Patent Publication Number: US-2022218457-A1

Title: Segmented skirted surgical mesh

Description:
REFERENCE TO PENDING PRIOR PATENT APPLICATIONS 
     This patent application: 
     (i) claims benefit of pending prior U.S. Provisional Patent Application Ser. No. 61/843,771, filed Jul. 8, 2013 by BG Medical, LLC and John W. Huelskamp et al. for SEGMENTED SKIRTED HERNIA MESH (Attorney&#39;s Docket No. BGMEDICAL-1 PROV); and 
     (ii) claims benefit of pending prior U.S. Provisional Patent Application Ser. No. 61/845,191, filed Jul. 11, 2013 by BG Medical, LLC and John W. Huelskamp et al. for SEGMENTED SKIRTED HERNIA MESH (Attorney&#39;s Docket No. BGMEDICAL-2 PROV). 
     The two (2) above-identified patent applications are hereby incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     This invention relates to medical procedures and apparatus in general, and more particularly to medical procedures and apparatus for repairing soft tissue defects such as abdominal hernias and the like. 
     BACKGROUND OF THE INVENTION 
     In the reconstruction of soft tissue defects in humans and animals, such as in abdominal hernia repairs, surgical mesh is often used to reinforce the soft tissue defect so as to facilitate healing and to prevent subsequent defect recurrence. More particularly, when performing a closure of a soft tissue defect in an anatomical wall (e.g., to repair an abdominal hernia), it is common to secure a surgical mesh to the soft tissue at the edge of the soft tissue defect, with some overlap between the surgical mesh and the soft tissue, so as to increase the healed strength of the surgical repair. The surgical mesh is typically secured to the soft tissue adjacent to the soft tissue defect with suture or tacks. 
     In practice, and looking now at  FIGS. 1-3 , in open procedures the soft tissue reconstruction is typically carried out using a “skirted” surgical mesh  5 . Skirted surgical mesh  5  generally comprises a base layer  10  of surgical mesh terminating in an outer edge  12 , and a continuous “skirt” or rim  15  of surgical mesh terminating in an outer edge  17  and an inner edge  18  which defines a central opening  19 . Continuous skirt or rim  15  overlies the outer portion of base layer  10  (e.g., so that outer edge  17  of continuous skirt or rim  15  is substantially aligned with outer edge  12  of base layer  10 ), and continuous skirt or rim  15  is secured to base layer  10  only at or adjacent to outer edge  17  of continuous skirt or rim  15 , such that the inner portions of continuous skirt or rim  15  (i.e., the portions adjacent to inner edge  18 ) can be lifted away from base layer  10  when desired. As a result, continuous skirt or rim  15  provides an easily accessed section of surgical mesh which facilitates fixation of skirted surgical mesh  5  to the soft tissue, i.e., by fixing continuous skirt or rim  15  of skirted surgical mesh  5  to the edges of the soft tissue defect using conventional suture or tack fixation. By providing skirted surgical mesh  5  with the continuous skirt or rim  15  of mesh material, when skirted surgical mesh  5  is being secured to the soft tissue, the sharp ends of the fixation elements (e.g., the suture needle or tack) are isolated from the delicate internal organs of the patient by base layer  10 , whereby to prevent inadvertent damage to the delicate internal organs of the patient. 
     However, it has been found that when pulling up on continuous skirt or rim  15  of skirted surgical mesh  5  (e.g., for suturing and/or tacking), this pulling up of the continuous skirt or rim  15  can cause base layer  10  to distort significantly (e.g., to transform from a smooth planar configuration to a curved configuration, such as is shown in  FIG. 4 ). Such distortion in base layer  10  of skirted surgical mesh  5  can make it difficult to provide a flat, symmetrical repair which is smooth and comfortable for the patient. More particularly, the configurations of surgical mesh used in these types of soft tissue repairs (e.g., the hernia meshes used in abdominal hernia repairs) are normally circular or oval in shape ( FIGS. 2-4  show exemplary surgical meshes which are oval in shape) and can possess very tight radii, particularly at the longitudinal ends  25  of oval skirted surgical meshes  5  (see  FIGS. 2 and 4 ). As the radii of continuous skirt or rim  15  of skirted surgical mesh  5  becomes tighter, the effect of “pulling up” on the continuous skirt or rim  15  of skirted surgical mesh  5  (e.g., with graspers  30 ,  FIG. 4 ) is increasingly distorting to base layer  10  of skirted surgical mesh  5 . 
