SBIR Phase I: Automated Clot Preventing Chest Tube

该小型企业创新研究（SBIR）第一阶段项目旨在制定缓解胸导管（胸管）堵塞的策略。克利夫兰诊所的一项研究确定，36%的胸管在一个点上完全阻塞，其中86%的血栓存在于胸腔中，临床医生未发现。胸管堵塞引起的并发症包括术后房颤、血胸和心包填塞。该团队将设计，开发和商业化一种新型胸管，以解决高影响的临床需求。这种新型胸管旨在减少心胸手术后引流相关并发症。该新型系统主动管理导管内腔内的流体流动，以便冲洗和引流导管，减少血液堵塞的发生率。拟议活动旨在开发一种胸管，该胸管主动提供流体流动，以防止心血管手术期间与引流流体和血液相关的血凝块形成。该产品引入了一种称为稀释性凝血病的新方法来解决凝血问题，其中主动使用无菌生理盐水或抗凝剂来减少封闭引流空间中的血栓形成，而不是依赖于化学或机械屏障的历史方法来减少或阻碍凝块形成。该项目旨在开发使用生物材料和制造方法的原型，适合最终的病人使用，并承担风险，证明概念验证和减少凝血的动物模型的术后引流并发症。该奖项反映了NSF的法定使命，并已被认为是值得的支持，通过评估使用基金会的智力价值和更广泛的影响审查标准。

This Small Business Innovation Research (SBIR) Phase I project aims to develop strategies to mitigate occlusion of thoracic catheters (chest tubes). A study by the Cleveland Clinic determined that 36% of chest tubes were completely obstructed at one point, with 86% of these clots existing in the thoracic cavity, undetected by clinicians. The complications that result from occluded chest tubes can include postoperative atrial fibrillation, hemothorax, and cardiac tamponade. The team will design, develop, and commercialize a novel chest tube to solve the high impact clinical need. This novel chest tube seeks to reduce drainage-related complications following cardiothoracic surgery. The novel system proactively manages fluid flow within the inner lumen of a catheter in order to flush and drain the tube, reducing the incidence of blood clogging.The proposed activity seeks to develop a chest tube that proactively provides fluid flow in order to prevent blood clot formation associated with draining fluid and blood during cardiovascular surgery. The product introduces a novel approach called dilutional coagulopathy for addressing clotting issues, where sterile saline or anticoagulants is proactively used to reduce thrombosis in an enclosed drainage spaces, rather than rely on historical methods of chemical or mechanical barriers for reducing or hindering clot formation. The project aims to develop prototypes using biomaterials and fabrication methods suitable for eventual patient use, and undertake the risks of demonstrating proof of concept and reduced clotting in an animal model of post-surgical drainage complications.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.