Biomechanical properties of abdominal organs in vivo and postmortem under compression loads

Accurate knowledge of biomechanical characteristics of tissues is essential for developing realistic computer-based surgical simulators incorporating haptic feedback, as well as for the design of surgical robots and tools. As simulation technologies continue to be capable of modeling more complex behavior, an in vivo tissue property database is needed. Most past and current biomechanical research is focused on soft and hard anatomical structures that are subject to physiological loading, testing the organs in situ. Internal organs are different in that respect since they are not subject to extensive loads as part of their regular physiological function. However, during surgery, a different set of loading conditions are imposed on these organs as a result of the interaction with the surgical tools. Following previous research studying the kinematics and dynamics of tool/tissue interaction in real surgical procedures, the focus of the current study was to obtain the structural biomechanical properties (engineering stress-strain and stress relaxation) of seven abdominal organs, including bladder, gallbladder, large and small intestines, liver, spleen, and stomach, using a porcine animal model. The organs were tested in vivo, in situ, and ex corpus (the latter two conditions being postmortem) under cyclical and step strain compressions using a motorized endoscopic grasper and a universal-testing machine. The tissues were tested with the same loading conditions commonly applied by surgeons during minimally invasive surgical procedures. Phenomenological models were developed for the various organs, testing conditions, and experimental devices. A property database-unique to the literature-has been created that contains the average elastic and relaxation model parameters measured for these tissues in vivo and postmortem. The results quantitatively indicate the significant differences between tissue properties measured in vivo and postmortem. A quantitative understanding of how the unconditioned tissue properties and model parameters are influenced by time postmortem and loading condition has been obtained. The results provide the material property foundations for developing science-based haptic surgical simulators, as well as surgical tools for manual and robotic systems.     

Finite element modeling of the left atrium to facilitate the design of an endoscopic atrial retractor

With the worldwide prevalence of cardiovascular diseases, much attention has been focused on simulating the characteristics of the human heart to better understand and treat cardiac disorders. The purpose of this study is to build a finite element model of the left atrium (LA) that incorporates detailed anatomical features and realistic material characteristics to investigate the interaction of heart tissue and surgical instruments. This model is used to facilitate the design of an endoscopically deployable atrial retractor for use in minimally invasive, robotically assisted mitral valve repair. Magnetic resonance imaging (MRI) scans of a pressurized explanted porcine heart were taken to provide a 3D solid model of the heart geometry, while uniaxial tensile tests of porcine left atrial tissue were conducted to obtain realistic material properties for noncontractile cardiac tissue. A finite element model of the LA was constructed using ANSYS Release 9.0 software and the MRI data. The Mooney-Rivlin hyperelastic material model was chosen to characterize the passive left atrial tissue; material constants were derived from tensile test data. Finite element analysis (FEA) models of a CardioVations Port Access retractor and a prototype endoscopic retractor were constructed to simulate interaction between each instrument and the LA. These contact simulations were used to compare the quality of retraction between the two instruments and to optimize the design of the prototype retractor. Model accuracy was verified by comparing simulated cardiac wall deflections to those measured by MRI. FEA simulations revealed that peak forces of approximately 2.85 N and 2.46 N were required to retract the LA using the Port Access and prototype retractors, respectively. These forces varied nonlinearly with retractor blade displacement. Dilation of the atrial walls and rigid body motion of the chamber were approximately the same for both retractors. Finite element analysis is shown to be an effective tool for analyzing instrument/tissue interactions and for designing surgical instruments. The benefits of this approach to medical device design are significant when compared to the alternatives: constructing prototypes and evaluating them via animal or clinical trials.     

Application of Novel Design Bone Grafting for Treatment of Segmental Acetabular Rim Defects During Revision Total Hip Arthroplasty

The study aimed to develop efficient techniques with different novel graft structures to enhance the treatment of acetabular bone deficiency.The inhomogeneous material properties Finite Element Analysis(FEA)model was reconstructed according to computed tomography images based on a healthy patient without any peri-acetabular bony defect according to the Ameri-can Academy of Orthopedic Surgeons(AAOS).The FEA model of acetabular bone deficiency was performed to simulate and evaluate the mechanical performances of the grafts in different geometric structures,with the use of fixation implants(screws),along with the stress distribution and the relative micromotion of graft models.The stress distribution mainly con-centrated on the region of contact of the screws and superolateral bone.Among the different structures,the mortise-tenone structure provided better relative micromotion,with suitable biomechanical property even without the use of screws.The novel grafting structures could provide sufficient biomechanical stability and bone remodeling,and the mortise-tenone structure is the optimal treatment option for acetabulum reconstruction.     

