Abstract:
An implantable hernia repair patch comprising a first portion in the form of a tubular surgical plastic mesh having a proximal and distal end and a second portion having the form of a planar sheet of surgical plastic mesh having a distal surface and a proximal surface. In some embodiments the first portion and the second portion are a single piece of surgical mesh. In other embodiments the first portion is attached the second portion by to form the patch. The first portion can be connected to the second portion by stitching, bonding, adhesives, or staples.

Description:
RELATED APPLICATIONS 
       [0001]    This application claims the benefit of priority to U.S. Provisional Application No. 61/733,155, entitled Implantable Hernia Patch, and filed on Dec. 4, 2012, the contents of which are incorporated herein in their entirety. 
     
    
     TECHNICAL FIELD 
       [0002]    This invention relates to laparoscopic hernia repair. More particularly, it refers to a flared mesh patch to repair an inguinal hernia during laparoscopic procedures and methods of using the same. 
       BACKGROUND 
       [0003]    The traditional inguinal approach to hernia repair results in recurrence ranging from seven to twenty-one percent for primary repair and up to eighteen percent after repair of recurrent hernias. In addition, recovery periods associated with herniorrhaphy can be lengthy and painful, sometimes lasting from three to six weeks. See the Journal of Laparoendoscopic Surgery, Volume 1, No. 5, p. 269, 1991, Mary Ann Liebert, Inc., publishers. In seeking to improve on these results and reduce recovery periods associated with herniorrhaphy, surgeons have been carrying out laparoscopic hernia repair employing laser surgery techniques. See the Journal of Laparoendoscopic Surgery, Vol. 1, No. 1, 1990, pages 41-45; and Contemporary Surgery, October 1991, Vol. 39, No. 14, pages 15-19. 
         [0004]    While it appears that laparoscopic hernia repair techniques have been successful, the insertion of polypropylene mesh into the opening in the inguinal region causing the hernia has sometimes resulted in bulging of the inguinal region. This could be caused by movement of the rolled up surgical mesh inserted into the hernia opening. A more perfect prosthetic mesh patch that can be delivered to the hernia site by laparoscopic techniques is needed to reduce side effects and recurrences from laparoscopic hernia repair surgery. 
       SUMMARY 
       [0005]    Implementations of the present invention are directed to an improved patch for use in laparoscopic hernia repair surgery and methods of using the same. 
         [0006]    In an example implementation the patch is made by rolling up a first sheet of a surgical plastic mesh, maintaining the rolled up configuration by at least two circumferential bands of cat gut, cutting longitudinal slits in one end of the rolled up mesh and flaring out the multiple flaps formed by the slits. A second planar sheet of surgical plastic mesh is then stitched to the flared out flaps. The flaps and planar sheet are then compressed together as a longitudinal extension of the first rolled up sheet and inserted into a cylindrical plastic delivery tube. The tube is inserted into the abdomen via a trocar and the patch is pushed out by a plunger into the hernia opening. The second planar sheet is stapled to the tissue adjacent the hernia opening with a stapling gun. 
         [0007]    In another example implementation the patch comprises a first portion in the form of a tubular surgical plastic mesh having a proximal and distal end and a second portion having the form of a planar sheet of surgical plastic mesh having a distal surface and a proximal surface. In some embodiments the first portion and the second portion are a single piece of surgical mesh. In other embodiments the first portion is attached the second portion by to form the patch. The first portion can be connected to the second portion by stitching, bonding, adhesives, or staples. 
         [0008]    In yet another example implementation the patch comprises a first portion having a tubular form with a proximal end and a distal end and an inner surface and an outer surface. The patch further comprises a planar sheet having a distal surface and a proximal surface. The first portion is connected to the second portion such that at the distal end of the first portion the inner surface of the first portion seamlessly merges to the distal surface of the second portion and the outer surface of the first portion seamlessly merges to the proximal surface of the second portion. 
         [0009]    In still a further example of the present invention, the distal surface of the planar sheet second portion comprises an outer layer to resist adhesion of the patch to bodily tissue. In one embodiment the proximal portion of the planar sheet second portion does not include an adhesion resistant outer layer. In another embodiment the distal surface and the proximal surface of the second portion and the inner surface of and the outer surface of the first portion include an adhesion resistant outer layer. The adhesion resistant outer layer may comprise ePTFE or PTFE. 
         [0010]    In certain embodiments the first and second portions may comprise any surgical plastic mesh material suitable for use in hernia operations, including PROLENE, sold by Ethicon, Inc., or a polypropylene or a polytetrafluoroethylene. The planar sheet second portion may be in the form of an oval, a circle, a square, a rectangle, a polygon, a tetrahedron, and an irregular form. The first portion, the second portion, or the first and second portion may include a shape memory feature, and/or may be resistant to deformation once unfolded and/or implanted. 
