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

SBIR 第一阶段：用于腹腔镜子宫切除术和其他微创手术中组织切除的更安全、更快速、更简单且更具成本效益的系统

• 批准号: 2036010
• 负责人: Daniel Francis
• 金额: $ 25.6万
• 依托单位: CLARIA MEDICAL, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-01 至 2021-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2036010&HistoricalAwards=false
• 关键词: SBIR; Phase; Safer; Faster; Simpler

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.

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是为子宫切除术提供更安全，更快速，更具成本效益的解决方案。在美国，每年进行大约500，000例子宫切除术，通常用于子宫肌瘤导致的子宫增大。在大约30%的子宫明显增大的病例中，迫切需要一种改进的解决方案。目前，子宫切除术的黄金标准，包含手动粉碎，是一种标签外技术，它是缓慢的（10个或更多的手术刀片和20-40分钟），并在包含潜在的癌细胞（8-41%记录的容器破裂）无效。另一种选择是开放手术，成本高昂，发病率/死亡率高（死亡率为1：5000，严重并发症为1：20），并且在服务不足的人群中还会出现其他并发症。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成本。该小型企业创新研究（SBIR）第一阶段项目开展基础材料，制造工艺和系统集成研究，作为开发新型微创子宫切除术工具集的基础。该研究的最终目标是使子宫切除术组织提取系统能够：1）降低癌症扩散的风险，降低微创手术期间的发病率和死亡率; 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换为微创手术-每位患者减少数千美元的医疗费用。这个第一阶段项目将开发和严格评估一种新的技术解决方案，以应对安全地、尽可能无创地从体内切除大组织块的手术挑战。在第一阶段项目中开发的创新适用于子宫切除术以外的许多手术（包括子宫肌瘤切除术，卵巢切除术等），并有可能广泛影响如何在手术领域进行微创组织提取。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。