Patent Abstract:
Novel mesh implant positioning systems for use in laparoscopic body wall defect repairs, such as hernia defects, are disclosed. The systems utilize one or more bar members combined with surgical sutures and needles to position a mesh implant adjacent to a body wall defect without the need for stay sutures. Also disclosed are assemblies of the positioning systems with surgical mesh repair implants, and methods of repairing body wall defects such as hernias with the assemblies.

Full Description:
FIELD OF THE INVENTION 
       [0001]    The field of art to which this invention pertains is medical devices and systems for repairing body wall defects, more particularly medical devices and systems for facilitating the implantation of tissue repair implants in hernia repair procedures. 
       BACKGROUND OF THE INVENTION 
       [0002]    Minimally invasive laparoscopic hernia repair procedures are well known in the art. In such procedures, the surgeon is able to remotely repair a body wall tissue defect, such as a hernia, by using conventional laparoscopic surgical techniques, including the insertion of trocar cannulas through the body wall for access to the defect site, the use of a camera for remote visualization, and the use of specially designed laparoscopic surgical tools and instruments to effect the repair. Tissue repair implants have also been specially designed for such laparoscopic procedures. The use of minimally invasive laparoscopic and endoscopic surgical procedures has been found to have many documented patient benefits and advantages when compared to conventional open surgical procedures. The benefits and advantages include minimal incisions through the body wall, reduced scarring, reduced duration of the procedure and concomitant time under anesthesia, decreased opportunity for contamination of the surgical repair site with pathogens resulting in a lower incidence of hospital acquired infections, reduced pain, reduced length stay in the hospital, faster recovery time, and reduced overall costs associated with the procedure. 
         [0003]    In a conventional endoscopic or laparoscopic ventral hernia repair procedure, the patient is anesthetized and prepared in a conventional manner. A Veress needle attached to a carbon dioxide gas source is inserted through the patient&#39;s body wall and the patient&#39;s abdominal cavity is insufflated sufficiently to provide an effective volumetric space between the body wall and the underlying viscera for both viewing and performing the surgical procedure. Next, several conventional trocar and trocar cannula combinations are penetrated through the body wall and the trocars are then withdrawn and removed from the cannulas. The cannulas serve as access ports for the insertion and removal of surgical instruments and tools, laparoscopes, various medical devices, implants, etc. A flat hernia tissue repair patch, typically mesh, is rolled or folded and inserted through the cannula and placed proximate to the hernia defect. The surgeon uses laparoscopic grasping tools to unroll or unfold the repair patch implant and place it over the hernia defect on the peritoneum. This aspect of the procedure is critical in that the implant needs to be substantially flat prior to fixation to the body wall in order to provide for an acceptable repair. The surgeon then passes several stay sutures, which were pre-mounted to the repair patch, through the abdominal wall to secure the implant over the hernia defect prior to tacking. The securement of the stay sutures requires that several open incisions be made to the exterior of the patient&#39;s body wall about the hernia or body wall defect. The surgeon then typically passes the distal end of a conventional suture passer through the partial incisions and into the patient&#39;s body cavity to retrieve the legs of each stay suture. Two passes through each incision and through the body wall are required to capture both legs of a stay suture and move them to the exterior of the body wall for securement. The legs of each suture are tensioned and are knotted together such that the knot is contained within the incision. Next, the implant is affixed to the peritoneum and body wall using a conventional laparoscopic surgical tacking instrument to complete the body wall defect repair. The procedure is completed by removing the cannulas and closing the trocar wounds, and, suturing or otherwise approximating the incisions for the stay sutures. 
         [0004]    There is a continuing need in this art for novel and improved systems and methods for performing laparoscopic hernia repair surgical procedures such as ventral hernia repair procedures. In particular, there is a need for devices which assist the surgeon in unrolling or unfolding a tissue repair implant and maintaining the implant in a flat configuration next to the peritoneum and body wall. There is also a need to reduce the number of or eliminate stay sutures required to position a tissue repair implant prior to affixation to the peritoneum and abdominal wall in order to minimize trauma to the patient&#39;s body wall, and eliminate unnecessary incisions and associated complications such as infections and scarring. 
