How to reduce time, error and costs for surgeons
Rui Soares, senior researcher and manager of innovation and intelligence area at CENTIMFE - technological center for the moldmaking, special tooling and plastic industries from Engineering & Tooling Cluster in Portugal, presents a case study on the advanced technological approaches for the development of medical devices.
The technologies related with product development and advanced manufacturing have experienced a huge evolution in recent years and these technological advances are changing the healthcare industry. Tooling and plastics industries are globally recognized as being technologically very advanced, both in terms of the equipment used and people skills. Therefore, it is no surprise that the adoption of these technologies has been a norm in its companies for many years.
The integration of technologies for the acquisition and manipulation of medical images like Computer Tomography (CT) and Magnetic Resonance (MR), Computer Aided Design and Simulation (CAD/CAE) with 3D Printing (3DP) and Advanced High Speed Milling (HSM) systems makes it possible to build physical models that reproduce anatomical structures which can leverage many advantages for medical applications. Such models are useful, for example, at the educational level, helping in the elaboration of complex surgical procedures, treatment planning, visualization of some specific anatomical structure, diagnostics, implant design, design of medical instruments and other applications.
These technologies can also be applied to the manufacturing of medical devices and customized implants that can be used in surgery and various pathological situations such as the repair of bone defects (such as those caused by bone loss) or the anatomical correction of bone structures being highly advantageous, as it can enable medicine to restore not only the function but also the shape of a damaged bone structure.
Case study
A case study developed within the Portuguese Engineering and Tooling Cluster involved a physical model of a fractured skull manufactured by 3D printing and a customized pre-surgical implant that allowed the surgeon to plan surgery and reduce time, error and costs. The personalization contributed to the aesthetic and functional outcome of the implant, since it considered the anatomy of the patient.
Virtual 3D models were produced from 2D DICOM images generated by CT and/or MR of the defective skull. Both defective part and the model for repairment were reconstructed digitally in CAD, converted to STL format and afterwards manufactured using 3D printing technology.
The manufacture of the repairment implant was made using an aluminum mold produced by HSM from the related 3D model geometry. This mold was then used during the chirurgical repairing procedure for injecting bone cement to quickly produce the repairing implant. This approach allows the surgeons to have control on the manufacture of the final customized implant and the use of a commonly known material in the medical field. The final dimensions of the implant and its assembly achieved very good results, indicating the efficiency of the technologies and methodology used.
All medical devices and models are unique, and the characteristics of each one should be carefully considered when selecting the manufacturing system.