SBIR Phase II: Preventing Pneumothorax During Lung Biopsy Using a Novel Hydrogel

该小型企业创新研究（SBIR）II期项目的更广泛影响/商业潜力是改善患者结局，并降低用于筛查肺癌的计算机断层扫描（CT）-肺活检期间与肺萎陷（气胸）相关的发病率和成本。在美国进行了超过400，000次CT引导肺活检，全球超过120万次。症状性气胸的管理和治疗通常需要多日住院，平均每位患者花费15，000美元，全球每年花费13亿美元。通过降低CT引导肺活检的风险，并允许偏远地区的小型门诊手术中心进行筛查，预防气胸可能会增加肺癌筛查的机会。目前，由于多次活检会增加气胸的风险，因此医生收集的活检样本有限。预防气胸可以允许医生收集更多数量的活检样本，并提供足够的组织来个性化癌症治疗并改善患者预后。 这个小企业创新研究（SBIR）第二阶段项目正在开发一种新型的生物密封剂，将减少或消除气胸。气胸-肺萎陷-是计算机断层扫描（CT）引导肺活检最常见的并发症，发生在所有CT引导肺活检的20-40%中。当前研究的重点是评估和证明使用生物密封剂和输送装置密封针道以在气胸发生之前预防气胸的可能性，从而填补当今解决方案中的一个大空白。I期数据支持在动物研究中成功预防气胸的可注射水凝胶制剂。在这个第二阶段的项目中，该团队致力于改进配方，以提高手术性能，并通过动物模型验证其有效性和安全性。该奖项反映了NSF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 impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to improve patient outcomes, and reduce the morbidity and costs associated with lung collapse (pneumothorax) during computed tomography (CT)-lung biopsies used for screening lung cancer. Over 400,000 CT-guided lung biopsies are performed in the US, and more than 1.2 million worldwide. Management and treatment of symptomatic pneumothorax often requires multi-day hospital stays and costs on average of $15,000 per patient and $1.3 billion yearly worldwide. Preventing pneumothorax may increase access to lung cancer screenings by de-risking CT-guided lung biopsies and allowing smaller ambulatory surgery centers in remote geographies to perform the screening procedure. Currently, physicians collect limited biopsy samples due to the increased risk of pneumothorax with multiple biopsy passes. Preventing pneumothorax may allow physicians to collect a greater number of biopsy samples and provide sufficient tissue to personalize the cancer treatment and improve patient outcomes. This Small Business Innovation Research (SBIR) Phase II project is developing a novel biosealant that will reduce or eliminate pneumothorax. Pneumothorax — a collapsed lung - is the most common complication of computed tomography (CT)-guided lung biopsies, occurring in 20-40% of all CT-guided lung biopsies. The focus of the current investigation is to evaluate and demonstrate the possibility of using a biosealant and delivery device to seal needle tracts to prevent pneumothorax before it occurs, thereby filling a large gap in today’s solutions. Phase I data supports an injectable hydrogel formulation that successfully prevented pneumothorax in animal studies. In this Phase II project, the team seeks to refine the formulation for improved surgical performance and validate it with an animal model to demonstrate both efficacy and safety.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.