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

Claria Medical, Inc., Mountain View CA

Investigators

Abstract

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.