Abstract:
Apparatus for closing a surgical incision comprise a base having left and right panels, a force distribution structure coupled to each panel, and a closure component which releasably attaches to the force distribution structure to draw the inner edges of the panels together in order to close adhered tissue edges. The force distribution structures allow the inner edges of the panels to expand while restraining expansion of the outer edges of the panels and limiting elongation of the lateral dimension of the panels. The incision closure appliance may be placed on skin or other tissue prior to forming the incision to be available to close said incision at the end of the surgical procedure.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation-in-part of U.S. patent application Ser. No. 13/286,757 (Attorney Docket No. 35383-709.201), filed Nov. 1, 2011, the full disclosure of which is incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates generally to medical apparatus and methods. More particularly, present invention relates to apparatus and methods for forming and closing surgical incisions. 
         [0004]    Surgical closure devices including an adhesive based patch with right and left panels are known. Of particular interest of the present invention, such devices are described in co-pending, commonly owned PCT application US 2010/000430, full disclosure which is incorporated herein by reference. As described in the PCT application, an adhesive patch is placed over a patient&#39;s skin at a site where it is desired to form a surgical incision. After the patch is placed, an incision is formed along an axial line extending through the middle of the patch. After it is formed, the incision can be opened to perform a desired procedure, and after the procedure is completed the incision may be closed by drawing the inner edges of the panels together with a clip, zipper, or other closure member. 
         [0005]    The principal objective of such surgical closure devices is to improved healing and reduce scaring from the incision. This objective, however, has been inhibited by certain characteristics of the presently available devices. For example, the tissue edges are not always brought together along an even line, which can increase the eventual scaring. Many such closure devices do not have the ability to adjust the closure force or distance on the tissue edges, limiting the ability to slightly “pucker” tissue which has been found to reduce scaring. Other shortcomings of the available incision and wound closure devices include difficulty of use and inability to conform to tissue manipulation during subsequent surgical protocols, i.e. those devices which are sufficiently rigid to securely close the tissue are often unable to conform to the tissue movement during the surgical procedure. 
         [0006]    A particular problem arises with self-adhesive wound closure patches when they&#39;re used beneath an adherent surgical incision drape. Such drapes are used to help maintain the sterility of a tissue surface during a surgical procedure, and the drapes may be placed over a previously positioned tissue closure patch. As the surgical incision drape has an adhesive lower surface which adheres to the tissue, the drape will adhere to an upper surface of an underlying tissue closure patch. Removal of the surgical incision drape will thus often remove or at least displace a previously placed tissue closure patch. If any significant portion of the tissue closure patch is removed or displaced, the patch will no longer be useful for closing a surgical wound. 
         [0007]    For these reasons, it would be desirable to provide improved surgical incision closure devices and methods for their use. It would be particularly desirable to provide incision closure devices which are able to adhere to the tissue, allow formation of the incision, conform to the deformation of the tissue during a subsequent surgical procedure, and provide controlled closure of the adjacent tissue edges subsequent to the procedure. In particular, it would be desirable if the incision closure devices were able to provide for the control and the uniform distribution of closure forces on the tissue edges while causing minimum restraint or stretching of the tissue during the surgical procedure. It would be still further desirable to provide improved surgical incision closure devices and methods for their use where the devices will resist removal and dislocation when used beneath a surgical incision drape. At least some of these objectives will be met by the inventions described below. 
         [0008]    2. Description of the Background Art 
         [0009]    Co-pending, commonly owned PCT application US 2010/000430 as been described above. Other surgical closure devices are described in the following U.S. Pat. Nos. 2,012,755; 3,516,409; 3,863,640; 3,933,158; 4,114,624; 3,926,193; 4,535,772; 4,676,245; 4,881,546; 4,905,694; 5,377,695; and 7,455,681; and U.S. Patent Publication Nos. 2005/0020956 and 2008/0114396. Commercial incision closure devices available from Ethicon, a division of Johnson &amp; Johnson, under the trade name Ethizip™ temporary abdominal wound closure device. 