     Efforts have been made to reduce this distortion of base layer  10  of skirted surgical mesh  5  when pulling up on continuous skirt or rim  15  of skirted surgical mesh  5 . 
     In one such effort, and looking now at  FIG. 5 , the inner edge  18  of continuous skirt or rim  15  is scalloped (i.e., a portion of inner edge  18  of continuous skirt or rim  15  is recessed, such as is shown in  FIG. 5  at  40 , from the remainder of inner edge  18  in an effort to minimize the distortion of base layer  10  of skirted surgical mesh  5  when pulling up on continuous skirt or rim  15  of skirted surgical mesh  5 . Unfortunately, in practice, this approach has proven to be of limited benefit. 
     In another such effort, and looking now at  FIG. 6 , a surgical mesh  45  is provided which comprises a base layer  50  of surgical mesh which is completely covered with a top layer  55  of surgical mesh, with top layer  55  being secured to base layer  50  about the outer edge(s)  60  of the two layers, and with top layer  55  being bifurcated at  65  so as to provide two separate pockets of surgical mesh. Then, during use, a first half of top layer  55  of surgical mesh  45  is pulled upward for fixation (e.g., by gripping the first half of top layer  55  with graspers  30  at the bifurcation line  65 ) and then the second half of the top layer  55  of surgical mesh  45  is pulled upward for fixation (e.g., by gripping that second half of top layer  55  with graspers  30  at bifurcation line  65 ). Unfortunately, this construction still suffers from distortion of base layer  50  when one or both halves of top layer  55  of surgical mesh  45  is drawn upward for fixation. 
     Thus there is a need for a novel surgical mesh which provides a skirt or rim of surgical mesh about the outer perimeter of a base layer of surgical mesh but which allows the skirt or rim of surgical mesh to be pulled upward without distorting the smooth planar configuration of the base layer of surgical mesh. 
     SUMMARY OF THE INVENTION 
     The present invention comprises the provision and use of a novel surgical mesh which provides a skirt or rim of surgical mesh about the outer perimeter of a base layer of surgical mesh but which allows the skirt or rim of surgical mesh to be pulled upward without distorting the smooth planar configuration of the base layer of surgical mesh. 
     In one preferred form of the invention, there is provided a segmented skirted surgical mesh for use in reconstructing a soft tissue defect, the segmented skirted surgical mesh comprising: 
     a base layer of surgical mesh, said base layer of surgical mesh comprising an outer edge; and 
     a segmented continuous skirt of surgical mesh comprising an outer edge and an inner edge which defines a central opening, said segmented continuous skirt of surgical mesh being secured to said base layer of surgical mesh at said outer edge of said segmented continuous skirt of surgical mesh, and said segmented continuous skirt of surgical mesh comprising a plurality of slits formed in said segmented continuous skirt of surgical mesh, wherein said plurality of slits extend outwardly from said inner edge of said segmented continuous skirt of surgical mesh, whereby to form a plurality of flaps of surgical mesh in said segmented continuous skirt of surgical mesh, such that at least one of said flaps of surgical mesh can be lifted away from said base layer of surgical mesh and secured to soft tissue without causing distortion of said base layer of surgical mesh. 