       SUMMARY OF THE INVENTION 
       [0005]    Therefore, novel devices and methods of positioning a tissue repair implant in a laparoscopic surgical procedure are disclosed. A first aspect of the present invention is a novel positioning system for use in facilitating a laparoscopic surgical hernia repair procedure. The system has a bar member having a top side, a bottom side, a center, and a suture receiving opening centrally located in the bar member. There is a surgical suture having a distal end and a proximal end, wherein the proximal end of the suture is mounted in the suture receiving opening of the bar member such that the suture extends out from the top side of the bar member. 
         [0006]    Another aspect of the present invention is a surgical repair assembly. The surgical repair assembly has a surgical repair mesh having a top side and a bottom side, a center, and a major axis and a minor axis. The surgical repair assembly has a positioning system. The positioning system has a bar member having a top side, a bottom side, a center, a longitudinal axis, and a suture receiving opening centrally located in the bar member. There is a surgical suture having a distal end and a proximal end, wherein the proximal end of the suture is mounted in the suture receiving opening of the bar members such that the suture extends out from the top side of the bar member. A surgical needle attached to the distal end of the suture. The top side of the bar member engages the bottom side of the mesh such that the longitudinal axis of the bar member is substantially aligned with the major axis of the mesh, and the needle and suture pass through the center of the mesh above the top side of the mesh. 
         [0007]    Yet another aspect of the present invention is a positioning system for use in facilitating a laparoscopic surgical hernia repair procedure. The positioning system has a first bar member having a top side, a bottom side, a center, a longitudinal axis, a central suture opening aligned with the center, first and second suture openings, and a first suture slot in the bottom side. A pivot hub member extends down from the bottom side of the first bar member, said hub member having a distal end with an outwardly extending flange, a central passage in communication with the central suture opening, and opposed lateral slots in communication with the central passage and the first suture slot. The positioning system has a second bar member pivotally mounted to the first bar member. The second bar member has a top side, a bottom side, a center, a longitudinal axis, and a slot through the bar member, said slot has a first end in alignment with the center and adapted to receive the distal end of the pivot hub member, and a second end adapted to receive a suture. There is a surgical suture having a distal end and a proximal end, wherein the proximal end of the suture is mounted in the suture receiving opening such that the suture extends out from the top side of the bar member. 
         [0008]    Still yet a further aspect of the present invention is a surgical repair assembly. The repair assembly has a surgical repair mesh having a top side and a bottom side, a center, and a major axis and a minor axis. The surgical repair assembly has a positioning system. The positioning system has a first bar member having a top side, a bottom side, a center, a longitudinal axis, a central suture opening aligned with the center, first and second suture openings, and a first suture slot in the bottom side. A pivot hub member extends down from the bottom side of the first bar member, said hub member having a distal end with an outwardly extending flange, a central passage in communication with the central suture opening, and opposed lateral slots in communication with the central passage and the first suture slot. The positioning system has a second bar member pivotally mounted to the first bar member. The second bar member has a top side, a bottom side, a center, a longitudinal axis, and a slot through the bar member, said slot having a first end in alignment with the center and adapted to receive the distal end of the pivot hub member and a second end adapted to receive a suture. There is a surgical suture having a distal end and a proximal end, wherein the proximal end of the suture is mounted in the suture receiving opening such that the suture extends out from the top side of the bar member. The top side of the first bar member engages the bottom side of the mesh such that the longitudinal axis of the top bar member is substantially aligned with the major axis of the mesh, and the longitudinal axes of the first and second bar members are substantially aligned. The suture passes through the mesh at the central suture opening and the first and second suture openings such that the suture extends out from the mesh above the central opening, and a first suture segment is formed on the top side of the mesh between the first and second suture openings, and a second suture segment is formed in the first suture slot between the second suture opening and the central suture opening. 
         [0009]    A further aspect of the present invention includes methods of repairing a tissue wall defect in a surgical procedure using the above described positioning systems and surgical repair assemblies 
         [0010]    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 
         [0011]      FIG. 1  is a perspective view of a hernia mesh implant of the prior art with four stay sutures mounted to the mesh for affixation to a body wall. 
           [0012]      FIG. 2  is a cut-away view of an abdominal cavity showing the implant of  FIG. 1  in position to be secured to the abdominal wall against the peritoneum and over a hernia defect; a suture retriever is shown penetrating the body wall in a position to catch a tail of a stay suture to move it to the exterior of the body wall for knotting and securement. 
