In 2015, Lumendi engaged Sage to enhance its flagship DiLumen Endoluminal Interventional Platform (EIP) by developing flexible articulating instruments — a grasper, electrosurgical knife, and electrosurgical scissors — which an endoscopist would operate by hand to visualize, retract, and dissect polyps during endoluminal procedures.
Physicians needed the ability to smoothly navigate the instruments through 5mm working channels across a long, tortuous path in the colon. They needed to operate the end-effectors with precise motion control and the proper force and tension to effectively manipulate tissue. They would do this using handheld controls, making ergonomics a high priority. Sage’s design also had to safely integrate monopolar power delivery into the knife and scissors, isolating internal mechanisms from the user’s hands without compromising usability.
Sage’s experience designing flexible articulating endoscopic instruments, understanding of how to apply loads and manipulate tissues over long distances, and acuity in power integration enable them to meet the complex mechanical, ergonomic, and regulatory requirements. They prototyped quickly and iterated through design and testing cycles to successfully complete Design Verification and Validation testing, enabling Lumendi to submit for and obtain FDA 510(k) clearance.
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