Get to know the latest developments in the field of implant production through well selected case studies, presented by industry trendsetters. Goal of these sessions is to discuss and set, in dialogue with th experts, the future standards for certified, validated implants.

The Rapid Implant Manufacturing Forum is organized in colaboration with EOS GmbH. 

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Program

Abstracts

Martin Bullemer, EOS GmbH, Germany
New Developments in Titanium DMLS

EOS was founded in 1989 and is today the world leading manufacturer of laser-sintering systems, the key technology for e-manufacturing™, the fast, flexible and cost-effective productions of parts, directly from electronic data.
Direct Metal Laser Sintering (DMLS) has been used for manufacturing prototypes, functional metal components and prototype tools for more than 10 years. During this period the technology has advanced to a level where direct production of complex metal parts for various applications is everyday life and the medical market with its various challenges is one of the main targets.
This paper presents the latest status of the DMLS technology in Titanium processing with the focus on the challenge to meet the requirements of international standards. An outlook in new developments in DMLS will be given to bring the technology to implant manufacturing. The key questions about certification and machine validation will be addressed, too.

Dr. Ola L. A. Harrysson, North Carolina State University, USA

Design and direct fabrication of implants with tailored properties

Direct metal fabrication technologies like Electron Beam Melting (EBM), Selective Laser Melting (SLM), and Selective Laser Sintering (SLS) have made it easier and more affordable to fabricate custom metal implants. These implants can be custom designed based on patient specific Computed Tomography (CT) for an optimal fit. However, the custom implant can be customized in many aspects and not just the shape and size. The direct metal fabrication technologies are capable of producing very complex structures. This presentation will describe the process of using Mimics to produce custom implants with tailored mechanical properties. Mimics is used to convert the CT images into a 3D model that the custom implant will be based off. The material properties of the region of interest are derived from the CT data as well so that the implant can be tailored to the specific patient. A mesh structure using different unit cells can be used for the initial design and optimization can be used to further enhance the mechanical properties. To generate the initial mesh structure with gradient cell densities, custom software has been developed. The optimization is also accomplished using an in-house developed approach and the resulting implants have been fabricated using our EBM A2 machine.

Dr. Stephen Rouse, Walter Reed Army Medical Center, Washington, DC, USA
The impact of rapid prototyping and manufacturing on combat life saving and injury reconstruction: case histories from Iraq and Afghanistan

Medical care following combat trauma requires a significant change in the way we think about, plan for, and select or construct custom implants or fixation. Many of the procedures that are performed to save lives and reconstruct them afterwards are a direct result of the techniques and materials available through advanced technology and rapid manufacturing.

This presentation will focus on case histories and examples of Rapid Prototyping and Rapid Manufacturing which have been instrumental in the reconstruction of craniofacial and orthopedic injuries from the combat arenas of Iraq and Afghanistan during the current conflict. The use of Mimics, Magics, and 3-matic in this process is vital in dealing with the complexity of the injuries, and each case history will detail their use with the focus on techniques and materials utilized in the fabrication of custom implants and fixation. Traditional techniques and materials as well as the development of innovative techniques and new materials will be discussed from neurosurgery and orthopedics, to maxillofacial prosthodontic applications.

Dr. Ir. Peter Mercelis, KULeuven and LayerWise, Leuven, Belgium
Rapid manufacturing of medical implants using SLM technology - state of the art and future outlook

Layered Manufacturing technologies like Selective Laser Melting technology offer tremendous possibilities for the production of medical implants. Through their nature, Layered Manufacturing technologies are ideally suited to produce complex shaped and unique implants, tailored to the individual patient. Nevertheless also the production of standard implants through Layered Manufacturing technologies may be considered, since increased functionality can be added to the implants compared to conventional manufacturing methods.
This presentation discusses the state of the art in Selective Laser Melting technology and illustrates the integration of implant design and implant manufacturing trough a number of case studies. Examples from the dental, cranio-maxillofacial and orthopedic area will be presented. Next to the technological aspects of the SLM process, also some implant design and software aspects will be discussed.
Finally, the use and manufacturing of porous scaffold structures will briefly be discussed, as this technology offers some very interesting possibilities to replace a large number of bone grafting applications in the near future.

Andrew Christensen, Medical Modeling Inc., Colorado, USA
Real world applications for rapid implant manufacturing with electron beam melting

Additive fabrication in biocompatible metals has only been possible for the last several years as new production techniques have been commercialized. Metallic materials commonly used in orthopaedic and cranio-maxillofacial surgery include commercially pure titanium, titanium alloy and cobalt-chrome alloy. Production in an additive environment of all of these materials is now possible with the Electron Beam Melting (EBM) rapid manufacturing technique. Titanium alloy produced with the EBM technique has had much scrutiny over the past two years with tests performed to characterize the material chemistry, microstructure, tensile strength, fatigue strength and more. Examples of how this technology fits into current manufacturing environments include custom components and off-the-shelf components of high complexity. Combining net-shape digital design with the ability to immediately fabricate in fully-dense, biocompatible metals is a powerful concept and many exciting applications have appeared. This presentation will focus on a technology update and several “real world” cases where EBM components have been implanted.

