scars, stretch marks or other skin irregularities; and/or delivering a drug to the skin or through the skin. 
         [0104]    In accordance with one or more embodiments of the present invention, the bandage  10  further comprises, in any convenient location, one or more designs, logos, advertisements, treatment information, contact names and numbers, and/or marketing information. 
         [0105]    In accordance with one or more embodiments of the present invention, the bandage  10 , as for example, illustrated in  FIGS. 2   a - 2   f  and  3   a - 3   c , comprises a length  11   a  of approximately 50 mm to 190 mm and a width  11   b  of 22 mm to 100 mm. The bandage further comprises a thickness  11   c  in the range of 100 microns to at least 1 mm. Greater thicknesses may be possible depending on the thickness of the pressure member and generally vary between 1 mm to 3 mm. 
         [0106]    Other bandages  10  may be suitably dimensioned in accordance with needs associated with a wound  110  or scarring  118 . 
         [0107]      FIG. 5   a  is a top plan view of a bandage in accordance with one or more embodiments of the present invention.  FIG. 5   b  is a bottom plan view of the bandage of  FIG. 5   a .  FIG. 5   c  is a longitudinal side view of the bandage of  FIG. 5   b.    
         [0108]    In accordance with one or more embodiments of the present invention, a bandage  10   a  is constructed similarly to bandage  10  except that the substrate assembly  16  has been replaced with a substrate assembly  16   a , which comprises a single substrate member  18   a . The single substrate member, preferably, comprises one or more layers made of material  19   b  and at least one covering made of material  19   a . However, preferably, two coverings made of material  19   a  sandwich the one or more layer made of material  19   b . Therein, the pressure member  14  may be disposed within the single substrate member in a manner taught above. 
         [0109]    The substrate member  18   a  may also consist of a single structural layer made of material  19   a . Then, the pressure member  14  is joined to an underside of the substrate member  18   a , i.e., the substrate assembly  16 , using an adhesive, sonic welding, heating, stamping, or any other suitable means that aids in avoiding unintended removal of the pressure member. 
         [0110]    The treatment device  22  is then secured directly to the pressure member by an adhesive, sonic welding, heating, stamping, or any other suitable means that aids in avoiding unintended movement of the treatment device relative to pressure member. 
         [0111]    Thus, the adhesive area  20   b  is disposed directly on the underside of the substrate member  18   a  and may also be disposed at least partially on an area of the pressure member  14  that is not covered by the treatment device  22 . 
         [0112]    Advantageously, the bandage  10   a  provides a simple and cost effective construction. 
         [0113]      FIG. 6   a  is a top plan view of a bandage in accordance with one or more embodiments of the present invention.  FIG. 6   b  is a bottom plan view of the bandage of  FIG. 6   a .  FIG. 6   c  is a longitudinal side view of the bandage of  FIG. 6   b.    
         [0114]    In accordance with one or more embodiments of the present invention, a bandage  10   b  is constructed similarly to bandage  10  except that the pressure member  14  is secured to the substrate assembly  16  on a side opposite to a side to which the treatment device  22  are secured. 
         [0115]    Therein, the pressure member  14  is secured to a first side  16   b  of the substrate assembly  16 . The substrate assembly  16  may be any substrate assembly as taught above, but, preferably, the substrate assembly  16  comprises a single substrate member  18   a  that, in turn, consists of a single structural layer made of material  19   a . The pressure member is secured to the first side by an adhesive, sonic welding, heating, stamping, or any other suitable means that aids in avoiding unintended movement of the pressure member relative to the substrate assembly. 
         [0116]    The treatment device  22  is secured directly to a second side  16   c  of the substrate assembly  16  by an adhesive, sonic welding, heating, stamping, or any other suitable means that aids in avoiding unintended movement of the treatment device relative to pressure member. 
         [0117]    The adhesive area  20   b  is disposed directly on the underside of the substrate member  18   a , i.e., substrate assembly  16 , in an area not covered by the treatment device  22 . 
         [0118]      FIG. 7   a  is a plan view of a pressure member in accordance with one or more embodiments of the present invention.  FIG. 7   b  is a cross-sectional view of the pressure member of  FIG. 7   a .  FIG. 7   c  is a first alternate cross-sectional view of the pressure member of  FIG. 7   a .  FIG. 7   d  is a second alternate cross-sectional view of the pressure member of  FIG. 7   a.    
