Comparison of multidirectional upper limb strength for non-disabled individuals and individuals with C4-C7 spinal cord injury in a seated position.

This study investigates the multidirectional upper limb strength of individuals with a C4-C7 spinal cord injury (SCI) and non-disabled individuals in a seated position by measuring multidirectional force at the hand. Current literature lacks quantitative strength data to evaluate strength requirements for people who have reduced upper limb function due to a cervical SCI. Seated multidirectional force measurements were recorded for eleven non-disabled and ten males with a C4-C7 SCI. Collected data was displayed using detailed force polar plots. The resulting plots revealed a clear difference in polar plot shape for non-disabled participants and participants with a C4-C7 SCI. Namely that SCI participants had more elliptical polar plots due to reductions in circumferential strength compared to non-disabled participants. However, the polar plots for higher SCIs tended to have an increasingly more circular shape. The results provide insight into the differences in strength between people with cervical SCI and no disability.

This paper presents seated multidirectional arm strength data from 21 SCI and non-disabled participants. Force polar plots display the applied force magnitudes and directions for reachable points which can be used to evaluate the force requirements based on SCI level. Results highlighted strength reductions for people with higher SCIs.

Quantitative functional assessment of multidirectional upper limb strength for individuals in a seated position.

Understanding the limitations that are imposed by a disability is critical to ensure engineers develop designs that can be used by people with reduced function. Current literature lacks detail on this information for people with cervical spinal cord injuries. The purpose of this study was to investigate the reliability of a novel testing methodology to quantitatively assess the multi-directional upper limb strength of individuals in a seated position. Eleven non-disabled males and 10 males with a C4-C7 spinal cord injury completed isometric strength tests on parasagittal (XY) planes using a novel method. Multidirectional (XY) force measurements were taken at discrete points within the participant's reach envelope. Isometric force trends and analysis of the coefficients of variation were used to evaluate the novel methodology. The isometric force trends were consistent in showing a reduction in strength for people with higher injury levels. Analysis of the coefficient of variation showed that the methodology produces repeatable results with an average coefficient of variation of 18% and 19% for the right and left upper limbs, respectively. These results show that the novel testing methodology is a reliable way to gather quantitative multidirectional upper limb strength data for individuals in a seated position.

Multiscale Analogue Modelling of Clinching Process to Investigate Thickness Tolerance and Tool Misalignment.

NEED-The effect of dimensional variability of sheet thickness (tolerance) and tool misalignment is poorly understood for the clinching process. Finite element analysis (FEA) is valuable but requires a lot of and is difficult to verify in this situation due to the asymmetrical geometry and nonlinear plasticity. OBJECTIVE-The objective of this work was to determine the effect of thickness tolerance, tool misalignment and sheet placement (top vs. bottom) in the clinching process, by use of analogue modelling with plasticine. METHOD-Experiments used a scaled-up punch and die, with plasticine as the analogue. Thickness tolerances were represented by sheet thicknesses of 11 and 7 mm, 12 and 8 mm, 8 and 12 mm and 13 and 9 mm for upper and lower sheets, respectively. Two types of lubricant were tested between sheets: glycerine and silicone oil. Angular variability was also introduced. Measured parameters were interlock (also called undercut) and neck thickness. Analogue results for deformation were compared with microscopy of metal clinching. FINDINGS-The results reveal that the multiscale analogue model is an efficient tool for studying the effect of dimensional deviation on a clinch joint. Thickness tolerance showed a critical relationship with interlock, namely a reduction to about half that of the nominal, for both maximum and least material conditions. Increased angular misalignment also reduced the interlock. Compared with glycerine, silicone oil tests showed reduced interlock, possibly the result of a lower coefficient of friction. ORIGINALITY-This work demonstrates the usefulness of analogue modelling for exploring process variability in clinching. The results also show that significant effects for sheet placement are ductility, lubricant (friction), thickness of samples and tool misalignment.

The Effects of Cooling and Shrinkage on the Life of Polymer 3D Printed Injection Moulds.

3D Printed Injection Moulds (3DIM), commonly used for low volume production and prototyping purposes, are known to fail abruptly and have a comparatively shorter life than conventional moulds. Investigating the underlying critical factors affecting failure may help in reducing the risk of abrupt failures and possibly prolong the 3DIM tool life. A hypothesis that the cooling time of the Injection Moulding (IM) process is a critical factor for 3DIM tool failure has been proposed. The failure hypothesis has been validated by theoretical calculations, FEA simulations and experimental investigations. Experiments were performed using two different materials for the 3DIM tool (Visijet M3-X and Digital ABS) and an engineering thermoplastic (Lexan 943-A) as the moulding material. Results showed that cooling time was a critical factor on tool life and managing the thermal loading on a 3DIM tool could lead to increased tool life. The paper identifies cooling time as the critical factor affecting 3DIM tool life and presents a cooling regime that could possibly lead to prolonged tool life.

Analysis of Raised Feature Failures on 3D Printed Injection Moulds.

