A functional approach towards the design, development, and test of an affordable dynamic prosthetic foot.

Humanitarian actors involved in physical rehabilitation, such as the International Committee of the Red Cross (ICRC), usually provide their beneficiaries with lower-limb prostheses comprising Solid Ankle Cushion Heel (SACH) feet as these are considered appropriate (price, durability, low profile to fit a majority of patients, appearance) and reliable for all ambulation levels. However, individuals in low-resource settings having higher ambulation abilities would greatly benefit from dynamic prosthetic feet with improved biomechanics and energy storage and release. Some attempts tried to address this increasing need (e.g. Niagara Foot) but most products proposed by large manufacturers often remain unaffordable and unsuitable to the context of low-resource settings. The design requirements and a price target were defined in partnership with the ICRC according to their initial assessment and used as a starting point for the development process and related technological choices. Numerical simulation and modeling were used to work on the design and to determine the required materials properties (mechanical, chemical, wear), and a cost modeling tool was used to select suitable materials and relevant processing routes (price vs. performance). A prosthetic foot comprising an internal keel made of composite materials, a filling foam, and a cosmetic shell with a foot shape was developed. Manufacturing processes meeting the cost criteria were identified and prototype feet were produced accordingly. These were successfully tested using a compression testing system before gait analyses were performed in the laboratory with non-amputees wearing testing boots. After validation in laboratory conditions, the prototype foot was tested in the field (Vietnam) with 11 trans-tibial unilateral amputees, who showed an increased mobility compared with the SACH foot. The collaboration of different research fields led to the development of a prosthetic foot which met the technical requirements determined by the ICRC's specific needs in its field of operation. The materials and selected production processes led to a manufacturing cost of less than 100 USD per part.

Numerical prediction of peri-implant bone adaptation: Comparison of mechanical stimuli and sensitivity to modeling parameters.

Long term durability of osseointegrated implants depends on bone adaptation to stress and strain occurring in proximity of the prosthesis. Mechanical overloading, as well as disuse, may reduce the stability of implants by provoking bone resorption. However, an appropriate mechanical environment can improve integration. Several studies have focused on the definition of numerical methods to predict bone peri-implant adaptation to the mechanical environment. Existing adaptation models differ notably in the type of mechanical variable adopted as stimulus but also in the bounds and shape of the adaptation rate equation. However, a general comparison of the different approaches on a common benchmark case is still missing and general guidelines to determine physically sound parameters still need to be developed. This current work addresses these themes in two steps. Firstly, the histograms of effective stress, strain and strain energy density are compared for rat tibiae in physiological (homeostatic) conditions. According to the Mechanostat, the ideal stimulus should present a clearly defined, position and tissue invariant lazy zone in homeostatic conditions. Our results highlight that only the octahedral shear strain presents this characteristic and can thus be considered the optimal choice for implementation of a continuum level bone adaptation model. Secondly, critical modeling parameters such as lazy zone bounds, type of rate equation and bone overloading response are classified depending on their influence on the numerical predictions of bone adaptation. Guidelines are proposed to establish the dominant model parameters based on experimental and simulated data.

Peri-implant bone adaptations to overloading in rat tibiae: experimental investigations and numerical predictions.

OBJECTIVES: (i) To assess the effects of mechanical overloading on implant integration in rat tibiae, and (ii) to numerically predict peri-implant bone adaptation. MATERIALS AND METHODS: Transcutaneous titanium implants were simultaneously placed into both tibiae of rats (n = 40). After 2 weeks of integration, the implants of the right tibiae were stimulated daily for 4 weeks with loads up to 5N (corresponding to peak equivalent strains of 3300 ± 500 µÎµ). The effects of stimulation were assessed by ex vivo mechanical tests and quantification of bone mineral density (BMD) in selected regions of interests (ROIs). Specimen-specific finite element models were generated and processed through an iterative algorithm to mimic bone adaptation. RESULTS: Bilateral implantation provoked an unstable integration that worsened when mild (2-4N) external loads were applied. In contrast, a stimulation at 5N tended to "counterbalance" the harmful effects of daily activity and, if applied to well-integrated specimens, significantly augmented the implants' resistance to failure (force: +73% P < 0.01, displacement: +50% P < 0.01 and energy: +153% P < 0.01). Specimen-specific numerical predictions were in close agreement with the experimental findings. Both local and overall BMD variations, as well as the implants' lateral stability, were predicted with small errors (0.14 gHA/cm3 and 0.64%, respectively). CONCLUSIONS: The rats' daily activity detrimentally affects implant integration. Conversely, external stimulations of large magnitudes counterbalance this effect and definitively improve integration. These changes can be predicted using the proposed numerical approach.

