SBIR Phase I:A Safer, Faster, Simpler and More Cost-Effective System for Tissue Removal in Laparoscopic Hysterectomy and Other Minimally Invasive Surgery

这项小企业创新研究（SBIR）一期项目的更广泛影响/商业潜力是提供一种更安全、更快速、更经济的子宫切除术解决方案。在美国，每年大约有50万例子宫切除术，主要是由于子宫肌瘤导致的子宫增大。在这些涉及子宫明显增大的病例中，大约30%迫切需要改进的解决方案。目前，子宫切除术的黄金标准是人工分块，这是一种未经批准的技术，速度慢（10个或更多的手术刀刀片，耗时20-40分钟），对含有潜在癌细胞无效（8-41%的记录容器破裂）。另一种选择，开放手术，费用昂贵，发病率/死亡率高（1:50 000死亡率，1:20严重并发症），在服务不足的人群中有额外的并发症。拟议的项目将开发一种改进的组织提取解决方案，以提高所有社区的患者安全，并降低相关的医疗保健费用。该小企业创新研究（SBIR）一期项目开展基础材料、制造工艺和系统集成研究，为开发一种新型微创子宫切除术工具集奠定基础。本研究的最终目标是使子宫切除组织提取系统能够：1)在微创手术中降低癌症扩散的风险，降低发病率和死亡率；2)在2小时的手术中节省20-40分钟的手术时间；3)使开放式子宫切除术转化为微创手术-每位患者减少数千美元的医疗保健费用。这个第一阶段的项目将开发并严格评估一种新的技术解决方案，以安全、无创地从身体上切除大块组织。本一期项目开发的创新技术适用于除子宫切除术（包括子宫肌瘤切除术、卵巢切除术等）外的许多手术，并有可能广泛影响微创组织提取在外科领域的应用。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 I project is to provide a safer, faster, and more cost-effective solution for hysterectomy. In the US, approximately 500,000 hysterectomies are performed per year, typically for uterine enlargement as a result of fibroids. There is an urgent need for an improved solution in approximately 30% of these cases involving significantly enlarged uteri. Currently the gold standard for hysterectomy, contained manual morcellation, is an off-label technique, which is slow (10 or more scalpel blades and 20-40 minutes), and ineffective at containing potentially cancerous cells (8-41% documented container breaches). An alternative, open surgery, is costly and has high morbidity / mortality (1:5000 mortality, 1:20 serious complications), with additional complications in underserved populations. The proposed project will develop an improved tissue extraction solution to increase patient safety for all communities and reduce associated health care costs. This Small Business Innovation Research (SBIR) Phase I project carries out fundamental materials, manufacturing process and systems integration research as a foundation for development of a novel minimally invasive hysterectomy toolset. The ultimate goal of the research is to enable a hysterectomy tissue extraction system that: 1) lowers the risk of cancer spread and reduces morbidity and mortality during minimally invasive surgery; 2) saves 20-40 minutes of operative time out of a 2-hour procedure; 3) enables conversion of open hysterectomies to minimally invasive surgeries–reducing healthcare costs by thousands of dollars per patient. This Phase I project will develop and rigorously evaluate a novel technical solution to the surgical challenge of removing a large tissue mass from the body safely and as non-invasively as possible. The innovations developed in this Phase I project are applicable to numerous procedures besides hysterectomy (including myomectomy, oophorectomy and others) and have the potential to broadly impact how minimally invasive tissue extraction is performed across surgical fields.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.