Mechanical reconfiguration mediates swallowing and rejection in Aplysia californica

Muscular hydrostats, such as tongues, trunks or tentacles, have fewer constraints on their degrees of freedom than musculoskeletal systems, so changes in a structure’s shape may alter the positions and lengths of other components (i.e., induce mechanical reconfiguration). We studied mechanical reconfiguration during rejection and swallowing in the marine mollusk Aplysia californica. During rejection, inedible material is pushed out of an animal’s buccal cavity. The grasper (radula/odontophore) closes on inedible material, and then a posterior muscle, I2, pushes the grasper toward the jaws (protracts it). After the material is released, an anterior muscle complex (the I1/I3/jaw complex) pushes the grasper toward the esophagus (retracts it). During swallowing, the grasper is protracted open, and then retracts closed, pulling in food. Grasper closure changes its shape. Magnetic resonance images show that grasper closure lengthens I2. A kinetic model quantified the changes in the ability of I2 and I1/I3 to exert force as grasper shape changed. Grasper closure increases I2’s ability to protract during rejection, and increases I1/I3’s ability to retract during swallowing. Motor neurons controlling radular closure may therefore affect the behavioral outputs of I2’s and I1/I3’s motor neurons. Thus, motor neurons may modulate the outputs of other motor neurons through mechanical reconfiguration.Valerie A. Novakovic and Gregory P. Sutton contributed equally to the paper.     

Stress distribution in cylindrical and conical implants under rotational micromovement with different boundary conditions and bone properties: 3-D FEA

Factors related to micromovements at bone-implant interface have been studied because they are considered adverse to osseointegration. Simplifications are commonly observed in these FEA evaluations. The aim of this study was to clarify the influence of FEA parameters (boundary conditions and bone properties) on the stress distribution in peri-implant bone tissue when micromovements are simulated in implants with different geometries. Three-dimensional models of an anterior section of the jaw with cylindrical or conical titanium implants (4.1 mm in width and 11 mm in length) were created. Micromovement (50, 150, or 250 μm) was applied to the implant. The FEA parameters studied were linear vs. non-linear analyses, isotropic vs. orthogonal anisotropic bone, friction coefficient (0.3) vs. frictionless bone-implant contact. Data from von Mises, shear, maximum, and minimum principal stresses in the peri-implant bone tissue were compared. Linear analyses presented a relevant increase of the stress values, regardless of the bone properties. Frictionless contact reduced the stress values in non-linear analysis. Isotropic bone presented lower stress than orthogonal anisotropic. Conical implants behave better, in regard to compressive stresses (minimum principal), than cylindrical ones, except for nonlinear analyses when micromovement of 150 and 250 μm were simulated. The stress values raised as the micromovement amplitude increased. Non-linear analysis, presence of frictional contact and orthogonal anisotropic bone, evaluated through maximum and minimum principal stress should be used as FEA parameters for implant-micromovement studies.     

The effects of plaque morphology and material properties on peak cap stress in human coronary arteries

Heart attacks are often caused by rupture of caps of atherosclerotic plaques in coronary arteries. Cap rupture occurs when cap stress exceeds cap strength. We investigated the effects of plaque morphology and material properties on cap stress. Histological data from 77 coronary lesions were obtained and segmented. In these patient-specific cross sections, peak cap stresses were computed by using finite element analyses. The finite element analyses were 2D, assumed isotropic material behavior, and ignored residual stresses. To represent the wide spread in material properties, we applied soft and stiff material models for the intima. Measures of geometric plaque features for all lesions were determined and their relations to peak cap stress were examined using regression analyses. Patient-specific geometrical plaque features greatly influence peak cap stresses. Especially, local irregularities in lumen and necrotic core shape as well as a thin intima layer near the shoulder of the plaque induce local stress maxima. For stiff models, cap stress increased with decreasing cap thickness and increasing lumen radius (R = 0.79). For soft models, this relationship changed: increasing lumen radius and increasing lumen curvature were associated with increased cap stress (R = 0.66). The results of this study imply that not only accurate assessment of plaque geometry, but also of intima properties is essential for cap stress analyses in atherosclerotic plaques in human coronary arteries.     

