Patent Publication Number: US-11033270-B2

Title: Means to prevent wound dressings from adhering to closure device

Description:
CROSS-REFERENCE 
     This application is a divisional of U.S. patent application Ser. No. 15/130,764, filed Apr. 15, 2016, now U.S. Pat. No. 10,123,801, which claims the benefit of U.S. Provisional Application No. 62/202,572, filed Aug. 7, 2015, which application is incorporated herein by reference. 
     The subject matter of this application is related to the subject matter of the following U.S. patents and co-pending U.S. patent applications: application Ser. No. 13/414,176, filed 7 Mar. 2012 and issued as U.S. Pat. No. 9,179,914 on 10 Nov. 2015; application Ser. No. 14/958,803, filed 3 Dec. 2015; application Ser. No. 14/958,818, filed 3 Dec. 2015; application Ser. No. 14/851,059, filed 11 Sep. 2015; application Ser. No. 13/286,757, filed 1 Nov. 2011 and issued as U.S. Pat. No. 8,323,313 on 4 Dec. 2012; application Ser. No. 14/625,366, filed 18 Feb. 2015; application Ser. No. 13/665,160, filed 31 Oct. 2012; application Ser. No. 14/180,564, filed 14 Feb. 2014 and issues as U.S. Pat. No. 9,089,328 on 28 Jul. 2015; and application Ser. No. 14/180,524 filed 14 Feb. 2014 and issued as U.S. Pat. No. 9,050,086 on 9 Jun. 2015 which are incorporated herein by reference. 
     The subject matter of this application is related to the subject matter of the following PCT applications: application Ser. No. PCT/US2010/000430, filed 3 May 2010; application Ser. No. PCT/US2015/049671, filed 11 Sep. 2015; application Ser. No. PCT/US2012/062820, filed 31 Oct. 2013; application Ser. No. PCT/US2013/067563, filed 30 Oct. 2013; application Ser. No. PCT/US2014/016587, filed 14 Feb. 2014; application Ser. No. PCT/US2015/010188, filed 5 Jan. 2015; and application Ser. No. PCT/US2015/028066, filed 28 Apr. 2015 which are incorporated herein by reference. 
    
    
     BACKGROUND 
     The present disclosure relates to medical devices, systems, and methods for wound closure. In particular, devices, systems, and methods for preventing undesired adherence of wound dressings to an applied closure device are disclosed. 
     Many surgical incision or wound closure devices comprise first and second base panels which are adhered to the skin on the two lateral sides adjacent the incision or wound. The base panels are then laterally coupled to one another (such as with tensioning elements) to close and maintain closure of the wound or incision. Such wound closure devices are disclosed by U.S. patent application Ser. No. 13/414,176 (U.S. Pat. No. 9,179,914), Ser. Nos. 14/958,803, 14/958,818, 14/851,059, 13/286,757 (U.S. Pat. No. 8,323,313), Ser. Nos. 14/625,366, 13/665,160, 14/180,564 (U.S. Pat. No. 9,089,328), and Ser. No. 14/180,524 (U.S. Pat. No. 9,050,086) and PCT application publication nos. PCT/US2010/000430, PCT/US2015/049671, PCT/US2012/062820, PCT/US2013/067563, PCT/US2014/016587, PCT/US2015/010188, and PCT/US2015/028066, which are incorporated herein by reference. Such closure devices are commercially available as the Zip® device available from Zipline Medical of Campbell, Calif. 
     After closure of the surgical incision or wound, many physicians, physician assistants, nurses, and other associate caregivers and medical professionals typically apply a wound dressing to the incision or wound. The purpose of the wound dressing use may vary, but can include any or all of the following: absorption of wound exudate, minimizing infection risk, protecting the wound during bathing and other patient activities, and preventing patient visualization and/or tampering with the wound site. Wound dressings may be applied immediately after surgical closure, or at any time during the post-surgical wound healing. Wound dressings may also be removed at any time during the post-surgical wound healing period, and replaced with a new dressing as needed. 
     Wound dressings can come in various shapes and configurations. One common dressing configuration is the “island dressing” which comprises of an absorbent central pad surrounded on all sides by a skin adhesive. Many commercially available dressings are available. Examples of dressing types desired for use with closure devices include, but are not limited to: Convatec Aquacel™ Ag, Smith &amp; Nephew Opsite® Post-Op, Argentum Medical Silverlon®, and Mölnlycke Mepilex® Border. 
     Typically the central pad does not have a skin adhesive, though some brands (e.g., Mölnlycke Mepilex® dressings) provide a low-tack adhesive such as silicone, across the pad. Other dressings may comprise of a thin polyurethane-acrylic adhesive film laminate (e.g., 3M Tegaderm®) to cover and protect the wound. Dressings can also be fashioned by the user, such as by applying gauze or Telpha pads to the wound and securing them with tape or polyurethane-adhesive films. The wound dressing pad and/or adhesive itself may or may not incorporate anti-microbial substances such as silver, chlorhexidine, and others well-known in the art. Pressure sensitive adhesives are typically used for adherence of the dressing to the skin, with the most common being derived from acrylic, hydrocolloid, or silicone. Other skin adhesives may also be used that are readily available from commercial sources. 
     SUMMARY 
     Because many closure devices rely on adhesion to the skin to function, premature loss of adhesion can result in the wound not having sufficient closure force and/or isolation from distraction forces to ensure adequate healing. Wound dressings applied over such closure devices may contain skin adhesives that strongly adhere the wound dressing to the closure device. Removal of the wound dressing can result in the closure device being removed from the skin before the wound is fully healed. Accordingly, it is desired to discourage adherence of the wound dressing to closure devices. 
     The present disclosure relates to devices, systems, and methods for protecting closure devices from wound dressing adhesives. Protection of the outer perimeter of the closure device adhesive base panels (e.g., those laminated with a polyurethane or polyethylene film) to prevent peel initiation from the dressing is desired. In many embodiments, the entire panel is protected. Protection of the tensioning elements crossing the incision (e.g., molded straps and locks adhered to each panel) may be desirable, but may not be as critical since these elements are often located under the non-adhesive pad of the wound dressing. 
     Aspects of the present disclosure provide methods of closing an incision or wound. First and second base panels of a closure device may be provided. The first and second base panels may be configured to adhere to tissue adjacent first and second lateral sides, respectively, of the incision or wound. The closure device may be coated with a low friction or non-stick coating. A wound dressing may be positioned over the cured coating and the closure device, with the closure device being adhered to tissue. The cured coating may allow the wound dressing to be removed from the closure device while adherence of the first and second base panels with the tissue is maintained. 
     The low friction or non-stick coating may comprise a non-stick fluoropolymer coating. The low friction or non-stick coating may comprise a silicone compound, a silicone oil, or parylene. The closure device may be coated with the low friction or non-stick coating at a thickness of 0.25 to 5.0 microns. The low friction or non-stick coating may be cured at a temperature of no more than 60° C., and in some cases, no more than 45° C. The cured coating may remain bound to the closure device after the wound dressing is removed. The cured coating may be removed from the closure device concurrently with removal of the wound dressing. At least a portion of the closure device may be masked before coating the closure device with the low friction or non-stick coating. For instance, areas of the left and right base panels where adhesive of the panels are exposed may be masked. The low friction or non-stick coating may comprise an anti-microbial coating. The cured coating may be stretchable. 
     Aspects of the present disclosure may also provide methods of closing an incision or wound. First and second base panels of a closure device may be adhered to tissue adjacent first and second lateral sides, respectively, of the incision or wound. First and second sacrificial cover strips may be positioned over the first and second base panels that are adhered to the tissue. The first and second sacrificial cover strips may be adhered to the first and second base panels, respectively. A wound dressing may be positioned over the first and second sacrificial cover strips that are adhered to the first and second base panels. The wound dressing may adhere to the first and second sacrificial cover strips. The first and second sacrificial covers may allow the wound dressing to be removed while leaving the closure device adhered to the tissue. 
     To position the first and second sacrificial cover strips over the first and second base panels, perimeters of the first and second sacrificial cover strips may be extended over perimeters of the first and second base panels, respectively. One or more of the first or second sacrificial cover strips may overlap full lengths of one or more of the first or second base panels, respectively. The first and second sacrificial strips may comprise upper adhesive surfaces having a first adhesive tack and lower adhesive surfaces having a second adhesive stack less than the first adhesive tack. 
     One or more of the first or second sacrificial cover strips may comprise one or more perforations, notches, or cutout spaces. One or more of the first or second sacrificial cover strips may comprise a polyurethane film layer. One or more of the first or second sacrificial cover strips may comprise a pressure sensitive adhesive layer. A release liner may be removed from the first and second cover strips prior to the first and second cover strips being adhered to the first and second base panels. 
