Validation of Reverse-Engineered and Additive-Manufactured Microsurgical Instrument Prototype

Abstract

With advancements in imaging techniques, neurosurgical procedures are becoming highly precise and minimally invasive, thus demanding development of new ergonomically aesthetic instruments. Conventionally, neurosurgical instruments are manufactured using subtractive manufacturing methods. Such a process is complex, time-consuming, and impractical for prototype development and validation of new designs. Therefore, an alternative design process has been used utilizing blue light scanning, computer-aided designing, and additive manufacturing direct metal laser sintering (DMLS) for microsurgical instrument prototype development. Deviations of DMLS-fabricated instrument were studied by superimposing scan data of fabricated instrument with the computer-aided designing model. Content and concurrent validity of the fabricated prototypes was done by a group of 15 neurosurgeons by performing sciatic nerve anastomosis in small laboratory animals. Comparative scoring was obtained for the control and study instrument. T test was applied to the individual parameters and P values for force (P < .0001) and surface roughness (P < .01) were found to be statistically significant. These 2 parameters were further analyzed using objective measures. Results depicts that additive manufacturing by DMLS provides an effective method for prototype development. However, direct application of these additive-manufactured instruments in the operating room requires further validation.