Dipl.-Phys. Simon Höges, Fraunhofer-Institut für Lasertechnik, Aachen, Germany
New possibilities for rapid manufacturing of bone substitude implants using SLM and DMLS

Selective Laser Melting (SLM) is a Rapid Manufacturing technique which enables direct fabrication of metal parts with high bulk density on the base of individual three-dimensional data, including computer tomography models of anatomical structures. At ILT SLM-produced parts out of the titanium alloy TiAl6V4 have been developed and tested for its applicability as hard tissue biomaterial. Tensile strength, yield strength and breaking elongation of SLM specimen match American Society of Testing and Materials (ASTM) specifications. Rotating bending tests revealed that the fatigue profile of SLM parts was comparable to casted and hot isostatic pressed parts. Based on these results a first implant (hip cup) was successfully manufactured by SLM and implanted in the human body. Further applications are the manufacturing of individual bone substitute implants, implants with adapted mechanical properties (i.e. spinal cages) or implants with adapted porosity for enhanced bone ingrowth. In this presentation an overview on the mechanical properties of TiAl6V4 implants manufactured with SLM / DMLS will be given. New possibilities for bone substitude implants as well as new developments in the manufacturing of innovative materials for bioresorbable implants (e.g. bioceramic, biopolymer) with SLM / DMLS are discussed in the presentation.

Dr. Igor Drstvensek, University of Maribor, Slovenia
Custom made skull implant production using EOSINT M270

Male patient after a car accident suffered from severe head injuries that resulted in loss of a part of skull in left temporal lobe. Since the bone material was lost the only solution for replacing the lost part of skull was custom made implant. Production of implant started after patient's rehabilitation, with CT data set of his head that was converted into a 3D model of patient’s skull using Materialise’s software package Mimics. Using the 3D model as a reference, an implant was modelled using Materialise’s software package 3-matic.
In previous attempts skull implants were produced using indirect approach by moulding PMMA in silicone rubber moulds. In this case direct production was selected using EOS M270 selective laser melting procedure. The implant was made out of Ti6Al4V alloy, which because of higher density requires thinner walls as compared to PMMA to obtain approximately the same weight of the implant as of the missing bone material. Because of relatively low knowledge about behaviour of SLM titanium implants, several standard probes were produced in the same job with implants. They were later on exposed to autoclave sterilisation and tested to obtain the tensile strength of produced implant. Metallographic probes were tested to obtain chemical properties of finished parts.

Emanuele Magalini, Eurocoating, Italy

Rapid manufacturing technology: mechanical performances and characterization of metallic materials done with EBM and laser technologies

The Rapid Manufacturing (RM) technology based on direct metal powder melting offers the possibility to examine new options for external structures that are intended to be used in contact with the bone tissue. The technology permits to design and realize actual geometries in complete freedom and overcoming limitation of conventional machining. Moreover the possibility to work with metal and metal alloys, suitable for implant application, permits to obtain not only functional prototypes but components potentially “ready to use”.
In recent times Eurocoating has collected results by using both laser (EOS) and e-beam (Arcam) techniques. The laser technology was used to create parts with pure Titanium and with Titanium alloy whereas the EBM one was used with Titanium alloy and CoCrMo alloy.
The aim of this work is to show the materials mechanical properties, chemical composition and microstructure to understand if they agree with the requests of the standards for medical application. Also, it would show the effect of some treatment (like thermal treatments) on the mechanical performances and the microstructure in order to improve the results or to obtain a more suitable material for the designed application. Finally, this data collection would represent a fundamental step for the validation of the technology for the production of orthopedic and dental component.

Dr. Shigeki Suzuki, NEXT 21 K.K., Tokyo, Japan

Free formation of remodeling bone

We, NEXT21 K.K. and Division of Tissue Engineering, The University of Tokyo Hospital have developed a novel bone implant, which is designed using the CT image of patient's bone and fabricated using the ink-jet printing technology. We import the CT image of the patient’s bone into Mimics and create the 3D plaster model of the bone defect site. Then the surgeon onlays the wax on the 3D model to construct the shape of the bone implant, and take CT scan to create STL data. We import the STL data into Mimics again and design inner structures to help induce fast bone remodeling. Based on this data, the printer spreads 0.1～0.2mm-thick layer of calcium phosphate powder and prints curing solution over the layer. Repetition of this procedure leads to custom-made remodeling bone implant.
Ten patients have been operated on at the University of Tokyo Hospital in a clinical study, with good postoperative outcomes. We will take this technology to the European market within the year.