Leakfree trocar for endoscopic surgery
Project Abstract:
A trocar sometimes also referred to as a cannula is a medical device that a surgeon inserts through the skin that provides surgical instrument access to the operative site during a minimally invasive endoscopic surgical procedure A laparoscopy is a surgical procedure in the abdomen and an arthroscopy is an orthopedic endoscopic surgical procedure in a joint capsule eg knee shoulder both types of procedures may use several trocars The problem with trocars is that they leak internally which can cause inconsistent pressure regulation and visualization in the operative site resulting in adverse events and waste of consumable supplies We propose the refinement of a leakfree trocar for laparoscopic and arthroscopic procedures Potential use in other adult and pediatric surgical procedures eg minimally invasive pulmonary artery banding is being explored No such device is commercially available for the several million endoscopic surgical procedures conducted in the United States annually This trocar will provide reliable distension of the operative site while maintaining consistent pressure which will reduce procedure time and patient adverse events as well as reduce the waste of consumable resources gasfluid ultimately reducing costs and minimizing leaked fluid hazard in the operating room To date proofofconcept models of the leakfree trocar which uses a unique design and arrangement of valves and seals has been developed and proven to work well enough in bench and fresh tissue human cadaver evaluation that a patent application has been submitted to the US Patent and Trademark Office Several details of design and component optimization are necessary to get to the point where the new trocar has commercialization potential The goal of the project is to continue design optimization efforts to advance the current model performance handling fabrication and documentation to the level of a product prototype that could be licensed for commercialization to a surgical device company This will be accomplished by employing unique design and precision fabrication methods available at the University of Louisville followed by performance testing on the bench in clinically relevant animal experiments and in fresh human cadavers Key milestones for this project include the assembly of a Design History File benchmarking performance of the proposed trocar with predicate trocars in bench animal and human cadaver tests and an educational presubmission meeting at the FDA Office of Device Evaluation Failure to achieve leakfree trocar performance during the bench animal or human cadaver evaluations constitutes a nogo decision gate Strengths of the project team include extensive clinical experience with laparoscopic and arthroscopic surgery extensive medical device development and device evaluation experience access to excellent facilities at the University of Louisville needed to conduct the project and three years of prior collaboration on the development and evaluation of the new trocar
