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3D-printed reconstructive implants get EU approval

08 March 2015

A cranial implant must fit precisely to ensure a satisfactory long-term outcome for the patient. Slovakian company CEIT Biomedical Engineering is taking steps to achieve this by making use of additive manufacturing technology.

Conventional subtractive metal-cutting has traditionally been used to manufacture custom components such as cranial implants. However, certain shapes are impossible to manufacture with sufficient accuracy, often necessitating additional manual intervention by the surgeon during an operation. While this process is limited in what it can achieve, moreover, it tends to be both lengthy and expensive.

CEIT Biomedical Engineering, a spin-off company of the Technical University of Košice, has set out to promote the use of additive manufacturing in the medical sector, as Associate Professor Radovan Hudak (managing director of CEIT Biomedical Engineering) explains:

“We wanted to explore the potential of additive manufacturing technology for implantology and at the same time develop solutions that were both helpful to patients as well as being economical. It was necessary to explore the limits of the technology and its potential, as well as to discover the optimum process and find a suitable material. 

“Precision, reproducibility and surface quality were all high on the list of requirements, along with a production process that was as free as possible from production errors. The main aim was then to acquire state certification for cranial, jaw, and facial bone implants.”

The CEIT team took a year to explore the market and to analyse which additive manufacturing systems were available, eventually deciding on 3D printing technology specialist, EOS as its technology provider and choosing the latter’s titanium alloy as the starting material for this study. Professor Hudak again:

“We are able to meet the technological criteria and manufacture extremely thin walls with the necessary uneven surface geometries. In addition, it is possible to introduce cavities into the implants, such as shapes comprising complex hollows or canals. Lattice structures have become a key element in the scope of the possibilities.”

Manufacturing the first implant involved producing a piece of replacement cranium, approximately 15cm across, from titanium Ti-6Al-4V, a biocompatible standard alloy for medical applications that also offers excellent mechanical characteristics.

The team used the results of a computed tomography examination of the patient to produce a CAD file, and subsequently used an EOS metal additive manufacturing system, the EOSINT M 280, to manufacture the implant; all design and manufacturing took place at CEIT’s facility.

The 1.5 mm thick implant weighed 63 grams, a notable feature being its hollow lattice structure, which promotes in-growth of bone tissue and allows the integration of micro-sensors for recording medical data. 

The process has now been registered by the Slovakian State Institute for Medicinal Control as an approved method for the manufacture of implants for cranial, facial and jaw reconstruction procedures – prompting official EU-wide approval. Negotiations with the largest national insurers with respect to cost also proved successful. 

This type of implant benefits from higher precision and a lower error rate in production, resulting in fewer side-effects and quicker recovery for the patient. When the wound has healed, the evidence of the procedure is far less noticeable, giving the patient confidence in the procedure and peace of mind.

CEIT is now producing bespoke implants as well as undertaking series manufacture of standard implants using EOS additive manufacturing technology.

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