     Aspects of the present disclosure provide systems for closing an incision or wound. The system may comprise a closure device and a sacrificial cover strip. The closure device may comprise first and second adherent base panels and a plurality of closure components to couple the first and second adherent base panels to one another. The sacrificial cover strip may comprise first and second sacrificial cover strips having an adherent bottom surface and a release liner coupled thereto. 
     The perimeters of the first and second sacrificial cover strips may be greater than perimeters of the first and second adherent base panels such that when adhered thereto, the first and second sacrificial cover strips can extend beyond the perimeters of the first and second adherent base panels, respectively. The full lengths of the first and second sacrificial cover strips may be greater than the full lengths of the first and second adherent base panels such that when adhered thereto, the first and second sacrificial cover strips can overlap the full lengths of the first and second adherent base panels, respectively. 
     One or more of the first or second sacrificial cover strips may comprise one or more perforations, notches, or cutout spaces. One or more of the first or second sacrificial cover strips may comprise a pressure sensitive adhesive layer. The first and second sacrificial cover strips may comprise adherent upper surfaces having a first adhesive tack, and the adherent bottom surfaces of the first and second sacrificial cover strips may comprise a second adhesive tack less than the first adhesive tack. The first and second sacrificial cover strips may each comprise a first polyurethane layer, a second polyurethane layer, and a pressure sensitive adhesive layer therebetween. 
     The closure device may be coated with a low friction or non-stick coating that may be cured onto at least a portion of the closure device as described above and herein. 
     Aspects of the present disclosure provide devices for covering an incision or wound closure device adhered to skin adjacent a wound or incision. An exemplary device may comprise a strip, a support film, and a release liner. The strip may be configured for placement over the closure device previously adhered to the skin adjacent the wound or incision. The support film may back the strip. The release liner may be releasably attached to a bottom surface of the strip. The bottom surface of the strip may be adhesive. The support film may comprise an absorbent material for absorbing exudate from the incision or wound. The strip may be porous. The support film may comprise an adhesive bottom surface. The support film may extend beyond the perimeter of the strip. The strip may comprise comprises a first portion and a second portion separable from one another. 
     Aspects of the present disclosure may provide methods of closing an incision or wound. First and second base panels of a closure device may be provided. The first and second base panels may be configured to adhere to tissue adjacent first and lateral sides, respectively, of the incision or wound. A wound dressing may be positioned over the closure device and incision or wound. The wound dressing may absorb exudate generated from the incision or wound between the first and second base panels. The wound dressing may comprise an absorbent material and a support film extending over the perimeter of the absorbent material. A portion of the support film extending over the perimeter of the absorbent material may be adhesive. The wound dressing may comprise a cover strip coupled to the absorbent material and support film. The cover strip may be porous. A release liner may be removed from the wound dressing prior to the wound dressing being positioned over the closure device and incision or wound. 
     Aspects of the present disclosure may provide systems for closing an incision or wound. The system may comprise a closure device and a wound dressing. The closure device may comprise first and second base panels configured to adhere to tissue adjacent first and second sides, respectively, of the incision or wound. The first and second panels may be releasably and adjustably attached to one another. The wound dressing may be configured to extend over the first and second base panels to adhere to the tissue adjacent the first and second sides of the incision or wound, thereby covering the closure device and incision or wound. The wound dressing may be configured to be peeled off the tissue without removing the first and second base panels adhered to the first and second sides, respectively, of the incision or wound. The wound dressing may comprise an adhesive peripheral portion and an absorbent inner portion. The absorbent inner portion may be configured to be positioned over the incision or wound when the wound dressing is adhered to the tissue adjacent the first and second sides of the incision or wound to absorb exudate therefrom. The wound dressing may comprise a releasable liner releasably adhered to a bottom surface of the wound dressing. The wound dressing may comprise first and second parts axially separable from one another. 
     INCORPORATION BY REFERENCE 
     All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The novel features of the present disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the present disclosure are utilized, and the accompanying drawings of which: 
         FIG. 1A  shows a perspective view of a surgical incision or wound closure device, according to many embodiments. 
         FIG. 1B  shows a perspective view of the closure device of  FIG. 1A  provided with additional lateral skirts, according to many embodiments. 
         FIG. 1C  shows a perspective view of an elongated closure device similar to that in  FIG. 1A  and additionally a magnified view showing its lateral tie assemblies. 
         FIG. 1D  shows an exploded view of a portion of an incision closure appliance, according to many embodiments. 
       FIG.  1 E 1  shows a perspective view of a cover for the incision closure appliances, according to many embodiments. 
       FIG.  1 E 2  shows an exploded view of the cover of FIG.  1 E 1 . 
       FIG.  1 F 1  shows an exploded view of an incision closure appliance assembly comprising the incision closure appliance of  FIG. 1D  and the cover of FIG.  1 E 1 , according to many embodiments. 
       FIG.  1 F 2  shows a perspective view of the incision closure appliance assembly of FIG.  1 F 1  adhered onto the skin of a patient, according to many embodiments. 
       FIG.  1 F 3  shows a top view of the elastomeric reinforcement layer of the cover of FIG.  1 E 1 . 
       FIG.  1 G 1  shows a perspective view of the incision closure appliance assembly of FIG.  1 F 1  adhered onto the skin of a patient in accordance with the principles of the present disclosure. 
       FIG.  1 G 2  shows a sectional schematic diagram of the incision closure appliance of FIG.  1 F 1  adhered onto the skin of a patient, according to many embodiments. 
       FIGS.  1 H 1 ,  1 H 2 , and  1 H 3  illustrate a method of applying the incision closure appliance assembly of FIG.  1 F 1  on the skin of a patient, according to many embodiments. 
       FIGS.  1 I 1 ,  1 I 2 ,  1 I 3 ,  1 I 4 , and  1 I 5  illustrate embodiments of a cover for wound dressings and incision closure appliances, according to many embodiments. 
         FIG. 2  shows a perspective view of a closure device similar to that in  FIG. 1C  provided with sacrificial cover strips and additionally a magnified view showing lateral notches of the sacrificial cover strip, according to embodiments of the present disclosure. 
         FIG. 3A  shows a perspective view of a closure device and sacrificial cover strip assembly, according to many embodiments. 
         FIG. 3B  shows an exploded view of the closure device and sacrificial cover assembly of  FIG. 3A . 
         FIG. 4A  shows a perspective view of a closure device and sacrificial cover strip assembly, according to many embodiments. 
         FIG. 4B  shows an exploded view of the closure device and sacrificial cover strip assembly of  FIG. 4A . 
         FIG. 4C  shows a magnified view of the closure device and sacrificial cover strip assembly of  FIG. 4A  showing lateral notches of the sacrificial cover strip, according to embodiments of the present disclosure. 
         FIG. 5  shows an exploded view of the closure device and sacrificial cover strip assembly of  FIG. 4 , including views of the different layers of the sacrificial cover strips. 
         FIG. 6A  shows a perspective view of a sacrificial cover strip assembly, according to many embodiments. 
         FIG. 6B  shows an exploded view of the sacrificial cover strip assembly of  FIG. 6A . 
         FIG. 6C  shows apertures of the adhesive layer of the sacrificial cover strip assembly of  FIG. 6A . 
         FIG. 7A  shows a perspective view of a sacrificial cover strip assembly, according to many embodiments. 
         FIG. 7B  shows an exploded view of the sacrificial cover strip assembly of  FIG. 7A . 
         FIG. 8A  shows a perspective view of a sacrificial cover strip assembly, according to many embodiments. 
         FIG. 8B  shows an exploded view of the sacrificial cover strip assembly of  FIG. 8A . 
         FIG. 9A  shows a perspective view of a modular wound dressing assembly with a protective layer, according to many embodiments. 
         FIG. 9B  shows an exploded view of the modular wound dressing assembly of  FIG. 9A . 
         FIG. 9C  shows placements of the modular wound dressing assembly of  FIG. 9A  on a knee. 
     
    
    
     DETAILED DESCRIPTION 
     The apparatus and methods of the present disclosure can be used during both the formation and the closure of surgical incisions made to a patient&#39;s skin or other tissue during surgical procedures or wounds in general. As described hereinafter, the direction of the incision or wound will define both “axial” and “lateral” directions as those terms are used herein. Most incisions will be made along a generally straight line which will define the axial direction. The lateral direction will generally be across the axial direction, typically but not necessarily being perpendicular or normal to the axial direction. Most incisions will be generally linear but in some cases the incisions could be curved or have other geometries. The term “axial” will then apply to the direction of the incision at any particular location, resulting in lateral directions which could also vary. 