     In another preferred form of the invention, there is provided a method for reconstructing a soft tissue defect, the method comprising: 
     providing a segmented skirted surgical mesh comprising:
         a base layer of surgical mesh, said base layer of surgical mesh comprising an outer edge; and   a segmented continuous skirt of surgical mesh comprising an outer edge and an inner edge which qdefines a central opening, said segmented continuous skirt of surgical mesh being secured to said base layer of surgical mesh at said outer edge of said segmented continuous skirt of surgical mesh, and said segmented continuous skirt of surgical mesh comprising a plurality of slits formed in said segmented continuous skirt of surgical mesh, wherein said plurality of slits extend outwardly from said inner edge of said segmented continuous skirt of surgical mesh, whereby to form a plurality of flaps of surgical mesh in said segmented continuous skirt of surgical mesh, such that at least one of said flaps of surgical mesh can be lifted away from said base layer of surgical mesh and secured to soft tissue without causing distortion of said base layer of surgical mesh;       

     positioning said segmented skirted surgical mesh adjacent to a soft tissue defect; and 
     lifting at least one of said flaps of surgical mesh away from said base layer of surgical mesh and securing said at least one flap of surgical mesh to soft tissue without causing distortion of said base layer of surgical mesh. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       These and other objects and features of the present invention will be more fully disclosed or rendered obvious by the following detailed description of the preferred embodiments of the invention, which is to be considered together with the accompanying drawings wherein like numbers refer to like parts, and further wherein: 
         FIG. 1  is a schematic view showing a soft tissue defect being reconstructed using a surgical mesh; 
         FIGS. 2 and 3  are schematic views showing a prior art skirted surgical mesh in greater detail; 
         FIG. 4  is a schematic view showing the prior art skirted surgical mesh of  FIGS. 2 and 3  becoming distorted as the continuous skirt or rim of the skirted surgical mesh is lifted away from the base layer of the skirted surgical mesh; 
         FIG. 5  is a schematic view showing a prior art skirted surgical mesh wherein the inner edge of the continuous skirt or rim of the surgical mesh is scalloped in an effort to minimize distortion of the base layer of the skirted surgical mesh as the continuous skirt or rim of the skirted surgical mesh is lifted away from the base layer of the skirted surgical mesh; 
         FIG. 6  is a schematic view showing a prior art surgical mesh which comprises a base layer of surgical mesh which is completely covered with a top layer of surgical mesh, with the top layer of surgical mesh being secured to the base layer of surgical mesh about the outer edges of the two layers, and with the top layer of surgical mesh being bifurcated so as to provide two separate pockets of surgical mesh; 
         FIGS. 7-10  are schematic views showing a novel segmented skirted surgical mesh formed in accordance with the present invention; 
         FIGS. 11 and 12  are schematic views showing another novel segmented skirted surgical mesh formed in accordance with the present invention; and 
         FIGS. 13-15  are schematic views showing another novel segmented skirted surgical mesh formed in accordance with the present invention; and 
         FIGS. 16-18  are schematic views showing another novel segmented skirted surgical mesh formed in accordance with the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The present invention comprises the provision and use of a novel surgical mesh which provides a skirt or rim of surgical mesh about the outer perimeter of a base layer of surgical mesh but which allows the skirt or rim of surgical mesh to be pulled upward without distorting the smooth planar configuration of the base layer of surgical mesh. 
     More particularly, and looking now at  FIGS. 7-10 , the present invention comprises the provision and use of a novel segmented skirted surgical mesh  105 . Novel segmented skirted surgical mesh  105  comprises a base layer  110  of surgical mesh terminating in an outer edge  112 , and a segmented continuous skirt or rim  115  of surgical mesh terminating in an outer edge  117  and an inner edge  118  which defines a central opening  119 . Segmented continuous skirt or rim  115  overlies the outer portion of base layer  110  (e.g., so that outer edge  117  of segmented continuous skirt or rim  115  is substantially aligned with outer edge  112  of base layer  110 ), and segmented continuous skirt or rim  115  is secured to base layer  110  only at or adjacent to outer edge  117  of segmented continuous skirt or rim  115 , such that the inner portions of segmented continuous skirt or rim  115  (i.e., the portions adjacent to inner edge  118 ) can be lifted away from base layer  110  when desired. 