     
    
     
       DESCRIPTION OF DRAWINGS 
         [0011]    The invention may be best understood by those having ordinary skill in the art by reference to the following detailed description when considered in conjunction with the accompanying drawings in which: 
           [0012]      FIG. 1A  is a top plan view of a piece of surgical plastic mesh being rolled into a cylindrical shape. 
           [0013]      FIG. 1B  is an elevation view of the rolled up surgical mesh of  FIG. 1A  with slits at one end. 
           [0014]      FIG. 2  is a perspective view of the patch of this invention. 
           [0015]      FIG. 3  is a perspective view of a rolled up patch being inserted into a delivery tube. 
           [0016]      FIG. 4  is a perspective view partially in phantom showing the patch being pushed out of the delivery tube. 
           [0017]      FIG. 5  is a frontal view of a patient undergoing laparoscopic hernia repair surgery. 
           [0018]      FIG. 6  is a section view along lines  6 - 6  of  FIG. 5  through the abdomen of a patient with a hernia visible. 
           [0019]      FIG. 7  is a section view along lines  6 - 6  of  FIG. 5  adding a showing of the patch being inserted into the opening of the hernia. 
           [0020]      FIG. 8  is a section view along lines  6 - 6  of  FIG. 5  adding a showing of the patch in place over the opening of the hernia. 
           [0021]      FIG. 9  is a perspective view of an alternate embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0022]    Throughout the following detailed description, the same reference numerals refer to the same elements in all figures. 
         [0023]    The prosthetic mesh patch  10  of the invention shown in  FIG. 2  has a first rolled up surgical plastic mesh portion  12  tied together by cat gut  14  near a first end  15  and a cat gut  16  about midway to two-thirds down the rolled up surgical plastic mesh  12 . Approximately five scissor slits  17  are made in the second end  18  of the rolled surgical plastic  12  so that six flared flaps  20  are produced. The flaps  20  are stitched  22  to a flat sheet  24  of surgical mesh. Thereafter, the patch  10  is rolled up as shown in  FIG. 3  and inserted into a plastic carrier  26 . An elongated plunger  28  as shown in  FIG. 4  is used to push out the patch  10  from its carrier  26  into the opening  30  of the hernia. 
         [0024]    As illustrated in  FIG. 2 , flat sheet  24  is of a generally rectangular shape approximately 120 mm in height and 90 mm in width. In some embodiments, flat sheet  24  may be of a generally circular, ovular, square, or polygonal shape. In some embodiments, the generate height and width of flat sheet  24  may be larger or smaller, depending on the physical constraints of the region in which the patch will be installed. In some embodiments, the dimensions and shape of flat sheet  24  may be varied to be more easily inserted into the plastic carrier  26 . In some embodiments, flat sheet  24  is not completely flat on a single plane, but rather of a three dimensional shape, such that it may fit more precisely against a non-flat surface. In such embodiments, flat sheet  24  may be of a generally conical, hemispherical, ellipsoidal, polyhedral, or irregular shape. 
         [0025]    As illustrated in  FIGS. 1 and 2 , plastic mesh  12  is rolled up several times to create a generally tubular shape. In some embodiments, plastic mesh  12  is rolled up fewer times while maintaining generally the same dimensions, creating a semi-hollow tubular shape that is more easily deformed for insertion into the plastic carrier  26 . 
         [0026]    In some embodiments, plastic mesh portion  12  may be fabricated in a three-dimensional tubular design, such that cat gut  14  or other similar securing method is not required to maintain its generally tubular shape. In some embodiments, plastic mesh portion  12  may be fabricated in a three-dimensional design that is generally tubular in shape, but with asymmetrical dimensional variations, such that it may fit into an irregularly shaped orifice. Example shapes include a funnel, a bent tube, or a tube with a bulging central area, among others. 
         [0027]    In some embodiments, plastic mesh  12  may be attached to flat sheet  24  using means other than stitched flaps. In some embodiments, plastic mesh  12  may be attached to flat sheet  24  using biocompatible adhesives, staples, or other fastening techniques and methods. In some embodiments, plastic mesh  12  and flat sheet  24  may of a single three-dimensional design, such that no fastening is required. 