           [0013]      FIG. 3  is a partial magnified view of the body wall of  FIG. 2  showing the implant of  FIG. 1  secured to the inner side of the abdominal wall. The implant is seen to be partially secured with the stay sutures. The knots of the sutures are seen to be contained within incisions below the surface of the skin made for access by the suture passer instrument. The sutures are seen to have formed loops. The implant is also seen to have been primarily secured with conventional surgical tacks after securement with the stay sutures. 
           [0014]      FIG. 4  is a perspective view of a positioning apparatus of the present invention having a single bar member. 
           [0015]      FIG. 5  is a perspective view of an alternate embodiment of a positioning apparatus of the present invention having two bar members. 
           [0016]      FIG. 6  is a perspective view illustrating the initial step in mounting the novel positioning system of  FIG. 4  to a conventional flat single layer mesh implant suitable for a laparoscopic ventral hernia repair; the needle tip has penetrated the center of the mesh from the bottom side. 
           [0017]      FIG. 7  shows the positioning system fully mounted to the bottom side of the mesh implant with the needle and suture completely drawn through the mesh and positioned above the top side of the mesh implant; the bar member is seen to be centrally located adjacent to the bottom side of the mesh with optional adhesive members also engaging the bottom side of the mesh. 
           [0018]      FIG. 8  is a perspective view illustrating the mesh implant and positioning system of  FIG. 7 , wherein the mesh implant has been rolled prior to insertion through a trocar cannula into the abdominal cavity; the attached needle and suture are seen to hang freely and the bottom of the mesh implant and the mounted bar can be seen. 
           [0019]      FIG. 9  is a perspective view of the mesh and positioning system assembly of  FIG. 8  showing the top of the mesh and a section of suture extending outwardly from the center of the mesh. 
           [0020]      FIG. 10  shows the mesh and positioning system assembly after insertion into the abdominal cavity with the mesh in the rolled-up configuration. The assembly is positioned adjacent to the hernia defect with the needle and suture in position for the needle and suture to be passed through the hernia defect. 
           [0021]      FIG. 11  shows the mesh and positioning system after the needle has been driven through the hernia defect; the mesh is still in a rolled-up configuration. 
           [0022]      FIG. 12  is a side sectional view showing the needle and suture pulled through the defect with the suture partially exiting the defect such that the assembly is in a position over the defect adjacent to the peritoneum. 
           [0023]      FIG. 13  is an interior perspective view showing clocking of the bar member to orient the mesh implant to an appropriate position over the body wall defect; the mesh is unrolled and has been placed back into a substantially flat configuration. 
           [0024]      FIG. 14  is a view from the interior of the patient&#39;s abdominal cavity that shows the assembly in position over the body wall defect after the periphery of the mesh implant has been secured with surgical tacks and prior to removal of the positioning apparatus. 
           [0025]      FIG. 15  is a perspective view of an alternate embodiment of a positioning system having a single bar. 
           [0026]      FIG. 16  illustrates the positioning system of  FIG. 15  being mounted to a single layer hernia mesh implant. 
           [0027]      FIG. 17  illustrates the positioning system and mesh of  FIG. 16  after the assembly has been completed. The mesh implant is drawn substantially transparent to illustrate the underlying positioning system. 
           [0028]      FIG. 18  is an exploded perspective view of an alternate embodiment of a double bar positioning system of the present invention. 
           [0029]      FIGS. 18A and 18B  are partial perspective views of the bottom of the top bar of the positioning system of  FIG. 18  showing the pivot hub and suture passing holes and a slot for receiving a suture segment. 
           [0030]      FIG. 19  is perspective view showing the two bars assembled into a positioning system. 
           [0031]      FIG. 20  is a magnified partial top view of the center section of the assembly of  FIG. 19  showing a surgical suture mounted to the assembly. 
           [0032]      FIG. 21  is a magnified partial bottom view of the center section of the assembly of  FIG. 19  showing a surgical suture mounted to the assembly. 
           [0033]      FIG. 22  is a perspective view of the positioning system of  FIG. 19  showing the rotational capacity of the bottom bar. 
           [0034]      FIG. 23  is a perspective view showing the positioning system of  FIG. 19  mounted to a flat, single layer mesh implant. The mesh implant is drawn substantially transparent to illustrate the underlying positioning system. 