     Referring now to  FIGS. 1A-1C , a closure device  100  usable with embodiments of the present disclosure is shown. The closure device or base assembly  100  may comprise a right base panel  102  and a left base panel  104 . The right base panel  102  may comprise an upper layer  106  and a lower layer  108 . Similarly, the left base panel  104  may comprise an upper layer  110  and a lower layer  112 . The upper layers  106 ,  110  will typically be flexible but stiff enough securely close tissue and minimize disruption of the incision and surrounding tissue. The upper layers  106 ,  110  may comprise a plastic layer made of rubber, latex, polyurethane, silicone, a thermoplastic elastomer, a woven fabric, a spun fabric, or similar materials. The adhesive bottom layers  108 ,  112  will typically be flexible and more elastic than the upper layers  106 ,  110  to follow any movement of the underlying skin and tissue to maintain adhesion, minimize blistering, and otherwise reduce irritation. The adhesive bottom layers  108 ,  112  may comprise a hydrophilic adhesive material such as a hydrocolloid, a hydrogel, an acrylic polymer, poly (ethylene glycol), and the like. 
     The right and left base panels  102 ,  104  may comprise structures to facilitate and limit axial and lateral stretching of the base assembly  100 . These structures may also evenly distribute the closure force exerted on an incision and may be disposed on the base assembly  100  along its axial length. The right base panel  102  may comprise one or more right force distribution structures or axial supports  114 . Each right axial support  114  may comprise an axial support portion or spine  114   a  and two lateral support portions  114   b  coupled to the axial ends of the spine  114   a . Together, the spine  114   a  and the two lateral support portions  114   b  form a C-shape which in some embodiments can open axially to a degree to facilitate axial stretching of the right base panel  102  between two laterally adjacent lateral support portions  114   b  of adjacent supports  114  while limiting the axial stretching between the two lateral support portions  114   b  of a single support  114 . In many embodiments, the C-shaped axial support  114  is only flexible enough to allow flexing vertically but is stiff to minimize axial and lateral stretching. The right axial supports  114  may be outward facing which may help to distribute any mechanical load against the tissue closure to the incision between the right and left base panels  102 ,  104 . Similarly, the left base panel  104  may comprise one or more left force distribution structures or axial supports  116 . Each left axial support  116  may comprise an axial support portion or spine  116   a  and two lateral support portions  116   b  coupled to the axial ends of the spine  116   a . Together, the spine  116   a  and the two lateral support portions  116   b  form a C-shape which in some embodiments can open axially to a degree to facilitate axial stretching of the left base panel  102  between two laterally adjacent lateral support portions  116   b  of adjacent supports  116  while limiting the axial stretching between the two lateral support portions  116   b  of a single support  116 . In many embodiments, the C-shaped axial support  116  is only flexible enough to allow flexing vertically but is stiff to minimize axial and lateral stretching. The left axial supports  116  may be outward facing which may help to distribute any mechanical load against the tissue closure to the incision between the right and left base panels  102 ,  104 . 
     As shown in  FIG. 1B , the base panel assembly  100  may further comprise skirts  124  and  126 . The skirts  124 ,  126  may be similar to the thin base assembly covers described below. For example, each skirt  124 ,  126  may comprise a 0.001 inch thick urethane film coupled to a 0.002 inch thick acrylic adhesive. The adhesive may be applied to the whole under-surface of the skirts  124 ,  126  or may just to the region of the skirts  124 ,  126  beyond the base panels  102  or  104 . During construction of the base panel assembly  100 , the skirts  124 ,  126  may be applied directly over all or a portion of the adhesive layers  108 ,  112 , respectively. The skirts  124 ,  126  may be applied in place of, or in addition to, the thin film upper layers  106 ,  110 , respectively. Release liners as described herein may further be provided to line the adhesive under-surface of the skirts  124 ,  126 . The skirts  124 ,  126  may extend beyond the outer border of the base panels  102 ,  104 , respectively, by 8 mm or in a range of 1 to 20 mm, for example, but does not span across the lateral area between the base panels  102 ,  104  to improve the ability to visualize and/or clean the incision site. Thus, the skirts  124 ,  126  may help provide additional adhesive support and/or creep reduction to the adhesive layers  108 ,  112  of the base panels  102 ,  104  without having to align and place a separate cover or cover sheet over the base panel assembly  100 . After manufacturing, the skirts  124 ,  126  are typically already precisely aligned relative to the base panels  102 ,  104 . A separate cover or cover sheet as described herein may still be used to prevent tampering of the incision site and components of the base panel assembly  100 . As the skirts  124 ,  126  already laterally extend over the base panels  102 ,  104 , respectively, such a separate cover or cover sheet may not require precise placement relative to the base panel assembly  100  and could be more narrow compared with other covers or cover sheets described herein. 
     One or more perforations  118  may be provided in-between axially adjacent right axial supports  114  on right panel  102  to facilitate the axial and/or lateral stretching of the right base panel  102 . The perforations  118  may be all the way through the upper and lower layers  106 ,  108  to provide aeration to the underlying tissue or may only be present on the upper layer  106 . Similarly, one or more perforations  120  may be provided in-between axially adjacent left axial supports  116  on left panel  104  to facilitate the axial and/or lateral stretching of the base panel  102 . The perforations  120  may be all the way through the upper and lower layers  110 ,  112  to provide aeration to the underlying tissue or may only be present on the upper layer  110 . There may only be a single perforation  118  or  120  between the axial supports  114  or  118 . There may be a plurality of perforations  118  or  120  in a lateral line between the axial supports  114  or  118 . The perforations  118 ,  120  may also reduce the stress incurred as the skin stretches radially outward from the incision such as during joint articulation and swelling. 
     A plurality of perforations  118 ,  120  may, for example, be provided in-between the axial ends of the right and/or left axial supports  114 ,  116 . A plurality of axially-aligned perforations may be provided such that at least the upper and lower layers  110 ,  112  of the base panels  102 ,  104 , respectively, may break into separate segments when axially stretched. In some instances, during the wear duration of the device  100 , the perforations  118 ,  120  may allow the layers  106  and  108  of right panel  102  and the layers  110  and  112  of left panel  104  to completely divide and separate at the perforation line. The ability to completely divide and separate further allows the skin to stretch axially as needed, with the elongation allowed (and limited) by the linkages of axial supports  114  and  116  and closure components  122  discussed below. As discussed herein, a flexible, compliant cover may be applied over the base panels  102 ,  104  after the incision is closed. The cover may further serve to provide (and limit) axial and lateral movement of the base structure  100 . Alternatively or in combination, one or more of the right or left base panels  102 ,  104  may be laterally cut and separated in-between the force distribution structures or axial supports  114 ,  116  to facilitate the axial and/or lateral stretching of the right and/or left base panels  102 ,  104 . 
     To couple the right and left base panels  102 ,  104  laterally together and optionally to tighten the right and left base panels  102 ,  104  against one another, the base assembly  100  may further comprise a plurality lateral closure components or tie assemblies  122 . The lateral closure components or tie assemblies  122  may comprise a ratchet mechanism. The lateral tie assemblies  122  may couple laterally adjacent right and left axial supports  114 ,  116  together, typically at their axial ends. As shown in  FIGS. 1A-1C , the placement of the right and left axial supports  114 ,  116  on the right and left panels  102 ,  104 , respectively, may be staggered or axially offset, and the right and left axial supports  114 ,  116  may be C-shaped structures with lateral end portions  114   b ,  116   b  that laterally face and align with one another (and are connected to one another by a lateral tie assembly  122 ). For example, the far end lateral portion  114   b  of a first right axial support  114  may be laterally aligned with the near end lateral portion  116   b  of a first left axial support  116 , the far end lateral portion  116   b  of the first left axial support  116  may be laterally aligned with the near end lateral portion  114   b  of a second right axial support  114 , and so forth. Thus, the lateral tie assemblies  122  and right and left axial supports  114 ,  116  may be connected to one another to form a line of consecutive lateral tie assemblies  122  and right and left axial supports  114 ,  116 , and this line may have a serpentine arrangement that laterally spans the right and left base panels  102 ,  104  (i.e., goes across the distance between the right and left base panels  102 ,  104 ) as shown in  FIGS. 1A-1C . The serpentine arrangement of lateral tie assemblies  122  and right and left axial supports  114 ,  116  may one or more of evenly distribute the closure forces provided by the base assembly  100  on an incision, provide (and limit) axial flexibility of the base assembly  100 , and provide rigidity or stiffness to the base assemblies  100  to sufficiently close an incision and allow it to heal with minimized disruption and distension (i.e., provide lateral and axial stability). In many embodiments, the lateral supports  114 ,  116  are stiff so that the areas of the base panels  102 ,  104  that are not covered with the lateral supports  114 ,  116  stretch. Because these uncovered areas are offset from one another from the right base panel  102  to the left base panel  104 , the tie assemblies  122  may pivot axially from their anchor points as the incision is axially stretched. Such axial pivoting of the tie assemblies  122  may bring the left and right panels  102 ,  104  closer together to maintain the closure of the incision. 
