JUSTRIGHT 5MM PEDIATRIC STAPLER

During minimally invasive surgical procedures, surgeons use standard laparoscopic surgical staples to divide tissue planes. Staples are preferred instead of sutures for these procedures as they are both easy to use and can fit into tight spaces. The standard for these staples is 10mm in length and requires a stapler sized accordingly. While this may be sufficient for adult patients, it poses a challenge when using the same device in pediatrics. To address this challenge, surgeons must alter how they perform certain procedures on pediatric patients, increasing the risk of complications for the patient. Synectic was approached by Bolder Surgical to develop a surgical stapler for use in pediatric patients. The biggest challenge was incorporating the current regulatory compliant standard 10mm staple into a 5mm stapler while still applying enough clamping force to form the staple correctly.

Synectic first performed a feasibility study to determine if reducing the stapler anvil size while keeping the staple size the same was even possible. Once we confirmed the design was feasible and the force required to form a 10mm staple successfully, Synectic reviewed and chose materials that would employ optimal strength while still passing biocompatibility and sterility parameters. The stapler head was modified from the classic six rows of six staggered staples to four rows to accommodate smaller tissue sizes while maintaining a secure staple line. While our mechanical engineers developed the stapler and anvil head, our industrial designers designed an intuitive handle design that employed additional safety features to assist surgeons in case of misuse. Additionally, the stapler shaft was designed in such a way to allow for easy replacement of stapler cartridges. Finally, we developed and tested clinician-friendly packaging.