Jonathan R Thompson, MD1, Brad M Watkins, MD2, Daniel E Abbott, MD2, Tayyab S Diwan, MD2. 1University of Cincinnati Research Institute, 2University of Cincinnati, Department of Surgery
Objective of the technology or device:
Laparoscopic sleeve gastrectomy (LSG) is the most commonly performed bariatric procedure in the United States, resecting 80% of the stomach and basing the tubular pouch on the lesser curvature. Staple line length in sleeve gastrectomy ranges from 160 to 300mm, while current endocutter staplers are 60mm in length. Between 4 and 8 staple fires are required to complete the staple line. The serial application of staple cartridges without a clear path can lead to suboptimal sleeve anatomy.
Because bougies—the contemporary stapling guide—are flexible and confined to the lumen of the stomach, they do not adequately assist the surgeon in avoiding specific technical complications of sleeve gastrectomy, including zig-zagging or spiraling. To address this need, we have developed a sleeve gastrectomy stapling guide (SSG). The SSG enables the surgeon to get a true representation of the entire staple line both anteriorly and posteriorly prior to the first stapler fire. We believe that stapling with the SSG will result in more predictable, optimized pouch anatomy during LSG, while minimizing technical complications.
Description of the technology and method of its use:
Rather than relying on a bougie alone to help the surgeon place serial staple cartridge applications, the SSG is placed laparoscopically alongside a down-sized bougie. The SSG is positioned with one clamping surface anteriorly on the stomach and one clamping surface posteriorly. Once the surgeon is satisfied with the planned staple line, the clamp is engaged, stabilizing the stomach during stapling. Serial staple cartridge applications follow the path provided by the guide (Figure 1).
Figure 1: Pictorial of sleeve gastrectomy stapling process with use of sleeve gastrectomy stapling guide as a stabilization platform during serial staple cartridge application. The stapler is placed to the anatomic left of the SSG. a through c demonstrate the first, second and last staple cartridge application; d demonstrates the completed sleeve gastrectomy staple line.
We have demonstrated both engineering and clinical feasibility of the SSG. In a simulated laparoscopic environment, the SSG was placed, a sleeve gastrectomy staple line was planned, the SSG was then clamped down to stabilize the stomach, and a staple line was created with serial applications of an endocutter stapler. The staple line was inspected by two bariatric surgeons and was found to be high quality, without gaps, spirals, or zig-zags. Furthermore, two bariatric surgeons have demonstrated the clinical feasibility of placing 250mm jaw elements laparoscopically in a human cadaver lab.
We have engineered and produced an alpha prototype of the SSG. In the next quarter, we expect our device will be sufficient to perform a clamping safety study in a porcine model. After ensuring clamping safety, we plan to conduct a first-in-man study in the summer of 2015. We expect to have a market-ready product in the United States in the first quarter of 2016. This innovative device provides a method of standardizing sleeve gastrectomy anatomy, maximizing stapling efficiency, with potential improvement in patient outcomes.