         [0028]    The patch  10  is used for repeating inguinal hernias. In repairing such a hernia, a patient is brought into an operating room and placed in the supine position. General endotracheal anesthesia is induced and the abdomen, groin and genitalia are prepped and draped in a sterile fashion using betadine solution. The patient is placed in a Trendelenburg position. A small vertical incision is made in the lower edge of the umbilicus and a Verres needle is inserted into the abdomen and a pneumoperitoneum of approximately three liters is carried out. A ten millimeter trocar  32  is then placed through the umbilicus and a laparoscope is threaded through the trocar  32 . The abdomen is inspected and the repair site  34  is visually observed. Usually there is a small sac associated with the hernia opening. A five millimeter trocar  36  is then inserted in the right abdomen and a twelve millimeter trocar  38  in the left abdomen parallel with the umbilicus. The dissecting trocars are inserted into the abdomen and the hernia sac is dissected out using a contact YAG laser to excise the sac. Normally, no bleeding is encountered. The patch  10  is backloaded into a twelve millimeter sleeve of an endopath stapler  29  and inserted into the abdomen through trocar  36 . Alternatively, the patch is pushed out of carrier  26  by plunger  28  through the trocar  36 . The patch  10  is inserted into the opening  30  so that the rolled up portion  12  is completely inserted into the opening. The flared portion  20  with the second plastic mesh sheet  24  is then stapled in place to adjacent tissue by the endopath stapler  29 . The incisions are repaired and the patient is then sent for recovery. 
         [0029]    The stapler  29  used for stapling the patch to the adjacent tissue is an endoscopic tissue repair stapling gun, such as, the ENDOPATH ES Endoscope sold by Ethicon, Inc., a division of Johnson &amp; Johnson Co. Such a stapler is designed for use with a twelve millimeter disposable surgical trocar. 
         [0030]    The surgical plastic mesh employed to make the patch of this invention can be any of the surgical plastic meshes suitable for use in hernia operations, such as, PROLENE, sold by Ethicon, Inc. Generally, the plastic mesh is either a polypropylene or a polytetrafluoroethylene. 
         [0031]    Specific portions of the present invention may be made of differing materials in order to vary the interaction between the present invention and the tissue upon it is implanted. In some embodiments, the plastic mesh portion  12  may be made of a polypropylene, such that a fibroblastic reaction is induced upon tissue that is contacted by the plastic mesh portion  12 . Such a fibroblastic reaction may form a strong fibrous wall of tissue around and through the plastic mesh, therefore creating a bond between the mesh portion  12  and the tissue in order to further strengthen the repair. 
         [0032]    In some embodiments, the flat sheet  24  may be made of a polypropylene in order to induce a similar fibroblastic reaction between the flat sheet  24  and the underlying tissue. In some embodiments, the flat sheet  24  may be made of polytetrafluoroethylene, a material with a low coefficient of friction and known to elicit minimal fibroblastic response upon interaction with tissue. In such embodiments, tissue contacted by flat sheet  24  will not form a fibrous wall around and through the flat sheet  24 , and no bond will be formed. 
         [0033]    In some embodiments, flat sheet  24  may be made of polypropylene on one face and polytetrafluoroethylene on the other face, such that tissue coming in contact with one face of the flat sheet  24  will become bonded through fibroblastic reaction, but tissue coming in contact with the other face of the flat sheet  24  will not. These embodiments may be used to selectively bond tissue to the flat sheet  24  to structurally strengthen the region of repair, while ensuring that vital tissue and organs, such as the bowels, are not undesirably bonded to the flat sheet  24 . In some embodiments, plastic mesh patch  10  made be made of polypropylene, while a second patch (not shown) made of polytetrafluoroethylene may be attached to one face of flat sheet  24 , in order to provide physical separation between flat sheet  24  and vital tissue and organs. The second patch (not shown) may be attached to flat sheet  24  using biologically compatible adhesive, staples, stitches, or other fastening techniques and methods. 
         [0034]    The stitches  22  used to keep the second plastic mesh  24  in place over the flaps  20  are also either a polypropylene or polytetrafluoroethylene thread commonly used in surgical sutures. The size of the plastic surgical mesh used in this invention is usually a two and one-half by four inch sheet of expanded polytetrafluoroethylene or polypropylene and such a sheet can be used for either the first rolled up mesh  12  or the second flat mesh  24 . The mesh  24  has to be large enough to overlap the opening of the hernia and provide adequate room for stapling into the adjacent peritoneum  40 . 
         [0035]    Modification of the materials used in the patch of this invention can be made depending upon the availability of new types of surgical mesh and improvements in the stitching or stapling materials. 
         [0036]    Due to the ease by which the present invention may be introduced into the human body, manipulated, and attached using existing laparoscopic surgical techniques, the present invention is ideal for use in endoscopic hernia repair. In particular, the present in invention may be used to repair indirect hernias, small direct hernias with well-defined margins and an otherwise strong abdominal floor, or recurrent inguinal hernias with defects in an otherwise strong abdominal floor.