Laser-Activated Collagen Adhesives for Herniorrhaphy

DESCRIPTION (provided by applicant): One million herniorrhaphies are performed annually in the US, most incorporating mesh reinforcement particularly for incisional and inguinal hernia. Yet this procedure usually results in prolonged and painful convalescence with recurrent complications such as inflammation and adhesion formation. In fact, adhesions represent a significant source of morbidity and mortality and are a common cause of small bowel obstruction in previously operated patients. Laparoscopic approaches have been developed to eliminate some of these problems but clinical acceptance has been hampered by the complex nature of the surgery requiring a high level of surgeon skill. Laser-assisted tissue welding using a derivatized collagen solder may avoid compression or tissue injury that frequently occurs with mechanical mesh fixation, inhibit adhesion formation, beneficial in minimizing postoperative pain due to tissue ischemia and nerve entrapment syndromes and is inherently compliant with laparoscopic formats. Phase I studies were conducted to evaluate a variety of solder and mesh configurations, tissue bonding strategies, comparison of acute tensile strength of bonded peritoneum and the assessment of mesh stability, tissue damage and the presence/type of adhesions in a six week chronic study. Secure mesh fixation was achieved with mesh/solder overlay but the embedded mesh configuration provided a simple means of anchoring mesh to tissue. The resultant mesh composites displayed a typical biological response with minimal adhesion formation and highlight the potential for use in laparoscopic herniorrhaphy, peritoneal closure, and reinforcement of anastomoses. Specific aims for Phase II are to develop and implement appropriate animal models for the optimization of laparoscopic herniorrhaphy. Task descriptions include preparation of sterile solder under stringent process controls, design and assembly of a compact preclinical laser system, optimization of a laser laparoscopic hand piece and solder introducer tool and conduct chronic animal studies using lapine and porcine subjects.