           [0035]      FIG. 24  is a side partial cross-sectional view of the central section of the assembly of  FIG. 19  with both bars in longitudinal alignment. 
           [0036]      FIG. 25  is a perspective view of the assembly of  FIG. 23  rolled in preparation for insertion through a trocar cannula. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0037]    The novel mesh positioning systems of the present invention are manufactured from conventional biocompatible materials, including polypropylene, ABS, polyester, nylon, polyurethane, and the like. The systems may be manufactured using conventional manufacturing processes including injection molding, cutting, machining, extruding, forming, ink jet printing, punching, combinations thereof and the like. The surgical sutures useful in the practice of the present invention include conventional braided and monofilament sutures. The sutures are made from conventional absorbable and nonabsorbable biocompatible polymeric materials and combinations of such materials. The absorbable polymers may include conventional absorbable polymers including synthetic polyesters such as lactones including polylactide, polyglycolide, polydioxanone, polyglycolic acid, epsilon-caprolactone, copolymers thereof and the like. The absorbable polymers may also include conventional natural polymers such as polypeptides, collagen, etc. The nonabsorbable polymers may include conventional nonabsorbable polymers such as polypropylene, polyethylene, polyester, Nylon, etc. The surgical needles mounted to the surgical sutures will be made from conventional biocompatible materials including but not limited to surgical stainless steels. The optional adhesive sections used with the systems of the present invention may be made from conventional biocompatible adhesive polymeric materials that provide a ready release including silicones, acrylics, polyurethanes, epoxies, cyanoacrylates, and the like. 
         [0038]    The tissue repair implants useful with the positioning systems of the present invention will typically be made from conventional surgical repair fabrics including meshes, nonwovens, films, combinations thereof, and the like. The tissue repair implants may be made from conventional biocompatible materials including absorbable polymers, nonabsorbable polymers, and combinations of absorbable and nonabsorbable polymers. The absorbable polymers may include conventional absorbable polymers including synthetic polyesters such as lactones including polylactide, polyglycolide, polydioxanone, polyglycolic acid, epsilon-caprolactone, copolymers thereof and the like. The absorbable polymers may also include conventional natural polymers such as polypeptides, collagen, etc. The nonabsorbable polymers may include conventional nonabsorbable polymers such as polypropylene, polyethylene, polyester, expanded polytetrafluoroethylene, Nylon, etc. The tissue repair implants preferably have conventional anti-adhesion barriers mounted on their visceral sides. Examples of such anti-adhesion barriers include oxidized regenerated cellulose, polyglecaprone 25, ptfe, polydioxanone, and the like. 
         [0039]    Referring initially to  FIGS. 1-3 , a prior art method of affixing a single layer mesh in a laparoscopic procedure wherein stay sutures are used is illustrated. Flat mesh tissue repair implant  5  is seen to have flat base member  10  having top side  12 , bottom side  14  and periphery  18 . The implant  5  is seen to have four stay sutures  30  mounted about the periphery  18 . The sutures  30  are mounted so that two legs/limbs  32  of the sutures  30  extend upwardly through base member  10  above top side  12 . As seen in  FIGS. 2 and 3 , the implant  5  has been moved into abdominal cavity  40  between underlying viscera  45  and the bottom side  54  of body wall  50 . In order to position the repair implant  5  over a defect  58  in body wall  50 , the surgeon makes cuts  62  (incisions) through the outer skin layer  60  on the top side  52  of body wall  50 . The distal end  82  of a suture passer  80  is passed through the body wall  50  through skin cuts  62  and is used to retrieve the limbs  32  of the sutures such that a section of each limb  32  extends beyond the cuts  62  and outer skin layer  60 . The end  82  of suture passer  80  must be passed through the body wall  50  each time a single limb  32  is retrieved. For each stay suture  30 , the distal end  82  of suture retriever  80  must be passed through twice at different angles in order to retrieve both limbs  32  of suture  30  and form a suture loop  35  having knot  38  in each suture  30 . Prior to forming the suture loop  35  the surgeon tensions the legs/limbs  32  to move the top side  12  of base member  10  adjacent to the peritoneum  55  on the bottom side  54  of body wall  50 . The legs/limbs  32  are then tied using conventional surgical knots  38 . The knots  38  are situated in the fascia underlying the outer skin layer  60 . This procedure is repeated for all of the stay sutures  30  in order to properly position the implant  5  over the body wall defect  58 . Once positioned, the base member  10  of the implant  5  can be affixed to the peritoneum  55  and body wall  50  using a plurality of conventional surgical tacks  70  located about the periphery  18 . Although this procedure provides for satisfactory location of the implant  5  about a defect in a body wall, there are several disadvantages attendant with its use. The disadvantages include multiple skin incisions and abdominal wall punctures necessary to retrieve the ends of the stay sutures in order to form suture loops and knots to secure the mesh implant to the peritoneum or interior of the body wall. This may result in significant trauma to the tissues of the abdominal wall, and may result in pain to the patient and an extension of the post-operative healing time. The incisions and penetrations may provide pathways for hospital acquired infections. The suture loops formed in the stay sutures remain in the patient after the procedure and may produce pain during typical daily movements by the patient, even after the healing process is complete. Other disadvantages include longer operation/procedure times associated with passing the suture limbs and making conventional knots on each transfascial suture. 