Influence of different mucosal resiliency and denture reline on stress distribution in peri-implant bone tissue during osseointegration. A three-dimensional finite element analysis

doi: 10.1111/j.1741‐2358.2011.00569.x Influence of different mucosal resiliency and denture reline on stress distribution in peri‐implant bone tissue during osseointegration. A three‐dimensional finite element analysis Objective: The aim of this study was to evaluate the influence of mucosal properties and relining material on the stress distribution in peri‐implant bone tissue during masticatory function with a conventional complete denture during the healing period through finite element analysis. Materials and Methods: Three‐dimensional models of a severely resorbed mandible with two recently placed implants in the anterior region were created and divided into the following situations: (i) conventional complete denture and (ii) relined denture with soft lining material. The mucosal tissue properties were divided into soft, resilient and hard. The models were exported to mechanical simulation software; two simulations were carried out with a load at the lower right canine (35 N) and the lower right first molar (50 N). Data were qualitatively evaluated using Maximum Principal Stress, in MPa, given by the software. Results: All models showed stress concentrations in the cortical bone corresponding to the cervical part of the implant. The mucosal properties influenced the stress in peri‐implant bone tissue showing a different performance according to the denture base material. The simulations with relined dentures showed lower values of stress concentration than conventional ones. Conclusions: It seems that the mucosal properties and denture reline have a high influence on the stress distribution in the peri‐implant bone during the healing period.     

A geometric approach to study the contact mechanisms in the patellofemoral joint of normal versus patellofemoral pain syndrome subjects

The biomechanics of the patellofemoral (PF) joint is complex in nature, and the aetiology of such manifestations of PF instability as patellofemoral pain syndrome (PFPS) is still unclear. At this point, the particular factors affecting PFPS have not yet been determined. This study has two objectives: (1) The first is to develop an alternative geometric method using a three-dimensional (3D) registration technique and linear mapping to investigate the PF joint contact stress using an indirect measure: the depth of virtual penetration (PD) of the patellar cartilage surface into the femoral cartilage surface. (2) The second is to develop 3D PF joint models using the finite element analysis (FEA) to quantify in vivo cartilage contact stress and to compare the peak contact stress location obtained from the FE models with the location of the maximum PD. Magnetic resonance images of healthy and PFPS subjects at knee flexion angles of 15°, 30° and 45° during isometric loading have been used to develop the geometric models. The results obtained from both approaches demonstrated that the subjects with PFPS show higher PD and contact stresses than the normal subjects. Maximum stress and PD increase with flexion angle, and occur on the lateral side in healthy and on the medial side in PFPS subjects. It has been concluded that the alternative geometric method is reliable in addition to being computationally efficient compared with FEA, and has the potential to assess the mechanics of PFPS with an accuracy similar to the FEA.     

Sensitivity of tissue differentiation and bone healing predictions to tissue properties

Computational models are employed as tools to investigate possible mechano-regulation pathways for tissue differentiation and bone healing. However, current models do not account for the uncertainty in input parameters, and often include assumptions about parameter values that are not yet established. The aim was to clarify the importance of the assumed tissue material properties in a computational model of tissue differentiation during bone healing. An established mechano-biological model was employed together with a statistical approach. The model included an adaptive 2D finite element model of a fractured long bone. Four outcome criteria were quantified: (1) ability to predict sequential healing events, (2) amount of bone formation at specific time points, (3) total time until healing, and (4) mechanical stability at specific time points. Statistical analysis based on fractional factorial designs first involved a screening experiment to identify the most significant tissue material properties. These seven properties were studied further with response surface methodology in a three-level Box–Behnken design. Generally, the sequential events were not significantly influenced by any properties, whereas rate-dependent outcome criteria and mechanical stability were significantly influenced by Young's modulus and permeability. Poisson's ratio and porosity had minor effects. The amount of bone formation at early, mid and late phases of healing, the time until complete healing and the mechanical stability were all mostly dependent on three material properties; permeability of granulation tissue, Young's modulus of cartilage and permeability of immature bone. The consistency between effects of the most influential parameters was high. To increase accuracy and predictive capacity of computational models of bone healing, the most influential tissue mechanical properties should be accurately quantified.     

