Patent Publication Number: US-2018036108-A1

Title: Single Plane Tissue Repair Patch

Description:
TECHNICAL FIELD 
     The field of art to which this invention pertains is implantable surgical tissue repair patches, more particularly implantable surgical mesh hernia patches for use in hernia repair procedures. 
     BACKGROUND OF THE INVENTION 
     Hernia repair is a relatively straightforward surgical procedure, the ultimate goal of which is to restore the mechanical integrity of the abdominal wall by repairing a muscle wall defect through which the peritoneum and possibly a section of the underlying viscera has protruded. There are various types of hernias, each with its own specific surgical repair procedure, including ventral hernias, umbilical hernias, incisional hernias, sports hernias, femoral hernias, and inguinal hernias. It is believed that most hernias are attributable to a weakness in sections of the tissues of the abdominal wall. 
     Precipitating events, such as unusual movements or lifting extremely heavy weights, may cause the weak spots in the abdominal wall tissue to be excessively stressed, resulting in tissue separation or rupture and protrusion of a section of peritoneum and underlying viscera, e.g., intestine, through the separated or ruptured tissue section. This weakness may be attributable to several factors. Weakness in the abdominal wall may be congenital or may be associated with a prior incision from a surgical procedure or a trocar wound. Other factors may include trauma, genetic predisposition, and aging. 
     Even though the commonly used, conventional surgical procedures for correcting or repairing the various types of hernias are somewhat specific, there is a commonality with respect to the mechanical repair. Typically, the protrusion of the peritoneum through a muscle or abdominal wall defect results in a hernia sack containing the underlying and protruding viscera. The hernia sack is dissected and the viscera are pushed back into the abdominal cavity. Then, a tissue reinforcing or repair implant such a mesh patch device is typically implanted and secured at the site of the abdominal wall defect. Autologous tissue quickly grows into the mesh implant, providing the patient with a secure and strong repair. In certain patient presentations, it may be desirable to suture or otherwise close the defect without an implant, although this is typically much less desirable for the optimal outcome. 
     One common type of hernia is a ventral hernia. This type of hernia typically occurs in the abdominal wall and may be caused by a prior incision or puncture, or by an area of tissue weakness that is stressed. There are several repair procedures that can be employed by the surgeon to treat such hernias, depending upon the individual characteristics of the patient and the nature of the hernia. In one technique, an onlay mesh is implanted on the dorsal surface of the anterior fascia of the abdominal wall. Another technique provides for an inlay mesh, where the prosthetic material is sutured to the abdominal wall and acts as a “bridge” to close the abdominal defect. Placement of a prosthetic mesh posterior to the rectus muscle of the abdominal wall is known as the Reeves Stoppa or retromuscular technique. In this technique, a mesh implant is located beneath the muscle of the abdominal wall but above the peritoneum. Implantation of the mesh in the intra-peritoneal location can be done via an open or laparoscopic approach. The mesh is inserted into the patient&#39;s abdominal cavity through an open anterior incision or via a trocar and positioned to cover the defect. The surgeon then fixates the mesh implant to the abdominal wall with conventional mechanical fixation or with sutures placed through the full thickness of the abdominal wall. There are a variety of such mechanical fixation devices that can be used in laparoscopic or open surgery, e.g., tacking instruments. Intraperitoneal placement of mesh via an open approach may be the desired technique of repair where the layers of the abdominal wall are attenuated and a laparoscopic approach is not desired. Placement of mesh via this technique presents several unique challenges including poor visibility during mesh handling and fixation, poor handling, and deficient ergonomics of the currently available products. Mesh repair patch implants designed for intraperitoneal placement typically requires an additional treatment or layer to function as a tissue separating component to separate the viscera from the prosthetic abdominal wall repair layer, and thereby prevent or substantially inhibit the formation of post-operative adhesions. The addition of this layer may add to the complexity of wound healing due to the presence and mass of an additional layer. 
     Although hernia repair patch implants exist for open ventral hernia repairs, there are deficiencies known to be associated with their use. The deficiencies include difficulty in handling the mesh, poor visibility during mesh handling, implantation and fixation, poor usability and ergonomics when using a laparoscopic instrument, and the use of dual or multiple layers of mesh. The commercially available meshes repair patch implants for this application typically have at least dual layers of mesh or fabric with pockets or skirts to provide for affixation to the parietal wall via the top layer or skirt. It can also be appreciated that multiple layer meshes introduce more foreign body mass and tend to be more expensive and complicated to manufacture than a single layer mesh implant 
     Accordingly, there is a need in this art for novel tissue repair implants, such as ventral hernia repair patch implants, that can be used in an open surgical procedure, and which do not require a mesh anchoring or affixation layer, and which may be secured to tissue using a single or multiple crown technique. 
     SUMMARY OF THE INVENTION 
     Accordingly, novel tissue repair patches are disclosed. The tissue repair patches have a substantially flat or planar base member. The base member is preferably a mesh. There is an opening located in the base member, and, there is a closure member associated with the opening. The base member has a top side and a bottom side. The patch may have a polymeric layer on at least part of at least one side of the base member. It is preferred that the side of the mesh that faces the viscera have a polymeric layer covering substantially all of that side. The tissue repair patches of the present invention are especially useful in an open hernia repair procedure, such as a ventral hernia repair, and are also useful in other types of body wall tissue repairs. 
     Another aspect of the present invention is a method of repairing a body wall defect, such as a hernia defect, in an open surgical procedure using the above-described tissue repair patch implants. 
     These and other aspects and advantages of the present invention will become more apparent from the following description and accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a plan view of an embodiment of a single plane tissue repair mesh patch of the present invention; the patch has a base member having an opening, and a closure patch member mounted to the top side of the base member over the opening. 
