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

SBIR II 期：用于腹腔镜经腹子宫切除术和子宫肌瘤切除术中组织切除的安全、快速且具有成本效益的系统

• 批准号: 2210308
• 负责人: Daniel Francis
• 金额: $ 100万
• 依托单位: CLARIA MEDICAL, INC.
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-15 至 2024-05-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2210308&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Safe; Fast

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.

该小型企业创新研究（SBIR）第二阶段项目的更广泛影响/商业潜力是通过引入新型组织容纳和切除系统，使涉及组织切除的微创手术更安全，更快速，更简单，更具成本效益。最初的目标市场将集中在改进子宫切除术或子宫切除术的程序上，通常是因为子宫肌瘤引起的子宫增大。在美国，妇科外科医生每年进行大约500，000例直肠切除术，并且迫切需要用于组织去除的改进的解决方案。拟议的系统：（1）降低了微创手术期间的发病率和死亡率风险;（2）节省了大量时间;以及（3）使得开放性膀胱切除术能够转换为具有更快和更安全工具的微创手术，从而使每位患者的医疗保健成本降低数千美元。这个小企业创新研究（SBIR）第二阶段项目旨在提供子宫切除术和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，证明新型腹腔镜系统是防止潜在隐匿性癌症升级的有效屏障，通过电气安全测试，通过灭菌确认，并通过生物相容性测试。其次，为外科医生用户制定适当的培训计划。第三，证明腹腔镜系统是直观的使用，安全，有效。这个奖项反映了NSF的法定使命，并已被认为是值得通过使用基金会的智力价值和更广泛的影响审查标准的评估支持。