         [0040]    Applicants&#39; novel mesh positioning system for mesh repair implants eliminates these disadvantages since it eliminates the need for conventional stay (transfascial) sutures. As seen in  FIGS. 4 and 5 , two embodiments of a novel mesh positioning system of the present invention are illustrated. Referring first to  FIG. 4 , the mesh positioning system  100  is seen to have a bar member  110 . Bar member  110  is seen to have opposed rounded ends  112 . Bar member  110  has top side  114  and bottom side  116 , and opposed lateral sides  118 . The bar member  110  has longitudinal axis  120  and center  125 . The proximal end  132  of suture  130  is seen to extend from top side  114  of bar member  110  at center  125 . The proximal end  132  of suture  130  may be attached to bar member  110  in a conventional manner including gluing, knotting, welding, mechanical fasteners, etc. The distal end  134  of suture  130  is mounted to the proximal end  142  of surgical needle  140  having distal piercing point  144 . Surgical needle  140  preferably has a straight configuration, but may have other configurations including curved. Adhesive sections  150  are seen on top side  114  on either end of bar member  110 . The adhesive sections  150  may consist of coatings, tapes, patches, etc. An alternative embodiment of a mesh positioning system  160  of the present invention is seen in  FIG. 5 . Positioning system  160  is seen to have top bar member  110  pivotally mounted in a conventional manner to bottom bar member  170  such that bar member  110  and bar member  170  may be rotated with respect to each other. Bar member  170  is seen to have opposed rounded ends  172 . Bar member  170  has top side  174  and bottom side  176 , and opposed lateral sides  178 . The bar member  110  has longitudinal axis  180  and center  185 . The bar members  110  and  170  are pivotally connected at their centers  125  and  185 , respectively. Surgical suture  130  with attached surgical needle  140  is seen to be affixed to and extend from bar member  130  in a similar manner as that described above. 
         [0041]    A method of affixing a mesh tissue repair implant over a defect in a body wall using the novel mesh positioning system  100  of the present invention is illustrated in  FIGS. 6-14 . Referring first to  FIG. 6 , a mesh positioning system  100  of the present invention is seen adjacent to a surgical mesh implant  200 . Surgical mesh implant  200  is seen to have bottom side  204 , top side  202 , and center  205 . The implant  200  has opposed lateral sides  210  connected by opposed end sides  212 . The mesh implant  200  will typically have a flat configuration. The mesh implant  200  is seen to have location marker  220  having longitudinal marker  224  and latitudinal marker  222 . The location marker  220  is centered on the mesh implant  200  such that longitudinal marker  224  and latitudinal marker  222  intersect at mesh implant center  205 . The bar member  110  is mounted to the bottom  204  of mesh implant  200  by aligning the longitudinal axis  120  of bar member  110  with the longitudinal marker  224 , and by aligning the center  125  of longitudinal member  110  with the center  205  of mesh implant  200 . The distal end  144  of surgical needle  140  is moved or pushed through the center  125  of mesh implant  200  also moving the suture  130  through the mesh implant  200  and causing the bar member  110  to be moved proximate the bottom side  204  of mesh implant  200 . Then, the top side  114  of bar member  110  is pushed against the bottom side  204  of mesh member  200  such that adhesive sections  150  releasably engage sections of bottom side  204  to form the assembly  240 . The resulting assembly  240  is now ready for use in a laparoscopic body wall defect surgical procedure, such as a hernia repair procedure. In order to insert the assembly through a conventional trocar cannula, it is necessary for the assembly  240  to be rolled up. A preferred way to roll the assembly  240  is seen in  FIGS. 8 and 9 . The assembly  240  is placed by the surgeon on a flat surface such that the top surface  202  of mesh  200  is adjacent to the flat surface. Then, the mesh  200  is rolled about bar member  110  by grasping both lateral sides  210  and rolling the sides inwardly to form rolls or rolled sections  215  adjacent to lateral sides  118  of bar member  110 . 
