Apparatus and method for developing an anatomic space for laparoscopic hernia repair and patch for use therewith

In a tunneling shaft assembly, a tunneling shaft having proximal and distal extremities, a tunneling member fixed to the distal extremity of the tunneling shaft, an obturator slidably mounted on the tunneling shaft and having proximal and distal extremities, the distal extremity having a blunt surface and a handle section secured to the proximal extremity of the tunneling shaft.

In a sheath assembly for use with a hand, an elongate tubular member formed of a relatively flexible material forming a sheath, said tubular member having a weakened region extending longitudinally thereof, said sheath having a proximal extremity and finger means secured to the proximal extremity of the sheath to permit a finger of the hand to engage the sheath for retraction of the same.

In a balloon assembly, first and second sheets of a non-elastomeric material, means bonding the outer margins of the sheets of material to each other to form an enclosed space, a tubular member extending into the balloon and having a balloon inflation lumen extending therein for introducing a balloon inflation medium into the space for inflating the balloon to a predetermined size and shape, as determined by the non-elastomeric material.

In a hernia repair graft, a flexible sheet of mesh material, said sheet of mesh material having a central portion and tail-like means secured to the central portion and adapted to extend substantially perpendicular to the sheet.

In a method for creating an anatomic space in tissue in a body, making an incision in the tissue, providing a deflated balloon in a wrapped-up configuration and introducing the balloon through the incision and into the tissue, progressively inflating the balloon to cause it to progressively unwrap and to attempt to lie in a plane and to create separation forces on the tissue generally perpendicular to the plane to form the anatomic space.

In a method for laparoscopic hernia repair through the preperitoneal space in a body having an abdominal area with an abdominal wall and a preperitoneal area underlying the abdominal wall, making an incision in the abdominal wall into the preperitoneal area, introducing a balloon in a deflated condition into the incision and into the preperitoneal area, inflating the balloon to create a dissected preperitoneal space, deflating the balloon, removing the balloon from the dissected preperitoneal space, inflating the dissected preperitoneal space with a gas, providing a graft in the dissected preperitoneal space and positioning the same so that it underlies the area of the hernia, deflating the dissected preperitoneal space to permit the graft to remain in contact with the area of the hernia in general alignment with the hernia to provide reinforcement for the abdominal wall in the area of the hernia.

In a method for laparoscopic hernia repair through the preperitoneal space of a patient having an abdominal area with overlying tissue and a peritoneum with a preperitoneal area being disposed between the overlying tissue and the peritoneum using laparoscopic apparatus of the type having an introducer device with a tubular member having a bore therein, a tunneling assembly disposed in the bore and a balloon wrapped about the tunneling shaft and a removable sleeve enclosing the balloon, the method comprising the steps of making an incision in the abdominal area, introducing the laparoscopic apparatus into the incision so that the tubular member of the introducer device is disposed in the preperitoneal area, advancing the tunneling rod with the balloon thereon to separate the overlying tissue from the peritoneum, removing the sleeve to expose the balloon, inflating the balloon with a balloon inflating medium to create a dissected preperitoneal space between the peritoneum and the overlying tissue, deflating the balloon, removing the balloon, insufflating the dissected preperitoneal space with a gas, introducing a graft into the dissected preperitoneal space, positioning the graft in the desired location, and deflating the preperitoneal space to permit the graft to come into contact with tissue overlying the peritoneum, removing the introducer device and closing the incision.