       SUMMARY OF THE INVENTION 
       [0010]    The present invention provides improved apparatus and methods for closing wounds, particularly wounds resulting from incisions performed during surgical procedures. The incisions would usually be formed in a patient&#39;s skin, such as through the abdomen, but in some cases could also be on internal organs, within the oral cavity, within body cavities, or alike. 
         [0011]    The devices and methods of the present invention will present minimum disruption of or interference with the surgical procedure which is performed after the incision is made. In particular, the devices and methods will permit the opposed edges of the incised tissue to be opened, stretched, and freely deformed with minimal restraint resulting from the presence of the closure device. Once the procedure has been completed, however, the devices and methods of the present invention will provide for a uniform distribution of closure forces to draw the tissue edges together in a manner which and minimize scaring. In particular, the closure devices can draw the tissue edges together at a slightly closer spacing than initially present at the forming of the incision in order to upwardly evert the tissue edges cause a “pucker” which can reduce scaring. 
         [0012]    The devices and methods of the present invention will also be able to avoid or reduce disruption when a incision closure appliance is used beneath surgical incision drape which must be removed from over the closure appliance. A sacrificial layer is provided over at least part of the upper surface of the closure appliance, where the sacrificial cover is held in place while the surgical incision drape is placed over the incision closure appliance. After the incision and surgical procedure have been completed, the surgical incision drape will be pulled from the patient&#39;s skin. Instead of adhering to and dislodging the tissue closure appliance, the surgical drape adheres to the sacrificial cover, and only the sacrificial cover is pulled from the patient with the drape, leaving the remainder of the incision closure appliance in place. 
         [0013]    In a first aspect of the present invention, an incision closure appliance comprises a base including a left panel and a right panel. Each panel has a tissue adherent lower surface, an upper surface, an inner edge, and an outer edge. The lower tissue adherent surface will typically be coated at least partially with a common tissue-adherent adhesive such as those used in surgical bandages and patches. 
         [0014]    The incision closure appliance further includes a force distribution structure coupled to each panel (i.e. each panel will have at least one force distribution structure coupled thereto), where each force distribution structure is adapted to allow axial expansion of the panel along the inner edge while limiting lateral expansion over the entire length and axial expansion along the outer edge. By permitting axial expansion of the panel along the inner edge, the tissue edges are minimally constrained to allow the tissue to deform when stretched during the surgical procedure. Conversely, by limiting both lateral expansion and axial expansion along the outer edge, the panel will be able to apply a controlled and distributed closure force when the panels are drawn together after the surgical procedure is complete, as described in more detail below. 
         [0015]    The incision closure appliance still further includes a closure component or assembly which attaches to the force distribution structure to draw the inner edges of the panels together after they had been adhered to the tissue on opposite sides of an incision site and the surgical procedure completed. Each panel of the base will typically comprise an at least partially elastic matrix, typically having an isotropic elasticity (i.e. the panel stretches evenly in all directions) but optionally having an anisotropic elasticity (where the matrix stretches preferentially in one direction or over a portion thereof). The elastic matrix may comprise an elastomeric membrane or sheet (for example Polyurethane sheet or Thermo Plastic Elastomers (TPE)), a woven fabric (typically woven at least partially from elastomeric filaments, threads, or fibers), a spun fabric, or the like. In certain embodiments, the elastomeric matrix may comprise a fabric woven from both elastic elements (typically threads, filaments, fibers, or the like) and having inelastic elements disposed along the outer edge and extending laterally there across in order to provide the expansion characteristics described above with respect to the force distribution structure. That is, in some cases, the force distribution structure may include or consist of inelastic elements woven or otherwise incorporated within a fabric membrane. 
         [0016]    Typically, the force distribution structure will comprise a separate component of the incision closure appliance, for example including a spine disposed axially adjacent to the outer edge of the panel and a plurality of axially spaced-apart lateral supports disposed laterally and extending from the spine toward the inner edge of the panel. Such a “comb-like” structure will typically be formed from flexible but non-distensible materials so that the elements can flex together with the tissue deformation but will not stretch along their lengths so that they may provide dimensional stability in the lateral direction as well as along the outer edge of the panel. Examples of such materials include Nylon, Polypropylene, Polyethylene and Polycarbonate or other thermo polymers. Notably, the force distribution structure will not limit the axial stretching of the inner edge of the panel in order to provide the desired expansibility and conforms to the tissue during the surgical procedure. Such separate force distribution structures may be attached to the upper surface of the panel, or alternatively may be embedded in or laminated within the panel. Typically, the force distribution structure will not extend into or past the lower surface of the panel so that it will not interfere with adherence of the panel to the skin or other tissue. 