     The material of the lateral tie assemblies  122  and the right and left axial supports  114 ,  116  may include, for example, a flexible, resilient plastic, typically a hard plastic, such as Nylon, Polypropylene, Polyethylene, Poly carbonate, and other thermoplastic polymers. Often, the lateral tie assemblies  122  and the right and left axial supports  114 ,  116  may comprise a material less elastic than that of the right and left base panels  102 ,  104 . Thus, greater stiffness (and less elasticity) may be provided toward the top of base assemblies  100 . In other words, there may be an elasticity gradient between the top and bottom of the base assemblies  100 . The tops of the base assembly  100  may be sufficiently rigid or stiff so that the incision closure appliance, when applied to an incision and surrounding tissue, prevents movement of tissue laterally adjacent the appliance to not substantially distend the covered incision and surrounding tissue. That is, movement of at least a portion of the applied incision closure appliance (e.g., a portion below the more stiff layers) is collective and does not disrupt the underlying incision. And, the bottom of the base assembly  100  may be sufficiently elastic such that blistering and adhesion loss due to movement of tissue adjacent the applied incision closure appliance are minimized. While a primary function of lateral tie assemblies  122  may be to apply tension to each base panel  102 ,  104  to hold the incision closed, in many embodiments, the lateral tie assemblies  122  may also serve to provide columnar strength so as to isolate the incision by minimizing effects of compression on (or bending/creasing along) the incision from distraction forces that could disrupt the incision edge alignment and apposition. The axial spacing, material property, and dimension of the lateral ties  122  may be optimized for sufficient axial bending flexibility and lateral compression and bending support. In preferred embodiments, the spacing between ties  122  is 10 mm, the material of the ties  1422  is nylon, and the dimension is a round cross-section of 0.030 inch. 
     The base assembly  100  may be placed over an incision in the skin of a patient or subject&#39;s joint, such as the knee, for example. In incisions placed in proximity to articulating joints, the knee in particular, closure device or closure appliance integrity is often challenged by a number of factors. These factors include longitudinal elongation, circumferential swelling, opening of the wound as articulation occurs, skin damage such as blistering, adhesion loss, and passage of wound exudates. Joints such as knee, elbow, ankle, and shoulder may undergo a movement which can sometimes result in articulation covering more than 135° movements, leading to the challenges noted above. 
     In a bent position, the skin around the knee can stretch up to 50% axially (i.e., parallel to the incision) and laterally (i.e., transverse or perpendicular to the incision). An incision closure appliance adhered to the skin in this area may preferably be able to provide enough tension to close the incision yet accommodate the stretch with minimal local stress. Minimizing the local stress may prevent local skin adhesion loss or damage to the skin if the adhesive loss does not occur. An important property for many incision closure appliances disclosed herein is the ability of the tension load of the appliance&#39;s closure elements to be distributed across an area larger than that of the tension element attachment point itself. Furthermore, the structure comprising the adhesive to which the tensioning elements are attached may in many cases have the ability to distribute the compliance of the structure across the region of skin stretch such that the appliance holds the incision in place while the skin moves around it. Embodiments described herein may include a composite design of non-stretching tension elements (commonly referred to as “straps”) that are linked to “locks” that hold the straps in place. For example, such elements may include the lateral tie assemblies  122  described above. These elements may be mounted over skin adhesives with elastic polymeric materials that help distribute the tension load. Such elastic polymers may in many cases have high elongation before yielding or permanently deforming and may include thermoplastic elastomers such as polyurethane as well as various grades of silicone. Such materials may also be easily formed into thin films necessary for maintaining a low profile and sufficient compliance. 
     The skin adhesive used in the appliance may also need to withstand the elongation of the skin and be able to retract/recoil when the skin is returned to an un-stretched condition (e.g., in the fully extended knee position). Hydrocolloid adhesives may provide such properties and may be preferably suited for this application. Other adhesives such as acrylic may also be used to provide this property. In general, such adhesives may need to be attached to an elastic thin film such as that described above in order to hold their structure during expansion and recoil. Without such support, the adhesive may tear and separate with repeated elongation. 
     Incision closure appliances constructed as a sequence of short segments may accommodate higher overall elongation without loss of adhesion or skin damage. Each individual segment may be subjected to the local stretching of the skin under it. The space between two adjacent segments may act as stress relieving space allowing the skin to stretch in that space. The segmentation may be achieved in number of ways: (1) by laying down individual segments along the incision line, or (2) allowing the device to divide into short segments as it is applied to the skin or after applying to the skin. 
     A preferred means of achieving segmentation after application to the skin comprises creating perforations (e.g., a lateral line of perforations to facilitate tearing) in the polyurethane layer (i.e., the upper layer  106 ,  110  of a base panel  102 ,  104 ) and leaving the underlying adhesive intact. The perforations may result in tearing of at least the upper layers (e.g., upper layers  106 ,  110 ) of the base panels along the perforated lines (e.g., lines  124 ,  126 ) when it undergoes stretching as the knee flexes (i.e., is articulated). In preferred embodiments, the adhesive panel on each side of the incision may be 12 mm wide, and the perforations within a given panel are spaced about 12-20 mm apart. Experimentation was performed and showed that a perforation of 3 mm cut and 1 mm tie distances are effective in achieving segmentation in 0.001 inch thick urethane base panels when the knee flexes. As the knee flexes, the skin may elongate in axial (along the incision) and lateral directions up to 50% in some locations. Separation of the polyurethane can thus relieve stress in the device as it undergoes stretch. 
     As an example, a surgically repaired knee may be inflamed for a number of days, which may result in approximately 30% radial swelling of the joint after closure. Elastic materials like polyurethane may allow the incision closure appliance to expand with this circumferential swelling. Minimizing the width of the appliance (e.g., 12 mm or less for each base panel segment  102 ,  104 ) may minimize the amount of the appliance subject to expansion in a direction perpendicular to the incision, and may thus preserve adhesion while minimizing potential for skin damage. Perforations in adhesive segments running in the lateral direction to the incision along lines may allow the base panels to stretch more easily axially. Perforations or other fenestrations could also be made near the outer edges of the adhesive segments parallel to the incision in order to reduce the stress incurred as the skin stretches radially outward from the incision such as during articulation and swelling. 
     Perforated segments of base panel upper layers, typically comprising polyurethane, may be held together with a continuous layer of the adhesive bottom layer, typically comprising a hydrocolloid adhesive, to allow laying down on the skin in one continuous motion. The incision closure appliances  100  may be provided with such a continuous adhesive bottom layer. 
     The base assembly or base panels of the incision closure appliances described herein preferably may be covered with a flexible adhesive film material at the end of a wound or incision closure. This film area preferably may be larger than the base incision closure panel elements such that it overlaps the elements onto the skin. The film may help prevent migration of the base and may prevent any accidental movements of the anchors and locking mechanisms. The cover film may be made from stretchable materials like rubber, latex, polyurethane, silicone or thermoplastic elastomer, etc. In preferred embodiments, a thin cover (e.g., laminate of 0.001″ urethane and 0.002″ thick acrylic adhesive), will have a greater compliance than the composite structure of the base panel elements. As a result, the cover may offer some strain relief between the exposed skin and the base segments. The cover may also be transparent to allow visual inspection of the incision. The cover may completely seal across the incision (e.g., as a barrier to infection) or there may be openings in the cover that are aligned with the incision line to allow passage of any exudates from the wound. The cover may also serve to improve the apposition of the incision edges by bridging the base panels and adhering to the skin edges between the base strips. The cover may also be constructed with additional reinforcing elements that improve the tensile strength between the base panel elements but allow for compliance along the incision length. A preferred embodiment may comprise a series of polyethylene adhesive tape strips applied to the cover. 
     While the user may apply the cover after the base assembly and panels are placed on the skin, it is also conceived that the cover material may be supplied as a “skirt” extending around the outer perimeter of the base segments. Thus, alignment of the cover materials relative to the base may not be dependent on the user placement. These same cover materials may provide the effects of preventing exposure of the hydrocolloid adhesive to patient clothing, limitation of migration of the hydrocolloid or other adhesive lower layer, providing strain relief for the tension on the base segments, etc. 