Influence of gait loads on implant integration in rat tibiae: experimental and numerical analysis.

Implanted rat bones play a key role in studies involving fracture healing, bone diseases or drugs delivery among other themes. In most of these studies the implants integration also depends on the animal daily activity and musculoskeletal loads, which affect the implants mechanical environment. However, the tissue adaption to the physiological loads is often filtered through control groups or not inspected. This work aims to investigate experimentally and numerically the effects of the daily activity on the integration of implants inserted in the rat tibia, and to establish a physiological loading condition to analyse the peri-implant bone stresses during gait. Two titanium implants, single and double cortex crossing, are inserted in the rat tibia. The animals are caged under standard conditions and divided in three groups undergoing progressive integration periods. The results highlight a time-dependent increase of bone samples with significant cortical bone loss. The phenomenon is analysed through specimen-specific Finite Element models involving purpose-built musculoskeletal loads. Different boundary conditions replicating the post-surgery bone-implant interaction are adopted. The effects of the gait loads on the implants integration are quantified and agree with the results of the experiments. The observed cortical bone loss can be considered as a transient state of integration due to bone disuse atrophy, initially triggered by a loss of bone-implant adhesion and subsequently by a cyclic opening of the interface.

A toolbox of oligopeptide-modified polymers for tailored elastomers.

Biomaterials are constructed from limited sets of building blocks but exhibit extraordinary and versatile properties, because hierarchical structure formation lets them employ identical supramolecular motifs for different purposes. Here we exert a similar degree of structural control in synthetic supramolecular elastomers and thus tailor them for a broad range of thermomechanical properties. We show that oligopeptide-terminated polymers selectively self-assemble into small aggregates or nanofibrils, depending on the length of the oligopeptides. This process is self-sorting if differently long oligopeptides are combined so that different nanostructures coexist in bulk mixtures. Blends of polymers with oligopeptides matching in length furnish reinforced elastomers that exhibit shear moduli one order of magnitude higher than the parent polymers. By contrast, novel interpenetrating supramolecular networks that display excellent vibration damping properties are obtained from blends comprising non-matching oligopeptides or unmodified polymers. Hence, blends of oligopeptide-modified polymers constitute a toolbox for tailored elastomers with versatile properties.

Factors affecting subject-specific finite element models of implant-fitted rat bone specimens: critical analysis of a technical protocol.

The authors propose a protocol to derive finite element (FE) models from micro computer tomography scans of implanted rat bone. A semi-automatic procedure allows segmenting the images using specimen-specific bone mineral density (BMD) thresholds. An open-source FE model generator processes the segmented images to a quality tetrahedral mesh. The material properties assigned to each element are integrated from the BMD field. Piecewise, threshold-dependent density-elasticity relationships are implemented to limit the effects of metal artefacts. A detailed sensitivity study highlights the coherence of the generated models and quantifies the influence of the modelling parameters on the results. Two applications of the protocol are proposed. The stiffness of bare and implanted rat tibiae specimens is predicted by simulating three-point bending and inter-implant displacement, respectively. Results are compared with experimental tests. The mean value and the variability between the specimens are well captured in both tests.

External mechanical microstimuli modulate the osseointegration of titanium implants in rat tibiae.

PURPOSE: To assess the effect of external mechanical microstimuli of controlled magnitude on the microarchitecture of the peri-implant bone beds in rat tibiae. MATERIALS AND METHODS: Tibiae of forty rats were fitted with two transcutaneous titanium cylinders. After healing, the implants were loaded to 1 to 3 N, five days/week for four weeks. These force levels translated into intraosseous strains of 700 ± 200 µÎµ, 1400 ± 400 µÎµ, and 2100 ± 600 µÎµ. After sacrifice, the implants' pullout strength was assessed. Second, the bone's microarchitecture was analyzed by microcomputed tomography (µCT) in three discrete regions of interest (ROIs). Third, the effect of loading on bone material properties was determined by nanoindentation. RESULTS: The trabecular BV/TV significantly increased in an ROI of 0.98 mm away from the test implant in the 1 N versus the 3 N group with an opposite trend for cortical thickness. Pull-out strength significantly increased in the 2 N relatively to the nonstimulated group. Higher values of E-modulus and hardness were observed in the trabecular bone of the 2 N group. CONCLUSION: The in vivo mechanical loading of implants induces load-dependent modifications in bone microarchitecture and bone material properties in rat tibiae. In pull-out strength measurements, implant osseointegration was maximized at 2 N (1400 ± 400 µÎµ).

