In Vitro Proof of Concept of a First-Generation Growth-Accommodating Heart Valved Conduit for Pediatric Use.

Currently available heart valve prostheses have no growth potential, requiring children with heart valve diseases to endure multiple valve replacement surgeries with compounding risks. This study demonstrates the in vitro proof of concept of a biostable polymeric trileaflet valved conduit designed for surgical implantation and subsequent expansion via transcatheter balloon dilation to accommodate the growth of pediatric patients and delay or avoid repeated open-heart surgeries. The valved conduit is formed via dip molding using a polydimethylsiloxane-based polyurethane, a biocompatible material shown here to be capable of permanent stretching under mechanical loading. The valve leaflets are designed with an increased coaptation area to preserve valve competence at expanded diameters. Four 22 mm diameter valved conduits are tested in vitro for hydrodynamics, balloon dilated to new permanent diameters of 23.26 ± 0.38 mm, and then tested again. Upon further dilation, two valved conduits sustain leaflet tears, while the two surviving devices reach final diameters of 24.38 ± 0.19 mm. After each successful dilation, the valved conduits show increased effective orifice areas and decreased transvalvular pressure differentials while maintaining low regurgitation. These results demonstrate concept feasibility and motivate further development of a polymeric balloon-expandable device to replace valves in children and avoid reoperations.

Design optimization of a cardiovascular stent with application to a balloon expandable prosthetic heart valve.

A cardiovascular stent design optimization method is proposed with application to a pediatric balloon-expandable prosthetic heart valve. The prosthetic valved conduit may be expanded to a larger permanent diameter in vivo via subsequent transcatheter balloon dilation procedures. While multiple expandable prosthetic heart valves are currently at different stages of development, this work is focused on one particular design in which a stent is situated inside of an expandable polymeric valved conduit. Since the valve and conduit must be joined with a robust manufacturing technique, a polymeric glue layer is inserted between the two, which results in radial retraction of the valved region after expansion. Design of an appropriate stent is proposed to counteract this phenomenon and maintain the desired permanent diameter throughout the device after a single non-compliant balloon dilation procedure. The finite element method is used to compute performance metrics related to the permanent expansion diameter and required radial force. Additionally, failure due not only to high cycle fatigue but also due to ductile fracture is incorporated into the design study through the use of an existing ductile fracture criterion for metals. Surrogate models are constructed with the results of the high fidelity simulations and are subsequently used to numerically obtain a set of Pareto-optimal stent designs. Finally, a single design is identified by optimizing a normalized aggregate objective function with equal weighting of all design objectives.

Mechanical considerations for polymeric heart valve development: Biomechanics, materials, design and manufacturing.

The native human heart valve leaflet contains a layered microstructure comprising a hierarchical arrangement of collagen, elastin, proteoglycans and various cell types. Here, we review the various experimental methods that have been employed to probe this intricate microstructure and which attempt to elucidate the mechanisms that govern the leaflet's mechanical properties. These methods include uniaxial, biaxial, and flexural tests, coupled with microstructural characterization techniques such as small angle X-ray scattering (SAXS), small angle light scattering (SALS), and polarized light microscopy. These experiments have revealed complex elastic and viscoelastic mechanisms that are highly directional and dependent upon loading conditions and biochemistry. Of all engineering materials, polymers and polymer-based composites are best able to mimic the tissue-level mechanical behavior of the native leaflet. This similarity to native tissue permits the fabrication of polymeric valves with physiological flow patterns, reducing the risk of thrombosis compared to mechanical valves and in some cases surpassing the in vivo durability of bioprosthetic valves. Earlier work on polymeric valves simply assumed the mechanical properties of the polymer material to be linear elastic, while more recent studies have considered the full hyperelastic stress-strain response. These material models have been incorporated into computational models for the optimization of valve geometry, with the goal of minimizing internal stresses and improving durability. The latter portion of this review recounts these developments in polymeric heart valves, with a focus on mechanical testing of polymers, valve geometry, and manufacturing methods.

A novel phase field method for modeling the fracture of long bones.

A proximal humerus fracture is an injury to the shoulder joint that necessitates medical attention. While it is one of the most common fracture injuries impacting the elder community and those who suffer from traumatic falls or forceful collisions, there are almost no validated computational methods that can accurately model these fractures. This could be due to the complex, inhomogeneous bone microstructure, complex geometries, and the limitations of current fracture mechanics methods. In this paper, we develop a novel phase field method to investigate the proximal humerus fracture. To model the fracture in the inhomogeneous domain, we propose a power-law relationship between bone mineral density and critical energy release rate. The method is validated by an in vitro experiment, in which a human humerus is constrained on both ends while subjected to compressive loads on its head, in the longitudinal direction, that lead to fracture at the anatomical neck. CT scans are employed to acquire the bone geometry and material parameters, from which detailed finite element meshes with inhomogeneous Young modulus distributions are generated. The numerical method, implemented in a high performance computing environment, is used to quantitatively predict the complex 3D brittle fracture of the bone and is shown to be in good agreement with experimental observations. Furthermore, our findings show that the damage is initiated in the trabecular bone-head and propagates outward towards the bone cortex. We conclude that the proposed phase field method is a promising approach to model bone fracture.

Probabilistic Model Updating for Sizing of Hole-Edge Crack Using Fiber Bragg Grating Sensors and the High-Order Extended Finite Element Method.

This paper presents a novel framework for probabilistic crack size quantification using fiber Bragg grating (FBG) sensors. The key idea is to use a high-order extended finite element method (XFEM) together with a transfer (T)-matrix method to analyze the reflection intensity spectra of FBG sensors, for various crack sizes. Compared with the standard FEM, the XFEM offers two superior capabilities: (i) a more accurate representation of fields in the vicinity of the crack tip singularity and (ii) alleviation of the need for costly re-meshing as the crack size changes. Apart from the classical four-term asymptotic enrichment functions in XFEM, we also propose to incorporate higher-order functions, aiming to further improve the accuracy of strain fields upon which the reflection intensity spectra are based. The wavelength of the reflection intensity spectra is extracted as a damage sensitive quantity, and a baseline model with five parameters is established to quantify its correlation with the crack size. In order to test the feasibility of the predictive model, we design FBG sensor-based experiments to detect fatigue crack growth in structures. Furthermore, a Bayesian method is proposed to update the parameters of the baseline model using only a few available experimental data points (wavelength versus crack size) measured by one of the FBG sensors and an optical microscope, respectively. Given the remaining data points of wavelengths, even measured by FBG sensors at different positions, the updated model is shown to give crack size predictions that match well with the experimental observations.