Design for Additive Manufacture of Fine Medical Instrumentation—DragonFlex Case Study

Abstract

The recently popularized domain of additive manufacturing (AM) has much to offer to medical device development, especially to the growing field of minimally invasive surgery (MIS). With the advancements in AM materials, one could soon envision materializing not only the proofs of concept but also the final clinically approved instruments. DragonFlex—the world's first AM steerable MIS instrument prototype—was recently devised with the aim to follow this vision. Apart from the medical device design restrictions, several limitations of AM materials and processes had to be considered. The aim of this paper is to present these insights to those opting for this means of manufacture, serving as a helpful design and material guide. Over the course of its development, DragonFlex has gone through four design generations so far, each differing in the AM material and process used. Due to being a prototype of a MIS instrument of miniature dimensions, the printing processes were limited to stereolithography (SLA), as to achieve the best possible precision and accuracy. Each SLA process and material brought along specific advantages and disadvantages affecting the final printout quality, which needed to be compensated for either at the design stage, during, or after printing itself. The four DragonFlex generations were printed using the following SLA techniques and materials in this order: polymer jetting from Objet VeroBlueâ„¢; SLA Digital Light Processingâ„¢ (DLP) method from EnvisionTECآ® NanoCure RCP30 and R5; conventional SLA from 3D Systems Accuraآ® 60; and DLP based SLA process from a ceramic composite. The material choice and the printing orientation were found to influence the final printout accuracy and integrity of thin features, as well as material's postproduction behavior. The polymeric VeroBlueâ„¢ proved structurally sound, although suffering from undermined accuracy and requiring postprocessing, hence recommended for prototyping of upscaled designs of looser manufacturing tolerances or overdimensioned experimental setups. The NanoCure materials are capable of reaching the best accuracy requiring almost no postprocessing, thus ideal for prototyping small intricate features. Yet their mechanical functionality is undermined due to the high brittleness of RCP30 and high flexibility of R5. The transparent Accuraآ® 60 was found to lose its strength and appeal due to high photosensitivity. Finally, the ceramic composite shows the best potential for medical use due to its biocompatibility and superior mechanical properties, yet one has to compensate for the material shrinkage already at the design stage.