Hybrid surgical stapler with tissue sensing technology

PROJECT SUMMARY Surgical staplers are important tools in modern-day surgery to perform sutures. Surgical staplers ensure greater efficiency, sterility, and are easier to use. They also significantly reduce the chances of infection. Modern specimens of the surgical stapler are equipped with various functional features and ergonomic designs for to enhance durability and minimize complications. However, there are several reports on the adverse effects and post-surgical complications associated with these devices. Patient injuries and manufacturing defects have led to the recall of over 3.4 million surgical staplers, staples, cartridges and components between 2013 and 2019 by leading manufacturers. Moreover, most of these devices are single equipment thus adding to the bulk of electronic waste. Hence, a surgical stapling device equipped with advanced engineering technology accompanied with ergonomic design and re-usability is a clinical requirement. RevMedica is developing Cybernetic, an innovative surgical stapler. Cybernetic is the first semi-reusable stapler with a tissue recognition mechanism. It allows automated firing through tactile sensor-based automated control unit. It can provide real-time feedback to the surgeon regarding the tissue thickness and optimal firing parameters, thus improving the performance of a surgeon, while decreasing the risks like misfiring and other complications. Cybernetic is economical, reduces downtime between surgeries, and substantially reduces toxic waste from healthcare facilities. Through this Small Business Innovation Research Phase I project RevMedica’s seeks to develop a prototype of surgical stapler: Cybernetic with a tissue- sensing mechanism and enhanced functional features and establish its efficacy and safety in benchtop and acute animal studies. The fundamental objectives in this Phase I project will be: 1) Development of the hardware components of the system and benchtop validation. 2) In vivo safety and efficacy testing of the prototype in acute animal studies. The proposed activities will allow the development and preliminary validation of the prototype. The successful implementation of the Phase I project will pave the way for further development of additional components and chronic animal studies for Phase II. In Phase II, further pre-clinical studies will be performed to enable FDA regulatory approval.