SILS™ Hand Instruments

During Concept Generation and Development, we collaborated with Covidien’s legal team to create new technical concepts for articulating laparoscopic instruments, taking into account the competitive landscape. A number of invention disclosures were generated from this work, which led to a series of utility patents (US 8,801,752 B2, US 9,883,880 B2) to help protect Covidien’s intellectual property. Our device concepts tied articulation to the movement of the handle, allowing the tip of the instrument to function as a natural extension of the handle. We designed, fabricated, and tested benchtop prototypes to evaluate these concepts in vitro. The team at Design by Boyd used the results from this testing to refine the concepts and initiate the Design and Development phase.

During the Verification & Validation phase, the team at Design by Boyd helped translate the technical specifications into verification and validation testing protocols. We supported all testing, including testing to show regulatory compliance with relevant standards for electrical safety and usability. As part of our work, we assisted Covidien’s regulatory team in preparing their 510 (k) submission (K091869), which was approved to clear the device for commercial sale.

Covidien successfully commercialized the SILS™ Hand Instruments and generated widespread adoption of the SILS™ Procedure, becoming a global leader in minimally invasive surgical equipment. The Company is now part of Medtronic.