         FIG. 2  is an exploded perspective view of the repair mesh patch of  FIG. 1 . 
         FIG. 3  is an illustration showing a surgical tacking instrument having an elongated shaft partially inserted underneath the flap member and through the opening of the base member of the repair patch of  FIG. 1 ; the instrument shaft is seen as having access to the bottom side of the base member. 
         FIG. 4  is a plan view of a tissue repair patch of the present invention that is similar to the repair patch shown in  FIG. 1 , but which has a rectangular closure patch member connected along its opposed minor sides; the closure patch member is seen to contain a direction guide for use by the surgeon in orienting the patch during implantation. 
         FIG. 5  is an exploded perspective view illustrating two halves of another embodiment of a tissue repair patch of the present invention; the two halves are connected to form a repair mesh patch having closure flaps. 
         FIG. 6  is a plan view of a tissue repair patch of the present invention made by joining the two halves seen in  FIG. 5 ; the flaps are in the at rest position. 
         FIG. 7  is a perspective view of the tissue repair patch of  FIG. 6 ; the flaps are in the at rest position. 
         FIG. 8  is a perspective view of the tissue repair patch of  FIG. 7  showing both of the flaps in the up position, uncovering the opening in the base member, thereby providing access through the base member. 
         FIG. 9  illustrates the tissue repair patch of  FIG. 8  with a curved shaft of a surgical tacking instrument inserted partially through the opening of the base member. 
         FIG. 10  is a plan view of another embodiment of a tissue repair patch of the present invention; the mesh patch is seen to have an opening with a surgical suture and surgical needle mounted about the opening in a continuous mattress suture configuration. 
         FIG. 11  illustrates the tissue repair patch of  FIG. 10 , wherein the opening has been closed by applying tension to the suture after the patch has been affixed to the parietal wall of the patient over the hernia defect. 
         FIG. 12  is an exploded perspective view of another preferred embodiment of a tissue repair patch of the present invention; the patch is seen to have an upper closure flap and a lower closure flap mounted about an opening in the base member. 
         FIG. 13  is a plan view of the tissue repair mesh of  FIG. 13 , showing the closure flaps mounted about the opening in the base member with one closure flap adjacent to the bottom side of the base member and one closure flap adjacent to the top side of the base member; the flaps are in an at rest position. 
         FIG. 14  is a plan view of a preferred embodiment of a tissue repair patch of the present invention; the patch is seen to have a pair of closure flap members. 
         FIG. 14 a    is a cross-sectional view of the repair patch of  FIG. 12  along View Line  14   a - 14   a.    
         FIG. 14 b    is a magnified partial view of the cross-section of  FIG. 12 a    illustrating the flaps positioned about the opening in the base member of the patch. 
         FIG. 15  is an exploded perspective view of two base member halves of the tissue repair patch of  FIG. 14 ; both halves have a closure flap member extending from the base member sections. 
         FIG. 16  is a perspective view of the tissue repair patch made by joining together the two halves seen in  FIG. 15 ; one closure flap is positioned below the base member and one closure flap is positioned above the base member. 
         FIG. 17  is a perspective view of the tissue repair mesh patch of  FIG. 16 ; both closure flaps are in the up position such that the opening in the base member is accessible between the flaps. 
         FIG. 18  is a perspective view of the mesh repair patch of  FIG. 17 , illustrating the distal end of a curved elongated shaft of a surgical tacking instrument partially inserted through the opening of the base member in a position below the patch to secure the mesh repair patch to tissue. 
         FIG. 19  is a perspective view of the tissue repair patch of  FIG. 18 , with both flaps optionally sutured together in an upward extending position to close the opening in the base member after the patch has been affixed to tissue. 
         FIG. 20  is a cross-sectional side view of the tissue repair patch of  FIG. 16  inserted into the abdominal cavity of a patient and positioned adjacent to the patient&#39;s peritoneum; a curved shaft of a surgical tacking instrument is seen inserted thorough an access opening such as a hernia defect in the patient&#39;s body wall and through the opening in the base member of the repair patch, such that the distal end of the shaft is in position below the patch to secure a section of the base member of the patch with a tack to the body wall. 
         FIG. 21  is a perspective view of the mesh repair patch of  FIG. 17 , illustrating the distal end of a straight elongated shaft of a surgical tacking instrument partially inserted through the opening of the base member in a position to secure the tissue repair patch to tissue. 
         FIG. 22  is a side view of the tissue repair patch of  FIG. 21  inserted into the abdominal cavity of a patient and positioned adjacent to the patient&#39;s peritoneum; a distal section of a straight shaft of a surgical tacking instrument is seen inserted thorough an access opening in the patient&#39;s body wall and through the opening in the base member of the repair patch, such that the distal end of the shaft is in position below the patch to secure a section of the base member of the patch with a tack to the body wall. 
         FIG. 23  is an illustration of a hernia repair procedure wherein a surgeon is securing the tissue repair patch of  FIG. 17  in position over a hernia defect using a surgical tacking instrument having a curved elongated shaft; the distal section of the shaft is inserted through an access opening in the patient&#39;s body wall and through an opening in the tissue repair patch in order to secure the tissue patch to the peritoneum; the surgeon&#39;s hand is seen palpating the abdomen above the distal end of the shaft of the instrument to place a tack in a desired position on the patch. 
         FIG. 24  is a cross-sectional side view illustrating a preferred embodiment of a tissue repair patch of the present invention in place over a hernia defect adjacent to a patient&#39;s peritoneum; a curved elongated shaft of a surgical tacking instrument has been positioned through an access opening in the patient&#39;s body wall and through an opening in the patch to attach a section of the base member of the patch to the peritoneum; the patient&#39;s visceral organs are seen positioned adjacent to the bottom side of the patch and the peritoneum, and the closure flaps are seen to extend upwardly through the opening in the body wall. 
