Developing a Needle-Knife Surgical Device

Introduction: Nowadays, a new era of orthopedic surgery is taking place. Procedures like video surgery, ultrasound-guided interventions, invasive pain interventions, orthopedic procedures, hydro dissection, dry needling, thermography-assisted pain management, and modern acupuncture started to be widely performed1,2. Background: In 2011 and 2012, Ravaglia & Cliquet presented papers on an Arthroscopic Needle-Knife Surgical Prototype Device (ANKSD)2 in Prague, TWC 20112, and in Dubai, OWC 20123. It was a paper presenting a prototype of a needle-knife for orthopedic procedures based on an 18G11/2 needle. Ravaglia and Cliquet wrote the paper “Comparison of two different needles used as knife on knee arthroscopic portal scalpel procedures”4, which was presented at the XXVI SICOT Triennial World Congress, in Guangzhou, China, in 2015. This research compares arthroscopic portal incisions using an 18G11/2 needle or a metal guide intravenous catheter 14Gx2. They concluded that there were no differences in complications such as infections, wound healing, hematoma, and skin healing time. After this, these researchers started a virtual development of a new needle-knife surgical device. Objective: The aim of the project is a virtual development of a needle-knife surgical device to be useful for minimally invasive ultrasound-assisted orthopedic surgical procedures, videos arthroscopic portals augmentation, and other surgical procedures. Method: Three different needle devices were compared. One is a base model 1 and the other two are experimental models (2 and 3). They are based on a metal guide for intravenous catheter 14Gx2''. The base one model 1 is the metal guide for intravenous catheter 14Gx2''; the experimental model 2 is a flat beveled edge, and experimental model 3 is a board bevel edge6,7,8,9,10,11,12,13,14,15,16. They are all graduated, parylene-coated, with a stop handle needle guard. The devices are multifunctional: Infusion, aspiration, and surgical sever.The devices were developed by 3D Design 3D STEP Standard Format, Catia V5 Format, and 2D Format Design and 3D Model. They were performed through simulation (Software Simulia Abaqus). They were biomechanically simulated with Virtual Biomechanical Strength Simulation17,18,19,20. The Strengths were assessed by Needle Strength Analysis (CAE Simulation)21.Results: For the displacement result, stiffness assessment, we have 7.48 mm for the baseline needle, 8.08mm for model 2, an increase of 8%, and for model 3 we have 7.75 mm, an increase of 3.6%. Conclusion: These devices seem suitable for echo-assisted orthopedic surgery interventions and other procedures according to virtual analysis. Further in vivo procedures shall be performed.