         [0042]    As seen in  FIGS. 10-14 , the surgeon inserts the rolled assembly  240  into a patient&#39;s abdominal cavity  250 . Abdominal cavity  250  is seen to be surrounded by abdominal wall  260  having inner peritoneal layer  270  and outer epidermal layer  265 . A body wall defect  280  is seen to protrude into body wall  260  along with a section of peritoneum  270  creating hernia sack  275 . The body wall defect  280  has outer periphery  282 . The surgeon then locates the center  285  of the defect  280  and pushes the needle  140  and suture  130  through the defect  280 , through the hernia sack  275 , and though body wall  260  such that the needle  140  exits the epidermal layer  265  of the body wall  260  along with a section of suture  130  and the top side  202  of the mesh  200  is positioned next to the peritoneum  270 . The surgeon positions assembly  240  such that the mesh  200  is properly aligned with the defect  280  about the defect center  285 . The surgeon then pulls on the needle  140  and attached suture  130  to assure that the top side  202  of mesh implant  200  is in apposition to the body wall  260  and peritoneal layer  270 . The suture  130  is then clamped adjacent to epidermal layer  265  using a surgical device such as a conventional hemostat  290  or other appropriate surgical instrument or device. The rolled mesh  200  and attached bar member  110  are clocked or rotated into the appropriate orientation to cover the hernia defect  280 . The surgeon then unrolls the rolled sections  215  such that the top surface  202  of the mesh  200  is in contact with peritoneum  270  and the mesh implant  200  extends sufficiently beyond the periphery  282  of hernia defect  280  to provide a margin for affixation, preferably with surgical tacks. Next, as seen in  FIG. 13  the unrolled mesh  200  is affixed about its periphery with conventional surgical tacks  295 . After successful placement and fixation of the mesh  200  the bar member  110  and the remaining segment of suture  130  are pulled backward away from the body wall  260  and removed from the abdominal cavity  250 . 
         [0043]    An alternative embodiment of a mesh positioning system  300  having a bar member  301 , surgical suture  340 , and surgical needle  350  useful in the practice of the present invention is illustrated in  FIGS. 15-17 . The bar member  301  is seen to have opposed rounded ends  302 . Bar member  301  has top side  304  and bottom side  306 , and opposed lateral sides  308 . The bar member  301  has longitudinal axis  320  and center  325 . The center hole  310  extends through bar member  301  at center  325 . Suture attachment hole  312  and suture passing hole  314  are located adjacent to and on either side of center hole  310 ; holes  312  and  314  pass through bar member  301 . The proximal end  342  of surgical suture  340  is attached to bar member  301  in suture attachment hole  312  and is seen to extend from suture attachment hole  312  from top side  304  of bar member  301 . The distal end  344  of suture  340  is mounted to the proximal end  352  of straight surgical needle  350  having distal piercing point  354 . The positioning system  300  is mounted to surgical repair mesh  360  to form assembly  390 . The mesh  360  is seen to have top side  362  and bottom side  364 . The mesh  360  has center  372 , major axis  374  and minor axis  376 . Mesh  360  has outer periphery  368 . In order to mount positioning system  300  to mesh  360  to form assembly  390 , the longitudinal axis  325  of bar member  301  is aligned with major axis  374  of mesh  360 . The top side  304  of bar member  301  is placed adjacent to bottom side  364  of mesh  360  such that the centers  325  and  372  are in substantial alignment. Next, the piercing point  354  of needle  350  is pushed through mesh  360  from the bottom side  364  at a location adjacent to center  372 , and the suture  340  is pulled through. The needle  350  is then passed down from top side  362  through mesh  360  and through opening  314  in bar member  301  forming top suture segment  346 . The needle  350  is then passed from the bottom side  306  of bar member  301  through center opening  310  and through mesh  360  along with the remaining suture  340 . Suture segment  348  is formed on bottom side  306 . This completes the assembly of the assembly  390 . The assembly  390  is used in a manner similar to assembly  240  as described above. 
