SBIR Phase I: Preventing Pneumothorax During Lung Biopsy Using Novel Hydrogel

SBIR一期项目的广泛/商业影响解决了介入放射科医生在经胸肺活检期间预防气胸（肺萎陷）的重要未满足的临床需求。每年，全世界有超过120万例经胸肺活检用于肺癌诊断（在美国有40万例）。气胸（PTX），肺萎陷，是该手术最常见的并发症，占所有经胸肺活检的20-40%。超过一半的PTX转为症状，需要侵入性胸管插入，这是PTX的最终治疗方法。这种并发症的成本平均为每次插入胸腔管15,000美元，全球治疗费用为13亿美元。这使得当天的诊断程序变成了昂贵的多天住院治疗。拟议项目的研究目标是评估和证明使用生物聚合物密封剂和新型通路/递送装置密封针道以防止经胸肺活检期间PTX的可行性。此外，将研究材料的体外和体内初步生物相容性以及与当前护理标准相比递送装置的功效。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader/commercial impact of this SBIR Phase I project addresses the important unmet clinical need of enabling interventional radiologists to prevent pneumothorax (collapsed lung) during transthoracic lung biopsies. Annually, over 1.2 million transthoracic lung biopsies are performed worldwide for lung cancer diagnosis (400,000 in the US). Pneumothorax (PTX), a collapsed lung, is the most common complication of this procedure, occurring in 20-40% of all transthoracic lung biopsies. More than half of PTX turn symptomatic and require an invasive chest tube insertion, the definitive treatment for PTX. This complication costs, on an average, $15,000 per chest tube insertion and $1.3 billion worldwide to treat. This turns a same-day diagnostic procedure into a costly multi-day hospitalization.The research objectives of the proposed project are to evaluate and demonstrate the feasibility of using a biopolymer sealant and novel access/delivery device to seal needle tracts to prevent PTX during transthoracic lung biopsies. Further, in-vitro and in-vivo preliminary biocompatibility of the material as well as efficacy of the delivery device as compared to the current standard of care will be investigated.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.