Rapid prototyping for biomedical engineering: current capabilities and Challenges

A new set of manufacturing technologies has emerged in the past decades to address market requirements in a customized way and to provide support for research tasks that require prototypes. These new techniques and technologies are usually referred to as rapid prototyping and manufacturing technologies, and they allow prototypes to be produced in a wide range of materials with remarkable precision in a couple of hours. Although they have been rapidly incorporated into product development methodologies, they are still under development, and their applications in bioengineering are continuously evolving. Rapid prototyping and manufacturing technologies can be of assistance in every stage of the development process of novel biodevices, to address various problems that can arise in the devices' interactions with biological systems and the fact that the design decisions must be tested carefully. This review focuses on the main fields of application for rapid prototyping in biomedical engineering and health sciences, as well as on the most remarkable challenges and research trends

DEVELOPMENT OF A VIRTUAL TESTING LABORATORY FOR LOWER LIMB PROSTHESIS

The introduction of computer-aided tools into the product development process allows improving the quality of the product, evaluating different variants of the same product in a faster way and reducing time and costs. They can play a meaningful role also in designing custom-fit products (especially, those characterized by a tight interaction with the human body), increasing the comfort and improving people’s quality of life. This thesis concerns a specific custom-fit product, the lower limb prosthesis. It is part of a research project that aims at developing a new design platform centred on the digital model of the patient and his/her characteristics. The platform, named Prosthesis Virtual Laboratory (PVL), is being developed by the V&K Research Group (University of Bergamo) and integrates ICT tools and product-process knowledge. It provides two environments: one for prosthesis design (named Prosthesis Modelling Lab), both transfemoral and transtibial, and one for the prosthesis testing (named Virtual Testing Lab). The main objective has been to embed within the Virtual Testing Environment numerical simulation tools to analyse the interaction between the socket and the residual limb under different loading conditions, allowing the prosthetist to automatically run the simulation and optimize socket shape. Simulation tools, such as Finite Element Analysis (FEA), permit to predict the pressures at the interface socket-residual limb, evaluate the comfort of socket and validate the socket design before manufacturing phase. However, the diffusion of simulation tools in orthopaedic laboratories is strongly limited by the high level of competence required to use them. Furthermore, the implementation of the simulation model is time consuming and requires expensive resources, both humans and technological, especially onerous for small orthopaedic labs. To effectively employ the numerical analysis in prosthesis design, the simulation process has been automated and embedded within the virtual design platform. Therefore, in such a context, the specific scientific objectives have been to: • Critically analyse the state of the art with regard to methods and tools to evaluate socket-residual limb interaction. • Identify the key issues to automate the simulation activities. • Define a set of simulation rules and the Finite Element Analysis model. • Implement and integrate within the new design platform the automatic simulation procedure. • Test the integrated design platform with a case study. • Identify future development trends. Research activities have been organized into four main activities as follows. The first activity consisted in an extensive analysis of the last two decades State of the Art on numerical models adopted to study residual lower-limb and prosthetic socket interaction. Starting from literature, the key issues of the simulation process (e.g., geometric models reconstruction, materials characterization, simulation steps, and boundary conditions), the methodologies and procedures have been identified. Particular attention has been also paid to the parameters commonly adopted to evaluate socket comfort. This phase played a fundamental role since it constituted the basis for the implementation of the embedded simulation procedure. It also permitted to highlight that current finite element models are stand-alone and not integrated with prosthetic CAD or Digital Human Modelling (DHM) systems. In the second activity the tools and methods necessary to develop the embedded simulation module have been selected. By using these tools, it was possible to identify the simulation rules and the best practice procedures, which are fundamental to implement an automatic simulation module. Initially, the modelling tools have been considered since they provide the geometric models for the numerical analysis of the socket-residuum interaction and for the virtual gait analysis of the patient’s avatar. Then, particular attention has been paid on the choice of the FE solver, that has been made according to the results of preliminary FE models. They were implemented using two different solvers: Abaqus (commercial) and CalculiX (open-source). The latter has been experimented to verify the possibility to develop a design platform totally independent from commercial tools. However, according to the results, Abaqus has been chosen because it allows managing adequately simulation problems characterized by large deformations and difficult contact conditions, its results are comparable with those found in literature, and its scripting code does not require specific customization. The last considered tool was the Digital Human Modelling system (LifeMOD) since it permits to enhance the accuracy of the numerical analysis. By performing the gait simulation of the patient’s avatar, it provides the directions and the magnitude of forces and moments that act on the socket. The third activity consisted in defining the architecture of the simulation module, implementing the module and the interfaces with the socket CAD tool (namely Socket Modelling Assistant-SMA) to get the geometric models of the involved parts (socket and residual limb) and with the DHM system to acquire forces acting on the socket during patient’s walking. The simulation module has been implemented using the Python language and the integrated environment works as follows. Once the prosthetist has created the 3D socket model, SMA acquires the input for the analysis (e.g., residual limb length, patient’s weight, friction coefficient, material properties), and produces the files required to generate the FE model. Abaqus automatically generates the FE model without any human intervention, solves the analysis and generates the output file containing the pressure values. Results are imported in SMA and visualized with a colour map. SMA evaluates pressure distribution and highlights the areas that should be modified. Geometry modifications are needed in the areas where pressure exceeds the maximum value and are carried out automatically by the system or by the prosthetist using the virtual tools available in SMA. Then, the system re-executes the simulation. Through this iterative process of adjustments, the socket shape is modified and optimized in order to eliminate undercuts, minimize weight and, especially, distribute loads in the appropriate way so that they can be tolerated for the longest period of time. The fourth and last activity concerned the test and validation of the simulation module integrated within the new design platform, by considering a transfemoral patient. The new virtual process and the key issues of the simulation procedure have been tested starting from the patient’s data acquisition to the release of the socket using also data coming from the gait simulation with the DHM system. The geometric model of the residual limb has been reconstructed from MRI images and the socket has been modelled using SMA. Through an iterative process, the socket shape has been optimized until the pressure distribution on the residuum was consistent. Preliminary activity concerning the FE model validation has been performed comparing the pressure distribution experimentally acquired with pressure transducers over the residuum with the simulation results. To accomplish this task, the geometric model of the real socket has been acquired using reverse engineering techniques. Two numerical simulations have been implemented, they differ for the residuum geometric models adopted: from MRI and from 3D scanning. Preliminary results have been considered positive but improvements are necessary. As an example, some geometric inconsistencies, occurred during the acquisition of the geometric model of the residual limb, have reduced the accuracy of the final results. To complete the evaluation of the simulation model, a new residuum geometric model is needed and a refinement of the material model characterization is desirable. To conclude, the simulation module embedded within Virtual Testing Laboratory has improved the prosthesis development process with the goal of assessing and validating the socket shape under different load conditions (static or dynamic) before the manufacturing phase. The testing phase of the new procedure has demonstrated the feasibility of the virtual approach for lower limb prosthesis design. The tests carried out permitted to highlight necessary improvements and future developments, such as the definition of a protocol to acquire the residual limb through MRI and 3D scan, refinement of the FE model (e.g., non-linear viscoelastic behaviour for soft tissues, friction coefficients), parallel computing to improve simulation performances, open-source solvers to implement a design platform totally independent from commercial systems, and a massive test campaign involving transtibial and transfemoral patients to fully validate the FE model and the design platform