         [0017]    The assembly of the base panels and the force distribution structures will typically be carried on a removable backing which covers and protects the adherent surface of the panels prior to use. The adherent backing may be removed in order to apply the base to the skin or other tissue at the site of the surgical intervention. Additionally, the right and left panels will typically be held together by removable tabs, an axial strip, or other removable covers or structures in order to hold the inner edges of the panel at a pre-determined distance or spacing as they are being adhered to the tissue. For example, removable tabs may be placed at each axial end of the base to temporarily secure the two base panels together. Alternatively, a removable strip or tape may be placed over an axial gap between the right and left panels to hold the panels in place relative to each other as the base is being adhered to the tissue surface. Such tabs or strips will typically be self-adhesive so that they may be secured to the panels and then removed by simply pulling off after the panels are properly placed. The cover, tabs, or strip may then be removed to leave the panels in place but unconnected prior to forming the surgical incision therebetween. 
         [0018]    A first exemplary construction of the closure component or assembly comprises a right engagement member, a left engagement member, and a plurality of lateral struts holding the engagement members laterally apart by a pre-determined distance. The right engagement member is adapted to releasably engage the supports of the right panel along an inner edge thereof, and the left engagement member is adapted to releasably engage the supports of the left panel along an inner edge thereof. In the specific embodiments, at least some of the supports of the force distribution component will have cleats near their inner edges, and the engagement members will have slots which receive the cleats. After the surgical intervention is complete, the closure component may then be placed over the force distribution structure with the cleats on one side first being engaged by an engagement member and then the opposite engagement member being pulled over the cleats on the opposite side. 
         [0019]    Alternatively, the closure component or assembly may comprise a plurality of independent lateral ties attached to at least some of the lateral supports. Such lateral ties are configured to be secured between the lateral supports, typically being fixed to one panel and being adjustably attachable to the other panel. For the exemplary embodiments, the adjustably attachable end may comprise a ratchet tightening mechanism or similar structure which allows each lateral tie to be independently adjusted at a different spacing between the right and left panels. In this way, the right and left panels may be differentially tensioned along their inner edges in order to control and optimize the forces applied to the adjacent tissue edges which are being drawn together. 
         [0020]    Optionally, the closure appliance of the present invention may further comprise a securing layer which is adapted to be placed over the assembly of the base and the closure component after the assembly has been secured over an incision on a patient&#39;s skin and the surgical procedure has been completed. A securing layer will typically have a self-adhesive lower surface which can be placed over the assembly of the base and closure component to help secure it in place and to maintain cleanliness. The securing layer may optionally have openings to permit access to the wound for observation, delivery of antiseptics, and the like. 
         [0021]    In a further aspect of the present invention, methods for forming an incision in tissue comprise providing an incision closure appliance as described above. The right and left panels of the appliance are adhered to the patient&#39;s skin, where the inner edges of the panels are spaced-apart by a pre-selected distance typically from 0.5 mm to 15 mm. An incision (typically linear) is formed in the tissue or skin surface between the inner edges of the panels, and the edges of the incised tissue are then separated to perform a desired surgical procedure. The inner edges of the panels can stretch and conform along with movement and deformation of the tissue edges while the outer edge and lateral extent of each panel remain dimensionally stable. After the procedure is complete, the closure component is secured to the force distribution structure to draw the inner edges of the panels back together. Optionally, the closure component has dimensions (or an adjustable inter-panel spacing) which draw the tissue edges closer together than they were immediately after the incision was formed. Such drawing together of the tissue causes the edges to evert and the tissue to “pucker” which can reduce scarring. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0022]      FIG. 1  is an exploded view of an incision closure appliance constructed in accordance with the principles of the present invention. 