         FIG. 25  is an exploded perspective view of an alternate embodiment of a mesh tissue repair patch of the present invention; the base member is seen to have an opening in the base member surrounded by a closure ring, and a closure patch having a mating closure ring is also shown. 
         FIG. 26  is a perspective view of the tissue repair patch of  FIG. 25  showing the patch secured to the base member. 
         FIG. 27  illustrates a peritoneal view of the bottom side of a preferred embodiment of a tissue repair patch of the present invention secured to the peritoneum with a double row of surgical tacks referred to as a double crown technique; the opening in the base member is seen to be closed, and both flaps have been positioned upwardly away from the top of the base member; the flaps are secured to close the opening in the base member. 
         FIG. 28  is a perspective view of an alternate embodiment of a mesh tissue repair patch of the present invention; the patch is seen to have a slit in the base member providing a central opening. 
         FIG. 29  is a perspective view of the patch of  FIG. 28  having a surgical suture mounted about the slit in a shoe lace type configuration to close the opening in the slit. 
         FIG. 30  is a perspective view of the tissue repair patch of  FIG. 29 , after the suture ends have been tensioned, thereby closing the opening and slit after the patch is secured to the patient&#39;s body wall. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The novel tissue repair patches or devices of the present invention are particularly useful in open ventral or incisional hernia repair surgical procedures. The tissue repair patch devices consist of a base member having an opening. The base member has a closure member or device associated with the opening for securing the opening after implantation. The repair patch devices of the present invention have utility in other conventional tissue repair procedures including inguinal hernia repair procedures, trocar puncture wounds, trocar incisional hernias, etc. 
     Tissue repair implants and surgical instruments for applying tacks to fixate tissue repair implants are disclosed in the following commonly assigned, co-pending patent applications, which are incorporated by reference: U.S. Ser. Nos. 12/464,151; 12/464,165; 12/464,177; 12/464,143; 12/944,651; and 12/815,275. 
     The tissue repair patches of the present invention may be made from any conventional biocompatible materials. The patches and their components are preferably made from conventional biocompatible polymers that may be nonabsorbable or bioabsorbable. The term bioabsorbable is defined to have its conventional meaning and includes both biodegradable and bioresorbable. Examples of such nonabsorbable polymers include polypropylene, polyester, nylon, ultra high molecular weight polyethylene, and the like and combinations thereof. Examples of suitable bioabsorbable polymers include polylactides (PLA), polyglycolides (PGA), polydioxanones (PDO, PDS), copolymers of PGA/trimethylene carbonate (TMC), copolymers of PLA/TMC, and the like. If desired, combinations of biocompatible nonabsorbable polymers and bioabsorbable polymers may be utilized to construct the tissue repair implant patch devices of the present invention. 
     Although it is preferred to use surgical meshes to construct the hernia repair patches of the present invention, other conventional woven or nonwoven surgical repair fabrics or thermally formed implants may also be used. In addition, the tissue repair patches may be made from other conventional implantable materials such as PTFE (polytetrafluoroethylene), e.g., ePTFE films and laminates. The patches may consist of composites of polymeric films and meshes, and/or fabrics. 
     The meshes useful in the hernia repair patch devices of the present invention will be manufactured in a conventional manner using conventional manufacturing equipment and methods including knitting, weaving, non-woven techniques, and the like. The meshes will typically have a pore size sufficient to effectively provide for tissue ingrowth; for example, they may have pore sizes in the range of about 0.3 mm to about 5 mm, and other conventional size ranges. Examples of commercially available nonabsorbable and bioabsorbable polymeric meshes that may be used to construct the hernia repair patches of the present invention include ETHICON PHYSIOMESH™ and ETHICON PROCEED™ Surgical Mesh, available from Ethicon, Inc., Route 22 West, Somerville, N.J. 08876. 
     When constructing the novel tissue repair patches of the present invention from surgical fabrics other than meshes, the fabrics will have open pores with a pore size sufficient to effectively provide for tissue ingrowth; for example, with a typical size of about 0.3 mm to about 3 mm. By “open pores” is meant openings that extend from one side of the fabric to the opposed side, providing a pathway through the fabric. The fabric repair members may be constructed from monofilaments, multifilaments, or combinations thereof. Examples of commercially available non-mesh fabrics that can be used to manufacture the hernia repair patches of the present invention include woven fabrics, textiles and tapes for surgical applications. Other fabrics or materials include perforated condensed ePTFE films and nonwoven fabrics having pore sizes of at least one millimeter. The non-mesh fabrics may be constructed of conventional biocompatible materials. 
     The fabric or mesh may contain, in addition to a long-term stable polymer, a resorbable polymer (i.e., bioabsorbable or biodegradable). The resorbable and the long-term stable polymer preferably contain monofilaments and/or multifilaments. The terms resorbable polymers and bioabsorbable polymers are used interchangeably herein. The term bioabsorbable is defined to have its conventional meaning. Although not preferred, the fabric or mesh tissue repair member may be manufactured from a bioabsorbable polymer or bioabsorbable polymers without any long-term stable polymers. 
