SBIR Phase I: Hybrid surgical stapler with tissue sensing technology

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to improve the current state of the art of surgical stapler devices. Despite their widespread adoption in surgical practices, stapler malfunctioning or misuse can cause severe surgical and post-surgical complications which include bleeding, sepsis, and death. Misfiring and cutting errors are the main causes of staplers malfunctioning. This project proposes a semi-reusable surgical stapler which will provide real-time feedback to surgeons to guide the firing, thus reducing staplers malfunctioning and increasing surgeries success rates. The proposed solution combines a reusable control system, which will decrease the amount of toxic waste generated by the healthcare system (adding up to landfill and accounting for 25% of healthcare expenditures), and a disposable handle, which will allow to cut down the cost and time required for surgery preparation (40% savings/procedure). The proposed solution will save hospital costs and improve surgeries performances, decreasing the risks of complications during surgeries. Additionally, this project will bring forward research in the field of smart devices in medical industry, potentially leading to innovation for other types of surgical devices. This Small Business Innovation Research (SBIR) Phase I project proposes to develop the control system to automate the tissue recognition of the firing system of the proposed surgical stapler. The stapler working parameters must be carefully selected in accordance with the tissue’s biomechanical properties. Tissues' intrinsic characteristics vary among organs and individuals, complicating the standardization of firing parameters. The proposed system will assist surgeons by providing real-time information over the tissue to clamp and advising over the optimal cartridge to be used. This project will feature the design of the control system capable of sensing the tissue in the clamp and deciding optimal staple firing parameters. First, the components of the control system will be designed. Successively, the algorithm to control firing speed, energy consumption, and articulation will be developed on an empirical dataset. The project will establish the correlation between clamping forces and tissue parameters. The benefits yielded by the developed surgical stapler, will be benchmarked against commercial solutions both in vitro and ex vivo. At the completion of this Phase I project, the proposed innovation will be ready to be tested in vivo. 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.