SBIR Phase II: Development of a bioabsorbable tissue adhesive

这一小型企业创新研究（SBIR）II期项目的更广泛影响/商业潜力是在开发用于胃肠道（GI）内手术应用的有效伤口闭合产品方面取得了进展。无效的胃肠道手术伤口闭合导致的吻合口泄漏与显著的医疗保健和经济成本相关。伤口的有效闭合降低了并发症的可能性，这些并发症会显著影响患者的结局并增加护理成本。开发增强型组织粘合剂以解决当前产品的局限性，有可能提供可靠的伤口闭合产品，以支持改善患者结局。增强型胃肠道伤口缝合产品的成功开发和商业化将为外科医生提供一种有效的组织粘合剂，该粘合剂易于使用，可安全用于内部胃肠道伤口的缝合，从而确保安全可靠的缝合，减少吻合口漏，并改善患者结局。此外，该项目有可能支持额外的产品开发，以产生用于广泛手术应用的改进的组织粘合剂/密封剂，这将有可能减少与无效伤口闭合相关的手术并发症。这个小型企业创新研究（SBIR）第二阶段项目将推进增强型组织粘合剂的开发，以改善胃肠道（GI）手术的手术伤口护理。胃肠道手术伤口的吻合口漏发生率很高，这是由于手术闭合不完全和次优所致。这些泄漏使患者感染的风险增加，并造成每1000名患者的住院和再入院费用估计为2860万美元。目前用于GI应用的组织粘合剂是生物衍生的，其适合内部使用，但存在感染风险。正在开发的技术是一种可生物降解、易于使用和生物相容的聚乙烯基粘合剂。该SBIR II期项目的总体目标是证明外科粘合剂用于GI手术伤口护理的体内疗效。为了实现这一目标，将对I期开发的外科粘合剂配方进行优化，以确定GI使用的理想配方，并将评估先导配方的体内性能。该项目的结果有可能确定一种安全、易于使用和有效的铅组织粘合剂，用于胃肠道手术应用，以防止吻合口瘘和改善胃肠道手术伤口闭合。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 advancement in the development of an effective wound closure product for internal gastrointestinal (GI) surgical applications. Anastomotic leaks resulting from ineffective GI surgical wound closures are associated with significant healthcare and economic costs. Effective closure of wounds decreases the likelihood of complications that significantly impact patient outcomes and increases the cost of care. Development of an enhanced tissue adhesive to address the limitations of current products has the potential to offer a reliable wound closure product to support improved patient outcomes. Successful development and commercialization of the enhanced GI wound closure product will provide surgeons with an effective tissue adhesive that is easy to use and can be safe for the closure of internal GI wounds, thus ensuring safe and reliable closure, decreasing anastomotic leaks, and allowing for enhanced patient outcomes. Additionally, this project has the potential to support additional product development to generate improved tissue adhesives/sealants for a wide range of surgical applications that will have the potential to decrease surgical complications related to ineffective wound closure. This Small Business Innovation Research (SBIR) Phase II project will advance the development of an enhanced tissue adhesive to improve surgical wound care specific to gastrointestinal (GI) tract surgeries. Gastrointestinal tract surgical wounds have a high rate of anastomotic leaks resulting from incomplete and sub-optimal surgical closures. These leaks put the patients at an increased risk of infection and creates an estimated $28.6 million in hospitalization and readmission costs per 1000 patients. Current tissue adhesives for GI applications are biologically derived, which are amenable for internal use but pose a risk of infection. The technology being developed is a polyurethane-based adhesive that is biodegradable, easy to use, and biocompatible. The overall goal of this SBIR Phase II project is to demonstrate in vivo efficacy for the use of the surgical adhesive in GI surgical wound care. To meet this goal, the surgical adhesive formulation developed from Phase I will be refined to identify the ideal formulation for GI use and a lead formulation will be assessed for in vivo performance. The results from this project have the potential to identify a safe, easy-to-use, and effective lead tissue adhesive for implementation in GI surgical applications to prevent anastomotic leaks and improve GI surgical wound closures.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.