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

SBIR 第一阶段：使用新型水凝胶预防肺活检期间的气胸

• 批准号: 1938459
• 负责人: Andrew Eisenthal
• 金额: $ 22.5万
• 依托单位: PNEUMONIX MEDICAL INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-10-15 至 2021-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1938459&HistoricalAwards=false
• 关键词: SBIR; Phase; Preventing; Pneumothorax; During

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.

该SBIR I期项目的更广泛/商业影响解决了使介入放射科医生能够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（美国有40万例）。气胸（PTX）是一种肺萎陷，是该手术最常见的并发症，发生在所有经胸肺活检的20-40%中。超过一半的PTX会出现症状，需要有创胸管插入，这是PTX的最终治疗方法。这一并发症的平均费用为每次胸管插入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日住院治疗。拟议项目的研究目标是评估和证明在经胸肺活检期间使用生物聚合物密封剂和新型进入/输送装置密封针道以防止PTX的可行性。此外，体外和体内的初步生物相容性的材料，以及疗效的输送装置相比，目前的标准的护理将investigated.This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知识价值和更广泛的影响审查标准。