     In many embodiments, a hydrocolloid adhesive is used for tensioning skin for incision closure. The hydrocolloid may be prevented from creep by one or more of (1) using a laminate on the surface to limit creep or (2) applying an adhesive cover across the skin and the hydrocolloid adhesive to prevent creep and to provide strain relief to the skin to prevent skin damage. 
     In many embodiments, a cover as used with the base assembly may include one or more of perforations or openings to allow removal of wound exudate (as well as any applied bandages/absorbent material) without removal of the adhered base assembly. 
     In many embodiments, the cover comprises a composite of flexible urethane and reinforced strips. The composite construction may provide strength across the incision as well as provide for compliance along the incision length. 
     In many embodiments, the cover in combination with the base assembly aligns the skin incision edges or significantly prevents subsequent misalignment of the skin edges, in both the axial and lateral directions. 
     In many embodiments, cover liner configurations are provided such that part of the cover can be applied to the skin first, which then aids in the removal of other liners and thus may help control the thin materials so they lay out evenly with minimal wrinkling. 
     In many embodiments, the removal of a first liner may allow visualization during placement and may prevent the remainder of the device from sticking to the user. 
     The skin adhesive used for each panel  104 ,  106  may preferably comprise a hydrocolloid adhesive. Alternatively or in combination, the skin adhesive may comprise one of many acrylic formulations known in the art. Hydrocolloid adhesives may have the benefit of being very tacky and able to absorb moisture and shedding skin cells. Thus, hydrocolloid adhesives may be particularly suited for long-term wear applications (e.g., up to 14 days). In at least some instances, the hydrocolloid structure may be soft, however, and may be prone to creep under tension unless reinforced in some manner such as by covering the hydrocolloid adhesive layer with stiffer base panels  102 ,  104  or other covering structures disclosed herein. 
     Accordingly, a further aspect of the present disclosure also provides various means of reinforcing and protecting the adhesive layer in the base assemblies of the incision closure appliances described herein as well as additional means of holding the skin edges together, particularly in the axial direction. In at least some cases, the hydrocolloid adhesive alone has very low tensile strength and may require a means of reinforcement to prevent it from tearing or creeping during use. As illustrated in  FIG. 1D , an adhesive layer  1211  used in base panels  1104 ,  1106  of a closure device may be laminated with a thin layer of a compliant plastic or polymer 1212, such as urethane, preferably 0.001 inch thick, with a potential range up to 0.010″ thick, that may help to maintain its structure during clinical use. The adhesive layer itself may nominally be 0.010 inch thick, but may range between 0.005 inch and 0.020 inch thick. Because tensioning elements comprising straps  1130  or locks  1132  attached to a load distribution component  1118  may be mounted to the top of the adhesive structure  1211 , the possibility exists that the material could creep over time. The laminate  1212 , as well as any other adhesive laminates  1215   a ,  1215   b  between the adhesive layer  1211  and the load distribution component  1118 , may help provide the structure to prevent creep of the adhesive layer. 
     To further prevent migration of the adhesive panel  1211 , a cover  1220  may also be applied over the panels  1104 ,  1106  as shown in FIG.  1 E 1 . As shown in FIG.  1 E 2 , the cover  1220  may comprise a thin, adhesive coated compliant elastomer  1221 . In many embodiments, the cover  1220  further comprises a thin urethane layer (preferably 0.001 inch thick) coated with a skin adhesive, such as an acrylic adhesive (preferably 0.002 inch thick), which may be provided on one or more release liners  1223   a ,  1223   b . The cover may further comprise reinforcing features  1225 . 
     As shown in FIGS.  1 F 1  and  1 F 2 , the cover  1220  may be constructed such that it may extend beyond the base panels  1104 ,  1106 , thereby bridging a distance, d 3 , between the skin S and the panels  1104 ,  1106 . A typical minimum necessary distance, d 3 , may be 8 mm but could range 2-15 mm. Besides helping prevent creep of the adhesive layer of the base panels  1104 ,  1106 , the urethane skin adhesive of the cover  1220  may also help to strain relieve the tension applied to the base panels  1104 ,  1106  from movement of the surrounding skin S. This may serve to prevent skin damage (e.g., from erosion or blistering) at the base panel  1104 ,  1106  edges. It should be noted, however, that the compliant nature of the hydrocolloid offers local protection from blistering by itself being able to move with the skin S and thus resist damage to the skin S. In many embodiments, even with stiffer structures mounted to the outer surface of the adhesive layers, the compliance within the nominal 0.010″ thickness of the adhesive layers down to the skin surface may provide resistance to skin damage. 
     Besides stabilizing and strain relieving the base panel structures, the cover  1220  may serve other purposes. By covering the location where a strap  1130  would engages a lock  1132 , the cover  1220  may prevent the patient from tampering with the locks  1132  to the point where the straps  1130  could be disengaged. As shown in FIGS.  1 F 1 - 1 F 2 , the cover  1220  may be fitted with openings  1224 ,  1224 ′ along the length of the region overlapping an incision, such that externally applied gauze may absorb wound exudate. In other embodiments, the cover  1220  may not have openings in order to protect the wound from sources of infection. The cover  1220  itself may have reinforcing features  1225 ,  1225 ′ to provide the base  1102  with additional resistance to the incision opening, particularly in regions between the straps  1130 . FIG.  1 F 3  shows a particular embodiment where the reinforcing features  1225 ′ could be rectangular strips of adhesive tape. The tape  1225 ′ may preferably be stiffer perpendicular to the skin incision than the surrounding compliant urethane layer  1221 . The tape  1225 ′ may be constructed from any combination of adhesive coated woven fabric, polymer fibers, polyethylene, polypropylene, nylon, PET, hydrocolloid, or other materials known in the art. The reinforcing features  1225 ′ may also add “body” or stiffness to the cover  1220  to aid in its placement. The urethane layer  1210  may be constructed of such materials to give it a bi-directional stretch. 
     The spacing of the reinforcing features  1225 ,  1225 ′ may be important to ensure the longitudinal (parallel to the incision line) compliance of the cover  1220  (e.g., due to the compliant thin urethane). This may serve to improve patient comfort and the resistance to skin damage by allowing the cover  1220  and the underlying base assembly  1102  to move with motions of the body. This effect may be from the cover  1220  alone or as a composite effect with features on the base assembly  1102  which may allow longitudinal compliance. The reinforcements  1225 ,  1225 ′ may also be of a uniform construct, but perforated, slit, or otherwise mechanically interrupted to allow stretch and/or controlled tearing with body motion. The thin urethane layer(s) of the cover  1220  may also be mechanically interrupted to the same effect. In at least some cases, the reinforcing features  1225 ,  1225 ′ of the cover  1220  may not extend the entire width (perpendicular to incision) of the cover  1220 . This limited covering width may help ensure strain relief to the body motion away from the base assembly  1102  perpendicular to the incision I. In preferred embodiments, the region of the cover  1220  reinforced by the reinforcement members  1225 ,  1225 ′ extends 10 mm in each direction away from the incision edge, but this may range from 2-50 mm. 
     Another feature of the cover  1220  may be to be able to add control to the incision edge, particularly between the tensioning elements  1130 ,  1132  of the base assembly. As illustrated in FIG.  1 G 1 , the tensioning elements  1130 ,  1132  combined with the base panels  1104 ,  1106  may serve to approximate the incision edges  1205  together. Once the skin S is approximated, it may be important that the skin edges be aligned vertically (perpendicular to the skin surface). Vertical misalignment may lead to slower healing and visible “step-off”, or ledge, in the incision that may result in poor scar cosmesis. By having portions of the cover  1220  adhere to each edge of the base panels  1104 ,  1106  along the incision, each edge may held under tension in vertical alignment as shown by arrows  1201   a ,  1201   b . Adhesive on portions of the cover  1220  crossing the incision I may also adhere directly to the skin S at the incision edge, further shortening the distance between the adhered incision edges and further enhancing vertical skin alignment. In preferred embodiments, the portions of the cover  1220  crossing the incision I are rectangular strips  1225 ′ of adhesive tape as shown in FIG.  1 F 3 . The width of each strip  1225 ′ and the axial gap between the strips  1225 ′ may be optimized for incision edge control, incision visibility, and the escape of wound exudate. A preferred embodiment may comprise a strip 12 mm wide and spaced 6 mm apart, with the straps located between each strip. Other widths and spacing are also contemplated. By not bridging/tenting over each strap  1130 , the strip  1225  may lay flatter against the skin S for better adhesion and edge control. 
