Abstract:
A reinforcement device comprises a sheet of biocompatible material equipped with a plurality of hooks or apertures for reinforcing the closure of a surgical incision, including elongated abdominal incisions. The reinforcement device, when implanted through surgery, reduces the likelihood of and/or prevents incisional hernias. The reinforcement device may be included in a surgical kit.

Description:
RELATED APPLICATION 
       [0001]    This disclosure is a continuation-in-part of U.S. patent application Ser. No. 14/530,170 filed Oct. 31, 2014, which is incorporated by reference in its entirety. 
     
    
     TECHNICAL FIELD 
       [0002]    This disclosure relates to medical devices, kits, and methods for reinforcing incision closures. Such devices, kits and methods may reduce the likelihood of incisional hernias. 
       BACKGROUND 
       [0003]    Incisional hernias are detectable defects in a surgical site following the creation of a surgical incision. Such hernias may become apparent as a palpable defect; that is, abdominal contents may protrude beyond where they should and therefore can be physical felt. In some instances, incisional hernias may present merely as a protrusion within a healed incision. 
         [0004]    Incisional hernias following surgery are a common complication following certain surgeries, including but not limited to a laparotomy. A laparotomy is a surgical procedure involving a incision through the abdominal wall to gain access into the abdominal cavity. There are numerous reasons why a particular patient might suffer from an incisional hernia following a laparotomy or other surgery. Patients suffering from obesity, diabetes, or malnutrition may be more susceptible to an incisional hernia. A patient may have poor tissue, or an infection at the incision site, making him or her more susceptible. In other instances, a closure of an incision may not be sufficiently strong to guard against incisional hernias. An unfortunate result is that incisional hernias are not particularly rare. In fact, following a laparotomy, the incidence of incisional hernia has ranged from 15-40%. 
         [0005]    The incidence of incisional hernias is serious. Correction usually calls for surgical intervention, re-operation, and/or prolonged hospitalization. Incisional hernias also may increase morbidity and mortality. In other words, the costs to the health care system and the patient are significant, fiscally and otherwise. 
         [0006]    It is desirable to reduce the incidence of incisional hernias, or to prevent them during an initial operation, by reinforcing surgical closures using medical devices, kits and/or methods. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0007]      FIG. 1  is a top view an exemplary reinforcement device; 
           [0008]      FIG. 2  is perspective view of an exemplary reinforcement device; 
           [0009]      FIG. 3  is atop view of an exemplary reinforcement device; 
           [0010]      FIG. 4  is a top view of the exemplary reinforcement device of  FIGS. 1 and 2  in connection with an abdomen of a patient; 
           [0011]      FIG. 5  is a perspective view of suture connecting an exemplary reinforcement device to a patient through a plurality of hooks. 
           [0012]      FIG. 6  is a perspective view of suture connecting an exemplary reinforcement device to a patient through a plurality of hooks. 
       
    
    
     DETAILED DESCRIPTION 
       [0013]    Multiple embodiments of the disclosed devices, kits and methods are described with reference to only a few exemplary drawings. Although a particular embodiment may be illustrated and described herein as including particular components in a particular configuration, such components and configuration are for exemplary purposes only. The figures and descriptions of the embodiments described herein are not intended to limit the breadth or the scope of the inventive concepts or the appended claims. Rather, the figures and detailed descriptions are provided to illustrate the inventive concepts to a person of ordinary skill in the art and to enable such person to make and use the inventive concepts. 
         [0014]    With reference to  FIGS. 1-3 , exemplary reinforcement device  10  is shown. Reinforcement device  10  comprises a sheet of biocompatible material which is exemplified as mesh sheet  12 . The biocompatible material may be bioabsorbable, non-bioabsorbable, partially bioabsorbable, or some combination of one or more of these. The biocompatible material may comprise any of a number of materials. By way of non-limiting examples, bioabsorbable materials may comprise polyhydroxy acids, polylactides, polyglycolides, polyhydroybutyrates, polyhydroxyvaleriates, polycaprolactones, polydioxanones, synthetic and natural oligo- and polyaminoacids, polyphosphazenes, polyanhydrides, polyorthoesters, polyphosphates, polyphosphonates, polyalcohols, polysaccharides, and polyethers. By way of non-limiting examples, non-bioabsorbable materials may comprise polyalkenes, polyethylene, fluorinated polyolefins, polytetrafluoroethylene, polyvinylidenefluoride, polyamides, polyurethanes, polyisoprenes, polystryrenes, polysilicones, polycarbonates, polyaryletherketones, polymetacrylates, polyacrylates, aromatic polyesters, and polyimides. 
