SBIR-STTR Award

The use of laser energy to weld tissue and to create sutureless anastomoses has great potential. Many laser-welded tissues can withstand physiologic stress without weakening and heal with good restoration of function. Investigators have welded bowel in rabbits and rats. Lasersurge, Inc. is developing a unique, patented, fiberoptic system that provides for the automated application of laser energy to intracorporal tissue sites for the production of sutureless anastomoses of hollow organs. The purpose of this proposal is to facilitate the further development and testing of the exoscope system for the production of bowel end-to-end anastomoses. Using Nd:YAG laser energy and rabbits, the feasibility, strength, and efficiency of small intestinal, exoscope-welded anastomoses (N=70) will be compared to standard sutured anastomoses (N=35). Using dog colon, 18 welded anastomoses will be compared to 6 sutured and 6 stapled anastomoses. Potential advantages of exoscope system laser-welding range from minimal inflammation with fewer strictures and adhesions to automated precision with diminished surgical time. Once fully developed and commercialized, Lasersurge, Inc.'s proprietary bowel exoscope system technology could gain worldwide acceptance as a human surgical technique.National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

In Phase I, LaserSurge, Inc., clearly established the feasibility of using the ExoScope System (TM) laser tissue-welding technique for creating excellent end-to-end small bowel anastomoses in rabbits. Through the automated, precise delivery of laser light to the anastomotic seam, the ExoScope SyStem (TM) produced immediately strong hermetic tissue bonds without foreign materials such as sutures or staples. Conventional sutured anastomoses were compared to ExoScope System-welded anastomoses at interoperative intervals ranging from 3 hours to 28 days. A pressure-monitored infusion system was used to determine the intraluminal pressure required to disrupt an anastomosis. In this model, the ExoScope SysteMTm bowel anastomoses were significantly stronger than those produced with sutures. This new surgical technique is also faster and easier to perform than suturing. Based on these encouraging results, LaserSurge, Inc., plans further refinements to and broader testing of the ExoScope System (TM) in Phase II.

Anticipated Results:
Over 150,000 bowel resections are performed each year in the United States. If the ExoScope SySteMTM laserwelded bowel anastomosis method proves superior to conventional suturing and stapling techniques, then a significant percentage of bowel anastomoses could be performed using this proprietary technology. LaserSurge, Inc., hopes to advance laser tissue-welding technology so that such equipment would become essential to modern operating rooms throughout the world.National Institute Of Diabetes And Digestive And Kidney Diseases (NIDDK)