Bone Plates Runout Prediction Through Tensile Strength and Geometric Properties for Regulatory Mechanical Testing

Mechanical tests on bone plates are mandatory for regulatory purposes and, typically, the ASTM F382 standard is used, which involves a four-point bending test setup to evaluate the cyclic bending fatigue performance of the bone plate. These test campaigns require a considerable financial outlay and long execution times; therefore, an accurate prediction of experimental outcomes can reduce test runtime with beneficial cost cuts for manufacturers. Hence, an analytical framework is here proposed for the direct estimation of the maximum bending moment of a bone plate under fatigue loading, to guide the identification of the runout load for regulatory testing. Eleven bone plates awaiting certification were subjected to a comprehensive testing campaign following ASTM F382 protocols to evaluate their static and fatigue bending properties. An analytical prediction of the maximum bending moment was subsequently implemented based on ultimate strength and plate geometry. The experimental loads obtained from fatigue testing were then used to verify the prediction accuracy of the analytical approach. Results showed promising predictive ability, with R2 coefficients above 0.95 in the runout condition, with potential impact in reducing the experimental tests needed for the CE marking of bone plates

The Maximal Pore Size of Hydrophobic Microporous Membranes Does Not Fully Characterize the Resistance to Plasma Breakthrough of Membrane Devices for Extracorporeal Blood Oxygenation

open4Extracorporeal membrane oxygenation (ECMO) in blood-outside devices equipped with hydrophobic membranes has become routine treatment of respiratory or cardiac failure. In spite of membrane hydrophobicity, significant amounts of plasma water may form in the gas compartment during treatment, an event termed plasma water breakthrough. When this occurs, plasma water occludes some gas pathways and ultimately cripples the oxygenator gas exchange capacity requiring its substitution. This causes patient hemodilution and increases the activation of the patient's immune system. On these grounds, the resistance to plasma water breakthrough is regarded as an important feature of ECMO devices. Many possible events may explain the occurrence of plasma breakthrough. In spite of this, the resistance to plasma breakthrough of ECMO devices is commercially characterized only with respect to the membrane maximal pore size, evaluated by the bubble pressure method or by SEM analysis of membrane surfaces. The discrepancy between the complexity of the events causing plasma breakthrough in ECMO devices (hence determining their resistance to plasma breakthrough), and that claimed commercially has caused legal suits on the occasion of the purchase of large stocks of ECMO devices by large hospitals or regional institutions. The main aim of this study was to identify some factors that contribute to determining the resistance to plasma breakthrough of ECMO devices, as a means to minimize litigations triggered by an improper definition of the requirements of a clinically efficient ECMO device. The results obtained show that: membrane resistance to breakthrough should be related to the size of the pores inside the membrane wall rather than at its surface; membranes with similar nominal maximal pore size may exhibit pores with significantly different size distribution; membrane pore size distribution rather than the maximal pore size determines membrane resistance to breakthrough; the presence of surfactants in the patient's blood (e.g., lipids, alcohol, etc.) may significantly modify the intrinsic membrane resistance to breakthrough, more so the higher the surfactant concentration. We conclude that the requirements of ECMO devices in terms of resistance to plasma breakthrough ought to account for all these factors and not rely only on membrane maximal pore size.openFragomeni Gionata, Terzini Mara, Comite Antonio, Catapano GerardoFragomeni, Gionata; Terzini, Mara; Comite, Antonio; Catapano, Gerard

Mechanical Behavior of Elastic Self-Locking Nails for Intramedullary Fracture Fixation: A Numerical Analysis of Innovative Nail Designs