           [0023]      FIG. 2  is a top view of the assembly of a base and a force distribution structure which is part of the incision closure appliance. 
           [0024]      FIG. 3  is a cross-sectional view taken along line  3 - 3  of  FIG. 2 . 
           [0025]      FIGS. 4-7  illustrate use of the incision closure appliance of the present invention for forming and closing an incision in a patient&#39;s skin. 
           [0026]      FIG. 8  illustrates an alternative construction of a closure component for the closure appliance of the present invention. 
           [0027]      FIG. 9  is an exploded view of a further embodiment of an incision closure appliance constructed in accordance with the principles of the present invention. 
           [0028]      FIG. 10  is an enlarged isometric view of the base and force distribution structure of the system of  FIG. 9 . 
           [0029]      FIGS. 11A and 11B  illustrate an alternative lateral tie construction which can be used in the appliances of either  FIG. 1  or  FIG. 9 . 
           [0030]      FIG. 12  illustrates a sacrificial cover positioned over an incision closure appliance in accordance with the principles of the present invention. 
           [0031]      FIGS. 13A through 13E  illustrate the principle of operation of the sacrificial cover illustrated in  FIG. 12  when used together with a surgical incision drape and performing methods according to the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0032]    The apparatus and methods of the present invention will 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. As described hereinafter, the direction of the incision 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. 
         [0033]    Referring now to  FIGS. 1-3 , an incision closure appliance  10  comprises a base assembly  12  including a right panel  14  and a left panel  16 . A right force distribution structure  18  is secured to the right panel  14 , typically by laminating the force distribution structure to an upper surface of the panel, and a left force distribution structure  20  is similarly attached to an upper surface of the left panel  16 . The incision closure appliance further comprises a closure component  22  which is removably attachable to the right and left forced distribution structures  18  and  20  in order to close an incision, as described in more detail below, and the appliance is completed with an optional securing layer  24  which may be placed over the combined base assembly  12  and closure component  22  after they have been secured to the patient and the incision has been closed by drawing the panels together using the closure component. 
         [0034]    The closure component  22  is intended and adapted to draw the inner portions of the force distribution structures  18  and  20  inwardly toward each other to close a surgical incision which has been formed therebetween. In the illustrated embodiment, a plurality of cleats  26  are formed on lateral supports  36  which are held axially by spine  37  of the force distribution structures  18  and  20 . The cleats  26  are received in slots  38  formed along inner edges of opposed engagement members  40  of the closure component  22 . The opposed engagement members  40  are held together by lateral struts  42  so that the engagement members are held at a fixed, laterally spaced-apart distance (in other embodiments the spaced-apart distance may be adjustable). The slots  38  are preferably formed on flexible tab-like structures  44  which allow the slots to be pulled upwardly over the corresponding cleats in order to secure the closure component  22  over the force distribution structures  18  and  20 . 
         [0035]    The lower surfaces  32  of each panel  18  and  20  will typically be covered with a pressure-responsive adhesive, where the adhesive is initially covered with a protective layer  48  which may be peeled away immediately prior to use. Additionally, pull-away tabs  50  or other similar structures may be provided in order to hold the right and left panels  14  and  16  together at a pre-determined spaced-apart distance after the layer  48  has been removed but prior to adhering the panels to a patient&#39;s skin or other tissue surface. It is important that the distance between the inner edges  28  of each panel  14  and  16  be maintained as close as possible to the original target spacing so that the tissue edges, when closed by the closure component  22 , will be precisely brought together, typically with a slight eversion. 
         [0036]    Referring now to  FIGS. 4 through 7 , a protocol for both forming an incision and subsequently closing the incision in accordance with the principles of the present invention will be described. Initially, the right and left panels  14  and  16  are placed on the patient&#39;s skin followed by reference letter S, as shown in  FIG. 4 . The panels  14  and  16  are applied by first pulling away the protective layer  18  and placing the panels onto the tissue, after which time the tabs  50  may be removed, leaving an incision path  52  defined between the inner edges  28 . The spacing of the inner edges  28  will be selected to provide a fixed, pre-determined distance d 1 . 
