Steerable Check Tube and Portable Suction/Infusion Machine for the Prevention of Retained Hemothorax after Injury

For all traumatic wounds in the military and civilian population, injuries to the chest are seen in about 60%. Fortunately, nearly 90% of all chest injuries can be treated non-operatively through chest decompression (chest tubes) and adequate pain control. Residual blood in the chest after drainage (retained hemothorax) can result in a persistent clot, constricting fibrin peel, pneumonia, and in the worst case, empyema. A recent multi-institutional study has shown an incidence of retained hemothorax of 31.3%. We believe that retained hemothorax is caused by one or both of the following phenomena: (1) the initial chest tube is functionally malpositioned in the pleural space, and (2) the rapid clotting of retained blood results in a thick, undrainable fluid. Our goal is to commercialize a steerable chest tube allowing the provider to guide it to the most effective location and provide access for clot dissolution. A functional prototype has been produced and has undergone initial testing in animals and cadavers. It consists of a three-lumen tube with sequential flexibility that accommodates a pull-wire, an insertable 5 Fr cannula, and a large central channel for high-volume drainage of fluid and air. Functionality and safety parameters have been proven with in vitro and animal and cadaver studies. The successful outcome of this proposed project will take us to the doorstep of commercializing a clinically acceptable steerable tube that is more effective with a safety profile that is superior to current technologies. Individual project goals include: #1 Achieve design freeze, establish production protocols, and produce enough devices for validation and verification. We will work with our extrusion and production collaborator to further refine and produce the device. Production protocols for extrusion, injection molding, assembly, pad printing, packaging, and sterilization will be finalized and confirmed.  Sufficient devices will be produced for validation studies. #2 Complete validation and verification tests required for FDA submission –All design history files and production logs will be maintained. All validation testing will follow FDA guidelines and be available for review. #3 Plan and complete pre-clinical cadaver and animal studies –At least one cadaver and two animal studies will be performed. All studies will be performed with a focus on FDA-acceptable standards and will be used as part of the 510(k) submission.  #4 Obtain FDA approval – Predicate devices will be identified, and the submission completed. #5 Implement a commercialization and marketing plan; establish relationships to acquire additional funding or corporate partnerships – Our capable staff will mature our business development plan and carefully study and chart the market landscape for these products. In-person focus groups, displays at national meetings, and internet marketing will showcase our device as a superior method of chest drainage for injured warfighters and civilians.