Proactive Dual-Irrigation Cardiac Chest Tube to Maintain Postoperative Patency

Circulatech Llc, Pembroke Pines FL

Investigators

Abstract

Abstract Over 455k cardiac procedures annually rely on chest tubes to drain blood from surgical wounds. However, dated chest drainage technologies result in significant issues—36% of tubes clog with blood, leading to complications in 17% of patients due to incomplete drainage. Hospitals spend approximately $9,617 per patient on these complications, totaling a yearly economic burden surpassing $2B in the US alone. The current practice of milking and stripping chest tubes is both labor-intensive and potentially risky, often leading to missed clots that compromise tube patency and patient adverse outcomes. CirculaTech’s ThoraFlush is a proactive clot preventing chest tube which utilizes proprietary dual irrigation technology to sustain drainage patency. ThoraFlush integrates seamlessly with hospital IV pumps to irrigate the chest tube with saline, obviating the labor-intensive manual manipulation, and automating chest tube maintenance. ThoraFlush saves nurses time and effort in maintaining chest tubes, reduces hospital costs linked to tube blockages, and promotes faster, smoother patient recovery with fewer complications. This NIH proposal will complete the following AIMs: 1) Optimize ThoraFlush’s efficacy of drainage patency in a mediastinum blood coagulation model (MBCM). 2) Sustaining ThoraFlush’s drainage volume in an in vivo model, superior than the standard of care. In AIM 1, the team will use an in vitro bench top mediastinum blood coagulation model, known as the MBCM to produce a functioning ThoraFlush prototype. The MBCM is hypothesized to be more rigorous than clinical practice due to its use of hypercoagulable porcine blood and mediastinal model geometries/materials promoting accelerated blood clot formation. Achieving a 6 hour benchmark of retaining device patency will prove significance to move to conducting AIM 2. In AIM 2, the team will translate their work in Aim 1 to animal testing using male Yorkshire Breed pigs to assess ThoraFlush's efficacy in live animals. The study involves a simulated heart surgery, replicating common cardiac procedures. This approach aims to comprehensively evaluate ThoraFlush's performance in a relevant physiological context. This model also proves as a first of its kind, mediastinum in vivo model for post-surgical recovery. Ultimately, the outcomes of this proposal will develop and prove that ThoraFlush meets patency requirements in the MBCM and show’s superior performance in an in vivo study, promoting its next stages into commercialization of the device.