         [0119]    Therein, a pressure member  202  is substantially identical to the pressure member  14  and may be used in any of the bandages taught above. However, the pressure member  202  comprises end portions  202   a , which correspond to end portions  14   a , that are wider laterally than central portion  202   b , which corresponds to the central portion  14   b . Advantageously, the configuration permits increasing the forces F 1   a  and F 1   b  and placing the force F 1   c  over a smaller surface area. Since pressure is the force per unit area, the force F 1   c  will thus be able to increase pressure the treatment device by concentrating the pressure over a smaller area. 
         [0120]    In addition or in the alternative, the pressure member  202  comprises ridges  202   c  that may be squared, rounded, or peaked and aid in increasing the amount of pre-tensioning possible and increasing the force F 1   c.    
         [0121]      FIG. 7   e  is a plan view of a pressure member in accordance with one or more embodiments of the present invention. Therein, a pressure member  204  is substantially identical to pressure member  14  and may be used in any of the bandages taught above. However, pressure member  204  comprises end portions  204   a , which correspond to end portions  14   a , that are wider laterally than the central portion  204   b , which corresponds to central portion  14   b . End portions  204   a  include one or more indentations  204   c , which permits the pressure member  204  to be more flexible at the end portions and be fitted in unusual anatomical situations to a patient. 
         [0122]      FIG. 7   f  is a plan view of a pressure member in accordance with one or more embodiments of the present invention. Therein, a pressure member  206  is substantially identical to pressure member  14  and may be used in any of the bandages taught above. However, the pressure member  206  comprises end portions  206   a  and central portions  206   b , all of which have been widened, but have portions that connect them and that are not as wide as the portions  206   a  and  206   b.    
         [0123]      FIG. 8   a  is a plan view of a pressure member in accordance with one or more embodiments of the present invention.  FIG. 8   b  is a longitudinal cross-sectional view of the pressure member of  FIG. 8   a .  FIG. 8   c  is an alternate longitudinal cross-sectional view of the pressure member of  FIG. 8   a.    
         [0124]    Therein, a pressure member  208  is substantially identical to pressure member  14  and may be used in any of the bandages taught above. However, the pressure member  208  comprises end portions  208   a , which correspond to end portions  14   a , that are wider laterally than central portion  208   b , which corresponds to central portion  14   b . End members  208   a  may also have a greater thickness than central portion  208   b . The difference in thickness may be distributed relative to one or both sides of the central portion. Advantageously, the configuration permits increasing forces F 1   a  and F 1   b  and placing force F 1   c  over a smaller surface area. Since pressure is the force per unit area, force F 1   c  will thus be able to increase pressure the treatment device by concentrating the pressure over a smaller area. 
         [0125]      FIG. 9   a  is a plan view of a pressure member in accordance with one or more embodiments of the present invention.  FIG. 9   b  is a plan view of a pressure member in accordance with one or more embodiments of the present invention.  FIG. 9   c  is a longitudinal cross-sectional view of the pressure member of  FIG. 9   b.    
         [0126]    Therein, a pressure member  210  is substantially identical to pressure member  14  and may be used in any of the bandages taught above. However, the pressure member  210  comprises a plurality of disconnected strips  210   a  that may be arranged in one or more planes. This permits the pressure member to be more flexible. 
         [0127]    The pressure member  210  may also comprise a plurality of disconnected strips  210   a  and  210   b  that may be arranged in one or more planes and/or may be stacked on top of each other. 
         [0128]    The strips  210   b  are preferably, but not necessarily, arranged at the end portions of the pressure member  210  causing the pressure member to have a greater thickness at one or more end portions than a central portion. This permits the pressure member to be more flexible as well as increasing the forces F 1   a  and F 1   b  and placing the force F 1   c  over a smaller surface area. Since pressure is the force per unit area, the force F 1   c  will thus be able to increase pressure on the treatment device. 
         [0129]      FIGS. 10   a - 10   c  and  11   a - 11   c  are, respectively, plan, side, and side on skin views of a bandage in accordance with one or more embodiments of the present invention. Therein, a bandage  10   d  or  10   e  comprises a plurality of pressure members  14  that are arranged to overlap and/or have a woven configuration. This permits the bandages  10   d  and  10   e  to conform in not flat situations, such as the antecubital fossa. 
