Abstract
BackgroundPercutaneous tracheostomy is frequently performed in intensive care units in patients who require prolonged mechanical ventilation. The first crucial step for the physician in these procedures is the precise needle insertion into the trachea. The primary aim of this technical note was to test the new filament and share our experiences in the implementation of the new device. The secondary aim was to show how a physician with basic training in computer-aided design and three-dimensional (3D) printing could independently create useful devices for clinical practice.MethodsTo simplify this referred clinical procedure and increase its safety, 3D printing and a new medical filament were used to develop a new translaryngeal Tracheostomy Needle Introducer (tTNI) for use in conjunction with the Fantoni’s method of percutaneous tracheostomy. The tTNI is composed of three parts: a support to fit on the rigid endotracheal tube of the Fantoni kit, an external particular shaped arm, and an introducer for the needle. The latest version of the device used a new filament based on a polyester matrix certified for skin contact that was sterilizable in a standard autoclave. Post-printing, minor technical interventions were required to correct small material deformities.ConclusionsOur experiences with the thread and the technical features of the material were reported herein in conjunction with some suggestions on how to solve the most frequently encountered problems. The 3D printing technique allows physicians to directly manage the prototyping process of new medical devices, making this process completely independent. The speed of the prototyping process and the testing of each piece allow faster creation of a prototype than with traditional industrial methods. Finally, the new biomedical filaments offer endless possibilities of creation and modelling.
Highlights
Percutaneous tracheostomy is frequently performed in intensive care units in patients who require prolonged mechanical ventilation
Version 1.0 of the Tracheostomy Needle Introducer (tTNI) was made with two Polylactic Acid (PLA) supports and a plywood arm (Fig. 1), was tested and improved after extensive trials on a mannequin for advanced life support and tracheostomy training
In our opinion, the translaryngeal tracheostomy (TLT) was the first choice of procedure owing to its intrinsic safety, especially for patients who faced an increased bleeding risk
Summary
Percutaneous tracheostomy is frequently performed in intensive care units in patients who require prolonged mechanical ventilation. The first crucial step for the physician in these procedures is the precise needle insertion into the trachea. To our knowledge, none of the devices fulfils all the essential safety standards These include a continuous endoscopic view of the trachea during the procedure, avoidance of the use of a metal stylet in the tracheal lumen, and prevention of a device from extending beyond the distal end of the endotracheal tube. Based on the technical need to solve this issue and aiming to simplify the procedure and increase its safety, three-dimensional (3D) printing was used to develop the translaryngeal Tracheostomy Needle Introducer (tTNI, Italian patent number 102017000035827, see supplementary materials) for use in conjunction with Fantoni’s kit of percutaneous tracheostomy [8, 9]. Based on the same principle, an external arm was developed to guide tracheal needle insertion based on the rigidity and known measurements of the tracheoscope used for Fantoni’s procedure (Covidien-DAR, Medtronic, Minneapolis, MN, USA)
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