Influence of anisotropic bone properties on the biomechanical behavior of the acetabular cup implant: a multiscale finite element study

Although the biomechanical behavior of the acetabular cup (AC) implant is determinant for the surgical success, it remains difficult to be assessed due to the multiscale and anisotropic nature of bone tissue. The aim of the present study was to investigate the influence of the anisotropic properties of peri-implant trabecular bone tissue on the biomechanical behavior of the AC implant at the macroscopic scale. Thirteen bovine trabecular bone samples were imaged using micro-computed tomography (μCT) with a resolution of 18 μm. The anisotropic biomechanical properties of each sample were determined at the scale of the centimeter based on a dedicated method using asymptotic homogenization. The material properties obtained with this multiscale approach were used as input data in a 3D finite element model to simulate the macroscopic mechanical behavior of the AC implant under different loading conditions. The largest stress and strain magnitudes were found around the equatorial rim and in the polar area of the AC implant. All macroscopic stiffness quantities were significantly correlated (R² > 0.85, p < 6.5 e-6) with BV/TV (bone volume/total volume). Moreover, the maximum value of the von Mises stress field was significantly correlated with BV/TV (R² > 0.61, p < 1.6 e-3) and was always found at the bone-implant interface. However, the mean value of the microscopic stress (at the scale of the trabeculae) decrease as a function of BV/TV for vertical and torsional loading and do not depend on BV/TV for horizontal loading. These results highlight the importance of the anisotropic properties of bone tissue.     

Experimental and computational analysis of micromotions of an uncemented femoral knee implant using elastic and plastic bone material models

It is essential to calculate micromotions at the bone-implant interface of an uncemented femoral total knee replacement (TKR) using a reliable computational model. In the current study, experimental measurements of micromotions were compared with predicted micromotions by Finite Element Analysis (FEA) using two bone material models: linear elastic and post-yield material behavior, while an actual range of interference fit was simulated. The primary aim was to investigate whether a plasticity model is essential in order to calculate realistic micromotions. Additionally, experimental bone damage at the interface was compared with the FEA simulated range.TKR surgical cuts were applied to five cadaveric femora and micro- and clinical CT- scans of these un-implanted specimens were made to extract geometrical and material properties, respectively. Micromotions at the interface were measured using digital image correlation. Cadaver-specific FEA models were created based on the experimental set-up. The average experimental micromotion of all specimens was 53.1 ± 42.3 µm (mean ± standard deviation (SD)), which was significantly higher than the micromotions predicted by both models, using either the plastic or elastic material model (26.5 ± 23.9 µm and 10.1 ± 10.1 µm, respectively; p-value < 0.001 for both material models). The difference between the two material models was also significant (p-value < 0.001). The predicted damage had a magnitude and distribution which was comparable to the experimental bone damage. We conclude that, although the plastic model could not fully predict the micro motions, it is more suitable for pre-clinical assessment of a press-fit TKR implant than using an elastic bone model.     

Modelling stress in the feeding apparatus of seahorses and pipefishes (Teleostei: Syngnathidae)

Seahorses and pipefishes are extremely fast suction feeders, and the fast strikes probably result in large and rapid pressure drops in the buccal cavity. These rapid drops in pressure imply heavy mechanical loading on the cranium; hence, the feeding apparatus is thought to experience high levels of stress. We used finite element analysis (FEA) to investigate where stress accumulates under strong suction pressure, and whether there is a difference in craniofacial stress distribution between long‐ and short‐snouted species. The expectation was that high stress levels would occur at the articulations and in the cartilaginous regions of the cranium, and that, given the same pressure, the skulls of long‐snouted species would exhibit lower stress levels than the skulls of short‐snouted species, as an evolutionary increase in snout length might have made these species structurally better adapted to deal with high suction pressures. The results partially support the first hypothesis: except for Dunckerocampus dactyliophorus, all models show peak stress concentrations at the articulations and cartilaginous regions. However, no simple relationship between snout length and the magnitudes of stress predicted by the FEA was found. In an attempt to explain this lack of a relationship, the methodology was evaluated by assessing the effect of hyoid position and model construction on the stress distribution. © 2011 The Linnean Society of London, Biological Journal of the Linnean Society, 2011, 104 , 680–691.     

Gross Damage Accumulation in Frozen Rabbit Liver Due to Mechanical Stress at Cryogenic Temperatures

The second phase of a pilot study dealing with the mechanical response of frozen biological tissues to external compressive load is presented. This stage deals with histological observations of the damage accompanying mechanically induced permanent deformation in frozen rabbit liver. No significant gross histological damage was observed in the liver samples due to either processing the tissue in the frozen state, due to slow cooling of the liver tissues down to −20°C, or due to rapid cooling of the samples down to −196°C. No histological changes were observed in tissue samples that were loaded within the elastic regime, that is, below the yield strength of the material. Therefore, it is concluded that histological changes due to mechanical stresses are associated with plastic (permanent) deformations. Histological observations indicate that linear cracks which appear to have no preferred orientation develop due to mechanical stress beyond the yield strength of the frozen tissue. These cracks accumulate until final failure of the frozen tissue, when the tissue sample collapses to rubble. Based on histological observations and concepts from solid mechanics, an interaction between crack formation and irregularities in the frozen medium is suggested. Significant sources for such irregularities, in an homogeneous tissue such as the liver, are blood vessels and bile ducts. These irregularities may either initiate crack formation or, on the other hand, may also arrest propagating cracks.     