     The tissue repair patches of the present invention may also include polymer films. The films may be attached to the top surface, the bottom surface or both surfaces and may also cover the peripheral edges of the repair patch devices or extend beyond the periphery of the repair patch devices. The films that are used to manufacture the tissue repair patch implant devices of the present invention will have a thickness that is sufficient to effectively prevent adhesions from forming, or otherwise function as a tissue barrier or tissue separating structure or membrane. For example, the thickness may typically range from about 1 μm to about 500 μm, and preferably from about 5 μm to about 50 μm, however this will depend upon the individual characteristics of the selected polymeric films. The films suitable for use with the repair patches of the present invention include both bioabsorbable and nonabsorbable films. The films are preferably polymer-based and may be made from various conventional biocompatible polymers, including bioabsorbable and nonabsorbable polymers. Non-resorbable or very slowly resorbable substances include polyalkenes (e.g., polypropylene or polyethylene), fluorinated polyolefins (e.g., polytetrafluoroethylene or polyvinylidene fluoride), polyamides, polyurethanes, polyisoprenes, polystyrenes, polysilicones, polycarbonates, polyarylether ketones (PEEKs), polymethacrylic acid esters, polyacrylic acid esters, aromatic polyesters, polyimides as well as mixtures and/or co-polymers of these substances. Also useful are synthetic bioabsorbable polymer materials for example, polyhydroxy acids (e.g., polylactides, polyglycolides, polyhydroxybutyrates, polyhydroxyvaleriates), polycaprolactones, polydioxanones, synthetic and natural oligo- and polyamino acids, polyphosphazenes, polyanhydrides, polyorthoesters, polyphosphates, polyphosphonates, polyalcohols, polysaccharides, and polyethers. However, naturally occurring materials such as collagen, gelantin or natural-derived materials such as bioabsorbable Omega 3 fatty acid cross-linked gel films or oxygenated regenerated cellulose (ORC) can also be used. 
     The films used in the tissue repair patch devices of the present invention may cover the entire outer surfaces of the hernia patch member or a part thereof. In some cases, it is beneficial to have films overlapping the borders and/or peripheries of the repair patches. The repair patches of the present invention may also have adhesion barrier layers attached to one or both sides. The adhesion barriers will typically consist of conventional biocompatible polymeric materials including but not limited to absorbable and nonabsorbable polymers. Examples of conventional nonabsorbable polymeric materials useful for adhesion barriers include expanded polytetrafluoroethylene, polytetrafluoroethylene, silicone, and the like. Examples of conventional absorbable polymeric materials useful for adhesion barriers include oxidized regenerated cellulose, poliglecaprone 25 (copolymer of glycolide and epsilon-caprolactone), and the like. 
     It is particularly preferred that the tissue repair patches of the present invention have a mesh construction, and the embodiments illustrated in the Figures have such a mesh construction. The tissue repair implants of the present invention have particular utility for hernia repair procedures, but may be used in other tissue repair surgical procedures as well. 
     Referring now to  FIGS. 1-3 , a tissue repair patch  10  of the present invention is seen. The patch  10  has a mesh construction. The repair patch  10  is seen to have substantially flat or planar base member  20  and closure patch member  30 . The base member  20  is illustrated having a substantially oval shape or configuration, but may have other configurations including square, rectangular, circular, polygonal, etc, combinations thereof and the like. The base member  20  is seen to have top side  22 , bottom side  24 , and periphery  26 . Extending through the base member  20  is the slot  40  having opening  42  bounded by opposed sides  44  and opposed ends  43 . The closure patch member  30  is seen to be a substantially flat or planar member having a substantially oval configuration. The closure patch member  30  is seen to have top side  32 , bottom side  34 , and periphery  35 . Closure patch member  30  is seen to have opposed curved ends  37  and opposed sides  38 . Patch member  30  is mounted to the top of base member  20  via connections  39  along the ends  37  such that the bottom side  34  of closure patch  30  is adjacent to the top side  22  of base member  20 . The closure patch is mounted using any conventional affixation method to create the connections  39 , including but not limited to sewing, welding, tacking, riveting, stapling, gluing, etc., and the like. The closure patch  30  is mounted to the base member  20  to cover the slot  40  and opening  42 . Openings  48  adjacent to sides  38  provide access passages for surgical instruments to and through opening  42  of slot  40 . A partial schematic of a surgical tacking instrument  60  which can be used to tack the base member  20  of patch  10  to tissue is seen in  FIG. 3 . The instrument  60  has proximal handle  62  and distally extending elongated shaft  70  having distal end  78 . A distal section  76  of the shaft  70  is seen to extend through opening  48 , underneath the bottom side  34  of closure flap  30  and through opening  42  of slot  40  such that it is positioned below the bottom side  24  of base member  20 . The distal end  78  is seen to be positioned in proximity to the periphery  26  of the base member  20  adjacent to bottom side  24  so that surgical tacks may be fired to secure the patch to tissue adjacent to the top side  22  of base member  20  and the top side  32  of closure patch member  30 . The repair patch  10  is fixated around its perimeter  26  to tissue with fixation points placed, for example, about every 1 to 2 cm, i.e., the fixation devices or tacks are separated by about 1 cm to 2 cm distances. Although in many embodiments of the tissue or hernia repair patches of the present invention it is preferred to have a slot in the base member to provide an opening through the base member, the opening may be a slit or other types of openings having different geometric configurations may be utilized including circular, oval, rectangular, polygonal, etc., combinations thereof and the like. Although not preferred, it is possible to form the tissue repair patches of the present invention such that the base member and/or closure member are curved or otherwise in more than one plane. 
     Once the tissue repair patch  10  of the present invention has been implanted and secured to tissue by tacking or other conventional methods (e.g., stapling, suturing, etc.), the shaft section  76  of surgical affixation instrument  60  is removed from the body through the slot  40 . The closure patch member  30  prevents underlying tissue or viscera from moving through the slot  40  and opening  42 . 