Implementation of the "loaded implant" model in the rat using a miniaturized setup--description of the method and first results.

OBJECTIVE: To miniaturize the "loaded implant" model to permit its application to small rodents. In this model, two titanium implants are placed 8 mm apart with their heads protruding from the skin and are forced together by a dedicated actuator. To assess the effect of (i) the post-implantation healing period and the duration of stimulation and (ii) the intratissular strain level on the microtomographical bone parameters BV/TV, Tb.N., Tb.Th. and BIC. MATERIALS AND METHODS: Implants, 1 × 8 mm, were machined, inserted into the tibiae of rats and activated. A total of 123 animals were used. In series 1, the implants were left to heal for 2/4 weeks and then loaded to generate intratissular strains of 1125 ± 5% µÎµ for 4/8 weeks. Series 2 had their implants loaded to 750, 1500 and 2250 ± 5% µÎµ, respectively. RESULTS: Bone to implant contact increased upon loading. In series 1, no difference was observed regarding the duration of healing or the stimulation period. In series 2, at 750 µÎµ, the bone parameters did not differ from baseline. At 1500 µÎµ, all four parameters increased. At 2250 µÎµ, three of four parameters decreased relative to 1500 µÎµ. CONCLUSIONS: (i) The loaded implant model can be miniaturized to the millimeter range; (ii) in the present model, implant activation beyond 4 weeks did not affect the bone parameters; (iii) mechanical stimulation increased bone to implant contact by up to 20%; (iv) the results obtained are consistent with the concept of an anabolic effect from 750 to 1500 µÎµ and deleterious effects at strains in the 2250 µÎµ range; and (v) strains at 2250 µÎµ did not lead to implant dis-integration.

Poroviscoelastic characterization of particle-reinforced gelatin gels using indentation and homogenization.

Hydrogels are promising materials for bioengineering applications, and are good model materials for the study of hydrated biological tissues. As these materials often have a structural function, the measurement of their mechanical properties is of fundamental importance. In the present study gelatin gels reinforced with ceramic microspheres are produced and their poroviscoelastic response in spherical indentation is studied. The constitutive responses of unreinforced gels are determined using inverse finite element modeling in combination with analytical estimates of material parameters. The behavior of composite gels is assessed by both analytical and numerical homogenization. The results of the identification of the constitutive parameters of unreinforced gels show that it is possible to obtain representative poroviscoelastic parameters by spherical indentation without the need for additional mechanical tests. The agreement between experimental results on composite gelatin and the predictions from homogenization modeling show that the adopted modeling tools are capable of providing estimates of the poroviscoelastic response of particle-reinforced hydrogels.

Hydro-mechanical coupling in the periodontal ligament: a porohyperelastic finite element model.

Harmonic tension-compression tests at 0.1, 0.5 and 1 Hz on hydrated bovine periodontal ligament (PDL) were numerically simulated. The process was modeled by finite elements (FE) within the framework of poromechanics, with the objective of isolating the contributions of the solid- and fluid phases. The solid matrix was modeled as a porous hyperelastic material (hyperfoam) through which the incompressible fluid filling the pores flowed in accordance with the Darcy's law. The hydro-mechanical coupling between the porous solid matrix and the fluid phase circulating through it provided an apparent time-dependent response to the PDL, whose rate of deformation depended on the permeability of the porous solid with respect to the interstitial fluid. Since the PDL was subjected to significant deformations, finite strains were taken into account and an exponential dependence of PDL permeability on void ratio - and therefore on the deformation state - was assumed. PDL constitutive parameters were identified by fitting the simulated response to the experimental data for the tests at 1 Hz. The values thus obtained were then used to simulate the tests at 0.1 and 0.5 Hz. The results of the present simulation demonstrate that a porohyperelastic model with variable permeability is able to describe the two main aspects of the PDL's response: (1) the dependency on strain-rate-the saturated material can develop volumetric strains by only exchanging fluid and (2) the asymmetry between tension and compression, which is due to the effect of both the permeability and the elastic properties on deformation.