Intramedullary nails constitute a viable alternative to extramedullary fixation devices; their use is growing in recent years, especially with reference to self-locking nails. Different designs are available, and it is not trivial to foresee the respective in vivo performances and to provide clinical indications in relation to the type of bone and fracture. In this work a numerical methodology was set up and validated in order to compare the mechanical behavior of two new nailing device concepts with one already used in clinic. In detail, three different nails were studied: (1) the Marchetti-Vicenzi's nail (MV1), (2) a revised concept of this device (MV2), and (3) a new Terzini-Putame's nail (TP) concept. Firstly, the mechanical behavior of the MV1 device was assessed through experimental loading tests employing a 3D-printed component aimed at reproducing the bone geometry inside which the device is implanted. In the next step, the respective numerical model was created, based on a multibody approach including flexible parts, and this model was validated against the previously obtained experimental results. Finally, numerical models of the MV2 and TP concepts were implemented and compared with the MV1 nail, focusing the attention on the response of all devices to compression, tension, bending, and torsion. A stability index (SI) was defined to quantify the mechanical stability provided to the nail-bone assembly by the elastic self-locking mechanism for the various loading conditions. In addition, results in terms of nail-bone assembly stiffness, computed from force/moment vs. displacement/rotation curves, were presented and discussed. Findings revealed that numerical models were able to provide good estimates of load vs. displacement curves. The TP nail concept proved to be able to generate a significantly higher SI (27 N for MV1 vs. 380 N for TP) and a greater stiffening action (up to a stiffness difference for bending load that ranges from 370 Nmm/° for MV1 to 1,532 Nmm/° for TP) than the other two devices which showed similar performances. On the whole, a demonstration was given of information which can be obtained from numerical simulations of expandable fixation devices

Finite Element Modeling Application in Forensic Practice: A Periprosthetic Femoral Fracture Case Study

The incidence of periprosthetic fractures has rapidly increased in the last two decades and has been the cause of a large number of revision surgeries and permanent physical disability for many patients, as well as a significant socioeconomic burden for many nations. This research deals with a periprosthetic femur fracture real event, occurred following a total hip arthroplasty and treated with one of the most widespread internal fixation methods: the implant of a periprosthetic femur plate system. A Finite Element analysis was performed to investigate the implanted femur plate break after a short follow-up and to understand the plate break causes. Such events are currently object of forensic debate as more and more often hospitals, surgeons, and medical device manufacturers are denounced by patients to whom similar events occur. In this work, different load situations acting on the femur during daily and incidental activities were simulated, in order to validate the correct behavior of the plate, according to the intended use recommended by the manufacturer. The analysis demonstrates that the plate failure can occur in situations of unconventional loading such as that caused by stumbling and in presence of incomplete bone healing

Stochastic PCA-based bone models from inverse transform sampling: Proof of concept for mandibles and proximal femurs

Principal components analysis is a powerful technique which can be used to reduce data dimensionality. With reference to three-dimensional bone shape models, it can be used to generate an unlimited number of models, defined by thousands of nodes, from a limited (less than twenty) number of scalars. The full procedure has been here described in detail and tested. Two databases were used as input data: the first database comprised 40 mandibles, while the second one comprised 98 proximal femurs. The “average shape” and principal components that were required to cover at least 90% of the whole variance were identified for both bones, as well as the statistical distributions of the respective principal components weights. Fifteen principal components sufficed to describe the mandibular shape, while nine components sufficed to describe the proximal femur morphology. A routine has been set up to generate any number of mandible or proximal femur geometries, according to the actual statistical shape distributions. The set-up procedure can be generalized to any bone shape given a sufficiently large database of the respective 3D shapes

In Silico Meta-Analysis of Boundary Conditions for Experimental Tests on the Lumbar Spine

The study of the spine range of motion under given external load has been the object of many studies in literature, finalised to a better understanding of the spine biomechanics, its physiology, eventual pathologic conditions and possible rehabilitation strategies. However, the huge amount of experimental work performed so far cannot be straightforwardly analysed due to significant differences among loading set-ups. This work performs a meta-analysis of various boundary conditions in literature, focusing on the flexion/extension behaviour of the lumbar spine. The comparison among range of motions is performed virtually through a validated multibody model. Results clearly illustrated the effect of various boundary conditions which can be met in literature, so justifying differences of biomechanical behaviours reported by authors implementing different set-up: for example, a higher value of the follower load can indeed result in a stiffer behaviour; the application of force producing spurious moments results in an apparently more deformable behaviour, however the respective effects change at various segments along the spine due to its natural curvature. These outcomes are reported not only in qualitative, but also in quantitative terms. The numerical approach here followed to perform the meta-analysis is original and it proved to be effective thanks to the bypass of the natural variability among specimens which might completely or partially hinder the effect of some boundary conditions. In addition, it can provide very complete information since the behaviour of each functional spinal unit can be recorded. On the whole, the work provided an extensive review of lumbar spine loading in flexion/extension