         [0044]    An alternative embodiment of a double bar mesh positioning system  400  of the present invention is seen in  FIGS. 18-25 . The positioning system  400  is seen to have top bar member  410  and bottom bar member  450 . Top bar member  410  is seen to have top side  412 , bottom side  414 , and opposed ends  416  connecting opposed lateral sides  418 . The bar member  410  has longitudinal axis  420  and center  425 . Suture passing holes  427  and  429  extend through bar member  410 . Extending downwardly from the bottom side  414  of bar member  410  and coextensive with center  425  is the pivot hub member  430 . Hub member  430  is seen to have a generally cylindrical configuration with lateral side slots  434  in communication with central passage  431 . Flange member  436  is seen to extend about the bottom end  432  of hub member  430 . Passage  438  is seen to extend up through bar member  410  and to be in communication with central suture passing hole  428 . Contained in the bottom  414  of bar member  410  is the suture receiving slot  440 . Slot  440  has bottom  441 , channel  442 , first end  443  in communication with lateral slot  434  of hub member  430  and second end  444  in communication with suture passing hole  429 . Bottom bar member  450  is seen to have top side  452 , bottom side  454 , and opposed ends  456  connecting opposed lateral sides  458 . The bar member  450  has longitudinal axis  460  and center  465 . Pivot hub receiving hole  470  is seen to extend through bar member  450  and is located at the center  465 . The bar member  450  is also seen to have suture passage slot  480  extending through bar member  450 . The slot  480  has channel  481 , first end  482  in communication with pivot hub receiving hole  470  and second rounded end  484  in communication with suture opening  429 . The bar members  410  and  450  are pivotally mounted to each other by forcing the end of hub member  460  into hub receiving hole  470  such that the flange member  436  is engaged on or below the bottom side  454  of bar member  450 . A surgical suture  500  having a proximal end  502  and a distal end  504  is mounted to opening  427  such that the suture extends from opening  427  above top side  412  of bar member  440 . This may be accomplished by mounting a plug like member  510  to proximal end  502  or by knotting the end  502 . The proximal suture end  502  can also be glued or cemented into opening  427 . The distal end  504  of suture  500  is mounted to the proximal end  532  of surgical needle  530  having distal end  534  and distal piercing distal tip  536 . 
         [0045]    The system  400  is mounted to a surgical repair mesh  550  to form a repair assembly  600  in the following manner. The bar members  410  and  450  are manipulated such that the longitudinal axes  420  and  460  are in alignment. Next the center  425  of bar member  410  is aligned with the center  560  of mesh  550 . The surgical needle  530  attached to suture  500  is then pushed through mesh  550  from bottom side  552  through top side  554 . The needle  530  is then pushed through the top side  554  of mesh  550  through underlying suture passing hole  429  and through opening  484  in bar members  410  and  450 , respectively, and a length of free suture  500  is also moved through forming top suture segment  520 . Next the needle  530  is moved through pivot hole  470  and out through central passage  431  and central suture passing hole  428 . As the suture  500  is withdrawn, a section of the suture  500  will pass through slot  434  and channel  481  in slot  480 , and as the suture  500  is further withdrawn and tightened suture segment  525  will move into channel  442  of slot  440 . The top side  414  of bar member  410  will now be engaged with the bottom side  552  of mesh  550 . The mesh may be rolled about the positioning system  400  to form rolls  565  to facilitated passage through a cannula into the abdominal cavity. If desired, the rolls  565  may be optionally secured with sutures  570 , which are then removed prior to unrolling the mesh  550  after movement through a cannula. The repair assembly  600  is used in a manner similar to that described above for assembly  400 , except that the bars  410  and  450  may be pivoted or rotated, sometimes described as “clocked”, with respect to each other to further support the mesh  550  and aid in placement over to the body wall defect next to the peritoneum. Optionally, as partially shown in  FIG. 25 , the bar members may be provided with measurement scale markings to indicate the lengths of the bars and the lengths of the attached meshes. Alternate conventional ways of pivotally mounting the bar members  410  and  450  together may be utilized including bolts, axles, pins, rivets, etc. 