         [0015]    Mesh sheet  12  may comprise a single layer of material, or it may comprise two or more layers of material. Separate layers of material may or may not be co-extensive in length and/or width. Mesh sheet  12  may be at least partially woven or knitted. Mesh sheet  12  have a reinforcing material  14  in or on at least a portion of the mesh sheet  12 . Reinforcing material may comprise any of a number of biocompatible materials, including but not limited to synthetic composite materials such as polyglactin and/or poly p-dioxane undyed yarn. The reinforcing material can be applied to the mesh sheet  12  using any of a number of impregnating or application techniques. Reinforcing material  14  may be in the form of ribs or strips on at least a portion of the periphery of mesh sheet  12 . Reinforcing material  14  may also be applied in the horizontal direction as a plurality of spaced apart rows. Although the strips of reinforcing material depicted in the drawings run the entire periphery of the reinforcing device  10  and include a plurality of spaced apart rows at a common length distance between adjacent rows, other configurations are contemplated. 
         [0016]    In the embodiments of  FIGS. 1 and 2 , mesh sheet  12  also is equipped with two or more columns of hooks  16   a,    16   b  that run parallel or substantially parallel to a longitudinal axis L of reinforcement device  10 . The hooks depicted are shaped like inverted U&#39;s, which are similar to wickets used in croquet. Other shapes and configurations of hooks are contemplated; the hooks are structures though which suture may pass in sewing the reinforcement device  10  to the patient. These hooks  16   a,    16   b  may be integrally formed with the mesh sheet  12  or added on or to the mesh sheet  12  using any of a number of methods. In the depicted embodiment, the common longitudinal distance between hooks within a spaced apart column is d1. 
         [0017]    One or more of hooks  16   a,    16   b  may also be affiliated with an aperture  17   a,    17   b.  In the depicted embodiment, each of hooks  16   a,    16   b  is affiliated with an aperture  17   a,    17   b.  The apertures  17   a,    17   b  are sized and shaped so that a marking end of a marking device may mark a patient&#39;s fascia where a needle and suture are to pierce a patient&#39;s fascia to attach the reinforcement device  10  to the patient. The ability to mark fascia may provide guidance in the form of a template to a surgeon for precision of location in a suturing process. Placement of apertures  17   a  and  17   b  is sufficiently distant from an incision point to avoid wound dehiscence. 
         [0018]    In the depicted embodiment of  FIGS. 1 and 2 , the column with hooks  16   a  and the column with hooks  16   b  are on opposite sides of a longitudinal center region  18  that is substantially rectangular and encompasses center line  18 ′. Center region  18  falls between the spaced apart columns of hooks. Center region  18  extends from opposite ends of the mesh sheet  12 , top edge to bottom edge. The top edge and bottom edge are opposite each other and are perpendicular to or substantially perpendicular to the longitudinal axis of mesh sheet  12 . Within this center region  18 , there is a reinforcing column of hooks  20 . Hooks  20  may be of the same or a different material and/or configuration than the hooks  16   a,    16   b.  Hooks  20  may be supported by reinforcing material  14 . The longitudinal distance between hooks  20  is d2. In the depicted embodiment, d2 is greater than d1. Different configurations and variations between the length d1 and d2 are contemplated. 
         [0019]    For example, d2 may be 1.5× greater, 2× greater, 2.5× greater, 3× greater, 3.5× greater or 4× greater than d1. Different ratios may also be suitable. 
         [0020]    Generally, reinforcement devices  10  may have a number of shapes and dimensions. In one non-limiting exemplary embodiment of a rectangular reinforcement device  10 , a horizontal width of mesh sheet  12  is about 5 cm, a longitudinal length is about 15 cm or about 30 cm, d1 is about 1 cm, and d2 is about 3 cm. The length of reinforcement device  10  depends upon the length of incision, and a surgeon may cut a commercially available reinforcement device  10  to fit the size of a particular incision. The about  5  cm width overlap of the incision may add tensile strength to the wound to assist in reducing the incidence of incisional hernias. Generally, for about every 1 cm of d1 required to close a particular incision, about 4 cm of suture may be used. Stated another way, an exemplary ratio of suture length to wound length of 4 is one embodiment suited for prevention or reduction of incidence of incisional hernias. Different dimensions and different ratios are contemplated; those identified in this paragraph are merely exemplary teachings. 