     In some embodiments, the reinforcing features  225 ,  225 ′ may be constructed to limit the amount of bending at the incision site. The reinforcing features  225 ,  225 ′ in these embodiments may be stiffer than the skin S, and preferably stiffer than the surrounding elements of the base panels  104 ,  106 . In this way, and bending or compression of the skin S through normal patient motion would be isolated, or the propagation limited, around the incision site. While this motion isolation or limitation would help strengthen the incision site in tension, a greater benefit may be to prevent the incision edges from significantly or unevenly inverting, everting, or shifting in a direction perpendicular to the skin surface. Reinforcing materials discussed above may be used, with the thickness tailored to create the desired stiffness. Preferably, the composite of the base assembly  102  and cover  220  may be constructed to create a smooth transition in stiffness and compliance from the surrounding skin to the isolated incision site. 
     In particular methods of use, after initial closure of the incision using the base assembly  1102  to approximate the skin edges, the base panels  1104 ,  1106  may be pushed together further to “pooch” the closed incision I upward to slightly evert the edges and/or compress the skin S around the incision edges to relieve tension. FIGS.  1 H 1 - 1 H 3  illustrate an embodiment of this method in an in-vivo tissue model. FIG.  1 H 1  shows a step  1250 A in which the base panels  1104 ,  1106  are adhered to the skin S adjacent an incision I and are pushed together to “pooch” the closed incision I upward. The base panels  1104 ,  1106  may be then pulled together further to hold the tissue in this orientation. These methods may be enhanced by positioning the base panels  1104 ,  1106  away from the incision edge by 5-10 mm. In a step  1250 B shown by FIG.  1 H 2 , the base panels  1104 ,  1106  may be locked in place relative to one another with the straps  1130  and the locks  1132 . In a step  1250 C shown by FIG.  1 H 3 , the cover  1220  may then be applied to lock in the relative location of the base panels  1104 ,  1106  and “pooched” incision I. The incision I could be further reinforced with the reinforcing elements  1225 ,  1225 ′ discussed above. 
     A given cover  1220  may in many embodiments be fitted with release liners to aid in user handling of the cover  1220  before and during application to the patient. As shown in FIGS.  1 E 1  and  1 E 2 , the cover  1220  may have release liners  1223   a ,  1223   b  applied in a three-part configuration. The user may first remove a longitudinal center liner  1223   b  to apply the center exposed adhesive to the base assembly  1102  and skin incision region. Removal of this liner  1223   b  first, in combination with visualization through the clear plastic and/or openings in the center of the base  1220 , may allow the user to see the base assembly  1102  underneath such that the cover  1220  can be properly aligned with the base assembly  1102  as the cover  1220  is applied. This may also help provide regions of the cover  1220  that do not stick to the user until the cover  1220  is initially secured to the base assembly  1102  and/or the skin S. Next, the side release liners  1223   a  may be removed in a direction perpendicular to the incision I. The liners  1223   a  hold and tension the very thin urethane to keep it from substantially wrinkling as it is applied to the skin S. Also, by sticking the center of the cover  1220  to the base assembly  1102  and/or the skin S first, the cover  1220  may be held in place such that sufficient tension and control may be applied to the side release liners  1223   a  for smooth application of the remainder of thin adhesive coated cover  1220  to the patient. Alternatively or in combination, the liners may be constructed such that the first liner is removed to expose a narrow strip over the full width of the cover  1220  (perpendicular to the incision I) to allow initial placement on the base assembly  1102  and/or skin S, followed by removal of one or two additional liners in a direction parallel to the incision I. The first liner may be in the middle of the length, on either end, or somewhere in between. If not on the end, two additional liners may be required, each removed in a direction from the location of the first liner outward along the length of the device. If the first liner was on one end, a second single liner may be removed from the location of the first liner out toward the end of the device. 
     Another release liner configuration may be to have a single liner which could be completely removed from the bottom of the cover  1220  before application. This type of liner may require an outer film, or casting sheet, be lightly adhered to the outer surface of the cover  1220  to help the thin urethane hold its shape and provide the user with locations at the sides and/or ends which do not have adhesive and thus would not stick to the user&#39;s hands during application. The outer film could be over the entire outer surface or just a particular width surrounding the perimeter of the cover  1220 . The film and/or the release liner could also have an area extending beyond that of the thin urethane in the cover  1220 . Once the cover adhesive is attached to the base assembly  1102  or skin S, the casting sheet may be easily removed from the outside of the cover  1220 . 
     As described herein, flexible wound dressings and wound or incision closure devices or appliances are typically flexible and stretchable to follow the contour of curved parts of the body (e.g., arm, longer incisions that are curvilinear, etc.) or the areas that undergo stretching (e.g., knee). To assist the draping of such devices, a backing material may be used which assists in maintaining the dressing shape during the application. Such temporary backing material described herein may have a number of advantages. The backing material may be clear to enable the visual of the wound. The material may be non-stretchable to prevent elongation of the dressing or closure device or appliance during application. The backing may be easily removable after the application of the wound dressing or closure device or appliance so as to not affect the adhesion of the actual dressing on the wound site. The backing material may also assist in the handling of the dressing during manufacturing process. In many embodiments, the backing material may couple to a dressing or closure device with peel-off release liners on the adhesive side of the dressing to enable easy and reliable removal of the backing material. 
     Referring now to FIG.  1 I 1 , a wound dressing cover  2600  may comprise a flexible sheet  2610  made of a flexible material like rubber, urethane, silicone, etc. The flexible material  2610  may laminated on a relatively stiffer material in the form of a casting sheet or carrier layer  2620 . The casting sheet  2620  prevents the flexible material  2610  from rolling onto itself and becoming unusable. The flexible sheet  2610  may have an adhesive on one side (e.g., the bottom side) and a relatively rigid (stiff) carrier layer or casting sheet  2620  on the other side. The adhesive side is protected by two liners  2630 ,  2640  that can be sequentially removed to expose the adhesive in a controlled manner. To apply the dressing  2600  on the wound or incision, a small strip of adhesive is exposed by removing one of the release liners, usually the smaller release liner  2630 . This release liner  2630  may be attached to the casting sheet  2620  using a tape  2650 . The exposed part of the flexible sheet  2610  may then be adhered at one end of the wound or incision. The flexible cover  2600  then follows the contour of the wound or incision and the curvature on the body as the second release liner  2640  is slowly removed to expose the adhesive sequentially. 
     The first release liner  2630  which is typically still attached to the casting sheet  2620  with the tape  2650  may then be used to lift the casting sheet  2620  from the flexible dressing  2610 . 
     A manufacturing process for the wound dressing cover  2600  and associated liners  2630 ,  2640  may be to use a single die to cut a common profile (perimeter) of the laminate of the release liners  2630 ,  2640 , the flexible dressing (with adhesive)  2610 , and the casting sheet  2620 . Upon removal of the liners  2630 ,  2640  and application of the dressing sheet  2610  to the skin, the casting sheet  2620  may remain on the dressing sheet  2610 . Removal of the casting sheet  2620  may require initiation by delaminating and peeling back an edge of the casting sheet  2620  from the dressing sheet  2610 . Once initiated, the continued peel and removal of the casting sheet  2620  may be straightforward. Initiation and lift of the edge of the casting sheet  2620  may not always be intuitive and may requires a free edge connected to the casting sheet  2620  to help identify the lift point and begin the peel. The tape  2650  may be used to bridge the casting sheet  2620  to the release liner  2630  and may provide an easily identifiable tab which can be used to initiate the peel. 
     Alternative configurations of the casting sheet  2620  may be used to initiate the peel of the casting sheet  2620  as shown in FIGS.  1 I 2 - 1 I 5 . 
     As shown in FIG.  1 I 2 , the casting sheet die may be cut such that the casting sheet  2620   a  extends axially beyond the flexible dressing sheet  2610  (e.g., the liners  2630 ,  2640  and urethane material of the flexible dressing sheet  2610  may be “kiss cut” to the surface of the casting sheet  2620   a ). 
     As shown in FIG.  1 I 3 , the casting sheet  2620  may have tape  2650  applied to either one or both axial sides to extend beyond the casting sheet. The tape  2650  may not necessarily be attached to the release liner  2630 . 
     As shown in FIG.  1 I 4 , casting sheet tape  2650  may be attached at or near the axial edge(s) of the casting sheet  2620  and also extends inside the profile of the casting sheet  2620 , with a loose non-adherent edge  2652  for the user to grasp. 
     As shown in FIG.  1 I 5 , the casting sheet die may be cut (e.g., kiss cut such that the casting sheet  2620  is not cut into the flexible dressing sheet  2610 ) from one axial edge to a partial or full-length distance to another axial edge of the casting sheet  2620 . The cut casting sheet  2620  may be separated with a “pinch” by the user to create an edge to grasp. The interior die cut edge may also have a tape or similar tab  2654  applied to one or both of the interior edges to grasp and peel as shown in  FIG. 115 . 
