SBIR Phase II: Novel Device for Maintaining Continuous Fluid Drainage in Small-Bore Chest Tubes after Cardiothoracic Surgery

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to significantly improve outcomes for cardiothoracic surgical patients while reducing healthcare costs by ensuring proper post-surgical drainage. In the United States, approximately 750,000 major cardiothoracic surgeries are performed each year. Each of these patients receives an average of two chest tubes to drain fluid and facilitate proper recovery, but approximately 36% of chest tubes become clogged. Patients with clogged chest tubes are more likely to experience post-surgical complications, which can result in life-threatening conditions and significantly increase the cost of care. To mitigate the risk of clogging, surgeons typically use large-bore chest tubes, which are more likely to be misplaced and to cause injury to surrounding organs. The novel device under development addresses these issues by preventing clog formation in small-bore chest tubes, thus maintaining proper fluid drainage. Anticipated impacts of the device include reduced time to ambulation and discharge, hospital readmissions, and nursing time. Commercially, the device addresses a $300 million initial market opportunity and has the potential to save the U.S. healthcare system approximately $1.7 billion per year from costs associated with preventable chest tube complications. The proposed project aims to develop a novel chest tube device to address the clinical need of maintaining proper fluid drainage after cardiothoracic surgery while enabling the use of small-bore chest tubes. Existing systems are prone to clogging, which can lead to life-threatening conditions, longer hospital stays, and increased costs. Building on the feasibility demonstrated in Phase I, the objective of this research is to continue development of the device and prepare for market entry; the research will be performed in three Aims. In the first Aim, critical aspects of usability and manufacturability will be addressed and incorporated into the final device design. In the second Aim, verification and validation activities will be performed to ensure the device meets all safety and functional requirements before clinical use. In the third Aim, the device?s supplemental ability to monitor lung healing status in patients undergoing thoracic surgery will be refined and tested on the benchtop and in an in vivo animal study.