SBIR-STTR Award

This SBIR Phase I project supports development of an innovative device for use in laparoscopy (minimally invasive surgery of the abdomen). Laparoscopic injuries most often occur during primary port entry, before visualization into the abdominal cavity is possible. Injuries are primarily to the bowel or vasculature and are very serious, with mortality rates up to 5% for bowel injuries and up to 15% for vascular injuries. To minimize this risk, surgeons lift the abdominal wall away from the vital organs that could be inadvertently punctured during primary port entry. Two lifting techniques are commonly utilized, but one is unreliable and the other invasive. The product in development utilizes suction instead of mechanical force to grasp the abdominal wall and is more reliable and less invasive than the current techniques. Projected benefits include better surgical outcomes, increased surgeon and patient satisfaction, and decreased patient post-op pain. Successful development of this product is forecasted to create 40 new jobs by 2023 with an annual payroll exceeding $2.5M. As a direct result of this Phase I grant, this innovative product can reach the U.S. market in 2019 and become the gold standard for abdominal wall lifting devices in the next five years.The technical innovation in this proposed project is a novel abdominal lifting device for use in laparoscopic surgery that is more reliable and less invasive than current lifting techniques. The novelty of the innovation is affirmed with one issued patent and an additional pending patent application. The device takes advantage of existing suction available in every operating room. This suction allows for the non-invasive attachment of the lifting device to the abdominal wall. Current lifting techniques include manually grasping the abdominal wall and using perforating towel clips. Manual grasp does not always provide a secure grip and perforating towel clips invasively perforate abdominal wall tissue to provide a handle by which to lift and elevate. The technical goals of this project focus on creating a minimum viable product produced with biocompatible materials using standard good manufacturing practices for FDA Class I medical devices. Production quality samples will be produced with five different materials to determine which performs best in terms of strength, reliability, and flexibility. These samples will also be used to determine if any further design changes are needed prior to commercialization.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.

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is a reduction in the negative effects of laparoscopies, procedures to enter the abdomen through a small incision. Over 15 million laparoscopies are performed worldwide each year, particularly gynecologists, who represent roughly half the surgeons performing these procedures in the U.S. The proposed procedure does not require surgeons to alter their surgical techniques and requires minimal training. It uses equipment already in the hospital. The benefits will include better surgical outcomes, decreased patient post-op pain, and increased surgeon and patient satisfaction. Furthermore, it can ultimately be used in other surgical interventions, such as pannus retention, wound management, and liposuction. This Small Business Innovation Research (SBIR) Phase II project addresses the need for a less invasive and more reliable method for lifting the abdominal wall during laparoscopic surgery. Current lifting techniques include manually grasping the abdominal wall and using invasive perforating towel clips. With manual grasp it can be difficult for the surgeon to maintain grip and proper elevation, especially with lean or obese patients. Alternatively, using perforating towel clips is invasive because the towel clips perforate the abdominal wall tissue to provide a handle by which to lift and elevate. The perforations can be a significant source of post-op discomfort and bruising for the patient. This project focuses on developing a medical device that uses suction to attach to and lift the abdominal wall more reliably than manual grasp and less invasively than perforating towel clips. 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.