Design of a Surgical Device for Performing Percutaneous Dilatational Tracheostomy

Percutaneous Dilatational Tracheostomy (PDT) is a routine bedside procedure performed on patients managed in Intensive Care Units (ICUs). Severe perioperative complications exist, and some, such as major bleeding and tracheal wall perforation, may be caused by operator errors when using PDT instruments, especially inserting and removing the needle and dilators. We designed a new device called TrachyPen for performing PDT puncture and dilation to reduce the complications associated with current PDT instruments and improve the procedure. The design followed the requirements developed from a questionnaire to twenty-one healthcare professionals, which mapped the mechanical design to the clinical needs. Either used manually or powered by a motor, the TrachyPen is designed to combine the PDT puncture, guidewire insertion, and dilation into a single step, eliminating the use of multiple instruments. Five healthcare professionals evaluated the conceptual design through a demo video and an online questionnaire. A structural analysis of the key parts was completed to evaluate the strength of the design. The results reinforced the feasibility and usability of TrachyPen in terms of matching the design requirements and clinical perspectives.