     In many embodiments, the casting sheet  2620 ,  2620   a  and/or tape  2650 ,  2652 ,  2654  may be of a different color or have markings to distinguish from the flexible dressing sheet  2610  and release liners  2630 ,  2640 . 
     One or more of the components of the incision closure appliances or incision closure appliance assemblies disclosed herein, including one or more of the various base assemblies, base panels, force distribution structures, axial supports, lateral supports, closure components, tie assemblies, straps, locks, adhesive layers, adhesive layers, covers, cover structures, drapes, etc., may be comprised of, be coated with, or otherwise incorporate one or more of an antifungal, antibacterial, antimicrobial, antiseptic, or medicated material. For example, such materials may be incorporated into the hydrocolloid adhesive layer, as another layer or coating between the skin and the adhesive layer (covering at least a portion of the adhesive layer), incorporated into the base assembly cover or at least its adhesive layer, etc. One or more wells, grooves, openings, pores, or similar structures may be provided on the device or apparatus components to facilitate such incorporation. In many embodiments, such materials may comprise one or more of silver, iodide, zinc, chlorine, copper, or natural materials such as tea tree oil as the active agent. Examples of such antifungal, antibacterial, antimicrobial, antiseptic, or medicated materials include, but are not limited to, the Acticoat™. family of materials available from Smith &amp; Nephew plc of the U.K., the Acticoat™ Moisture Control family of materials available from Smith &amp; Nephew plc of the U.K., the Contreet™ Foam family of materials available from Coloplast A/S of Denmark, the UrgoCell™ Silver family of materials available from Urgo Limited of the U.K. (a subsidiary of Laboratoires URGO of France), the Contreet™ Hydrocolloid family of materials available from Smith &amp; Nephew plc of the U.K., the Aquacel™ Ag family of materials available from ConvaTec Inc. of Skillman, N.J., the Silvercel™ family of materials available from Kinetic Concepts, Inc. of San Antonio, Tex., Actisorb™ Silver 220 available from Kinetic Concepts, Inc. of San Antonio, Tex., the Urgotul™ SSD family of materials available from Urgo Limited of the U.K. (a subsidiary of Laboratoires URGO of France), the Inadine™ family of materials available from Kinetic Concepts, Inc. of San Antonio, Tex., the Iodoflex™ family of materials available from Smith &amp; Nephew plc of the U.K., the Sorbsan Silver™ family of materials available from Aspen Medical Europe Ltd. of the U.K., the Polymem Silver™ family of materials available from Ferris Mfg. Corp. of Burr Ridge, Ill., the Promogram™ family of materials available from Kinetic Concepts, Inc. of San Antonio, Tex., the Promogram Prisma™ family of materials available from Kinetic Concepts, Inc. of San Antonio, Tex., and the Arglaes™ family of materials available from Medline Industries, Inc. of Mundelein, Ill. Components of the closure devices described in commonly owned U.S. Pat. Nos. 8,313,508, 8,323,313, and 8,439,945; U.S. Patent Publication No. 2013/0066365; and PCT application nos. US 2010/000430, US 2011/139912, US 2011/40213, US 2011/34649, and US 2013/067024 and others incorporated herein may also be comprised of, be coated with, or otherwise incorporate one or more of an antifungal, antibacterial, antimicrobial, antiseptic, or medicated material, including but not limited to one or more of the materials listed above. 
     In many embodiments, topical medicinal agents are incorporated directly into the wound closure appliances described herein. Because a wound closure device is often applied in close proximity to a wound or incision in need of medicinal protection, the incorporation of such medicines directly into the closure device may be beneficial. In wounds at risk of infection, incorporation of anti-microbial agents may be beneficial, for example. Anti-microbial agents may include antibiotic medicines as well as antiseptic metal ions and associated compounds which may include silver, iodine, copper, and chlorine, or natural materials such as tea tree oil. In wounds prone to fungus, medicinal agents such as zinc may be warranted, for example. Combinations of any of these agents may also be of benefit and thus may be incorporated into wound closure appliances. 
     Topical medicinal agents may be incorporated into the closure devices in a way to give the closure devices the ability to wick exudate away from the wound (e.g., to direct unwanted organisms away from the wound and/or prevent skin maceration), while keeping the wound sufficiently hydrated for improved healing. 
     Coatings. 
     According to further aspects of the present disclosure, after assembly of a closure device (such as closure device  100 ) a coating can be applied to the outer surface to prevent adhesion to the wound dressing. An exemplary coating may utilize a non-stick fluoropolymer coating applied and cured to the device  100 , typically with a process that does not require temperatures exceeding 60° C. for 5 min., and more preferably under 45° C. for any period of time. The adherence of the coating with the polyurethane film of the wound closure device may be most desired, though protection of all external surfaces may be desirable as well. The fluoropolymer film thickness may range from 0.25 to 5.0 microns, preferably about 1-3 microns. Coating would typically take place with release liners or other suitable material in contact with the skin adhesive surface to prevent contamination of the skin adhesive with the coating. Such a coating would typically be applied as part of the manufacturing process such that no additional coating is required to be applied by the user. However, in other embodiments, just before dressing application, the user may instead apply a preferably sterile oil-based liquid or gel to the outside of the Zip device to prevent adhesion. Examples include petrolatum and silicone oil. 
     Other coatings that do not require cure temperatures that can damage the device adhesives (typically above 60° C.) may be applied. These may include silicone compounds or oils (cured to the material or uncured), parylene, and other coatings well-known in the art. The coating may preferably remain bound to the closure device upon removal of the dressing, though could also act by deadening the applied adhesive, and/or acting as a sacrificial layer that is pulled up with the dressing instead of the underlying device. Sacrificial coatings may be thicker, more in the range of 0.0005″-0.010″. 
     While preferable to apply to the entire finished device, the coating could be applied to selective regions of the device by masking areas to not be coated. This may be useful if coating is incorporated into an intermediary process where component bonding must be subsequently performed to non-coated regions of the device, or if coating of other components (e.g., the locks and straps) results in undesirable low friction (e.g., straps don&#39;t stay engaged in locks or strap slips out of user&#39;s hands). In other cases, the coating may be on a material that is applied separately to the device (e.g., a strip of polyurethane film). This may be useful if the coating process requires an elevated temperature or use of solvents that are incompatible with the rest of the device. 
     In other embodiments, the coating material may have an antimicrobial compound incorporated into the coating. The coatings described above are preferably conformal to the device surfaces and remains adhered to the closure device at least until the wound dressing is applied. The coatings described also offer minimal resistance to closure device stretch (up to 50%) and themselves do not loose protective effects while the dressing is worn against the closure device. 
     Low Tack Adhesive Protective Strips. 
     According to further aspects of the present disclosure, one or more removable protective strips  201  of material (also referred to as “dressing shields”) may be applied over the closure device  100  to protect the closure device from the adhesive of any wound dressing, as illustrated in  FIGS. 2-5  for example. The protective strip(s)  201  may act as a sacrificial layer. The protective strip(s)  201  are preferably constructed from a material that does not stick to the underlying closure device  100 . Each strip  201  may preferably be coated on the side facing the closure device  100  with the material that prevents adhesion to the closure device  100 . The strip  201  may preferably be constructed from an elastic material  201   a , for example, polyurethane, and may be coated with an adhesive  201   b  formulated and/or constructed to have lower tack to the closure device  100  than the closure device  100  has to skin, thus ensuring removal of the strips  201  does not disrupt adhesion of the closure device  100  to the skin. The strip  201  may be comprised of a single material layer with no adhesive, two layers where one layer is an adhesive or non-stick coating, or more than one material layer with the multiple layers laminated using heat or by incorporating a layer of adhesive between the layer(s), wherein the laminate adhesive may or may not be the same as the adhesive facing the closure device  100 . In some embodiments, the strip  201  is a composite of elastic fibers, elastic film, and elastic adhesive. The strip  201  may comprise perforations, notches, cutout spaces (e.g., holes), and the like sufficiently sized to maximize elasticity and breathability of the strip  201  while minimizing the degree of adhesion from the dressing. The strip material may also comprise of a blown polyurethane film that is more elastic and porous for a given thickness than non-blown films, or other breathable non-woven material known in the art, typically fabricated from polyester, polyethylene, and polypropylene. The non-woven material may be constructed to be air permeable but not liquid permeable (without apertures) or may incorporate apertures for very high breathability and moisture transfer. The material could also be constructed from a woven fabric, preferably containing elastic fibers and/or antimicrobial coatings known in the art. Providing a very thin material (approximately 0.0005″-0.001″) can aid in breathability and conformability, while thicker films or fabrics (up to approximately 0.025″) may aid in user handling. The optimal design thickness may be in-between depending on desired elasticity and materials and construction chosen. 