     The segmented continuous skirt or rim  115  of surgical mesh is segmented by providing a plurality of breaks or cuts or slits  122  in the continuity of segmented continuous skirt or rim  115  of surgical mesh  105 , whereby to form a plurality of segments or flaps  123 A,  123 B,  123 C, etc. of the segmented continuous skirt or rim  115 . In one preferred form of the invention, there are at least three breaks or cuts or slits  122  in the continuity of segmented continuous skirt or rim  115  of surgical mesh  105 , whereby to form at least three segments or flaps  123 A,  123 B,  123 C, etc. 
     Each of the segments or flaps  123 A,  123 B,  123 C, etc. of segmented continuous skirt or rim  115  provides an easily accessed section of surgical mesh which facilitates fixation of segmented skirted surgical mesh  105  to the soft tissue, i.e., by fixing the various segments or flaps  123 A,  123 B,  123 C, etc. of segmented continuous skirt or rim  115  to the edges of the soft tissue defect using conventional suture or tack fixation. By providing segmented skirted surgical mesh  5  with the segmented continuous skirt or rim  115  of surgical mesh, when segmented skirted surgical mesh  105  is being secured to the soft tissue, the sharp ends of the fixation elements (e.g., the suture needle or tack) are isolated from the delicate internal organs of the patient by base layer  110  of segmented skirted surgical mesh  105 , whereby to prevent inadvertent damage to the delicate internal organs of the patient. At the same time, and significantly, by providing a segmented continuous skirt or rim  115  of surgical mesh, where the segmented continuous skirt or rim  115  is segmented (through the provision of breaks or cuts or slits  122 ) into a plurality of segments or flaps  123 A,  123 B,  123 C, etc., distortion of base layer  110  of segmented skirted surgical mesh  105  can be reduced or eliminated when segmented continuous skirt or rim  115  is pulled upward, since then only the surgical mesh of a particular segment or flap  123 A,  123 B,  123 C, etc. is pulled upward—the remainder of the segments or flaps  123 A,  123 B,  123 C, etc. of the segmented continuous skirt or rim  115  are unaffected, which results in reduced distortion of base layer  110  of segmented skirted surgical mesh  105 . 
     By way of example but not limitation, having three or four evenly-spaced breaks or cuts or slits  122  in segmented continuous skirt or rim  115  of a small oval or circular segmented skirted surgical mesh  105  keeps base layer  110  of segmented skirted surgical mesh  105  substantially flat even when some or all of segments or flaps  123 A,  123 B,  123 C, etc. of the segmented continuous skirt or rim  115  is lifted up from base layer  110  of segmented skirted surgical mesh  105  ( FIGS. 7-10 ), since then only the surgical mesh of a particular segment or flap  123 A,  123 B,  123 C, etc. is pulled upward—the remainder of the segments or flaps  123 A,  123 B,  123 C, etc. are unaffected, which results in reduced distortion of base layer  110  of segmented skirted surgical mesh  105 . 
     In larger constructions, an oval configuration ( FIGS. 7-10 ) is typically used, inasmuch as defects in a body wall cavity (e.g., an abdominal hernia) are typically oblong in shape (due to the stress orientation in the soft tissue). These oval configurations have opposing tight end radii  125  which benefit even more than circular configurations by providing breaks or cuts or slits  122  in segmented continuous skirt or rim  115 . 
       FIGS. 11 and 12  show a segmented skirted surgical mesh  105  having a circular configuration. Note that the segmented continuous skirt or rim  115  of segmented skirted surgical mesh  105  of  FIGS. 11 and 12  has three breaks or cuts or slits  122 , whereby to provide three segments or flaps  123 A,  123 B and  123 C. 