     An alternative embodiment of the tissue repair patch  10  is seen in  FIG. 4 . The patch  10  is seen to have similarly shaped base member  20 , however the closure member  50  is seen to have a substantially rectangular shape with opposed minor end sides  56  and opposed major sides  57 . Closure member  50  has top side  52  and bottom side  54  adjacent to top side  22  of base member  20 . The patch member  50  is mounted to base member  20  over slot  40  by connections  59  along minor sides  56 . The connections may be made as described previously. Openings  48  beneath sides  57  provide access to slot  40  and opening  42 . As seen in  FIG. 4 , the tissue repair patch  10  is seen to have a directional indicator  80  contained on or in the closure member  50 . Indicator  50  may be conventionally sewn, molded or formed, printed, dyed or laminated into or onto the member  50 . The indicator  80  is seen to have central section  81 , having opposed transverse sections  82  extending therefrom. Extending longitudinally in an opposed manner are the longitudinal sections  85  and  87 . Section  87  is seen to be thicker than section  85 . The indicator  80  allows the surgeon to determine the location of the patch with respect to the patient after insertion by aligning the respective axes of the tissue repair patch  10  with respect to the patient and the incision, allowing for more precise fixation, either using a tacking instrument or using surgical sutures for affixation. Such directional indicators may be used with other embodiments of the tissue repair patches of the present invention. 
     Referring now to  FIGS. 5-9 , an alternative embodiment of a tissue repair patch  100  of the present invention is seen. The patch  100  is seen to have substantially flat or planar base member  110  formed from substantially flat or planar base sections  120  and  140 . The base member  110  has bottom side  112 , top side  114  and periphery  116 . Base section  120  is seen to have straight side  122  having ends  124 . Base section  120  is also seen to have curved side  126  having ends  128  that connect to ends  124 . Extending out from straight side  122  is the closure flap member  130  having hinged side  132  and free end  134  separated from side  122  by slot  136 . Slot  136  has closed end  137  and open end  138 . The closure flap member  130  is seen to have a generally rectangular configuration, but may have other geometric configurations including circular, oval, polygonal, etc., combinations thereof and the like. Base section  140  is seen to have straight side  142  having ends  144 . Base section  140  is also seen to have curved side  146  having ends  148  that connect to ends  144 . Extending out from straight side  142  is the closure flap member  150  having hinged side  152  and free end  154  separated from side  142  by slot  156 . Slot  156  has closed end  157  and open end  158 . The closure flap member  150  is seen to have a generally rectangular configuration, but may have other geometric configurations including circular, oval, polygonal, etc., combinations thereof and the like. The base member  110  and the tissue repair patch  100  are formed from the base sections  120  and  140  by connecting the base sections along straight sides  122  and  142  along seams  118 . This can be done in any conventional manner including sewing, welding, tacking, stapling, gluing, etc., and combinations and equivalents thereof. It can be seen that only the straight sides  122  and  142  are connected on either side of the closure flap members  130  and  150 . The closure flaps members  130  and  150  are mounted together such that hinged side  132  of closure flap  130  is contained in slot  156  of flap member  150  and hinged side  152  of closure flap  140  is contained in slot  136  of closure member  130 . 
     This creates the slit  160  in base member  110  having through opening  165  bounded by interior portions of straight sides  122  and  142  of the base sections  120  and  142 , respectively, and also bounded by the hinged sides  132  and  152  of the flap members  130  and  150 , respectively. In the at rest position as seen in  FIG. 6 , the flap member  130  rests upon the top side  145  of the base section  140  of base member  110 , while the flap member  150  rest upon the top side  125  of base section  120 . In this at rest configuration the slit  160  and opening  165  are covered. The tissue repair patch  100  is seen in the ready position in  FIG. 8 , with the closure flap members  130  and  150  in the upright position exposing the slit  160  and opening so that a fixation instrument can be inserted through the opening  165 . A tacking instrument  170  is illustrated in  FIG. 9  with tissue repair patch  100  of the present invention. The tacking instrument  170  is seen to have proximal handle  172  and actuation trigger  174 . Extending from the distal end  176  of handle  170  is the curved shaft  180  having distal section  182  and distal end  184 . The distal section  182  is seen to be inserted through slit  160  and opening  165  between upwardly extending flaps  130  and  150  such that the distal end  184  may be moved about the bottom side  112  of the base member  110  in order to secure the base member to tissue with surgical tacks. Once tacks are placed through the base member  110  of patch  100  to secure the patch  100  to tissue, the tacking instrument  170  may be removed from the slit  160  and the two flap members  130  and  150  can be interlocked by folding or rotating the flap members downwardly onto the top  114  of the base member  110 . One or both of the flap members may be optionally bonded or affixed to the base member  110  using various conventional closure methods including adhesives, sutures, surgical fasteners, etc. 
     An alternate embodiment  400  of a single plane tissue repair patch of the present invention is seen in  FIGS. 10 and 11 . The repair patch  400  has a base member  410  having a top side  412  and a bottom side  414 . The patch has a periphery  416 . Located in the base member  410  is a slit  420  having an opening  424  bounded by sides  422 . The slit  420  has ends  428 . Mounted about the slit  420  is a surgical suture  430  having ends  432  and  434  and surgical needle  436  mounted to end  432 , and optionally, although not shown, to end  434 . The suture  430  is mounted about the opening  424  in a conventional mattress suture (continuous) configuration. As seen in  FIG. 11 , the opening  424  is closed by tensioning the suture ends  432  and  434 , causing the sides  422  to approximate. If desired, the suture needles  436  can be used to engage tissue with the suture  430 . Referring to  FIGS. 28 and 29 , a variation of suture mounting is illustrated. The repair patch  450  is similar to repair patch  400 , but has a rectangularly shaped base member  451  having opposed major sides  454  and opposed minor sides  456  connected by rounded corners  457 . The base member  451  has bottom side  458  and top side  459 , and outer periphery  452 . The base member  451  has centrally located slit  460  having an opening  464  bounded by sides  462 . The slit  460  has ends  468 . Mounted about the slit  460  is a surgical suture  470  having ends  472  and  474 . The suture  470  is mounted in a “shoe lace” type configuration. The suture  470  is seen to be mounted to slit  460  by engaging opposed sides  462  of slit  460  about the opening  464 . Suture  470  is seen to have ends  472  and  474  located adjacent to one another along one end  468  of slit  460 . The slit  460  is secured after placement of the patch  450  by pulling on ends  472  and  474  thereby closing opening  464 . The suture  460  may optionally have surgical needles mounted to one or both of the ends  472  and  474 . The base members  410  and  451  may have any suitable geometric configuration. 
