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

MRI with MR Angiography in Endovascular Repair of Abdominal Aortic Aneurysms

The aim of this study was to evaluate MRI with contrast enhanced MR angiography (MRI/CE MRA) as imaging method before and after endovascular repair of abdominal aortic aneurysms (AAA). A 1.5 T scanner was used for all examinations. In this prospective study 26 consecutive patients were included. Follow-up was performed between February 1995 and May 2002 (median follow-up; 36 months, range 8-84 months). In Paper I, we assessed the value of MRI/CE MRA as follow-up method. MRI/CE MRA provided the relevant information. MRI was the sole method demonstrating intramural thrombus organization and vertebral body infarction. In Paper II, we evaluated MR safety; ferromagnetism and heating of a nitinol stent-graft. Image artefacts were also evaluated on MRI/CE MRA and CT. In addition, an extended MR protocol including velocity mapping was assessed. MRI in a 1.5 T system may be performed safely in patients with the nitinol stent-graft (Vanguard). MRI/CE MRA provided diagnostic image information with only minor metal artefacts. Image evaluation on CT can be disturbed at the graft limb junction and graft bifurcation by the beam hardening artefacts. MR velocity mapping did not provide additional information. In Paper III, we compared measurements for stent-graft planning. MRI/CE MRA was compared with DSA and CT. The MRA post processing techniques MIP and VRT were also compared. The length measurements obtained with MRA-MIP were significantly shorter, but probably more correct, than those obtained with DSA. The diameter measurements obtained with MRI/CE MRA were more variable. Improvements of the MRA technique and a standardized determination of the vessel boundaries are needed for more reliable diameter measurements. In Paper IV, we compared costs of follow-up with MRI/CE MRA with costs of follow-up with CT with DSA, or CTA. The cost analysis included a risk analysis of contrast media induced nephropathy. MRI/CE MRA can be cost-effective for follow-up depending on the risk of contrast media induced nephropathy for CT with DSA, or CTA. In Paper V, we presented mid-term results with the Stentor and Vanguard stent-grafts assessed with MRI/CE MRA. Complications and secondary interventions were common. Long-term follow-up is mandatory. This study has shown that for MR-compatible stent-grafts, MRI/CE MRA could be the method of choice for follow-up of endovascularly repaired AAA. For patients with pre-existing renal insufficiency MRI/CE MRA should be the method of choice

3D surface reconstruction for lower limb prosthetic model using modified radon transform

Computer vision has received increased attention for the research and innovation on three-dimensional surface reconstruction with aim to obtain accurate results. Although many researchers have come up with various novel solutions and feasibility of the findings, most require the use of sophisticated devices which is computationally expensive. Thus, a proper countermeasure is needed to resolve the reconstruction constraints and create an algorithm that is able to do considerably fast reconstruction by giving attention to devices equipped with appropriate specification, performance and practical affordability. This thesis describes the idea to realize three-dimensional surface of the residual limb models by adopting the technique of tomographic imaging coupled with the strategy based on multiple-views from a digital camera and a turntable. The surface of an object is reconstructed from uncalibrated two-dimensional image sequences of thirty-six different projections with the aid of Radon transform algorithm and shape-from-silhouette. The results show that the main objective to reconstruct three-dimensional surface of lower limb model has been successfully achieved with reasonable accuracy as the starting point to reconstruct three-dimensional surface and extract digital reading of an amputated lower limb model where the maximum percent error obtained from the computation is approximately 3.3 % for the height whilst 7.4%, 7.9% and 8.1% for the diameters at three specific heights of the objects. It can be concluded that the reconstruction of three-dimensional surface for the developed method is particularly dependent to the effects the silhouette generated where high contrast two-dimensional images contribute to higher accuracy of the silhouette extraction. The advantage of the concept presented in this thesis is that it can be done with simple experimental setup and the reconstruction of three-dimensional model neither involves expensive equipment nor require any service by an expert to handle sophisticated mechanical scanning system

The effect of prefabricated wrist-hand orthoses on performing activities of daily living