         [0130]      FIG. 12   a  is a longitudinal side view of a pre-stressed pressure device is configured as a stress guard prior to being applied to a patient in accordance with one or more embodiments of the present invention.  FIG. 12   b  is a longitudinal side view of the stress guard of  FIG. 12   a  applied to a patient when initially applied to an open incision site.  FIG. 12   c  is a longitudinal side view of the stress guard of  FIG. 12   a  after being stressed.  FIG. 12   d  is a first detail view of the stress guard of  FIG. 12   a .  FIG. 12   e  is a second detail of the stress guard of  FIG. 12   a.    
         [0131]    A pre-stressed pressure device is configured as a stress guard  40 . Returning to  FIG. 1   a , the stress guard  40  is preferably used to treat the wound  110 , which may be a wound caused by a surgical incision, and prevent scarring associated with the wound. Therein, the wound  110  typically will be sutured, and, thus, the wound area  112  is nil and the treatment area  114  extends to encompass the area scarred by scarring  118 . To treat the wound  110  and prevent likely scarring  118 , a pressure  192 , i.e., a stress  192  is applied by a treatment device on at least a portion of the treatment area  114  using the stress guard  40 . 
         [0132]    Therein, the stress guard  40  is preferably pre-stressed with a curve designed to maximize inward force while applied to the skin with preferably a peelable adhesive disposed on end portions of the stress guard but not on the central portion. The stress guard can be manually strained and applied flat to the skin. The stress at the wound site may be reduced to the levels below that experienced by normal skin. 
         [0133]    In accordance with one or more embodiments of the present invention, the stress guard  40  comprises a pressure member  44 , which exerts pressure  192  on the wound  110  to close the wound area  112 , if open, and/or relieve stress in the wound area  112 , and an adhesive  46   a  applied in one or more adhesive areas  46   b.    
         [0134]    The pressure member  44  comprises one or more layers of one or more pressure materials. A pressure material may be any suitable material that is elastic and capable of holding an initial non-flat shape, preferably a curved shape. However, preferably, the pressure material is a polymer material. More preferably, the pressure material is selected from the group of polyvinyl chloride (PVC), acrylonitrile butadiene styrene (ABS); nylon polymers including polyamide 6, polyamide 66, homopolymers, and co-polymers; polyester resin; low-density polyethylene terephthalate (PET); low-density polyethylene, high-density polystyrene; high-density polyethylene; and rubberized and/or plasticized PVC. 
         [0135]    The pressure member  44  comprises, but not necessarily, a generally rectangular shape in plan view having end portions  44   a  (each defined as being generally, but not necessarily, the one-third end area in side view of the pressure member) spaced distal from a central portion  44   b  (defined as being generally, but not necessarily, the center one third area in side view of the pressure member) and has a thickness  44   c . The thickness  44   c  is preferably sufficient to prevent the longitudinal edges of the pressure member  44  from curling inwards towards a longitudinal centerline of the pressure member. That is, the thickness  44   c  is chosen such that the pressure member remains rigid in a cross-section perpendicular to the longitudinal centerline of the pressure member. 
         [0136]    Therein, the thickness  44   c  may be varied as needed for the specific embodiment of the stress guard  40  and may be non-uniform and variable in thickness across the width and/or along the length of the pressure member  44 . The thickness preferably also provides stress guard with sufficient load carrying capacity to achieve the desired pressure  192 . The thickness  44   c  of the pressure member  44  may be tapered near the edges for added comfort and/or safety of use. 
         [0137]    The pressure member  44  normally has a curved shape in at least part of the central portion  44   b  while the end portions  44   a  are straight. In other words, the pressure member  44  has a normally curved state  45   a , i.e., first state. This state occurs prior to the stress guard  40  being applied to the skin of the user. 
         [0138]    The curved shape in at least part of the central portion  44   b  may be achieved by casting, extruding, and/or forming central portion to be curved. Therein, the central portion  44   b  may have any suitable curve while the end portions  44   a  are straight. 
         [0139]    The curved shape may also be made by pre-tensioning the pressure member in a pre-stressed area (not shown), such as being heat-treating. Therein, the pre-stressed area is preferably disposed in the central portion  14   b . In the pre-stressed area, the pressure member has been stressed increasing a compression side, moving the neutral axis in the pre-stressed area, and causing a tension side to be reduced. 
