This project focuses on the development of a novel surgical tool designed to facilitate internal tissue closure in minimally invasive surgery, specifically targeting mesenteric defect closures during Gastric Bypass procedures.
The tool incorporates innovative staples and barbed sutures, distinct from conventional methods and existing market tools. The surgical tool features optimized staples made from biocompatible NiTinol, with dimensions of 1.5 x 5.5 x 0.5 millimetres, facilitating tissue penetration while minimizing tissue squishing. The barbed sutures, composed of PBT with dual-cut barbs in alternating tri-radial rows, provide a secure closure mechanism. The applicator, with a diameter of 9 mm and usable length of 35 cm, enables single-handed operation with right- and lefthanded use. The cartridge consists of 80 staples and 30 centimetres of barbed suture, enough to close an entire defect. The tool’s design and functionality aim to enhance the efficiency of internal tissue closure procedures, reducing time, physical exertion, and cognitive load for surgeons.
The project follows a systematic and iterative design approach, best represented by the triple diamond method. A first phase involved extensive literature and market research, exploration and observations in the operation room. In a second phase, various methods such as brainwriting and CAD design are employed to generate ideas and models. Then in a final phase, through comprehensive testing and evaluation, a first version of the device called StapleStitcher, has been established, serving as a solid foundation for future iterations.
The evaluation of the proposed surgical tool has yielded overall positive feedback from bariatric surgeons. This was conducted through a questionnaire. They recognised its innovativeness and some explicitly expressed interest in further development.
Additionally, a risk analysis was conducted to identify potential hazards associated with the use of the surgical tool. The analysis addressed factors such as mechanical failure and user-related issues. Mitigation strategies derived from the analysis and feedback from surgeons informed recommendations for further research, collaboration, and development to optimize the surgical tool for clinical implementation.
In conclusion, the development of the novel surgical tool presents an opportunity to simplify and enhance internal tissue closure procedures in minimally invasive surgery. By incorporating innovative staples and barbed sutures, the tool offers potential improvements in surgeon comfort and efficiency. However, further research, collaboration, and refinement are necessary to fully harness the StapleStitcher’s potential and ensure successful integration into clinical practice.