Sensor-Based Adaptive Control and Optimization of Lower-Limb Prosthesis.

Recent developments in prosthetics have enabled the development of powered prosthetic ankles (PPA). The advent of such technologies drastically improved impaired gait by increasing balance and reducing metabolic energy consumption by providing net positive power. However, control challenges limit performance and feasibility of today’s devices. With addition of sensors and motors, PPA systems should continuously make control decisions and adapt the system by manipulating control parameters of the prostheses. There are multiple challenges in optimization and control of PPAs. A prominent challenge is the objective setup of the system and calibration parameters to fit each subject. Another is whether it is possible to detect changes in intention and terrain before prosthetic use and how the system should react and adapt to it. In the first part of this study, a model for energy expenditure was proposed using electromyogram (EMG) signals from the residual lower-limbs PPA users. The proposed model was optimized to minimize energy expenditure. Optimization was performed using a modified Nelder-Mead approach with a Latin Hypercube sampling. Results of the proposed method were compared to expert values and it was shown to be a feasible alternative for tuning in a shorter time. In the second part of the study, the control challenges regarding lack of adaptivity for PPAs was investigated. The current PPA system used is enhanced with impedance-controlled parameters that allow the system to provide different assistance. However, current systems are set to a fixed value and fail to acknowledge various terrain and intentions throughout the day. In this study, a pseudo-real-time adaptive control system was proposed to predict the changes in the gait and provide a smoother gait. The proposed control system used physiological, kinetic, and kinematic data and fused them to predict the change. The prediction was done using machine learning-based methods. Results of the study showed an accuracy of up to 89.7 percent for prediction of change for four different cases

Soma Series: Somatic Metaphors Evidenced in a series of medical transactions?

Aspects of the orthodox medical-gaze have long been the concern of artists, theorists and Complementary Medical Practitioners. This research explored an aspect of the pre-surgical transactional-interview related to the 'quest for prosthesis', as a specific paradigm of the way the medicalgaze implicitly disciplines its 'subjects'. A pragmatic feminist standpoint approach was engaged in conjunction with an Ayurvedic/holistic perspective, from which to observe and critique fieldwork and create visual outcomes from it, as it was observed to somatically affect both patients and medical team in an Orthopaedics Department of an NHS hospital. Soma-Series: Somatic Metaphors Evidenced as a Series of Medical Transactions? parodically explored aspects of role-play and behavioural patterns that were seen to manifest through body-language that rendered the interaction as a simulation of events that were in themselves already 'artificial' as a result of the orthodox disciplines that engaged it. Threedimensional images as interpretations of this 'evidence' were subsequently transformed into a 'scripto-visual' interactive hypertext. Through visual experimentation, new research was developed as www.soma-series.org.uk in conjunction with an exhibition of selected images as Soma-Series: Ten Constructs at the Northern General Hospital, Sheffield, U.K. [May 2002], for its Ethics Committee; fieldwork participants and members of the public. The thesis compared this 'evidenced-based' approach to art making with the work by two contemporary women artists whose visual work also juxtaposed socio-medical discourse with art-practice [Jane Prophet and Christine Borland]. The outcomes as website 'artwork' anticipated opening up links between aspects of socio-medical discourse, cyberspace and feminism. Inviting audience response to the site was a central part of the research paradigm, with a view to expanding the debate relating to quest for prosthesis and its implications for notions of a 'bionic' body