Design of a loading system for cyclic test on sutured organs

The design of loading systems to test biologic samples is often challenging, due to shape variability and non-conventional loading set-ups. In addition to this, large economic investments would not be justified since the loading set up is usually designed for one single or for a limited range of applications. The object of this work is the development of a loading set-up finalised to on-site testing of sutures whose main function is applying a localised tensile load. The main challenges of this design process can be so summarized: • Applying cyclic tensile loads on the suture wire, mimicking the physiologic condition where both suture anchorage points have a certain compliance; • Designing a loading system as versatile as possible, in order to be able to accommodate organs with different geometries and sizes; • Keeping low both the complexity and costs of realization.All these considerations and the design calculi are here reported in detail, discussing the novelty of the system, and its main advantages

Biomechanical role and motion contribution of ligaments and bony constraints in the elbow stability: A preliminary study

In flexion-extension motion, the interaction of several ligaments and bones characterizes the elbow joint stability. The aim of this preliminary study was to quantify the relative motion of ulna respect to humerus in two human elbow specimens and to investigate the constraints role for maintaining the joint stability in different dissections condition. Two clusters of 4 markers were fixed respectively to ulna and humerus, and their trajectory was recorded by a motion capture system during orthopedic maneuver. Considering the medial ulnar collateral posterior bundle (pMUCL) and the coronoid, two dissection sequences were executed. The orthopedic maneuver of compression, pronation and varus force was repeated at 30°, 60°, 90° flexion for the functional investigation of constraints. Ulna deflection was compared to a baseline flexion condition. Respect to intact elbow, the coronoid osteotomy influences the elbow stability at 90° (deflection=11.49±17.39 mm), while small differences occur at 30° and 60°, due to ligaments constraint. The contemporary pMUCL dissection and coronoid osteotomy causes elbow instability, with large deflection at 30° (deflection=34.40±9.10 mm), 60° (deflection=45.41±18.47 mm) and 90° (deflection=52.16±21.92 mm). Surgeons may consider the pMUCL reconstruction in case of unfixable coronoid fracture

Data from cyclic tensile tests on sutured organs to evaluate creep behaviour, distraction, and residual thread strength

A number of applications in the surgical practice are based on tensile sutures aimed to keep soft tissues in place and compensate the exit of neuropathies, prolapses or general tissue relaxation. Long-term behaviour of these constructs need to be carefully examined in order to define tensile forces to be applied and to compare different suture anchors. Data here reported refer to equine laryngoplasties, where a suitable loading system has been designed in order to be able to test sutures in-sito, applying known forces (“On-site testing of sutured organs: an experimental set up to cyclically tighten sutures” (Pascoletti et al., 2020 [1])). The loading protocol was made of two steps: in the first step, 3000 loading cycles have been performed; in the following step, a tensile test up to rupture was performed. Cyclic load/displacement curves allow evaluating suture distraction, as a consequence of suture migration and/or soft tissues creep. Tensile curves allow evaluating the residual thread strength and its ultimate displacement. These data can provide a detailed insight of long-term suture behaviour and can be a reference to compare different threads and/or suture anchors

Feature-Based Modelling of Laryngoscope Blades for Customized Applications

AbstractLaryngoscopes are used as diagnostic devices for throat inspection or as an aid to intubation. Their blade must be geometrically compatible with patients' anatomy to provide a good view to doctors with minimal discomfort to patients. For this reason, this paper was aimed to investigate the feasibility of producing customized blades.The customizable blade model was developed following a feature-based approach with eight morphological parameters. The thickness of such a blade was determined through numerical simulations of ISO certification tests, where the finite element mesh was obtained by morphing a 'standard' mesh.The following procedure was applied: the model was built from the selected parameters; the blade was tested in silico; finally, the blade was produced by additive manufacturing with an innovative biodegradable material (Hemp Bio-Plastic® -HBP-) claimed to feature superior mechanical properties. The procedure evidenced that the mechanical properties of current biodegradable materials are unsuitable for the application unless the certification norm is revised, as it is expected