SBIR Phase II: A Safe, Fast, and Cost-Effective System for Tissue Removal in Laparoscopic Transabdominal Hysterectomy and Myomectomy

这项小企业创新研究（SBIR）二期项目的更广泛的影响/商业潜力是，通过引入一种新的组织遏制和去除系统，使涉及组织去除的微创手术更安全、更快、更简单、更经济。最初的目标市场将集中于改善子宫切除术或子宫切除的程序，通常是由于子宫肌瘤引起的子宫肿大。在美国，妇科外科医生每年进行大约50万例子宫切除术，迫切需要改进组织切除的解决方案。该系统：(1)降低了微创手术的发病率和死亡率；(2)节省大量时间；(3)使用更快、更安全的工具将开放式子宫切除术转化为微创手术，每位患者可减少数千美元的医疗成本。这个小企业创新研究（SBIR）二期项目旨在提供子宫切除术和子宫肌瘤切除术组织遏制和手术提取系统。该项目有三个主要目标：首先，证明一种新型腹腔镜系统是防止潜在隐匿性癌症的有效屏障，通过电气安全测试，通过灭菌验证，并通过生物相容性测试。其次，为外科医生使用者制定适当的培训计划。第三，证明腹腔镜系统使用直观、安全、有效。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 make minimally invasive surgeries involving tissue removal safer, faster, simpler, and more cost-effective through the introduction of a novel tissue containment and removal system. The initial target market will focus on improving procedures for hysterectomy or uterus removal, usually because of enlargement due to uterine fibroids. Gynecologic surgeons perform approximately 500,000 hysterectomies per year in the United States and there is an urgent need for improved solutions for tissue removal. The proposed system: (1) lowers the risks of morbidity and mortality during minimally invasive surgery; (2) saves substantial time; and (3) enables conversion of open hysterectomies to minimally invasive with faster and safer tools, reducing healthcare costs by thousands of dollars per patient. This Small Business Innovation Research (SBIR) Phase II project aims to provide a hysterectomy and myomectomy tissue containment and surgical extraction system. This project has three main objectives: First, demonstrate that a novel laparoscopic system is an effective barrier in preventing potential upstaging of occult cancers, passes electrical safety testing, passes sterilization validation, and passes biocompatibility testing. Second, develop an appropriate training program for surgeon users. Third, demonstrate that the laparoscopic system is intuitive to use, safe, and effective.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.