The development of a material model and wheel–tissue interaction for simulating wheeled surgical robot mobility

In vivo surgical robot wheel and tissue interaction was studied using a nonlinear finite element model. A liver material model, derived from laboratory experiments, was implemented as a viscoelastic material. A finite element simulation of this laboratory test confirmed the accuracy of the liver material model. This material model was then used as the tissue model to study wheel performance. A helical wheel moving on the liver model was used to replicate laboratory experiments that included several different slip ratios and applied loads. The drawbar force produced in this model showed good agreement with the physical tests. These results have provided the baseline for studying how changes in wheel geometry, such as tread height, tread spacing and wheel diameter, affect drawbar force and ultimately wheel performance. These results will be used in future surgical robot wheel designs.     

A machine learning approach to investigate the relationship between shape features and numerically predicted risk of ascending aortic aneurysm

Geometric features of the aorta are linked to patient risk of rupture in the clinical decision to electively repair an ascending aortic aneurysm (AsAA). Previous approaches have focused on relationship between intuitive geometric features (e.g., diameter and curvature) and wall stress. This work investigates the feasibility of a machine learning approach to establish the linkages between shape features and FEA-predicted AsAA rupture risk, and it may serve as a faster surrogate for FEA associated with long simulation time and numerical convergence issues. This method consists of four main steps: (1) constructing a statistical shape model (SSM) from clinical 3D CT images of AsAA patients; (2) generating a dataset of representative aneurysm shapes and obtaining FEA-predicted risk scores defined as systolic pressure divided by rupture pressure (rupture is determined by a threshold criterion); (3) establishing relationship between shape features and risk by using classifiers and regressors; and (4) evaluating such relationship in cross-validation. The results show that SSM parameters can be used as strong shape features to make predictions of risk scores consistent with FEA, which lead to an average risk classification accuracy of 95.58% by using support vector machine and an average regression error of 0.0332 by using support vector regression, while intuitive geometric features have relatively weak performance. Compared to FEA, this machine learning approach is magnitudes faster. In our future studies, material properties and inhomogeneous thickness will be incorporated into the models and learning algorithms, which may lead to a practical system for clinical applications.     

Biomechanical properties of the pelvic floor muscles of continent and incontinent women using an inverse finite element analysis

Pelvic disorders can be associated with changes in the biomechanical properties in the muscle, ligaments and/or connective tissue form fascia and ligaments. In this sense, the study of their mechanical behavior is important to understand the structure and function of these biological soft tissues. The aim of this study was to establish the biomechanical properties of the pelvic floor muscles of continent and incontinent women, using an inverse finite element analysis (FEA). The numerical models, including the pubovisceral muscle and pelvic bones were built from magnetic resonance (MR) images acquired at rest. The numerical simulation of Valsalva maneuver was based on the finite element method and the material constants were determined for different constitutive models (Neo-Hookean, Mooney-Rivlin and Yeoh) using an iterative process. The material constants (MPa) for Neo-Hookean (c₁) were 0.039 ± 0.022 and 0.024 ± 0.004 for continent vs. incontinent women. For Mooney-Rivlin (c₁) the values obtained were 0.026 ± 0.010 vs. 0.016 ± 0.003, and for Yeoh (c₁) the values obtained were 0.031 ± 0.023 vs. 0.016 ± 0.002, (p < 0.05). Muscle displacements obtained in the numerical simulations of Valsalva maneuver were compared with the muscle displacements obtained through additional dynamic MRI. Incontinent women presented a higher antero-posterior displacement than the continent women. The results were also similar between MRI and numerical simulations (40.27% vs. 42.17% for Neo-Hookean, 39.87% for Mooney-Rivlin and 41.61% for Yeoh). Using an inverse FEA coupled with MR images allowed to obtain the in vivo biomechanical properties of the pelvic floor muscles, leading to a relationship between them for the continent and incontinent women in a non-invasive manner.     