         [0140]    In the curved state  45   a , the pressure member  44  is curved in the pre-stressed area, while the end portions  44   a  are straight. Therein, the end portions  44   a  are preferably, but not necessarily, equidistant from the central portion  44   b  in lateral and offset directions and are curved in the same direction. When the pressure member  44  is in the curved state  45   a , the stress guard  40  generally follows the same curved contour as the pressure member  44  and also is in the curved state  45   a.    
         [0141]    In accordance with one or more embodiments of the present invention, one or more hinges  43  define the boundary between the central portion  44   b  and respective end portions  44   a . Therein, the hinge  43  may be a plastic hinge or hinge having a groove or a channel  43   a . The groove or channel  43   a  may be formed to be a V opening wherein each leg of the V has equal length, or has an unequal length. 
         [0142]    Preferably, the adhesive  46   a  may be one or more suitable pressure-sensitive adhesives as is known in the art for adhesive bandages. Due to their excellent adhesion strength, usability, costs, and/or length of use, the adhesive  46   a  is preferably selected from the group of acrylic, silicone, butyl rubber, nitrile, styrene block copolymers (SBC), ethylene-vinyl acetate (EVA), or a combination thereof. In addition or in the alternative, the adhesive  46   a  may be a polyacrylate-based, polyisobutylene-based, and/or silicone-based pressure-sensitive adhesive; or a synthetic rubber, acrylic, hydrocolloid, or a like compound adhesive. In addition or in the alternative, adhesive  46   a  may also be a light-curable or heat-curable adhesive. 
         [0143]    Preferably, regardless of type, adhesive  46   a  comprises a T-peel release force of in the range of 0.45 N/cm to at least 19 N/cm. Therein, the T-peel release force and blunt probe tack force of pressure-sensitive adhesives is in accordance with ASTM D1876 and ASTM D2979 or other appropriate methods. 
         [0144]    The adhesive  46   a  is applied in the adhesive area  46   b , which is preferably a portion of or all of end portions  44   a . The adhesive  46   a  is preferably not applied in the central portion  44   b.    
         [0145]    The stress guard  40  is applied to the patient  100 , for example, by straining it manually and then using the adhesive  46   a  to secure it to skin of the patient. Therein, the pressure member  44  will be in a non-curved, substantially the non-curved state  45   b , i.e., second state. When the pressure member  44  is in substantially non-curved state  45   b , the stress guard  40  follows the same contour as the pressure member  44  and also is in substantially the non-curved state  45   b . Substantially non-curved state  45   b  may be a flat state or contour, and/or may be one where the pressure member, i.e., stress guard, follows the contour of the skin. 
         [0146]    In either curved state  45   a  or substantially the non-curved state  45   b , the pressure member  44  has the forces F 3  and F 4 , which combine as pressure  192  and are directed toward each other to pull the wound  110  closed. That is, when the pressure member  44  is curved, the forces F 3  and F 4  pull toward each other closing the wound  110  or keeping the marginal edges of the wound closed. 
         [0147]    Preferably, a stress guard  40  is selected so that it is sufficiently sized, for example, by laying in a substantially non-curved state  45   b  when applied to a wound, as shown in  FIG. 12   b , and the wound&#39;s edges are being pulled toward each other to close the wound area  112 , if open, and/or relieve stress in the wound area  112 . As the wound heals, the wound area  112  becomes nil and the stress guard changes to a substantially curved state  45   a.    
         [0148]    Advantageously, the pressure material may be pre-stressed to a predetermined amount, and thus, the amount of curvature may be selectively predetermined to the pressure member  44 . In turn, by varying the curvature, the central portion  44   b  can be predetermined to exert specific forces F 3  and F 4  on the wound  110 . In addition or in the alternative, the shape and/or the thickness  44   c  of the pressure member may be selected, as taught further herein, to provide further predetermined refinement of forces F 3  and F 4 . Forces F 3  and F 4  are transferred as pressures to the patient via the treatment device, since pressure is force per unit area. 
         [0149]    Therein, increasing forces F 3  and F 4  will yield an increase in pressure applied to at least the treatment area  114  via the treatment device. 