     A preferred embodiment of a tissue repair patch  200  of the present invention is seen in  FIGS. 12 and 13 . The patch  200  is seen to have a substantially flat or planar base member  210  having a top  212 , bottom  214  and periphery  216 . The base member  210  is seen to have an oval shape, but may have other geometric shapes including rectangular, circular, square, polygonal, combinations thereof and the like. Located in the base member  210  is the slot  220  having opening  222  therethrough. Slot  220  is bounded by opposed sides  224  and  225  and curved ends  226 . The patch  200  is seen to have upper closure flap  230  and lower closure flap  240 . Upper closure flap  230  is seen to have a substantially rectangular shape, although it may have other geometric configurations including circular, oval, rectangular, polygonal, etc., and the like. Flap  230  is seen to have top side  231  and bottom side  232 . The flap  230  also has opposed sides  235  and  236  connected by opposed end sides  237 . The flap  230  is mounted to the top side  212  of base member  210  adjacent to side  224  of slot  220  by connecting the flap  230  along its side  235  in a conventional manner such as sewing, gluing, stapling, welding, riveting and the like to create a seam  239 . In this manner, the flap  230  has its bottom side  232  facing the top side  212  of base member  210 , and is positioned to cover slot  220  and opening  222  in the at rest position. The closure flap may be rotated upwardly about seam  239  to uncover slot  220  and opening  222 . Mounted to the bottom side  214  of base member  210  is the other closure flap  240 . Flap  240  is seen to have top side  241  and bottom side  242 . The flap  240  also has opposed sides  245  and  246  connected by opposed end sides  247 . The flap  240  is mounted to the bottom side  214  of base member  210  adjacent to side  225  of slot  220  by connecting the flap  240  along its side  245  in a conventional manner such as sewing, gluing, stapling, welding, riveting and the like to create a seam  249 . In this manner, the flap  240  has its top side  241  facing the bottom side  214  of base member  210 , and is positioned to cover slot  220  and opening  222  in the at rest position. The closure flap may be rotated downwardly about seam  249  to uncover slot  220  and opening  222 . The flap  240  may also be rotated upwardly about seam  249  through slot  220  and opening  222 . 
     Referring now to  FIGS. 14, 14   a ,  14   b , and  15 - 17 , a preferred tissue repair patch  250  of the present invention is seen. The patch  250  is similar to patch  200 , but is constructed in a different manner from two separate base section members. The patch  250  is seen to have substantially flat or planar base member  260  formed from substantially flat or planar base sections  270  and  280 . The base member  260  has bottom side  264 , top side  262  and periphery  266 . Base section  270  is seen to have straight side  272  having ends  274 . Base section  270  is also seen to have side  276  having curved ends  278  that connect to ends  274 . Extending out from straight side  272  is the closure flap member  290  having hinged side  292  and free side  294 . The closure flap member  290  is seen to have a generally rectangular configuration, but may have other geometric configurations including, circular, oval, rectangular, polygonal, etc. and the like. Base section  280  is seen to have straight side  282  having ends  284 . Base section  280  is also seen to have side  286  having curved ends  288  that connect to ends  284 . Extending out from straight side  282  is the closure flap member  300  having hinged side  302  and free side  304 . The closure flap member  300  is seen to have a generally rectangular configuration, but may have other geometric configurations including circular, oval, rectangular, polygonal, etc., and the like. The base member  260  and the hernia closure patch  250  are formed from the base sections  270  and  280  by connecting the base sections along straight sides  272  and  282  along seams  268 . This can be done in any conventional manner including sewing, welding, tacking, stapling, gluing, etc., and combinations and equivalents thereof. It can be seen that the straight sides  272  and  282  are connected on either side of the closure flap members  290  and  300 , thereby creating a slit  310  between the members  290  and  300  having an opening  315 . The slit  310  is bounded by the hinged sides  292  and  302  of the closure flap members  290  and  300  and has opposed ends  312 . When assembling the patch  250  and base member  260 , closure flap  290  is inserted through opening  315  in slit  310 . In the at rest position as seen in  FIGS. 12 and 16 , the flap member  300  rests upon the top side of the base section  270  of base member  260 , while the flap member  290  rests upon the bottom side of base section  280 . In the at rest state, closure flaps  290  and  300  each cover the slit  310  and opening  315 . It will be appreciated that either closure flap may be rotated through the slit  310  and opening  315 , although patch  250  as illustrated shows closure flap member  290  rotated though the slit and resting adjacent to the bottom side  264  of base member  260 . In addition slit  310  may have other geometric configurations and shapes including a slot, etc. 