Three-dimensional morphometry of strained bovine periodontal ligament using synchrotron radiation-based tomography.

The periodontal ligament (PDL) is a highly vascularized soft connective tissue. Previous studies suggest that the viscous component of the mechanical response may be explained by the deformation-induced collapse and expansion of internal voids (i.e. chiefly blood vessels) interacting with liquids (i.e. blood and interstitial fluids) flowing through the pores. In the present work we propose a methodology by means of which the morphology of the PDL vascular plexus can be monitored at different levels of compressive and tensile strains. To this end, 4-mm-diameter cylindrical specimens, comprising layers of bone, PDL and dentin covered by cementum, were strained at stretch ratios ranging from lambda = 0.6 to lambda = 1.4 and scanned using synchrotron radiation-based computer tomography. It was concluded that: (1) the PDL vascular network is layered in two distinct planes of blood vessels (BVs): an inner layer (close to the tooth), in which the BVs run in apico-coronal direction, and an outer layer (close to the alveolar bone), in which the BVs distribution is more diffuse; (2) during tension and compression, the porosity tissue is kept fairly constant; (3) mechanical straining induces important changes in BV diameters, possibly modifying the permeability of the PDL and thus contributing to the viscous component of the viscoelastic response observed under compressive forces.

The role of the fluid phase in the viscous response of bovine periodontal ligament.

The mechanical response of the periodontal ligament (PDL) is complex. This tissue responds as a hyperelastic solid when pulled in tension while demonstrating a viscous behavior under compression. This intricacy is reflected in the tissue's morphology, which comprises fibers, glycosaminoglycans, a jagged interface with the surrounding porous bone and an extensive vascular network. In the present study we offer an analysis of the viscous behavior and the interplay between the fibrous matrix and its fluid phase. Cylindrical specimens comprising layers of dentine, PDL and bone were extracted from bovine first molars and affixed to a tensile-compressive loading machine. The viscous properties of the tissue were analyzed (1) by subjecting the specimens to sinusoidal displacements at various frequencies and (2) by cycling the specimens in 'fully saturated' and in 'partially dry' conditions. Both modes assisted in determining the contribution of the fluid phase to the mechanical response. It was concluded that: (1) PDL showed pseudo-plastic viscous features for cyclic compressive loading, (2) these viscous features essentially resulted from interactions between the porous matrix and unbound fluid content of the tissue. Removing the liquid from the PDL largely eliminates its damping effect in compression.

Bone reactions to controlled loading of endosseous implants: a pilot study.

OBJECTIVES: To validate an experimental setup designed to apply load onto bone tissue using osseointegrated implants in a rabbit model. Specifically, (1) to design an apparatus capable of generating controlled forces, (2) to assess implant placement, maintenance and loading and (3) to evaluate outcome variables using three radiological methods. MATERIAL AND METHODS: New Zealand White rabbits were used. Two dental implants were inserted 15-18 mm apart in the animals' tibiae. After 3 months of healing, the implants were loaded normal to their long axes using a pneumatically activated device. A 15 min load regimen at 1 Hz was applied 5 days per week. Every week the applied load was increased by 5 N up to week 8 and by 10 N up to 100 N by week 14. Groups of animals (n=3) were sacrificed at load levels 25, 50 and 100 N. One unloaded controlateral implant in each group provided the baseline data. The rabbits were computer tomography (CT) scanned and radiographed using conventional frames every 4-5 weeks. After sacrifice, a volume of interest (VOI) located in the inter-implant zones and a VOI set as a ring surrounding the distal implant were analyzed using micro computer tomography (microCT). RESULTS: A variety of osseous responses was observed, ranging from minor alterations to significant increases in porosity and lamelling of the cortical layer. microCT data of the inter-implant VOI demonstrated an initial increase in total volume (upto 50 N) followed by stabilization. Concomitantly, bone volumetric density first decreased and then augmented until the end of the experiment. This phenomenon was not observed in the peri-implant VOI, for which volumetric density augmented from the beginning to the end of the experiment. CONCLUSIONS: 1. In future trials the loading devices must be constructed so as to sustain heavy cyclic loads over prolonged periods. 2. When properly handled, rabbits are cooperative animals in this application. In a third of the sites, signs of inflammation were observed. 3. In the inter-implant VOI, the cortical bone tended to react in two phases: first, as an increase in porosity and lamelling and second, as an augmentation of bone volumetric density. The peri-implant VOI adapted only by augmenting volumetric density.