Project overview
Developed a modified surgical stapler for colorectal anastomosis designed to replace the traditional purse-string technique with a more controlled stapled seal. The project aimed to improve anastomotic consistency, reduce leakage risk and simplify laparoscopic and robot-assisted surgery.
Approach
Designed a modified Endo Gia Universal Stapler with a 3.6 mm radius notch in the lower jaw to capture the anvil, a modified blade to prevent obstruction and an upper jaw designed to avoid staple ejection near the anvil. The prototype combined a flexible SLA-printed upper component with a machined aluminium lower jaw, followed by mechanical, leak and stapling tests using tissue models.
Outcome
The proposed design achieved a jaw articulation of 48.91 degrees, an aperture of 18.75 mm, an expected leak pressure of 66.8 +- 27.2 mmHg and fewer than 1.4% malformed staples when tested on 4 mm tissue. The project also defined a potential FDA 510(k) Class II pathway, supported by ISO 14971:2019 risk-management considerations.