A novel approach to in vivo mitral valve stress analysis

Three-dimensional (3-D) echocardiography allows the generation of anatomically correct and time-resolved geometric mitral valve (MV) models. However, as imaged in vivo, the MV assumes its systolic geometric configuration only when loaded. Customarily, finite element analysis (FEA) is used to predict material stress and strain fields rendered by applying a load on an initially unloaded model. Therefore, this study endeavors to provide a framework for the application of in vivo MV geometry and FEA to MV physiology, pathophysiology, and surgical repair. We hypothesize that in vivo MV geometry can be reasonably used as a surrogate for the unloaded valve in computational (FEA) simulations, yielding reasonable and meaningful stress and strain magnitudes and distributions. Three experiments were undertaken to demonstrate that the MV leaflets are relatively nondeformed during systolic loading: 1) leaflet strain in vivo was measured using sonomicrometry in an ovine model, 2) hybrid models of normal human MVs as constructed using transesophageal real-time 3-D echocardiography (rt-3DE) were repeatedly loaded using FEA, and 3) serial rt-3DE images of normal human MVs were used to construct models at end diastole and end isovolumic contraction to detect any deformation during isovolumic contraction. The average linear strain associated with isovolumic contraction was 0.02 ± 0.01, measured in vivo with sonomicrometry. Repeated loading of the hybrid normal human MV demonstrated little change in stress or geometry: peak von Mises stress changed by <4% at all locations on the anterior and posterior leaflets. Finally, the in vivo human MV deformed minimally during isovolumic contraction, as measured by the mean absolute difference calculated over the surfaces of both leaflets between serial MV models: 0.53 ± 0.19 mm. FEA modeling of MV models derived from in vivo high-resolution truly 3-D imaging is reasonable and useful for stress prediction in MV pathologies and repairs.     

Connecting incremental shear modulus and Poisson's ratio of lung tissue with morphology and rheology of microstructure

The width and curvature of the collagen and elastin fiber bundles in the human pulmonary interalveolar septa and alveolar mouths are measured. The data, together with the known mechanical properties of collagen and elastin fibers, are used to derive the incremental elastic moduli of the lung tissue. The constitutive equation for small incremental stress and strain superposed on a homeostatic inflated lung is linear and isotropic, and characterized by two material constants.     

Effect of surgical stress on nuclear and mitochondrial DNA from healthy sections of colon and rectum of patients with colorectal cancer

Surgical resection at any location in the body leads to stress response with cellular and subcellular change, leading to tissue damage. The intestine is extremely sensitive to surgical stress with consequent postoperative complications. It has been suggested that the increase of reactive oxygen species as subcellular changes plays an important role in this process. This article focuses on the effect of surgical stress on nuclear and mitochondrial DNA from healthy sections of colon and rectum of patients with colorectal cancer. Mitochondrial DNA copy number, mitochondrial common deletion and nuclear and mitochondrial 8-oxo-2′-deoxyguanosine content were measured. Both the colon and rectal tissue were significantly damaged either at the nuclear or mitochondrial level. In particular, mitochondrial DNA was more damaged in rectum than in colon. The present investigation found an association between surgical stress and nuclear and mitochondrial DNA damage, suggesting that surgery may generate an increase in free radicals, which trigger a cascade of molecular changes, including alterations in DNA.     

Finite element analysis of heel pad with insoles

To design optimal insoles for reduction of pedal tissue trauma, experimental measurements and computational analyses were performed. To characterize the mechanical properties of the tissues, indentation tests were performed. Pedal tissue geometry and morphology were obtained from magnetic resonance scan of the subject's foot. Axisymmetrical finite element models of the heel of the foot were created with 1/4 of body weight load applied. The stress, strain and strain energy density (SED) fields produced in the pedal tissues were computed. The effects of various insole designs and materials on the resulting stress, strain, and SED in the soft pedal tissues were analyzed. The results showed: (a) Flat insoles made of soft material provide some reductions in the maximum stress, strain and SED produced in the pedal tissues. These maximum values were computed near the calcaneus. (b) Flat insoles, with conical/cylindrical reliefs, provided more reductions in these maximum values than without reliefs. (c) Custom insoles, contoured to match the pedal geometry provide most reductions in the maximum stress, strain and SED. Also note, the maximum stress, strain and SED computed near the calcaneus were found to be about 10 times the corresponding peak values computed on the skin surface. Based on the FEA analysis, it can be concluded that changing insole design and using different material can significantly redistribute the stress/strain inside the heel pad as well as on the skin surface.