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

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.

[1]  Tsuhan Chen,et al.  Efficient feature extraction for 2D/3D objects in mesh representation , 2001, Proceedings 2001 International Conference on Image Processing (Cat. No.01CH37205).

[2]  Barry Berman,et al.  3D printing: the new industrial revolution , 2012, IEEE Engineering Management Review.

[3]  Giovanna Sansoni,et al.  Three-dimensional optical measurements and reverse engineering for automotive applications , 2004 .

[4]  Mika Salmi,et al.  Designing and Additive Manufacturing A Prototype for A Novel Instrument for Mandible Fracture Reduction , 2012 .

[5]  D. Dimitrov,et al.  Advances in three dimensional printing – state of the art and future perspectives , 2006 .

[6]  Hans-Florian Zeilhofer,et al.  3D Surface Measurement for Medical Application—Technical Comparison of Two Established Industrial Surface Scanning Systems , 2007, Journal of Medical Systems.

[7]  P. Gu,et al.  A reverse engineering system for rapid manufacturing of complex objects , 2002 .

[8]  Elspeth M McDougall,et al.  Validation of surgical simulators. , 2007, Journal of endourology.

[9]  Thomas Childs,et al.  Metal Machining: Theory and Applications , 2000 .

[10]  David G. Armstrong,et al.  Three-dimensional printing surgical instruments: are we there yet? , 2014, The Journal of surgical research.

[11]  W A Kalender,et al.  Rapid protyping technology in medicine--basics and applications. , 1999, Computerized medical imaging and graphics : the official journal of the Computerized Medical Imaging Society.

[12]  Shwe Soe,et al.  Medical reverse engineering applications and methods , 2010 .

[13]  Zheng Li,et al.  Computer aided modeling and analysis of a new biomedical and surgical instrument , 2011 .

[14]  Fábio Pinto da Silva,et al.  Medical design: Direct metal laser sintering of Ti–6Al–4V , 2010 .

[15]  Ying Mao,et al.  Comments on instrumentation in neurosurgery. , 2011, World neurosurgery.

[16]  Miroslav Trajanovi,et al.  MEDICAL APPLICATIONS OF RAPID PROTOTYPING UDC 620 , 2007 .

[17]  Massimo Martorelli,et al.  Surface roughness visualisation for rapid prototyping models , 2002, Comput. Aided Des..

[18]  Mitsuo Niinomi,et al.  Recent metallic materials for biomedical applications , 2002 .

[19]  David L. Bourell,et al.  Direct Selective Laser Sintering of high performance metals for containerless HIP , 1997 .

[20]  Philip C. Treleaven,et al.  3D Body Scanning and Healthcare Applications , 2007, Computer.

[21]  Paolo Cappabianca,et al.  Neuroendoscopy: general aspects and principles. , 2013, World neurosurgery.

[22]  Richard H M Goossens,et al.  Face, content, and construct validity of a novel portable ergonomic simulator for basic laparoscopic skills. , 2014, Journal of surgical education.

[23]  Sulaiman Hasan,et al.  Surface roughness analyses on hard martensitic stainless steel by turning , 2008 .

[24]  J. Restrepo,et al.  A User Centred Approach to Eliciting and Representing Experience in Surgical Instrument Development , 2009 .

[25]  C. Lallas,et al.  Face, content, and construct validation of the da Vinci Skills Simulator. , 2012, Urology.