BACKGROUND: Polymer-based 3D Printed Injection Mould (3DIM) inserts are used as a cost-effective method for low volume injection moulding (50-500 parts). However, abrupt failure leading to a short tool life is a common shortcoming of 3DIM. Need: The underlying causes of raised feature failures on 3DIM are not well known. Failure is commonly attributed to bending or shearing of raised features on the tool. Understanding the causes may help in delaying the failure and increasing tool life. APPROACH: Tool failure was analysed from a first-principles perspective, using pressure and temperature fields as determined by mould flow simulation. Experimental results were also obtained for two types of tool material (Visijet M3-X and Digital ABS) with polycarbonate (Lexan 943A) as the part material. FINDINGS: Results find against the idea that pin failure in 3DIM tools is caused by bending and shear failures induced by injection pressures. We also conclude that failure of raised features is not necessarily an abrupt failure as mentioned in the literature. Originality: The generally accepted explanation for the failure of raised features in 3DIM tooling is that injection pressures cause bending and shear failure. This paper disconfirms this notion on theoretical and experimental grounds.

Computational modelling and experimental validation of drug entrainment in a dry powder inhaler.

In a passive dry powder inhaler (DPI) a patient inhales to entrain drug powder. The goal of this study is to demonstrate experimentally that an Eulerian-Eulerian (EE CFD) computational fluid dynamics (CFD) method can accurately predict the entrainment of the dry powder formulation in DPIs. A CFD method that makes accurate predictions of the entrainment process can be applied in DPI design and optimization processes. Three different DPI entrainment geometries were tested. For each geometry, a transparent entrainment module was prepared. In each experiment, the chosen entrainment module was first filled with lactose powder and attached to an inhalation simulator (a computer controlled pump). The entrainment process was recorded with a high-speed camera. The resulting video footage was analysed and compared with CFD predictions. The observed distribution of powder in the entrainment compartment and the measured rate of drug entrainment were in good agreement with CFD predictions. Through a process of experimental validation, this study established the first demonstration that two-dimensional EE CFD methodology provides robust and accurate predictions of aerosol generation from DPI entrainment chambers. The findings support the wider application of EE CFD for the design optimization of DPI devices.

A personalized medicine approach to the design of dry powder inhalers: Selecting the optimal amount of bypass.

In dry powder inhalers (DPIs) the patient's inhalation manoeuvre strongly influences the release of drug. Drug release from a DPI may also be influenced by the size of any air bypass incorporated in the device. If the amount of bypass is high less air flows through the entrainment geometry and the release rate is lower. In this study we propose to reduce the intra- and inter-patient variations of drug release by controlling the amount of air bypass in a DPI. A fast computational method is proposed that can predict how much bypass is needed for a specified drug delivery rate for a particular patient. This method uses a meta-model which was constructed using multiphase computational fluid dynamic (CFD) simulations. The meta-model is applied in an optimization framework to predict the required amount of bypass needed for drug delivery that is similar to a desired target release behaviour. The meta-model was successfully validated by comparing its predictions to results from additional CFD simulations. The optimization framework has been applied to identify the optimal amount of bypass needed for fictitious sample inhalation manoeuvres in order to deliver a target powder release profile for two patients.

Optimizing the Entrainment Geometry of a Dry Powder Inhaler: Methodology and Preliminary Results.

PURPOSE: For passive dry powder inhalers (DPIs) entrainment and emission of the aerosolized drug dose depends strongly on device geometry and the patient's inhalation manoeuvre. We propose a computational method for optimizing the entrainment part of a DPI. The approach assumes that the pulmonary delivery location of aerosol can be determined by the timing of dose emission into the tidal airstream. METHODS: An optimization algorithm was used to iteratively perform computational fluid dynamic (CFD) simulations of the drug emission of a DPI. The algorithm seeks to improve performance by changing the device geometry. Objectives were to achieve drug emission that was: A) independent of inhalation manoeuvre; B) similar to a target profile. The simulations used complete inhalation flow-rate profiles generated dependent on the device resistance. The CFD solver was OpenFOAM with drug/air flow simulated by the Eulerian-Eulerian method. RESULTS: To demonstrate the method, a 2D geometry was optimized for inhalation independence (comparing two breath profiles) and an early-bolus delivery. Entrainment was both shear-driven and gas-assisted. Optimization for a delay in the bolus delivery was not possible with the chosen geometry. CONCLUSIONS: Computational optimization of a DPI geometry for most similar drug delivery has been accomplished for an example entrainment geometry.

Potential of a cyclone prototype spacer to improve in vitro dry powder delivery.

PURPOSE: Low inspiratory force in patients with lung disease is associated with poor deagglomeration and high throat deposition when using dry powder inhalers (DPIs). The potential of two reverse flow cyclone prototypes as spacers for commercial carrier-based DPIs was investigated. METHODS: Cyclohaler®, Accuhaler® and Easyhaler® were tested with and without the spacers between 30 and 60 Lmin−1. Deposition of particles in the next generation impactor and within the devices was determined by high performance liquid chromatography. RESULTS: Reduced induction port deposition of the emitted particles from the cyclones was observed due to the high retention of the drug within the spacers (e.g. salbutamol sulphate (SS): 67.89 ± 6.51% at 30 Lmin−1 in Cheng 1). Fine particle fractions of aerosol as emitted from the cyclones were substantially higher than the DPIs alone. Moreover, the aerodynamic diameters of particles emitted from the cyclones were halved compared to the DPIs alone (e.g. SS from the Cyclohaler® at 4 kPa: 1.08 ± 0.05 µm vs. 3.00 ± 0.12 µm, with and without Cheng 2, respectively) and unaltered with increased flow rates. CONCLUSION: This work has shown the potential of employing a cyclone spacer for commercial carrier-based DPIs to improve inhaled drug delivery.