     The breaks or cuts or slits  122  in segmented continuous skirt or rim  115  of segmented skirted surgical mesh  105  are preferably accomplished by cutting through segmented continuous skirt or rim  115 , preferably starting at inner edge  118  of segmented continuous skirt or rim  115  and extending radially outwardly, and preferably terminating just short of the outer edge  117  of segmented continuous skirt or rim  115 . In one preferred embodiment, breaks or cuts or slits  122  extend at an angle of 90 degrees to the adjacent inner edge  118  of segmented continuous skirt or rim  115 . Alternatively, the breaks or cuts or slits  122  in segmented continuous skirt or rim  115  may be made at varying angles to inner edge  118  of segmented continuous skirt or rim  115  so as to further minimize distortion in base layer  110  of segmented skirted surgical mesh  105  when segments or flaps  123 A,  123 B,  123 C, etc. are subjected to lifting away from base layer  110 . 
       FIGS. 13-15  show another segmented skirted surgical mesh formed in accordance with the present invention. And  FIGS. 16-18  show still another segmented skirted surgical mesh formed in accordance with the present invention. Note that with the segmented skirted surgical meshes of  FIGS. 13-15  and  FIGS. 16-18 , segmented continuous skirt or rim  115  is modified so as to provide different sized central openings  119 . 
     The breaks or cuts or slits  122  in segmented continuous skirt or rim  115  preferably extend almost all the way to outer edge  117  of segmented continuous skirt or rim  115 , although the breaks or cuts or slits may also extend all the way to outer edge  117  if desired, or may terminate intermediate of segmented continuous skirt or rim  115  if desired. 
     The number of cuts or breaks or slits  122  formed in segmented continuous skirt or rim  115  of segmented skirted surgical mesh  105 , and the placement of those breaks or cuts or slits  122 , may be optimized so as to (i) minimize distortion of base layer  110  when a segment or flap  123 A,  123 B,  123 C, etc. is pulled upward, and (ii) minimize the overall number of segments or flaps  123 A,  123 B,  123 C, etc. that the segmented continuous skirt or rim  115  is divided into (since “too many segments or flaps” has the potential to complicate the fixation process for the surgeon). In practice, it is generally preferred to make three or four cuts or breaks or slits  122  in the segmented continuous skirt or rim  115  of segmented skirted surgical mesh  105 , whereby to provide three or four segments or flaps  123 A,  123 B,  123 C, etc. in segmented continuous skirt or rim  115  of segmented skirted surgical mesh  105 , since providing less than three cuts or breaks or slits  122  in segmented continuous skirt or rim  115  makes it difficult to lift the segments or flaps of continuous segmented skirt or rim  115  away from base layer  110  without distorting base layer  110 . 
     It should also be appreciated that, if desired, outer edge  117  of segmented continuous skirt or rim  115  could terminate inboard of outer edge  112  of base layer  110 . Alternatively, outer edge  117  of segmented continuous skirt or rim  115  could overlap outer edge  112  of base layer  110  (e.g., outer edge  117  of segmented continuous skirt or rim  115  could be folded over edge  112  of base layer  110 ). 
     By minimizing the distortion of base layer  110  of segmented skirted surgical mesh  105  when one or more of the segments or flaps  123 A,  123 B,  123 C, etc. of segmented continuous skirt or rim  115  is lifted up during fixation, the fixation itself is facilitated, i.e., the fixation will take less time and the final repair geometry is controlled so that there are no gathered areas that might lead to potential sites of discomfort for the patient. Thus, the segmented skirted surgical mesh of the present invention benefits both the surgeon (through facilitated fixation) and the patient (by producing a more cosmetic and comfortable reconstruction). 
     MODIFICATIONS OF THE PREFERRED EMBODIMENTS 
     It should be understood that many additional changes in the details, materials, steps and arrangements of parts, which have been herein described and illustrated in order to explain the nature of the present invention, may be made by those skilled in the art while still remaining within the principles and scope of the invention.