     Referring now to  FIGS. 17-22 , the repair patch  250  is seen in a ready position for securement to tissue in a tissue repair procedure such as a hernia repair procedure. As seen in  FIG. 17 , the patch has been placed in a ready position by rotating flap  300  upwardly away from the top  262  of base member  260 . Flap  290  is also seen to be rotated upwardly through slit  310  and opening  315 . By rotating closure flaps  290  and  300  in this manner, the slit  310  and opening  315  are uncovered providing access to a surgical instrument, such as a tacking instrument, or the surgeon&#39;s fingers. A surgical tacking instrument  320  is seen in  FIG. 18  along with tissue repair patch  250  of the present invention. The tacking instrument  320  is seen to have proximal handle  322  and actuation trigger  324 . Extending from the distal end  326  of handle  322  is the curved shaft  330  having distal section  332  and distal end  334 . The distal end section  332  is seen to be inserted through slit  310  and opening  315  between upwardly extending closure flaps  290  and  300  such that the distal end  334  may be moved about the bottom side  264  of the base member  260  in order to secure the base member  260  to tissue with surgical tacks. The hernia patch  250  is seen implanted in a patient in  FIG. 20 . A cross-section of a body wall  370  having a surgically created opening  372  is seen. The body wall  370  is seen to have an inner peritoneal layer  374 , a next upper fascia layer  375 , a next muscle layer  376 , a fat layer  377 , and finally a top dermal layer  378 . The top side  262  of base member  260  is seen to be mounted adjacent to the peritoneal layer  334 , with the closure flap members  290  and  300  extending out and through the opening  332 . Shaft  330  of tacking instrument  320  is seen inserted through surgical opening  332 , through slit  310  and opening  315  and into the patient&#39;s underlying body cavity. The distal end section  332  and distal end  334  are seen to be positioned adjacent to bottom side  264  of base member  260  in order to attach a section of the base member  260  to the peritoneal layer  374 . Referring to  FIG. 19 , the patch  250  is seen with the flap members  290  and  300  optionally secured along their bottom sides  302  and  292  respectfully by surgical suture  380  having ends  381  and  382 . Surgical needle  388  is attached to suture end  281 . The sutured flap members close the opening  315  in slit  310 . Alternatively, the flap members may be joined or secured together to close the slit  310  by conventional adhesives, surgical fasteners, etc. The flap members  290  and  300  may alternatively be utilized in their at rest position during implantation. The shaft of a tacking instrument would be inserted beneath flap  300  through slit  310  and opening  315  without rotating the flaps upwardly. After securement, the flaps may be left in the at rest position without additional securement of the flaps. The flap  290  would prevent tissue or visceral from moving into slot  310  and opening  315 ; any pressure against flap  290  would cause it to seal against the bottom side  264  of base member  260 , closing off slit  310 . 
     A surgical tacking instrument  340  having a straight shaft  350  that can be used to secure a tissue repair patch of the present invention is seen in  FIGS. 21 and 22 . The instrument  340  has a proximal handle  342  with an actuation trigger  344 . Extending from the distal end  346  of handle  340  is the straight shaft  350  having distal section  352  and distal end  354 . The distal end section  352  is seen to be inserted through slit  310  and opening  315  between upwardly extending closure flaps  290  and  300  such that the distal end  354  may be moved about the bottom side  264  of the base member  260  in order to secure the base member  260  to tissue with surgical tacks. The tissue repair patch  250  is seen implanted in a patient in  FIG. 22 . A cross-section of a body wall  370  having a surgically created opening  372  is seen. The body wall  370  is seen to have an inner peritoneal layer  374 , a next upper fascia layer  375 , a next muscle layer  376 , a fat layer  377 , and finally a top dermal layer  378 . The top side  262  of base member  260  is seen to be mounted adjacent to the peritoneal layer  374 , with the closure flap members  290  and  300  extending out and through the opening  332 . Shaft  350  of tacking instrument  350  is seen inserted through surgical opening  372 , through slit  310  and opening  315  and into the patient&#39;s underlying body cavity. The distal end section  352  and distal end  354  are seen to be positioned adjacent to bottom side  264  of base member  260  in order to attach a section of the base member  260  to the peritoneal layer  374 . 
       FIGS. 23 and 24  illustrate the implantation of a tissue repair patch  250  of the present invention in a patient during a surgical procedure to repair a hernia defect. The surgeon is seen to be holding the handle  322  of a surgical tacking instrument  320  with one hand while engaging the trigger  324 . The instrument has a curved shaft  330 , and the proximal section  332  of shaft  330  has been placed through opening  372  of body wall  370 , and through slit  315  and opening  350  of hernia repair patch  250 . Repair patch  250  has been implanted in the patient&#39;s body cavity such that the upper side  262  of base member  260  is adjacent to the peritoneal layer  374 . The closure flaps  290  and  300  have been rotated upwardly to expose slit  310  and opening  315  and extend out through opening  372  of body wall  370  so that they extend partially above dermal layer  378 . The patient&#39;s viscera  379  are seen to be adjacent to the bottom side  264  of base member  260 . Shaft  330  of tacking instrument  320  is seen inserted through surgical opening  372 , through slit  310  and opening  315  and into the patient&#39;s underlying body cavity. The distal end section  332  and distal end  334  are seen to be positioned adjacent to bottom side  264  of base member  260  in order to attach a section of the base member  260  to the peritoneal layer  374 . The surgeon&#39;s other hand is seen to be palpating the patient&#39;s body wall  370  above the distal end  334  in order to locate the position of a tack prior to delivering it by actuating trigger  324 . Referring to  FIG. 26 , after implantation of the patch  250  and securement with tacks  380 , the bottom side  264  of base member  260  may have two concentric crowns of tacks  382  and  384  to secure the patch  250  to the peritoneal layer  374 . 