Wrist-hand orthoses (WHOs) are commonly prescribed to manage the functional deficit associated with the wrist as a result of rheumatoid changes. The common presentation of the wrist is one of flexion and radial deviation with ulnar deviation of the fingers. This wrist position Results in altered biomechanics compromising hand function during activities of daily living (ADL). A paucity of evidence exists which suggests that improvements in ADL with WHO use are very task specific. Using normal subjects, and thus in the absence of pain as a limiting factor, the impact of ten WHOs on performing five ADLs tasks was investigated. The tasks were selected to represent common grip patterns and tests were performed with and without WHOs by right-handed, females, aged 20-50 years over a ten week period. The time taken to complete each task was recorded and a wrist goniometer, elbow goniometer and a forearm torsiometer were used to measure joint motion. Results show that, although orthoses may restrict the motion required to perform a task, participants do not use the full range of motion which the orthoses permit. The altered wrist position measured may be attributable to a modified method of performing the task or to a necessary change in grip pattern, resulting in an increased time in task performance. The effect of WHO use on ADL is task specific and may initially impede function. This could have an effect on WHO compliance if there appears to be no immediate benefits. This orthotic effect may be related to restriction of wrist motion or an inability to achieve the necessary grip patterns due to the designs of the orthoses

XXII International Conference on Mechanics in Medicine and Biology - Abstracts Book

This book contain the abstracts presented the XXII ICMMB, held in Bologna in September 2022. The abstracts are divided following the sessions scheduled during the conference

Development of endovascular stent-grafts based on a nanocomposite polymer

Objective: To use a novel nanocomposite polymer based on polyhedral oligomeric silsesquioxane-poly(carbonate-urea)urethane with superior bio-mimetic properties in the development of endovascular stent-grafts. Methods: A self-expanding and sutureless aortic stent-graft was developed using nanocomposite polymer bonded to Nitinol. A new aortic model was designed for physiological assessment of stent-grafts and compliance and viscoelasticity were measured and compared with porcine aortas as control. The stent-grafts (n=4) were fatigue tested using in vitro accelerated model for 400-million cycles equivalent to 10-years in human body and compared with zero-cycled control. A curved and conformable stent-graft was developed for thoracic aorta and aortic arch. Compliance and stiffness index of the thoracic stent-graft were measured in vitro and compared to FDA-approved Gore TagTM stent-graft based on ePTFE (expanded polytetrafluoroethylene). MRI compatibility of the thoracic stent-graft was assessed by analysing signal attenuation and velocity measurements (flux) and compared to FDA-approved Medtronic ValiantTM. Results: The stent-graft had expanded diameter of 31.1 mm and was successfully collapsed to 6.5 mm to achieve delivery profile similar to current devices. The thoracic stent-graft had uniform graft thickness of 150.7±6.6 µg and conformed to the curvature of aortic arch. The new aortic model was significantly more compliant than porcine aortas with no significant difference in elastic stiffness. All the stent-grafts successfully completed accelerated pulsatile fatigue testing. Scanning electron microscopy images confirmed uniform surface topography. There was no loss of tensile strength, or compliance and no evidence of thermo-mechanical degradation in the nanocomposite polymer. Compliance of the thoracic stent-graft was significantly better compared with ePTFE stent-graft (3.3±0.61 vs. 2.3±0.95 %/mm Hg x 10-2; P=0.0003). On MRI, there was no significant signal attenuation and no significant difference in flux between Valiant and nanocomposite polymer stent-grafts (102±2.27 vs. 99.8±2.4 ml/sec; P=0.33). Conclusions: A new endovascular stent-graft based on novel design and nanocomposite polymer with properties of compliance, viscoelasticity, anti-thrombogenicity and MRI compatibility has been developed. Sutureless technology with new biocompatible material bonded to Nitinol stents proved to be robust with no separation over accelerated 10-year cycle. These stent-grafts have the potential to address poor long-term durability, thrombogenicity, and compliance mismatch associated with present generation devices and reduce reintervention rate