         [0037]    After the right and left panels  14  and  16  are in place, an incision I can be formed in the space between the panels using a scalpel or other surgical cutting device CD, as shown in  FIG. 5 . 
         [0038]    After the incision I is made, a surgical procedure may be performed by opening the inner edges of the incision which in turn deforms the inner edges  28  of the right and left panels  14  and  16 , as shown in  FIG. 6 . As the inner most ends of the supports  36  are not connected, they are free to separate and allow the elastic matrix of the right and left panels  14  and  16  to expand, as clearly in  FIG. 6 . The dimensional stability of the remainder of the panels, however, will be preserved by the lateral supports  36  as well as the axial spines  37  which do not elongate under the influence of the force applied by stretching opening the incision. 
         [0039]    After the surgical procedure is complete, the closure component  22  will be secured over the force distribution structures  18  and  20 , as illustrated in  FIG. 7 . In particular, the slots  38  in the tab-like structures  44  are engaged over opposed cleats  26  in order to draw opposed edges of the panels as well as of the tissue incision together. By properly spacing the depth of the slots  38 , the closure component  22  can be tailored so that the panels  14  and  16  are brought together by a pre-selected distance d 2 . Typically, the distance d 2  will be less than the initial separation d 1  so that the inner edges of the tissue are brought together to cause the tissue edges along the incision to slightly evert (pucker upwardly) which can improve healing and reduce scarring. 
         [0040]    Optionally, as shown in  FIG. 8 , a closure component  22 ′ may include engagement members  40 ′, where one end of each lateral strut  42 ′ is joined by an adjustable clasp or other mechanism  54  so that the distance between the inner edges of the opposed engagement members  40 ′ can be adjusted in order to increase or lessen the distance d 2  therebetween. 
         [0041]    An alternative embodiment  100  of the incision closure appliance of the present invention is illustrated in  FIGS. 9 and 10 . The appliance  100  includes a base assembly  102  having a right panel  104  and a left panel  106 . A positioning or alignment strip  108  is provided to secure the inner edges of each panel together, as shown best in  FIG. 10  and includes an end tab  109  that allows the user to pull the strip from the panels  104  and  106  after the panels have been put in place on a tissue surface. 
         [0042]    The incision closure appliance  100  further includes a backing  110  having an end which may be partially folded back to expose an underlying adhesive backing on the panels and allow that end of the base assembly  102  to be adhered to the tissue while the remainder of the base assembly is still covered by the backing. A securing layer  112  which includes a reinforcement frame  113  is provided for placement over the right panel  104  and left panel  106  after the base assembly  102  has been closed over an incision, generally is described in connection with the previous embodiment. Usually, a holding tray  114  will be provided for maintain the components of the appliance together in a sterilized condition where the tray  114  will be covered with conventional medical packaging cover. 
         [0043]    As illustrated in  FIGS. 9 and 10 , a right force distribution structure  116  and a left force distribution structure  118  are provided on the upper surfaces of the right panel  104  and the left panel  106 , respectively. The right force distribution structure  116  includes a right axial spine  120  and a plurality of lateral supports  122 . Typically, the right axial spine  120  comprises a serpentine or zig-zag number which is embedded in or laminated to a base strip  121 . The serpentine axial spine  120  would typically be formed from a flexible, resilient plastic, typically a hard plastic, while the base strip  121  will be comprised of a polyurethane or similar plastic layer. The lower surface of the polyurethane layer will be covered with a hydrocolloid layer for tissue adhesion. The structure of the left forced distribution structure  118  will be the same including a left axial spine  124 , left lateral supports  126 , and a left base strip  127 . 