     Another embodiment of a tissue repair patch of the present invention is seen in  FIGS. 25 and 26 . The repair patch  500  is seen to have substantially flat base member  510  having top side  512  and bottom side  514 . Base member  510  is seen to have circular opening  520  bounded by periphery  522 . Closure ring  530  is seen to be mounted about periphery  522  of circular opening  520 . The patch  500  also has closure patch  540  having top side  542  and bottom side  544 . Mounted to the bottom side  544  of patch  540  is mating closure ring  548 . Mating closure ring  548  is removeably engageable with closure ring  530 . When used in a surgical procedure, the surgeon removes the closure patch  540  from base member  510  thereby exposing opening  520 . The base member  510  is then implanted in a body cavity of a patient such that the top side  512  of base member  510  is adjacent to the inner layer of the body cavity such as the peritoneum. The surgeon then inserts a distal section of the shaft of an attachment instrument such as a surgical tacker through opening  520  into the body cavity below bottom side  514  of the base member  510 . After the base member  510  has been secured to the inner layer of tissue and the shaft of the securement instrument has been removed, the surgeon mounts the closure patch  540  to the top side  512  of the base member  510  such that the mating closure ring  548  and the closure ring  530  are engaged. 
     The repair patches of the present invention may optionally contain or be coated with sufficiently effective amounts of an active agent such as a therapeutic agent. Substances which are suitable as active agents include conventional agents that may be naturally occurring or synthetic and may include but are not limited to, for example, antibiotics, antimicrobial s, antibacterials, anti septics, chemotherapeutics, cytostatics, metastasis inhibitors, antideabetics, antimycotics, gynaecological agents, urological agents, anti-allergic agents, sexual hormones, sexual hormone inhibitors, haemostyptics, hormones, peptide-hormones, antidepressants, vitamins such as Vitamin C, antihistamines, naked DNA, plasmid DNA, cationic DNA complexes, RNA, cell constituents, vaccines, and cells occurring naturally in the body or genetically modified cells. 
     In one embodiment, the active agents may be antibiotics including such agents as gentamicin or ZEVTERA™ (ceftobiprole medocaril) brand antibiotic (available from Basilea Pharmaceutica Ltd., Basel Switzerland). In one embodiment, an implant may include broadband antimicrobials used against different bacteria and yeast (even in the presence of bodily liquids) such as octenidine, octenidine dihydrochloride (available as active ingredient Octenisept® disinfectant from Schulke &amp; Mayr, Norderstedt, Germany as), polyhexamethylene biguanide (PHMB) (available as active ingredient in Lavasept® from Braun, Switzerland), triclosan, copper (Cu), silver (Ag), nanosilver, gold (Au), selenium (Se), gallium (Ga), taurolidine, N-chlorotaurine, alcohol based antiseptics such as Listerine® mouthwash, N a-lauryl-L-arginine ethyl ester (LAE), myristamidopropyl dimethylamine (MAPD, available as an active ingredient in SCHERCODINE™ M), oleamidopropyl dimethylamine (OAPD, available as an active ingredient in SCHERCODINE™ O), and stearamidopropyl dimethylamine (SAPD, available as an active ingredient in SCHERCODINE™ S). In one embodiment, the agent may be octenidine dihydrochloride (hereinafter referred to as octenidine) and/or PHMB. 
     Although it is preferred to have a single, centrally located opening in the hernia repair patch devices of the present invention, the opening and associated closure member may be offset from the center. Additionally, more than one opening and closure member may be utilized in the hernia repair devices of the present invention. 
     The following examples are illustrative of the principles and practice of the present invention, although not limited thereto. 
     EXAMPLE 1 
     A patient with a ventral or incisional hernia is prepared for an open hernia repair procedure in the following manner. The skin area surrounding the hernia is scrubbed with a conventional antimicrobial solution such as betadine. The patient is administered conventional general anesthesia in a conventional manner by induction and inhalation. The surgeon then initiates the surgical procedure by making an incision in the skin and subcutaneous tissue overlying the hernia. In the case of planned intra-peritoneal mesh placement, the hernia sac is opened. The edges of the healthy fascia around the defect are examined and any attachments of the viscera to the abdominal wall are divided to create a free space for fixation of the mesh. 
     At this point in the procedure, the surgeon then prepares a mesh tissue repair hernia patch of the present invention having closure flaps and a base member for insertion through the abdominal wall defect and into the abdominal cavity such that the top side of the mesh is adjacent to the peritoneum surrounding the defect, and the bottom side of the mesh device is facing down toward the patient&#39;s viscera. Stay sutures may be placed through the mesh into the abdominal tissue as desired, i.e. at the four compass points of the mesh (North, South, East, West). The flaps are rotated upwardly after placement to expose the opening in the base member of the mesh. The mesh is fixated with a conventional surgical tacker or other means of fixation. A tacker is inserted through the opening such that the distal end of the tacker is between the mesh and the viscera. The perimeter of the mesh is then fixated using a plurality of tacks in a crown configuration. The tacker is removed and the opening in the mesh is closed by folding the flaps as appropriate for the present invention. The flaps may be optionally secured using adhesive, suture, rivets, or other closure means, or may be returned to their at rest position without securement to each other. The hernia defect may be primarily closed if desired. The skin incision is closed using appropriate suturing or closure techniques, and the incision is appropriately bandaged and the patient is moved to a recovery room. 
     The novel hernia repair devices of the present invention have numerous advantages. The novel repair patch devices provide a single layer mesh repair device that can be affixed via tacking in an open intraperitoneal hernia repair procedure. The repair patch devices have additional advantages including less foreign material (i.e., lower mass of foreign material) and the ability to implant a single layer tissue repair mesh in open procedures. The tissue repair devices of the present invention, preferably made from mesh, may potentially accelerate the rate of tissue integration, provide less area for biofilm formation, have a lower cost of manufacture, and are easier to package, sterilize, and use with improved ergonomics. 
     Although this invention has been shown and described with respect to detailed embodiments thereof, it will be understood by those skilled in the art that various changes in form and detail thereof may be made without departing from the spirit and scope of the claimed invention.