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

这个小企业创新研究（SBIR）二期项目的更广泛的影响/商业潜力是改善患者的预后，并减少在计算机断层扫描（CT）期间与肺塌陷（气胸）相关的发病率和成本，CT是用于筛查肺癌的肺活检。在美国有超过40万例ct引导下的肺活检，在全球有超过120万例。症状性气胸的管理和治疗通常需要住院数天，每位患者的平均费用为15,000美元，全世界每年的费用为13亿美元。通过降低ct引导下肺活检的风险，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，由于多次活检增加了气胸的风险，医生收集的活检样本有限。预防气胸可以让医生收集更多的活检样本，并提供足够的组织来个性化癌症治疗和改善患者的预后。这个小型企业创新研究（SBIR）二期项目正在开发一种新型生物密封剂，可以减少或消除气胸。气胸（肺萎陷）是计算机断层扫描（CT）引导下肺活检最常见的并发症，占所有CT引导下肺活检的20-40%。目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束以防止气胸发生的可能性，从而填补当今解决方案的巨大空白。I期数据支持一种可注射水凝胶配方，在动物研究中成功预防气胸。在这个二期项目中，该团队试图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 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.