         [0044]    The incision closure appliance  100  will include a closure mechanism comprising a plurality of lateral tie assemblies  128  as shown on  FIG. 9 . As best seen in  FIG. 10 , each lateral tie assembly  128  will include a rod which is secured at one end to the left lateral support  126  and a ratchet mechanism  132  which is secured to the right lateral support  122 . Each rod  130  will usually be aligned with the axis of the left panel  106  parties so that a gap  129  between the right panel  104  and left panel  106  will be left open so that an incision can be made there between. After the incision is made, each rod  130  will be pulled over to the associated ratchet  132  on the right panel  104 . A series of ratchet rings on each rod will be pulled into the associated ratchet mechanism  132 , and the rod then pulled laterally until the desired closing tension is applied at that point along the base assembly  102 . It is a particular advantage that each of the lateral tie assemblies  128  may be individually adjusted to supply the desired closing tension across the tissue along the length of the incision being closed. Once the desired closing tension has been provided along the entire incision, the securing layer  112  may be placed over base assembly  102  to hold the appliance and tissue in place. 
         [0045]    Referring now to  FIGS. 11A and 11B , an alternative design for the lateral tie assemblies  140  of the present invention is illustrated. These lateral tie assemblies  140  may be utilized with either of the incision closure appliances  10  or  100  described previously. Each lateral tie assembly  140  includes a right force distribution structure  142  and a left force distribution structure  144 . The right force distribution structure includes a right spine  146  and a plurality of lateral supports  148 . Although three are shown, it will be appreciated that four, five, six or more lateral supports could be included. The left force distribution structure  144  similarly includes a left spine  150  and a plurality of left lateral supports  152 . To provide closure, the right force distribution structure  142  includes a rod  154  which extends from the center lateral support  148 . Typically, the rod  154  is joined to the support by a live or passive joint  158 . A pull loop  156  is provided at the free end of the rod  154 , and a plurality of ratchet teeth  162  are provided along the midsection of the rod  154 . 
         [0046]    The left force distribution structure  144  includes a ratchet mechanism  160  adapted to receive the teeth  162  on the rod  154  of the right force distribution structure. In this way, the rod  154  can be lowered into the ratchet  160  to engage teeth  162 , allowing the rod to be pushed forward in order to draw the right and left force distribution structures  142  and  144  together in order to apply tension to the right and left panels. 
         [0047]    As illustrated in  FIG. 12 , a further aspect of the present invention is illustrated. The incision closure appliance  100  is illustrated schematically with only the right and left panels  104  and  106  and the right and left force distribution structures  116  and  118  being illustrated. The remaining system components are not shown for ease of illustration. 
         [0048]    The right panel  104  is covered by a right sacrificial cover  170  and the left panel  106  is covered by a left sacrificial cover  172 . Each cover  170  and  172  is detachably secured along each edge of the associated base panel so that the covers remain in place during normal handling and placement of the incision closure appliance  100  over the tissue surface to be incised. The use and purpose of these sacrificial covers  170  and  172  is described with reference to  FIGS. 13A and 13E . 
         [0049]      FIG. 13A  illustrates the right and left panels  104  and  106  in place on a tissue surface T prior to an incision being made. The right panel  104  is covered by right sacrificial cover  170  and the left panel  106  is covered by left sacrificial cover  172 . As is common in many surgeries, an adherent surgical incision drape  180  is placed over the tissue surface T. Any conventional drape may be used such as the Ioban™ antimicrobial incise drape, available from 3M, St. Paul, Minn. 
         [0050]    After the incision drape  180  is in place over the incision closure appliance, a surgical incision I may be made for performing a desired surgical intervention. As can be seen, the incision I will cut through the surgical drape  180  between the right and left panels  104  and  106 , respectively. After the surgical procedure is completed, the surgical drape  180  will be removed from the tissue surface T. As the surgical drape has a lower adherent surface, prior to the present invention, removal of the drape might have displaced either or both of the right panel  104  and left panel  106 . Presence of the sacrificial layers  170   m  and  172 , however, prevents such displacement. Removal of the surgical drape  180  will remove the sacrificial layer  170  and  172 , but as each of these layers is configured to break off with a relatively low separation force, removal of the sacrificial layers will not cause the underlying panels  104  or  106  to be displaced. Thus, the panels  104  and  106  will be left in place, as shown in  FIG. 13D , and the force distribution structures  116  and  118  can be used as described previously for closing the panels together to close the incision as shown in  FIG. 13E .