         [0021]    In the depicted embodiment of  FIG. 3 , one or more of the spaced apart columns of hooks and the reinforcing columns of hooks are eliminated from the reinforcement device  10  and. In this embodiment, there a plurality of spaced apart apertures arranged in columns. The depicted exemplary embodiment shows two columns of apertures left of a center line  18 ′, and two columns of apertures right of the center line  18 ′. The outermost columns of apertures  30   a  and  30   b  (distal from the center line  18 ′) are depicted as having a larger diameter than the innermost apertures  31   a  and  31   b  (proximal center line  18 ′). In one embodiment, the outermost apertures  30   a  and  30   b  have a diameter of about 2.5 mm, and the innermost apertures  31   a  and  31   b  have a diameter of about 1.3 mm. The vertical distance between center points of the outermost apertures  30   a  may be about 5 mm, and the horizontal distance between center points of the outermost apertures  30   a  and  30   b  may be about 15 mm. The dimensions may vary and may be smaller or larger so long as for about every 1 cm of incision required to be closed, about 4 cm of suture may be used in connection with the reinforcement device  10 . 
         [0022]    Referring to  FIGS. 4-6 , examples are shown where an exemplary reinforcement device  10  is used in connection with the closing of an abdominal incision. The surgeon places the reinforcement device  10  over the fascia, attempting to align the center region  18 , and the center line  18 ′ with the incision itself. The surgeon may then mark a patient&#39;s fascia through the apertures  17   a  and  17   b  to indicate where the needle and suture are to pierce fascia to sew the reinforcement device  10  to the patient. In one non-limiting embodiment, the apertures  17   a  and  17   b  are about  1  cm in horizontal distance from the center line  18 ′. If using an exemplary embodiment as shown in  FIG. 3 , such marking of the fascia may be performed through apertures  30   a  and  30   b.    
         [0023]    The particular suture  22  and/or needle(s) (not shown) for use with the reinforcement device  10  may be provided in a surgical kit including the reinforcement device  10 , along with other medicaments, sterilizers, marking devices, cutting tools, and other medical devices and equipment. Any of a number of commercially available sutures  22  may be used with the reinforcement device  10 . The suture  22  may, for example, be bioabsorbable or non-bioabsorbable. 
         [0024]    When the fascia is marked, a surgeon may position reinforcement device  10  in a position to commence suturing. Such position may be intra-peritoneal or extra-peritoneal, depending upon the materials of the reinforcement device  10 . For example, non-bioabsorbable materials may be positioned to avoid potential for adhesion to internal organs. Generally, the suturing involves inserting the sutures  22  through the fascia, then looping the suture through hooks  16   a  to fascia to  16   b  to fascia to  16   a  to fascia to  16   b,  etc. in a series of generally Z-shaped formations or a series of generally X-shaped formations, possibly using a double needled suturing technique. Eventually, as a suturing pattern encounters a hook  20  in its general path, the surgeon may gain additional reinforcement by passing the suture  22  at least once through and/or around hook  20  before completing the connection between a hook  16   a  and a hook  16   b.  An exemplary non-limiting suturing pattern is indicated in  FIG. 5 , and another in  FIG. 6 . Other suturing patterns are contemplated. 
         [0025]    Surgical placement of the reinforcement device  10  in a patient may be within the abdominal cavity if the materials making up reinforcement device  10  do not stick to organs. In another embodiment, surgical placement of the reinforcement device  10  may be beneath the fascia and above the peritoneum. In this surgical placement, when using an embodiment such as one as described in  FIG. 3 , both the apertures  30   a,    30   b  and  31   a,    31   b  may be useful. Marking may performed through the distal apertures  31   a  and  30   b,  while sutures may be placed through the proximal apertures  31   a  and  31   b.  Surgical placement of the reinforcement device  10  in a patient may be above the fascia. In such a placement, the exemplary embodiment of  FIG. 3  may be used where apertures are used to secure the device  10  in place. 
         [0026]    With regard to the devices, kits, methods, etc. described herein, it should be understood that, although the steps of such methods, etc. have been described as occurring according to a certain ordered sequence, such methods could be practiced in an order other than the order described. It should also be understood that certain steps could be performed simultaneously, that other steps could be added, or that certain steps could be omitted. 
         [0027]    The above description is intended to be illustrative, not restrictive. The scope of the invention should be determined with reference to the appended claims along with the full scope of equivalents. It is anticipated and intended that future developments will occur in the art, and that the disclosed devices, kits and methods will be incorporated into such future embodiments. Thus, the invention is capable of modification and variation and is limited only by the following claims.