         [0046]    Although it is preferred that the surgical sutures useful with the positioning systems and repair assemblies of the present invention have surgical needles mounted to an end, it will be appreciated that surgical sutures may be utilized without mounted surgical needles. In such a configuration, the suture would be passed through tissue and/or the implant using conventional surgical instruments such as conventional suture passing instruments. Also, if desired although not preferred, multiple sutures may be used with the positioning systems of the present invention. 
         [0047]    The following example is illustrative of the principles and practice of the present invention, although not limited thereto. 
       Example 1 
       [0048]    A patient presenting with a ventral hernia is prepared for a laparoscopic surgical hernia repair procedure in a conventional manner. After conventional preparation and administration of conventional anesthesia, the surgeon insufflates the patient&#39;s abdominal cavity using a conventional Veress needle attached to a medical grade carbon dioxide gas source. After insufflation, the surgeon inserts several trocar cannulas through the abdominal wall using conventional trocars. The trocar cannulas provide access to the abdominal cavity and access to the surgical site. A conventional laparoscope is inserted into one of the cannulas and connected to a camera to provide the surgeon with remote visualization. The surgeon views the hernia defect in the patient&#39;s abdominal wall and measures the defect with a surgical ruler. The surgeon then selects an appropriately sized surgical hernia defect repair mesh implant. The surgeon is provided with a mesh positioning system of the present invention having a single bar member. After determining the center of the mesh implant, the surgeon pushes the surgical needle and suture of the positioning system through the bottom side of the mesh implant at the center and pulls the needle and suture until the top surface of the bar member is next to and in contact with the bottom side of the mesh implant. The surgeon then aligns the bar member with the longitudinal axis of the mesh implant and applies force to the top side of the mesh over the optional adhesive sections on the top side of the bar member to secure the mesh to the positioning system. The surgeon then rolls the sides of the mesh about the centrally located bar member in order to move the positioning system and mesh assembly through a conventional trocar cannula into the patient&#39;s abdominal cavity. The mesh of the assembly is unrolled using conventional laparoscopic grasping tools. The assembly is then moved toward the defect and the mesh is placed in apposition to the peritoneum adjacent to the hernia defect. The surgeon then grasps the surgical needle with a laparoscopic needle grasper instrument and pushes the needle and a section of the suture through the hernia defect and the hernia sack and body wall tissue layers over the defect. The needle is then grasped exterior to the body wall and tensioned such that the top side of the mesh is moved against the interior of the abdominal wall (i.e., the peritoneum) and the edges of the defect are overlapped by the mesh in the surrounding peritoneum. The tensioned suture is maintained in position by applying a surgical hemostat to the protruding suture, and the needle is cut away from the suture. The surgeon then views the position of the mesh implant over the body wall tissue defect and makes positional changes as required. The mesh is observed to be maintained in a flat configuration against the peritoneum with substantially no wrinkles. The surgeon then inserts the distal end of a conventional surgical tacking instrument into the patient&#39;s abdominal cavity and proceeds to tack the mesh implant about its entire periphery with a continuous line of spaced apart tacks. The surgeon then removes the mesh positioning system from the bottom of the mesh implant by disengaging the hemostat from the exterior section of suture and pulling the bar member away from the implant thereby pulling the remaining suture segment back into the abdominal cavity. The positioning system is then removed through a cannula. Then, the instruments, cannulas and Veress needle are removed from the patient. The trocar incisions for the cannulas are then taped with conventional surgical tape and the repair procedure is complete. Alternatively, if there is no surgical needle attached to the suture of the positioning system, a conventional suture passer can be used by the surgeon to pull the suture through the abdominal wall and position the mesh on the interior of the body wall. Prior to affixing the mesh implant to the body wall over the defect, the surgeon may decide to optionally remove all or part of the hernia sack. In addition, the surgeon may decide to suture the tissue surrounding the hernia defect together prior to affixing the mesh implant. 
         [0049]    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.

Technology Classification (CPC): 0