     The strips  201  may be designed to ensure protection of the closure device but not interfere with the contact of the dressing with the wound or incision. As shown in  FIG. 2 , the outside of the strip  201  should not extend further than necessary beyond the outer perimeter  100   c  of the closure device  100  in order to maximize dressing contact with the skin. For a closure device  100  having a panel width of 17.5 mm, a 25 mm wide strip may be preferable to ensure optimal overlap of the strip and allow tolerance for hand alignment by the user. The strip length may be provided long enough to overlap the full length of the closure device  100  by approximately 5 mm on each end. The strip  201  may preferably be made from a material (e.g., thin polymer films) that can be trimmed to the desired length with surgical scissors. 
     In some embodiments, as shown in  FIGS. 3A and 3B , the strip  201  may comprises a 0.001″ thick elastomeric film such as polyurethane film  201   a  coated with a 0.011″ thick silicone adhesive as a gel or pressure sensitive adhesive  201   b . The adhesive layer  201   b  may be protected with a release liner  301  until use. The silicone adhesive may preferably be constructed to be low tack such that it does not disrupt the closure device adhesive during removal. This may be achieved with the chemical formulation and/or by crosslinking the adhesive using irradiation such as electron beam or gamma. The silicone could also be formulated to be fully cured and/or cross-linked to have no adhesive properties. 
     In some embodiments, similar to the sacrificial cover strip assembly shown in  FIGS. 3A and 3B , the strip  201  may comprise a 0.002″ thick polyurethane film  201   a  with a low-tack 0.002″ thick acrylic or urethane pressure sensitive adhesive (PSA)  201   b  applied to one side. The strip  201  may be supplied to the user with a release liner  301  to protect the adhesive until ready for application. The low-tack adhesive is formulated to be releasable from the surface of the closure device  100  (and patient&#39;s skin) before the closure device releases from the skin. 
     In some embodiments, illustrated in  FIGS. 4A-5 , a 25 mm wide strip  201  may comprise of a first 0.001″ thick polyurethane film  201   a  and a second 0.001″ thick polyurethane film  201   c  of the same size laminated to the first with a 0.002″ acrylic PSA layer  201   b  therebetween. The second film  201   c  may be constructed to have notches  202  along the outer perimeter removed such that the PSA  201   b  may be exposed on one surface in the notch locations. As illustrated in  FIGS. 4A-4C , the notches  202  may be approximately 2 mm×3 mm in size and spaced approximately 10 mm apart. By both controlling the notch size and recessing the adhesive below the surface of the second layer  201   c , the strip  201  may provide the desired low tack sufficient to hold it in place against the closure device  100  and the desired release force of the strip  201  from the closure device  100  and skin. This may also allow the use of relatively strong PSA (e.g., the same formulation as used on the closure device  100 ) that will still release from the closure device  100 . Other combinations of film thickness, notch size, cutout space, and adhesive strength may be achieved to a similar result. In other embodiments, the notches  202  or cutout spaces may be other shapes such as circles for holes, or may be closely spaced gaps between film strips  201 . 
     In some embodiments, shown in  FIGS. 6A-6C , a single strip assembly  400  may be configured to cover the entire closure device  100  instead of comprising of the separate strips discussed previously. The single strip  400  may be provided with apertures  407  such that wound exudate may pass through the strip where it covers the incision. As illustrated in the exploded view of  FIG. 6B , the strip assembly  400  may comprise an outer support film  405  lightly adhered to the outer surface of the strip material  406  to aid in placement of the strip. The support film  405  may then be removed by the user after placement. The support film  405  may be constructed from paper, polyethylene, or other suitable material. The support film  405  may preferably extend beyond the border of the strip  406  to aid in handling, but may also be die-cut to the same perimeter as the strip material  406 . Similar to previous embodiments, the strip  400  may be provided with an adhesive layer, preferably a low-tack silicone adhesive as a gel or PSA protected by a release liner  408  until use. As illustrated in  FIG. 6C , the apertures may preferably be approximately 1.0 mm in diameter and spaced approximately 2.5 mm apart for ˜13% aperture exposure. The size and spacing of the apertures  407  may be varied to optimize exudate passage against protection of the closure device  100  surface. The aperture size and space may also be varied to optimize the low-tack silicone adhesive adhesion to be releaseable from the surface of the closure device  100  (and patient&#39;s skin) before the closure device  100  releases from the skin. 
       FIGS. 7A and 7B  show a single strip assembly  401   a  similar to the single strip assembly  401  described above with respect to  FIGS. 6A-6C . The single strip assembly  401   a  does not use a support frame  405 . The release liner  408  in any of the above embodiments may incorporate a split or crack to aid in removal of the strip  406  from the release liner  408 . 
     In embodiments similar to the above, the adhesive is applied to a single film (or film composite) in an interrupted pattern and/or discrete areas to minimize the total adhesive surface area to achieve low tack and optimal breathability. 
     For the above closure device protection embodiments, the method of application may be similar. 
     In a first step, the closure device may be applied to the patient, the closure device may be closed and have their straps cleaned, and the wound area may be cleaned. 
     In a second step, protective strip(s)  201  may be removed from the release liner  301  and applied over the outside of each base panel of the closure device  100  (e.g., base panels  102  and  104 ). The outer edges of the closure device  100  may be overlapped by the protective strip. The protective strip(s) may be lifted and repositioned as necessary. 
     In a third step, the wound dressing may be applied to the outside of the closure device  100  having the protective strips  201  in place. 
     In a fourth step, the wound dressing may be removed. The wound dressing may be removed prior to the removal of the closure device  100 . The protective strips  201  may be removed along with the dressing, leaving the closure device  100  intact and adhered to the skin. 
     In a fifth step, if another dressing is required, new protective strips  201  may be placed over the closure device  100  and repeat the third step above may be repeated. 
     A protective layer similar to those described above with reference to  FIGS. 6A-6C  and  FIGS. 7A-7B  may be incorporated directly into the wound dressing to prevent the wound dressing from adhering to the closure device  100 .  FIGS. 8A-8B  illustrate an exemplary island dressing  500  which may comprise a protective layer  504 . The protective layer  504  may be similar in material and design as those described above with reference to  FIGS. 6A-6C  and  FIGS. 7A-7B , except that the protective layer  504  may be adapted to be adhered to the exudate absorption layer  503  using PSAs, heat welding processes, or stitching techniques. Apertures in the protective layer  504  may allow passage of exudate into the absorption layer or exudate pad  503 . The island dressing  500  may also include a skin adhesive layer  502  and protective film  501  to which the exudate pad  503  is adhered. Release liners  505  may protect the skin adhesive  502  and protective layer  504  until use. The protective layer  504  may also be of a construction similar to the sacrificial cover strip assembly  300  described above with reference to  FIGS. 3A-3B , where two strips (each of which may or may not contain apertures) are adhered to the layer  503 , with gap between the strips intended to align closely with the incision and encourage unimpeded passage of exudate. 
     As illustrated in  FIGS. 9A-9B , a dressing  510  may be provided in two parts, first part  511  and second part  512 . The first part  511  may be provided in a construction similar to that of dressing  500  in  FIGS. 8A-8B , except that a short release liner portion of  505  is provided on each end, with a longer release liner between. This first part  511  may be cut transversely by the user into two parts  511   a  and  511   b  at a desired location between the short release liners. Alternatively, the first part may be provided to the user pre-cut in two parts  511   a  and  511   b  as illustrated in  FIG. 9B . The user may then trim one or both of the two cut first parts to a shorter length as desired, such that the two cut lengths are shorter than the total closure device length by an amount less than the length of the provided second device part  512 . As illustrated in  FIG. 9C , a selected first part  511   a  may be applied to the skin overlapping one end of the closure device, after first removing the small release liner. The remainder of the longer release liner can then be removed and the remainder of the cut first part  511   a  is adhered over the incision and Zip device. The remaining cut first part  511   b  is then applied in a similar manner beginning at the opposite end of the incision and closure device. The second part  512  may then be applied over the gap  513  between the two applied first parts such that the second part overlaps the ends of the two cut first parts. The advantage of this configuration and application technique may be that the user may easily center the cut first parts of the dressing over the closure device. Another advantage can relate to placement over a joint. The two cut first parts may be applied over the ends of the incision on either side of the joint in a manner that relatively few folds in the dressing are required. The uncovered section over the joint may then be covered with the shorter second part where the folds are more easily managed. Managing the folds can be important to minimize folds and to tightly crease them to minimize ingress or egress of fluids or other contamination in spaces formed by the folds. 
     While preferred embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the scope of the present disclosure. It should be understood that various alternatives to the embodiments of the present disclosure described herein may be employed in practicing the present disclosure. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.