A new design approach for customised medical devices realized by additive manufacturing

Abstract

The aim of this work is the design of a new customised elbow orthosis completely realized by Additive Manufacturing and the development of generative algorithms for parametric modelling and creation of 3D patterns to be adapted to the CAD model. This work describes a method to perfect the design of a custom elbow orthosis. A reverse engineering approach has been used to digitalize the patient’s arm and the subsequent CAD modelling of the structure of the custom elbow orthosis has been performed. In particular, two algorithms have been implemented for the creation of 3D patterns and Voronoi tessellations. Subsequently, FEM analyses have been carried out to validate the design. Finally, a prototype of the elbow orthosis with Voronoi tessellation has been realized by means of the SLS technology. The results obtained have demonstrated that the implemented algorithm solved the problems found during CAD modelling with conventional software. Furthermore, the results of FEM analyses have validated the design choices. All this allowed realizing the prototype by AM technologies without problems. Moreover, the new proposed modelling approaches allows creating, in an interactive way, patterns on complex surfaces. The results of this research activity present innovative elements of originality in the CAD modelling sector, which can contribute to solving problems related to the modelling for Additive Manufacturing. Furthermore, another innovative characteristic of the device is the use of torsion springs that simulate the action of physiotherapists during exercises for patient rehabilitation.

Limb Prostheses: Industry 1.0 to 4.0: Perspectives on Technological Advances in Prosthetic Care

“…Socket liners will become active monitoring and data collection components that complement microprocessor-controlled components at the knee, ankle, elbow or wrist. Data bases resulting from smart sockets and liners will be cross referenced with existing anthropometric and biomechanics data bases to which machine learning (M/L) and generative design practices will be applied ( 57 ). This will support the development of components that allow more complex and natural movement ( 58 ) and which will integrate sensors that enable temperature, touch and pressure to be incorporated into local feedback loops.…”

A Designers' Perspective on Additive Manufactured Smart Wearables for Paediatric Habilitation

“…Meanwhile, Ricotta et al (2020) present a new approach to design customised orthosis via AM, following a reverse engineering methodology. Their study highlights the advantages of customisation and flexibility offered by AM, however it does not include the participation of relevant stakeholders.…”

Detailed design for additive manufacturing and post processing of generatively designed high tibial osteotomy fixation plates

“…Design engineers have amplified the patient specificity of implants by exploiting design for AM (DfAM) approaches, such as imaged-based personalisation, lattice structures and TO [34]. To date, application of GD for medical devices has been limited to concept designs of orthosis and prothesis [35,36]. Rajput et al [36] illustrate how the translation and initialisation phase can produce concept designs for a lightweight prosthetic leg.…”