SBIR Phase I: Development of a bioabsorbable tissue adhesive

该SBIR一期项目的广泛影响/商业潜力将推动生物可吸收组织密封剂的开发，用于封闭外科手术部位的内部伤口。伤口护理与巨大的医疗保健和经济成本相关。外科伤口占急性伤口的大多数，因为全球每年有超过1亿个手术切口，其中约80%需要缝合产品。手术伤口关闭不当或无效会导致许多并发症，包括感染、疤痕、愈合不当和失血。由于通用性低、安全性问题和固化时间慢，目前可用的产品用于闭合内部外科伤口，其有效性往往受到限制。理想的组织胶粘剂应具有足够的强度和生物可吸收性，从而为内部和外部应用提供有效的伤口闭合。Bezwada生物医学公司寻求通过开发一种基于聚氨酯的内外科伤口粘合剂来满足这一未满足的需求，这种粘合剂具有可生物降解、易于使用和生物相容性。这项技术的成功商业化将为临床医生和外科医生提供一种有效的、通用的伤口闭合产品，用于外科手术，从而减少严重影响患者预后和增加护理成本的并发症的可能性。这个小企业创新研究（SBIR）第一阶段项目将通过创新的化学方法，开发一种基于聚氨酯的组织粘合剂，该粘合剂采用安全的、生物相容性好的化合物，结合可水解的连接桥接。可水解特性将该技术与现有的可吸收聚氨酯区分开来，它是高活性的芳香族异氰酸酯的结果，芳香族环之间有一个可水解的连接，允许安全可调的降解。拟议计划的总体目标是确定单一铅聚氨酯配方，其技术目标有两个：1)单体合成和配方开发；2)评估物理、机械、功能、生物相容性和易用性，以确定最佳配方。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 SBIR Phase I project will advance the development of a bioabsorbable tissue sealant for use in the closure of internal surgical site wounds. Wound care is associated with significant healthcare and economic costs. Surgical wounds account for the majority of acute wounds, as there are over 100 million surgical incisions a year globally, where approximately 80% require a closure product. Improper or ineffective closure of surgical wounds can result in a number of complications, including infection, scarring, improper healing, and blood loss. Currently available products for use in closing internal surgical wounds are often limited in their effectiveness due to low versatility, safety concerns, and slow curing times. An ideal tissue adhesive would provide sufficient strength and be bioabsorbable, thus providing for effective wound closure for internal and external applications. Bezwada Biomedical seeks to meet this unmet need through the development of a polyurethane-based adhesive for internal surgical wounds that is biodegradable, easy to use, and biocompatible. Successful commercialization of this technology will provide clinicians and surgeons with an effective and versatile wound closure product for surgical applications, thus decreasing the likelihood of complications that significantly impact patient outcomes and increase the costs of care.This Small Business Innovation Research (SBIR) Phase I project will develop a polyurethane-based tissue adhesive incorporating hydrolyzable linkage bridging using safe and biocompatible compounds through an innovative chemistry approach. The hydrolyzable feature differentiates the technology from existing absorbable polyurethanes and is the result of highly reactive aromatic isocyanates with a hydrolyzable link connecting the aromatic rings, allowing for safe and tunable degradation. The overall goal of the proposed program is to identify a single lead polyurethane formulation with two Technical Objectives: 1) synthesis of monomers and development of formulations; 2) assessment for physical, mechanical, functional, biocompatibility, and ease-of-use properties to identify the optimal formulation.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.