         [0150]    The pressure member  44  may have a thickness of 100 microns to at least 2 mm, but preferably with a range of about 220 microns to about 500 microns, or more preferably 300 microns to 400 microns. The pressure member  44  preferably has a length of approximately 10 mm to 190 mm, i.e., 1 cm to 19 cm, and/or a width of 8 mm to 100 mm, i.e., 0.8 cm to 10 cm. 
         [0151]    In accordance with one or more embodiments of the present invention, a kit for treating the wound  110  of the patient  100  comprises two different types pre-stressed pressure devices, i.e., the pressure bandage  10  and the stress guard  40 , used at different times during the treatment for effective wound healing and to reduce the possibility of scarring. The pressure bandage  10  is indicated for use during the acute and late wound phases. These phases are immediately after the occurrence of the wound and up to 2 weeks after the occurrence of the wound. To treat the wound during the intermediate phase, between 2 and 12 weeks, the stress guard  40  is indicated. Therein, the system offers an ultimate solution to the skin wound treatment and scar tissue relief. 
         [0152]      FIG. 13  is a diagram illustrating a treatment system for making a pre-stressed pressure device for treating a wound and/or reducing scarring in accordance with one or more embodiments of the present invention. Therein, the treatment system  500  for treating a wound and/or reducing scarring comprises an imaging device  502 , a computing device  504  executing a computer-readable software  506  stored on a non-transitory computer readable media  508 , a 3D printer  510 , a supply  512  of pressure material, a heating device  514 , a supply  516  of substrate members  18   a  and  18   b , and a supply  518  of treatment device  22 . 
         [0153]    Therein, when a patient  100  presents with a wound  110  or with scarring, a user of the system, who preferably, but not necessarily a qualified medical professional, uses imaging device  502 , such as a digital camera, smartphone camera, ultraviolet imaging apparatus, to take an image of the wound or scarring and/or the contours of the area surrounding the wound or scarring. Using a network or a storage device, the image is then transferred to a computing device  504  such as a computer, mainframe device, tablet computer, smartphone, or other device. The network herein may be any kind of network including a cellular, wireless, Wi-Fi, LAN, Ethernet, internet, private, public, or a combination thereof. 
         [0154]    In accordance with one or more embodiments of the present invention, the image is utilized by the user to define treatment area  114 . Software  506  stored on a non-transitory computer readable media  508 , such as CD-ROM or DVD, uses the defined treatment and/or contours of the surrounding area to design the pressure member  14 , including the shape of the end portions  14   a , the central portion  14   b , the thickness  14   c  for any portion and any variations therein as taught above, and transmits that information, preferably over a network, to the 3D printer  510 . The software then also calculates the amount of pre-tensioning required and transmits that information, preferably over a network, to heating device  514 . 
         [0155]    Therein, the 3D printer  510  may be any suitable additive manufacturing printer. The printer  510 , using supply  512  of the pressure material, manufactures the pressure member  14  according to the information sent by computing device. The same user or another user then places the pressure member in the heating device  514 . 
         [0156]    The heating device  514  may be any kind of suitable device that imparts energy into the pressure member  14 . Thus, heating device  514  may be a microwave, a radiant heater, a sonic welding device, or a combination thereof. Using the information sent by the computing device, the heating device  514  heats the pressure device  14  in the pre-stressed area  14   d  to impart the pre-tensioning. In order to prevent unintended heating, a protective layer may be printed on areas of the pressure device other than the pre-stressed area  14   d.    
         [0157]    In addition or in the alternative, the pressure member  14  may also be made to be curved in the printer  512  and heating with the heating device  514  may not be necessary. 
         [0158]    After the pre-tensioning has been imparted in the pressure member  14 , it is joined to one or more substrate members  18   a  and  18   b  that are provided via a supply  516  and a treatment device  22  from the supply  518 . If necessary, the substrate members  18   a  and  18   b  and the treatment device  22  may be sized according to sizing information provided by the computing device  504  to produce a pre-stressed pressure device configured, for example, as the bandage  10  that may be applied to the patient. Similarly, the stress guard  40  may be produced by the treatment system  500  by itself and/or in conjunction with the pressure bandage  10 . 
         [0159]    While the invention has been described in conjunction with specific embodiments, it is to be understood that many alternatives, modifications, and variations will be apparent to those skilled in the art in light of the foregoing description.